TWI233804B - Herbal pharmaceutical compositions for treating immunological disorders - Google Patents

Abstract

The present invention provides a pharmaceutical composition which comprises water extracts of Tuber Ophiopogon, Tuber Pinelliae, Radix Glycyrrhizae, and Radix Pancis Quinquefoli, and 50% alcohol extraction of Herba Tridacis procumbentis. The pharmaceutical compositions are especially effective in treating patients with immunological disorders, such as asthma, atopic eczema, atopic dermatitis, allergic rhinitis and rheumatoid arthritis.

Description

1233804 Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs A7 ___ B7 V. Description of Invention () Related Application This application is US Application No. 09/73 5,5 36 (applied on December 14, 2000, and in 2002 On May 7, part of the serial applications that were approved to be published as US 63 83 525B1) are hereby incorporated herein. The US application number 09 / 735,53 6 has also been filed in the Republic of China, with the case number 90 1 28 893, which was filed on November 20, 2001. FIELD OF THE INVENTION The present invention relates to novel herbal compositions and their applications in the treatment of immune disorders, especially diseases mediated by IgE, including, but not limited to, allergic rhinitis, allergic conjunctivitis, allergic asthma, allergies Atopic eczema, atopic dermatitis, food allergies, Ig E syndrome, and rheumatoid arthritis. The novel herbal composition contains aqueous extracts of Ophiopogon, Pinellia ternata, licorice, pneumonia, and American ginseng. The present invention also relates to a method for producing herbal compositions and therapies for these pharmaceutical compositions. BACKGROUND OF THE INVENTION Antigen-induced (especially allergen-induced) immune disorders, such as asthma, are one of the serious health conditions known in the world. Allergies affect more than 20% of the world's population in various forms. Statistics in recent years show that the age of onset of allergy-related immune disorders has gradually decreased, and more children and adolescents have already developed immune disorders caused by allergies. For example, the prevalence of infantile asthma in Taiwan increased from 1.3% in 1974 to 5.07% in 1985 and 5.8% in 1991. Allergic (please read the precautions on the back before filling this page) This paper size applies the Chinese National Standard (CNS) A4 specification (210X 297 mm) -4-1233804 Printed by the Consumers ’Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs A7 ___ _B7 V. Description of the invention (J rhinitis has increased from 7.84% in 1985 to 20.6% in 1991. In addition, atopic eczema has increased from 1.74 in 1974. 43%, from 1.23% in 1985 to 3.84% in 1991. It is generally believed that early-onset allergic immune disorders may be caused by environmental pollution. Respiratory allergies are caused by an immunoglobulin E (IgE) A kind of reaction [Refer to Brinker published in the journal Yi Yiran Therapeutic Journal ... (J. Naturopathic Medieine; (1 9 9 3) 4: 6 4 — 6 8)] There are two types of allergic reactions caused by respiratory allergies: the most direct Allergic reactions include: allergic rhinitis (straw fever) and allergic (exogenous) bronchial asthma. Allergic rhinitis is caused by the combination of antigen / Ig E on allergic mast cells and basophils, causing cyclic monophosphate replacement (C A Μ P) decreases, and releases eosinophil chemokine (ECF) and Caused by weaver. Histamine binds to the Hi receptor, which can increase vasodilation, increase microvascular permeability, and cause smooth muscle contraction, causing nasal congestion, runny nose, sneezing, and itchy eyes. Allergic asthma is Another immune response induced by I g E, metabolites of histamine, bradykinin, arachidonic acid, including leukotrienes (ie, slow allergic reactions) released by mast cells Reactants) and vasoconstrictors such as Thromboxanes / Prostagandins. Platelet activating factor released by some white blood cells is another factor that induces asthma. According to this one In some cases, histamine is released after c A MP decreases, and then acts on Hi receptors, causing bronchoconstriction. Parasympathetic reflex effect, and half of the prostaglandins are caused by allergic reactions in bronchus. National Standard (CNS) A4 specification (210X297 feet) (Please read the notes on the back before filling this page) Intellectual Property Bureau of the Ministry of Economic Affairs Printed by the Industrial and Consumer Cooperatives 1238804 A7 ______ B7 V. Explanation of the invention (j Reason for contraction. The percentage of patients and the severity of the disease have been rising, but the current methods of treating allergies still rely on experience and attempts, not relying on scientific methods. Currently, most patients are treated with drugs aimed at controlling the symptoms of the release of the cells from the cells. Although some drugs appear effective in a short time and have few side effects, the long-term effects and side effects are still unknown. For example, long-term oral preparations, such as steroid therapy (used to treat asthma), are now known to have side effects such as delayed growth, osteoporosis, and inhibition of the adrenal cortex. Chinese herbal medicines and medicinal compositions have been known for improving the function of the immune system and treating chronic immune disorders. For example: Hamasaki et al. And other articles published in J. Ethnopharmacology (199.7) 5 0: 1 2 3-1 31 1 show Chinese herbal medicine Xinpi soup (mysterious soup) ), Can inhibit Ig E-induced leukotriene synthesis in rat basophilic leukemia cells. Mystery Soup is a freeze-dried Chinese herbal medicine made from seven Chinese herbal medicines, namely ephedra, almond, magnolia, tangerine peel, licorice, bupleurum, and perilla leaf. Mystery soup is useful for children to breathe. Toda et al. (Toda et al.) In J. Ethnopharmacology (1988) 24: 303-309, published Chai Pu Tang, confirmed that it can inhibit the release of histamine from mast cells in the peritoneum of mice . Chai Pu Tang contains ten kinds of Chinese herbal medicines, namely Bupleurum, Pinellia, Poria, Cotinus coggygria, jujube, ginseng, Magnolia, Su Ye and ginger. Li et al. In Immunopharmacology (1 9 9) '4 3: 1 1 — 2 1 refers to the paper size applicable to the Chinese National Standard (CNS) A4 specification (210X297 mm) ) (Please read the precautions on the back before filling this page) 1233804 A7 B7 V. Description of the invention (j (Please read the precautions on the back before filling out this page) Debuzhong Yiqi Decoction can restore stress-induced immunosuppression .Buzhong Yiqi Decoction contains ten flavors of Chinese herbal medicines, namely ginseng, atractylodes, astragalus, angelica, jujube, Chenpi, Bupleurum, Zhigancao, ginger and Cimicifuga. Zhou et al. (Zou et al.) In Chinese and Western Medicine Journal (19 9 6): 5 2 9-5 3 2 pointed out that Wenyangtong complexing agent can treat cold asthma. It can improve lung ventilation function, regulate peripheral blood and lymphatic sympathetic yS-receptors, and Decrease the concentration of 5-hydroxytryptamine in blood tincture. Wenyangtong complexing agent contains twelve Chinese herbal medicines, namely red ginseng, edible tablets, epimedium, dried ginger, scutellaria baicalensis, angelica, Ephedra, Polygala, Morus alba, Raw Stone Bone, Schisandra, and Licorice. Also on the Internet (www.herb.com.tw) Shemai asparagus soup is composed of six Chinese herbal medicines: asparagus, pinellia, stem rice, jujube, ginseng, licorice. It can be used to treat bronchitis and bronchial asthma. It is printed by the Consumers' Cooperative of the Intellectual Property Bureau of the Ministry of Qi and printed on Chinese herbs. The quality control of herbal medicine is very important, because the growth conditions, harvest season and processing methods of herbal medicine will affect its contents and effective ingredients. If any of these important conditions or factors, such as origin, harvest season, and processing methods The effectiveness of Chinese herbal medicines will be different at different times. So far, there are no reports showing that there are any scientific methods to monitor the quality of Chinese herbal medicines. The present invention provides novel and non-toxic Chinese herbal medicines, which are mainly made from herbs in Taiwan and China The use of these Chinese herbal medicines is unprecedented in literature reports. These prescriptions are particularly effective in treating patients with immune disorders, especially Ig E-induced diseases. The pharmaceutical composition of the present invention is effective for interleukin 4 (IL-1 4) Down regulation and inhibition of I g E have special effects. In addition, the present invention uses thin layer chromatography (T LC) and high paper size are applicable to Chinese National Standard (CNS) A4 specification (210X297 mm) 1233804 A7 B7 V. Description of the invention (g high performance liquid chromatography (ΗPLC), and 4 Kanan 丨 Shishen > Analysis of fingerprints of each flavor of Jelle in Zhongfeng Formula to effectively control its quality. ^^ η 土 一 κ 人 仏, 口 口 口 口, and ensure that the herbs contained in each flavor of Yue are consistent and reproducible. (Please read the notes on the back before filling this page) Brief description of the invention The present invention provides a pharmaceutical composition that is effective for immune disorders, including 'but not limited to' allergic rhinitis, allergic conjunctivitis, allergic asthma Atopic eczema, atopic dermatitis, food allergies, g e syndrome and rheumatoid arthritis. The pharmaceutical composition in this case contains aqueous extracts of Ophiopogon, Pinellia ternata, Licorice, American Ginseng and Pneumonia. Ophiopogon, pinellia, licorice and ginseng are best extracted with water, pneumonia is best extracted with alcohol, and 50% alcohol is better. The best weight ratio is Ophiopogon sylvestris: Pinellia: Glycyrrhiza: American Ginseng: Pneumonia = 3: 2: 1: 1: 1. The employee cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs prints Ophiopogon, Pinellia ternata, Licorice, Each aqueous extract of American ginseng and pneumonia is best filtered and concentrated separately. The solid content of the concentrate of O. asparagus accounts for about 20-30% by weight of O. asparagus crude, preferably about 25 %. The solid content in the concentrate is the concentrate from which moisture is removed. Taking asparagus as an example, its concentrate contains a considerable amount of water (that is, about 58% of the asparagus concentrate is water), and the rest The concentration of herbal concentrates is about the same as that of the concentrate (that is, there is not much water). Pinellia concentrate accounts for about 15-25% of Pinellia crude drug, preferably about 20% by weight. Licorice concentrate accounts for About 15-25% of licorice shengle, preferably about 20% by weight. American ginseng concentrate is about 19-29% of ginseng shengsheng, preferably about 24.3% by weight. Pneumonia paper Standards are applicable to China National Standard (CNS) A4 specifications (210X297 mm) -8- 1233804 A7 __ ___B7 V. Description of the invention (g The grass concentrate accounts for about 5-10% of the pneumoniae crude drug, preferably about 7.8% by weight. (Please read the precautions on the back before filling this page.) Except for asparagus, the pinellia and licorice 'Ginseng and early pneumonia concentrates are made into granules respectively. Glycyrrhiza granules account for about 16-26% of the licorice crude drug, preferably about 21% by weight. Ginseng particles account for about 27-37% of the ginseng crude drug. It is about 32% by weight. The pneumonia granules account for about 37-47%, preferably about 42% by weight of the pneumonia herbal medicine. The present invention also provides a method for manufacturing the pharmaceutical composition. Asparagus, Pinellia ternata, licorice, American ginseng, and pneumonia. O. asparagus, Pinellia ternata, licorice, and American ginseng are decoction extracted with water. Pneumonia spp. Is made with alcohol, preferably 50% alcohol, with hot reflux. Extraction. The extracted extracts are separately filtered to remove the drug residue, and each filtrate is concentrated under reduced pressure at a temperature of 55 ° C and a pressure of 30 Torr. Each concentrate is added with an excipient. It is best to use corn starch to make a paste-like extract. Granulated at a temperature of about 105t and a discharge temperature of about 76-77 ° C. The granules of Pinellia ternata, licorice, American ginseng, and pneumonia are mixed with the concentrate of Ophiopogon to form a granular mixture for filling In the capsule. Printed by the W Industrial Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs. The ratio of the extract (volume) to the crude drug (weight) is about 20: 1. The water extraction time is preferably about 30 minutes. The alcohol extraction time is about 30. Although the pharmaceutical composition of the present invention contains the same five kinds of herbal medicine mixture as the pharmaceutical composition of the parent application, the difference of the present invention is that it contains an aqueous extract of these herbs; while the pharmaceutical composition of the parent application contains The main thing is the powder of these herbs (though Macedonian also uses aqueous extracts). In terms of action and efficacy, the composition in this case is superior to the composition in the mother case. It may be that during the extraction process, the paper size is applicable to China National Standard (CNS) 8 4 (210X297 mm) -9-1233804 Α7 Β7 Economy Printed by the Ministry of Intellectual Property Bureau's Consumer Cooperatives 5. The invention description (9 reasons for the release of the effective ingredients. The diagram is a simple illustration. Figure 1 is a map of Mai Mendong's PLC PLC. The graphics of the entire map are using the PL C. Analysis Method 1 (As described below), measured at a wavelength of 2 1 4 nm. There are two peaks in the figure, 6115-1 and 6115-2, with retention times of 1 1 · 5 minutes and 13 minutes respectively. These two peaks can be used to Identification of Ophiophyllum. Figure 2 is the PLC spectrum of P. ternata. It has two chemical index components, namely adenine and guanosine. The P. PLC analysis method 2 was used to measure 2 6 0 nm. Wavelength measurement. The retention time of adenine is 14.8 minutes, and the retention time of guanosine is 17 minutes. Figure 3 is the HP LC spectrum of glycyrrhiza. There is a chemical index component, glycyrrhizin is analyzed by HPLC Method 1, measured at 250 nm, with a retention time of 4 6 _ 4 points. Figure 4 is the HP LC spectrum of American ginseng. There is a chemical index component, ginsenoside Rbi (ginsenoside Rbi), which is determined by HPLC analysis method 3 at a wavelength of 230 nm. Its retention time is 37. 5 minutes Figure 5 is the Η PLC spectrum of P. pneumoniae. There are 4 unique peaks 'F Υ — 1 to F Υ — 4 measured by the Η PLC analysis method 2' at a wavelength of 2 50 nm. The residence time is F Υ 1 = 2 8 points; FY— 2 = 31 · 6 points; FY — 3 2 · 33 · 5 points; FY — 4 = 1 8. 3 points. This paper scale applies Chinese national standard rate ( CNS) Α4 specifications (210X297 mm) _ 1〇- (Please read the precautions on the back before filling this page)

、 1T -line _ · 1233804 A7 Printed by B7 of Consumer Cooperative of Intellectual Property Bureau of the Ministry of Economic Affairs V. Invention description (d Figure 6 is a comparison of American Ginseng (1) powder, (2) 95% alcohol extract, (3) water Extracts, (4) The effect of 50% alcohol extracts on IgG2a and IgE 値. The mean is expressed as mean ± S EM. This figure shows the 50% alcohol extract of American ginseng in reducing IgE and increasing IgG. Better than water extract. Figure 7 compares (1) powder, (2) 95% alcohol extract, (3) water extract, (4) 50% alcohol extract against IgE, IgG2a, IL- 4 and the effect of IFN-γ. It is expressed as the average soil SEIvi. * Indicates a significant difference compared with the control group. The results show that the 50% alcohol extract of pneumonia grass is the most effective in inhibiting IgE and increasing IgG. Figure 8 compares the effects of STA-36, STA-4 and the control group (placebo group) on the IgG and IgE 値 in the blood 淸 of BALB / c mice. Sine A_30 is a pharmaceutical composition disclosed in the mother case. STA-4 is a pharmaceutical composition of the present invention. * Indicates a significant difference between STA-4 and the control group (p < 0.05). Numbers are expressed as the mean 値 iS EM. The dose of STA-36 20 mg / 20 g rat weight) is twice the dose of STA-4 (10 mg / 20 g rat weight) (ie STA6: STA-4 = 2: 1). The results show that although both STA-36 and STA-4 are IgE is inhibited, but only STA-4 and the control group have significant differences. As for IgG, STA-36 and STA4 all increase IgG. Although STA-36 increases the IgG tritium more than STA-4, but both Compared with the control group, the increase was not significantly different. Figure 9 is a comparative study of the effects of STA-3 6 and STA-4 on lung function. Numbers are expressed as the average soil S EM. Compared with the control group (P < 0.05), both STA-36 and STA-4 showed improvement in lung function (determined by the determination of acetylcholine). According to the treatment of both STA-36 and STA-4, although this paper Standards are applicable to China National Standard (CNS) A4 specifications (210X297 mm) (Please read the precautions on the back before filling out this page) -11-Μ 1233804 Β7 ____ 5. Description of the invention (j STA-4 is more effective than ST A-36 Good, but due to the insufficient number of animals in each group, the difference between STA-36 and STA-4 was not statistically significant. The dose of STA-36 (20 mg / 20 g mouse weight) is twice that of STA-4 (10 mg / 20 g mouse weight). Figure 10 compares STA-4 with general treatment drugs including Ketotifen, Predisolone, and Aminophylline for IgE, IgG 'IL-4 and Effect of IFN-γ. Figures are shown as mean ± SEM. * Indicates significant difference between control and control group. This study showed that STA-4 significantly reduced IgE 値, but significantly increased IgG2a, 1IL-4 and IFN-γ 値. Detailed description of the invention In the parent case (U.S. Patent Application No. 09/73 5,536, Republic of China No. 90 1 28 893 Patent Application), 6 pharmaceutical compositions (so-called STA-3 series of STA-3 are provided 1 to STA-36). STA-3 1 ~ STA-3 6 The contents of the herbal composition are shown in Table 1 (please read the precautions on the back before filling this page) Order printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs, Table 1, STA-3 series of herbs Composition Herb Composition Herb 1 Herb 2 Herb 3 Herb 4 Herb 5. STA-31 Maimendong Pinellia Glycyrrhiza Codonopsis Taiwan Mochi Paste STA-32 Maimendong Pinellia Glycyrrhiza Codonopsis Houttuynia STA-33 Maimendong Ban Licorice Dangshen Pneumonia STA-34 Maimens Pinellia Glycyrrhiza American Ginseng Taiwan Hemp, Mihu STA-35 Maimens Pinellia Glycyrrhiza American Ginseng ^ / < r, / | Mouth /] Houttuynia STA-36 Wheat Asparagus pinellia licorice ginseng pneumonia pneumonia herbal paper scales apply Chinese National Standard (CNS) M specifications (2 × 〇χ297 mm) 1233804 A7 _ B7 V. Description of the invention (、 In the 6 components of this STA-3 series, STA-3 6 is the best. (Please read the notes on the back before filling this page)

The present invention aims to improve the curative effect of STA-36, and uses various extraction methods for the herbs contained in STA-36, namely, asparagus, pinellia ternata, licorice, American ginseng and pneumonia. The resulting pharmaceutical composition is called STA-4. Both STA-36 and STA-4 are effective in treating immune disorders, especially in inhibiting the production of IgE. Antigenic or allergen-induced asthma is a disease of the respiratory system, mainly due to a chronic inflammatory response. This inflammatory response is due to the release of inflammatory factors such as platelet activating factor, histamine, prostaglandin, leukotrienes, etc. from the cells. The inflammatory response stimulates T-lymph (T-cell), especially the antigen response in CD4 + cells. CD4 + cells have two types. CD4 + cells of Thl type secrete cytokines (IFN-γ); CD4 + cells of Th2 type secrete interleukins (IL-4). Most patients with allergic asthma are of type Th2. Allergens stimulate Th2 cells to produce IL-4, and IL-4 in turn induces B lymphocytes to produce and secrete IgE. STA-3 6 and STA-4 are compared as shown in Table 2. Table 2 Herbal contents of STA-36 and STA-4 Maitongdong pinellia licorice Ginseng pneumonia pneumoniae STA-36 Water extract crude drug powder crude drug powder crude drug powder crude drug powder STA-4 water extract water extract water extract water extract 50% Alcohol Extract. The pharmacological names, botanical names, family names, and main ingredients of each of the pharmaceutical ingredients in STA-3 printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs are shown in Table 3. This paper size applies Chinese National Standard (CNS) A4 specification (210X297 mm) -13-! 233804 V. Description of the invention (A7 B7 Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 袠 3 STA-3 series of pharmaceutical composition composition medicine taste The name of the original medicine, botanical, and the main ingredient of the herb, the name of the medicine, the name of the plant, the name of the family, the name of the main ingredient, Tuer Ophiopogonis Japanici Ophiopogon japonicus Ker. Gawl ruscogenin), β-sitosterol, stigmasterol, Radix Panacis Quinquefolii Panax quinquefolium L. Pentaquinone, Tuber Pinellia Rhizoma Pinellia Tematae Pinellia ternata (Thunb. Breitenbach Coniine, protoanemonin, homogentisic acid, nicotine, aspartic acid, glutamic acid, arginine, β-sitosterol Radix Glycyrrhizae Uralensis Glycyirhiza uralensis Fischer or Glycyrrhiza glabra Linne Alkan-2-carboxylic acid, aspartate, homoserine, diaminobutyric acid, digitin pneumonia Herba Tridacis Procumbentis Tridax procumbens Linn. Compositae polysaccharide (please read the precautions on the back before filling (This page) The size of the paper used for this edition applies to the Chinese National Standard (CNS) A4 (210X297 mm) -14- 1233804 A7 ____B7

V. Description of the invention (A (please read the notes on the back before filling out this page) Ophiopogon belongs to the family Liliaceae, and its tubers have medicinal effects. The best harvest time is summer. After harvest, tubers are washed to remove impurities And fine roots, and then stored for future use. Ophiopogon is a swollen portion of the root. Ophiopogon is produced in Zhejiang, China and Sichuan, and sold by Jiang Su and others. Shi et al.

Chinese Materia Medica) 16: 584-585 reported that aqueous extracts of Ophiopogon asparagus can strengthen the elimination of coke particles in veins in mice and antagonize white blood cell deficiency caused by clophosphamide. American ginseng belongs to the family Acanthaceae, and its medicinal effect is in the root. Ginseng is produced in North America and Canada. It is also cultivated in France and northern China. The best harvest season is autumn. Pinellia belongs to Araceae and its tubers have medicinal effects. Pinellia is produced in Sichuan, Hubei, Henan, Guizhou and Anhui provinces in China. The normal harvest period is between July and September. It is also found in Taichung County, Taiwan. Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs Licorice belongs to the family Leguminosae. Its roots and grape stems are with or without epidermis, and have medicinal effects. Licorice contains more than 2.5% glycyrrhizic acid (calculated based on dried medicinal materials), which can be used as an index component of licorice. Licorice grows in Inner Mongolia, Gansu, Xinjiang, and the northeast of China. The best harvest season is spring or autumn. Licorice is also found in Taichung County, Taiwan. Licorice roots have anti-inflammatory effects and can be used alone to help relieve asthma symptoms. See H.W.Mr n i n g s t a r 's book: Sensitive Harmony [Sentient Times: Alternative for Personal and Community Transformation (19 9 8); 6: 16-17. Licorice root is also good for bronchitis. See T. Da Vlt's book: Revolutionary Work (199 7), PP · 66-79. This paper size applies to China National Standard (CNS) Α4 size (210 × 297 male ~ ~ 1233804 A7 _________B7

V. Description of the invention (A Pneumoniae belongs to the family Asteraceae. The entire plant is dry and has medicinal effects. Pneumonia is found in Nantou County, Taichung County, Yuanlin County and Taichung City in Taiwan. Please read the note on the back Please fill in this page again.) There is beauty too.

Dlwan et al. Published in g 8 3) '2 7: 3 2-36, revealing the effect of juice extracted from pneumonia leaves on wound closure and granulation growth, similar to dexamethasone, but in tension and In terms of epithelial formation, it has an antagonistic effect with dexamethasone. Gan et al. Disclosed in Chinese Medicine ^^ (197 7) ′ 8 · 5 26 ′ the leaves of pneumonia grass can be used for anti-inflammatory, antipyretic, treatment of pneumonia and cough. The preparation method of STA-36 and STA-4 herbal composition is as follows: A. Preparation of SJA-36 herbal composition The preparation method of STA-36 herbal composition is as follows: (1) Roots of Pinellia ternata, licorice and ginseng and pneumonia The whole grass is finely cut, dehydrated, honed and sieved with a sieve (preferably a sieve of 40 to 120 mesh) to make a herbal powder. Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs (2) The roots of Mai Mendong are cut into small frying pots and soaked in water. The water volume should be at least 10 cm over the herbs. Heat this water-soaked asparagus to a temperature of 97 ~ 103 ° C for about 60 minutes, and cook for two times to prepare an extract of asparagus. The extract of this asparagus was filtered through a sieve (about 100 mesh). After the filtrate was collected, the filtrate was concentrated to a desired concentration at a temperature of 50 to 60 ° C and a pressure of 400 to 650 mm-Hg. The concentrated solution is preferably 1/14 the amount of the aspartate filtrate. (3) The mixture of Ophiopogon condensate and other medicinal materials is sent to the paper. The size of the paper is applicable to the Chinese National Standard (CNS) A4 (210X297 mm) -16- 1233804 A7 _- _ B7

V. Description of the invention (A in the mobile granulator and the nozzle made with filter cloth. The granulator is set to 90 ~ 110 ° C for 5 minutes, and the mixture starts to granulate. (Please read the precautions on the back before filling in this page.) 4 ~ 5 5 seconds, after spraying a certain amount, the spray tube will beat to shake the powder, and the beat frequency is once every 10 seconds. After granulation, the granules are dried and cooled, then sieved, and then packed in polyethylene (PE) bags. The moisture content of the granules is preferably below 6%. The granules can be refilled in any kind of traditional capsules' including natural Gelatin, pectin 'casein, collagen, protein, modified starch and polyvinylpyrrolidone (PVP). B. Preparation of STA-4 herbal composition. Preparation of STA-4 herbal composition. I. Pneumonia (1) The whole pneumonia grass is shredded. (2) — 20 parts (by volume) of 50% alcohol (extraction solvent) of pneumonia grass tablets. (3) Extraction of herbs and solvents under reflux for about 30 minutes This produces an alcohol extract of pneumonia. Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs (4) After the extract is cooled, filter through a sieve (about 100 mesh) and collect the filtrate. The filtrate is concentrated under reduced pressure at a temperature of 50 to 60 ° C (preferably 55 ° C) and a vacuum of about 30 Torr. (Torr) to obtain a concentrate. The solid content in the concentrate is about 7.8% by weight of the crude drug. The solid content in the concentrate is that the concentrate removes 50% alcohol. Take pneumonia as an example, its concentration The content of solids in the material is similar to that of the concentrate (due to the low water content in the concentrate). ____ This paper size applies to China National Standard (CNS) A4 (210X 297 mm) -17- 1233804 A7 Intellectual Property of the Ministry of Economic Affairs Printed by the Bureau's Consumer Cooperatives B___ V. Description of the invention ((5) Add appropriate amount of corn starch (an excipient) to the concentrate to make a paste. (6) The paste is made by spray drying Into pneumonia grass granules (preferably about 42% by weight of crude drugs) II. Pinellia ternata, licorice root and American ginseng (1) pinellia tubers and roots of licorice and American ginseng are shredded separately. (2) each herb Each portion (weight) is added with about 20 times (volume ratio) water. (3) Each dip The crude drugs in the water are preheated and boiled for about 30 minutes each to produce aqueous extracts of Pinellia ternata, licorice and American ginseng. (4) After each extract is cooled, it is filtered through a sieve (about 1000 mesh). The filtrate was collected, and each filtrate was concentrated under reduced pressure to obtain a liquid concentrate at a temperature of 50 to 60 ° C (preferably 55 ° C) and a vacuum of about 30 torr. The solid substance of the pinellia concentrate is preferred. The content is 20% of Pinellia crude drug, the solid content of licorice concentrate is 20% of licorice crude drug, and the solid content of ginseng concentrate is 24.3% of ginseng crude drug. The content of the solids in the concentrate is one in which the concentrate removes moisture. (5) An appropriate amount of corn powder (an excipient) is added to each concentrate, and granules of the respective herbs are prepared by spray drying. (6) Each granule is mixed with pneumonia granules to form mixed granules. III. Asparagus tuber The asparagus tuber is made into a concentrate according to steps II, (1) to (4). Mai (please read the notes on the back before filling this page) This paper size is applicable to China National Standard (CNS) A4 specification (210X297 mm) -18- 1233804 A7 B7 V. Description of the invention (, Asparagus concentrate and other half The only difference between summer, licorice, and American ginseng concentrates is that the asparagus concentrate contains a considerable amount of water, while the other concentrates contain almost no moisture. For 9 grams of asparagus crude, the concentrate weighs about 5.4 grams, of which solids account for 2.25 grams, and moisture accounts for 3.15 grams. The liquid concentrate of oatmeal is mixed with other herbal granules. The gram weight of each crude drug in STA-36 and STA-4 is shown in Table 3a. 3a ST A-36 and ST A-4 The total weight of each crude drug of O. asparagus, Pinellia oleifera, Ginseng, Pseudomonas pneumoniae (oral dose) STA-36 / STA-4 (dose ratio) Raw materials 9g 6g 3g 3g 3g 24 g STA-36 5,40 g (2.25gSC * + 3.15g moisture) 6g (drug powder) 3 g (drug powder) 3g (drug powder) 3 g (drug powder) 20.4 g (drug powder) 2 STA-4 5.40 g concentrate (2.25gSC * + 3.15g moisture) 1.50g granules (1.20gSC * + 0.30g corn starch) 0.63g granules (0.60gSC * + 0.03g corn flour) 0.96g granules (0.73gSC * + 0.23 corn flour 1.25g granules (0.25gSC * + 1.02g corn starch) 10.20g (9.74g granules and wheat asparagus concentrate + 0.46g corn palace Powder) 1 * SC = solid content, that is, dry concentrate (concentrate removes water or solvent) The raw material column in Table 3a shows the weight of each herb before treatment. STA-36 and STA-4 columns Shown are (1) the final form of each herb and (2) the final weight. For example, in STA-36, except for asparagus in a concentrated form, Pinellia ternata, licorice, American ginseng, and pneumonia are all herbs Powder type. In addition, except for the weight of oatmeal as compared with its raw materials, the remaining herbal powders are in accordance with the Chinese National Standard (CNS) A4 specification (210X 297 mm) for this paper size. (Please read the note on the back first Please fill in this page for the matters) • ^ 1,-口-Printed by the Consumer Cooperatives of the Intellectual Property Office of the Ministry of Economic Affairs, printed 12338804 kl ___ _B7 V. Description of the invention (^ The raw materials have the same weight. (Please read the notes on the back before filling this page ) However, in STA-4, except for asparagus, it is the same as STA-36. , The remaining herbs after extraction, was concentrated and granulation, which are gram weight really reduced, as shown in Table 3a. In addition, in order to help the stability of the concentrates when granulating, each excipient is added with an excipient (such as corn starch), and the amount depends on the stability of the concentrate. The final product of STA_4 is a pellet type, and its weight is about half that of STA-36, although both are made from the same amount of raw materials. The following examples are illustrative and should not be construed as limiting the scope of the invention. Reasonable changes may be made within the scope of the present invention, as used by those skilled in the art. Example 1 闬 Quality control of herbal medicines in STA-36 and STA-4 by high performance liquid chromatography. Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs. The invention uses high performance liquid chromatography (HPLC) to ensure the herbal medicines. Quality is well regulated. Three HPLC methods were developed to match the chemical and physiological characteristics of each herb. These three methods are described below. (A) HPLC analysis method 1 Method 1 uses a pre-column Lichrospher R P — 1 8 (endcapped) (5 ′ 4 · 0 inner diameter X 1 〇mm ’Merck) and

Cosmosil 5C18— MS tube (5 // m Nacalai tesque -20- This paper size applies to Chinese National Standard (CNS) A4 specifications (210X297 mm) 1233804 A7 B7 V. Description of the invention) 8 5 C18— MS, inner diameter 4 · 6x25mm) operate at room temperature (please read the precautions on the back before filling this page). Mobile phase mining gradient extraction of the column, including (A) Η 20: K Η 2 P0 4: 10% H3P 0 4 (1000mi: 2.72 g: 1 m 1; v / w / v); (B) CH 3 CN; (C) H2O & (D) CH 3 ◦ H. The gradient extraction program is shown in Table 4. The flow rate is 1.0 m 1 / min, the detection wavelength is 250 nm, and the analysis time is 60 minutes. Table 4 Method 1 ) (A) (%) (B) (%) (C) (%) (D) (%) — start 90 10 0 0 30 75 25 0 0 — 40 65 35 0 0 _ 55 0 75 25 0 ^ 60 0 10 90 0 Subsequent extraction 1 5 mi η Printed by (B) HPLC Analytical Method 2 of the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 2 Η PL · C Analytical Method 2 'Using the pre-column Lichrospher RP-18 (endcapped) (5 // m, 4 · 0 inner diameter x 1 Omrr, Merck) and Cosmosil 5C 1 8-MS column (5 // rr Nacalai tesque 5 C 1 8- MS, 4.6 inner diameter x 2 5 0 mm) , Working temperature 3 5 ° C, its mobile phase mining gradient extraction, containing (a) 10mM KH2P〇4 + l OmM K 2 Η P 0 4 + This paper size applies Chinese National Standard (CNS) A4 specifications (210χ 297 mm ) -21-1233804 A7 B7 V. Description of the invention (^ 0.01% H3p〇4 (KH2P〇4: K2HP〇4: 10 / ^ H3P〇4 * H20) 22 · 36g: 1 · 74g: 1ml: 1 0 0 0 ml); (b) C Η 3 CN; ((:) ^ 12〇 and (D) C Η 3〇Η, the gradient extraction The formula is shown in Table 5. The outflow rate is 1.0 m 1 / mi 1Ί, the detection wavelength is 260 nm, and the total retention time of the analysis is 35 minutes. Table 5. Gradient extraction program time (min. ) S (A) (B) (C) (D) Start 100 0 0 0 25 60 0 20 20 30 20 0 20 60 35 100 0 0 0 Subsequent extraction 1 5 min (C) Η PLC analysis method 3 method 3 Use Lichrospher RP-1 8 as the pre-column and Cosmosil 5 C 1 8 — MS (5 // m, Nacalai tesque, 5C18- MS, 4.6 inner diameter x 25mm), working temperature 3 5 ° C, The mobile phase is a gradient elution, containing (A) Η 20: KH2PO4 (1000 ml: 2.72 g ^ v / w); (B) CH 3 CN; (C) H 2 0 and (D) CH 3 0 H, the gradient The extraction procedure is shown in Table 6. The outflow velocity was 1.0 m 1 / m i n, the detection wavelength was 2 0 3 n m, and the analysis time was 60 minutes. This paper size applies to China National Standard (CNS) A4 (210X297 mm) (Please read the precautions on the back before filling this page)

Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs, 22T-1233804 A7 B7 V. Description of the invention (i Table 6 Method 3 Gradient extraction program time for mobile phase (minutes) (Α) (Β) (C) (D ) Start 80 20 0 〇40 65 35 0 0 55 0 80 20 0 60 0 20 80 0 Subsequent withdrawal 1 5 mi η (Please read the precautions on the back before filling out this page) The HPLC analysis methods for the herbs used in the production of STA-36 include methods, the main index components and the detection wavelength of each herb are summarized in Table 7. The HPLC chart of the herbs of STA-36 is shown in Figures 1 to 5. This paper size applies to China National Standard (CNS) A4 specification (210X297 mm) l2338〇4 _ V. Description of invention (4 7 table

Analysis of CL P Η for Herbal Medicine 6 3-ATS Name of Herbal Medicine PLC Analysis Index Component Retention Time Detection Wavelength-Method (Minutes) (nm) Maimendong Method 1 6115-1 11.5 214 -------- 6115-2 13.0 214 Pinellia method 2 Adenine 14.8 250 --- Guanosine 17.0 250 _Glycyrrhiza method 1 Glycyrrhizic acid 46.4 250 American ginseng method 3 Ginsenoside 37.5 203 Rbi Pneumonia method 1 FY-1 28.0 250 FY-2 31.6 250 FY-3 33.5 250 (Please read the notes on the back before filling out this page) Specimens were mixed with a 70% methanol solution of 20 m 1. The specimen solution was ultrasonically perturbed for 15 minutes at room temperature 'and placed in a rotary water cylinder at 40 ° C for 20 minutes and 1 li. The rotation rate was 160 revolutions per minute. Leave the test solution for 30 minutes to settle the slag particles. Aspirate 10 m 1 of scum solution with a straw and pass through a filter membrane of 0.4 5 // m. The filtrate was then used for ΗPLC analysis. Take the filtrate 2 0 // 1 for Η P L C analysis. Result This paper size is in accordance with Chinese National Standard (CNS) A4 specification (210X 297 mm) -24-1233804 A7 B7 V. Description of the invention (; The chromatogram of the PLC of Tomomi maidenensis is shown in Figure 1. As shown in Table 7 It is detected using the Η PLC analysis method 1 ′ at a wavelength of 2 1 4 nm. Two distinct peaks can be identified on the Η PLC spectrum of Mai Mendong, 6 1 1 5 1 and 6 1 1 5 — 2. 6 The retention time of 1 1 5 — 1 is 1 1 · 5 minutes, and 6 1 1 5-2 is 1 3 minutes. Although the chemical composition of the two peaks has not been identified, they can be used to ensure the quality of Ophiopogon. The HP L · C chromatogram of Figure 2 is shown in Figure 2. As shown in Table 7, using the PLC analysis method 2 and detected at a wavelength of 251111, pinellia has two significant index components, adenine and guanine. (Adenine and gUanosine), both of which are nucleic acid components. Adenine has the effect of increasing aldolase (a 1 d ο 1 ase). The retention time of adenine is 14.8 points, and guanopurine The score is 17 points. The PLC chromatogram of Glycyrrhiza uralensis is shown in Figure 3. As shown in Table 7, Glycyrrhiza uralensis was analyzed with G. PLC analysis method 1 at a wavelength of 250 nm. A chemical index component of Glycyrrhiza chinensis was found in the PLC chromatogram. Glycyrrhizin. Glycyrrhizin (C42H62〇16) is a very sweet substance. 'It is known to have detoxification, anti-inflammatory and hemolytic effects and is used in Treatment of Edison. Its retention time is 46.4 minutes. The Η PLC chromatogram of ginseng is shown in Figure 4. As shown in Table 7, Η PLC analysis method 3 was used to detect ginseng at a wavelength of 230 nm. A chemical index component was found in its HP LC chromatogram, ginsenoside R bi. Ginsenoside rbi is effective in dilating blood vessels, eliminating fatigue and avoiding hemolysis. The HPLC chromatogram of pneumonia is shown in Figure 5. As shown in Table 7, the Chinese standard (CNS) A4 specifications (21 × X 297) are applicable to this paper size (please read the precautions on the back before filling out this page) ^ 1 Printed by the Employees ’Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs System-25- [233804 A7 ____________B7

V. Description of the invention (A Η PLC analysis method 1, pneumonia detected at a wavelength of 250 nm. Four significant peaks FY-1 ~ FY-4 were found. FY —; [retention time of 28.8. , F γ-2 is 3 1 · 6 points, F γ-3 is 3 3 · 5 is FY-4 is 18.3 points. Since the appearance of the four peaks is always the same, although its chemical composition has not been identified, They can still be used to identify pneumonia and to ensure its quality. For example, Thin Layer Migration (TLC) method to identify Glycyrrhiza, Oleifera, Pinellia and Pneumonia (please read the precautions on the back before filling this page) • Xin

ST A Printed by the Intellectual Property Bureau of the Ministry of Economic Affairs of the Ministry of Economic Affairs and Consumer Cooperatives as the fixed to determine the use of ethanol, according to the solvent on the water and ethanol. This second medium contains two chloroform solvents, 5 // 1 point contains mobile phase PLC, thin layer chromatography (TL C) can also be used to identify 3 6 pharmaceutical composition c C using silicone 60 phase, and three types of mobile Kind of solvent. The first 4: 1: 2 (v) grass identification is particularly good, according to the 5: 2: 1 solvent pair identification of wheat gate and methanol, according to 5: identification of pneumonia grass is particularly on the TLC board. Solvent, let some herbs on the solvent. F 2 5 4 (phase (or expanded solvent containing B / v / v) is used. The second type (V / V / winter and American ginseng 1 (v / v is easy to use. Place it as a TTLC and move it by 9 cm. Attach to T The volume ratio of the solvent, ethyl acetate, and the solvent containing butyl v) is particularly good.) The volume ratio LC measurement TLC tank TLC measurement LC plate) Depending on the characteristics of the herbal medicine 4 N ammonia and examples. The first alcohol is mixed with 4 N ammonia. The second solution is mixed. At this time, the results of the test room and the tank are described in detail.

、 1T This paper size applies the Chinese National Standard (CNS) A4 specification (210X 297 mm) -26- 1233804 A7 B7 V. Description of the invention (1 as follows: (A) Licorice TLC analysis Licorice uses a stationary phase attached to a τ LC plate Gel 6 0 F 2 5 4, mobile phase is ethyl acetate: 4 N ammonia: 4: 1: 2 (v / v / v). After the sample point is on the TLC plate, the DLC plate is placed in the chamber containing the mobile phase. , The height of the solvent should not exceed the horizontal position of the sample on the plate. When the solvent rises to the original point, remove the TLC plate and let it dry in the air. After drying, spray the TLC plate with vanillin / Sulfuric acid reagent, and in 105 minutes 2 minutes, a yellow licorice will appear on the plate at a position where R f = about 0.5. The distance between the two colored points of R f and the point where the specimen is applied / moving distance ( That is 9 cm). The silicon on the TLC 9 c XXX ° c heats the color point, and the solvent is moved (please read the precautions on the back, and then fill out this page) ^ 1-Order printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs ( B) TLC analysis of asparagus. Asparagus uses a stationary phase of silicone 6 0 F 2 5 4 attached to a τ LC plate, and a mobile phase of n-butanol: 4 N ammonia water: ethanol = 5: 2: 1 (v / v / v). After applying the sample, place the TLC plate in the TLC tank containing the mobile phase solvent, and do not exceed the height of the solvent on the TLC plate. The origin of the body. When the solvent is moved up to 9 cm from the origin, remove the TLC plate and allow it to dry in the air. Spray the vanillin / sulfuric acid reagent on the TLC, and set it at 105 ° C is heated for 2 minutes. A brown spot representing Macedonian appears at the position of R f = 0.4. This paper size applies the Chinese National Standard (CNS) A4 specification (210X297 mm) -27- 1233804 A7 B7 V. Description of the invention (Earth (C) American Ginseng TLC analysis of American Ginseng. The stationary phase used was silicone 6 0 F 2 5 4 attached to the TLC board, and the mobile phase was n-butanol: 4 N ammonia: ethanol = 5: 2: 1 (v / v / v). After applying the sample, the TLC plate is placed in the TLC tank containing the mobile phase solvent, and the height of the solvent should not exceed the origin of the sample on the TLC plate. Let the solvent move away from the origin. At a distance of 9 cm, take out the TLC plate and allow it to dry in the air. Spray the TLC plate with vanillin / sulfuric acid reagent, and apply Heat for 2 minutes. A purple spot representing American ginseng appears at R f = 0.3 on the TLC plate. (D) Pneumonia spp. The stationary phase used for the TLC analysis of pneumonia spp. Is a latex glue 60F254 attached to the TLC plate. The mobile phase is chloroform: methanol = 5: 1 (ν / ν). After applying the specimen, the T L C plate is placed in the TL C tank containing the mobile phase solvent. The height of the solvent should not exceed the position of the origin of the specimen on the TLC plate. When the solvent is moved up to 9 cm from the origin, remove the TLC plate and allow it to dry in the air. Place the TLC plate in an ultraviolet detector and detect it at a wavelength of 3 6 6 nm. One can be seen at the position R f 0.2. Represents a yellowish spot of pneumonia. Example 3 Method for determination of IgG, IgE, IL-4 and IFN-v in animals This paper size applies Chinese National Standard (CNS) A4 specification (210X297 mm) (Please read the precautions on the back before filling this page) «1 11. Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs -28- 1233804 A7 Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs ___B7______ V. Description of the invention (▲ STA-3 6 and STA-4 and the various herbs contained in it, It was used to investigate the immunoglobulin G (I g G), immunoglobulin E (I g E) and cells induced by BALB / C mice sensitized with dust mite antigen (Der P 5). Effectiveness of interleukin 4 (IL-4), etc. Dust mites are small worms in the dust in the house. It acts like an antigen and can cause allergic asthma in people with specific reactions. Experimental design (A) Animal female BALB / C mice, 4 to 6 weeks old, weighing about 20 grams, taken from the National Taiwan University Animal Feeding Center. The sex and age of the animals must meet each experiment. (B) Purification of the dust mite allergen Der P 5 Using p GEX-2 T plastids to express dust mite resistance in E. coli 5-Glutathione S-transferase (GST). The molecular weight of the fusion protein is about 4 2 k D. This protein is purified by glutathione-conjugated agarose gel column chromatography. E. coli (transfected) was cultured in a culture solution containing Ampicillin (100 / g / m1) to select a single colony (positive response to the dust mite Der P 5 -GST ( c ο 1 ο ny). The colony was cultured again to produce a sufficient amount of dust mite antigen (Der P5-GST). Then the bacterial culture solution was collected and separated by centrifugation. The supernatant liquid was used to remove TBS (p Η 7. 5) ) Collected in a centrifuge tube after washing. After TBS is opened (please read the precautions on the back before filling this page) This paper size is applicable to China National Standard (CNS) A4 size (210 × 297 mm) -29- 1233804 A7 B7 V. Description of the invention (Immediately 0.1 M phenylmethylsulfonyl fluoride (Phenylmethylsulfonyl fluoride) is added to the bacterial solution, and then DN ase I, T wee η 2 0, and lysozyme (Lysozyme) are added. The bacterial solution is thawed by freezing. Procedures to release dust mite antigen (Der P 5 — GST) protein EDTA was added to the cell lysate and separated by centrifugation. The pellet was discarded after centrifugation, and the supernatant was poured into a column containing glutathione-bound agarose gel. This column can absorb dust mite antigens. De r P5-GST. The column was first washed with TBS buffer at 4 ° C, and then washed with Tris — base (p Η 8 · 0) containing reduced glutathione to remove the dust mite antigen Der P 5- GST was isolated from the agarose gel particles. The purity of the dust mite antigen De r P5-GST can be confirmed by SDS-P A G E. The amount of protein can be measured by traditional protein analysis methods. Sensitized BALB / c mice that were sensitized to animals were injected intraperitoneally with 10 // g dust mite antigen (Der P 5) and 4 mg of hydrogen. Alumina (Weich's Pharmaceutical, Punchbowl, Australia) sensitized it. Seven days after the first sensitization, the mice in each group except the placebo group were fed with the Chinese herbal medicine composition STA-36 and STA-4 until the end of the 21st day. On the 21st day after the first sensitization, the mice were supplemented with dust mite antigen De r P 5 again. At 48 hours after the second additional injection, the mice were placed in a round plastic container, and then stimulated with 0.1% De r P5 by ultrasonic spraying (Challenge). This paper size applies to China National Standard (CNS) A4 (210X 297 mm) (Please read the precautions on the back before filling this page) «丨

Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs of the Ministry of Economic Affairs of the People's Republic of China-30- 1233804 A7 B7 V. Description of the invention (4 A few hours after stimulation, anesthetize mice with phenobarbital 100 mg / ml, and remove them from the heart or tail vein Blood was collected, and the blood was allowed to stand at room temperature for 1 hour, and then centrifuged. The blood pupae were collected and stored at -80 ° C for ELISA analysis of IgE and IgG2a (see below). The alveolar lavage solution was centrifuged at 1,000 rpm for 10 minutes. The supernatant was used to analyze cytokine, IL-4 and IFN-γ. The cell pellet was washed away with PBS, and the inflammatory cells were calculated by cell centrifugation (cyt ◦ spi η). (D) D er P 5 —Determination of specific I g G and I g E. To determine the amount of Der P 5 -specific I g G and I g E, use "enzyme-linked immunoassay" (ELISA). There is strong adsorption on proteins The top of the forceful microtiter plate was coated with purified Der P 5 at a concentration of 10 0 // 1 at 10 mg / m 1, and diluted with coating buffer (containing 3% BSA; PBS pH 2 · 4). 5 // g / ml. After the microtiter disk was left standing at 4 t: overnight, it was washed three times with 0.05% Tween 20 in PBS. 3% (w / v weight / volume) BSA-PBS buffer was choked for 2 hours at 25 ° C. Diluted to 1: 1 0 when measuring I g G, and diluted to 1: 1 when measuring I g E: 10 and repeat it twice. Incubate at 4 ° C overnight, add the monoclonal antibody of rat anti-mouse I g E that binds to Biotin, or rat anti-mouse I g Monoclonal antibodies to G. These antibodies are diluted in 0.05% gelatin buffer, 2 hours after antibody addition, rinsed 6 times, and then added avidin-alkaline phosphate Enzyme (1: 1 0 0 0) solution, and then left at 25 ° C for 1 hour. This paper size applies the Chinese National Standard (CNS) A4 size (210X 297 mm) (Please read the precautions on the back before (Fill in this page) · «1 Order printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 1233804 A7 B7 V. Description of the invention ('The color reaction can be added to the phosphatase base phosphate p-nitrophenyl ester disodium salt (pNPP' alkaline phosphate Enzyme substrate, Sigma N-2770) and read with an immune microplate reader (ELISA reader, DyneX MRX) at a wavelength of 40 5 nm. Read 値Isotype control standard commercially available, i.e. mouse anti - T N P antibody monoclonal antibody, IgGl (1〇7.3), IgG2a (G 1 5 5 - 1 7 8), and IgE (IgE- 3). (E) ELISA for measuring cytokines (IL-4 and IFN-γ). Microtiter disks (Costar, No. 3590) with high protein and high binding capacity are coated with purified anti-cytokine antibodies (2pg for IL-4 measurement) / ml of PharMinge 18191D IL-4 antibody; 3pig / ml of PharMinge 18181D IFN-γ antibody was used to measure IFN-γ). The microtiter disks were coated with a PBS solution containing 3% BSA, and then rinsed with a PBS solution containing 0.05% Tween-20, pH 7.4. The supernatant of 100 μΐ of alveolar fluid, together with the cytokine standard solution, was added to a microtiter plate, and placed at 4 ° C for one night. Then 100 μΐ of biotin-mouse-IL-4 (PharMinge 1 8042D, 1 pg / ml) or biotin-anti-mouse-IFN-γ (PharMinge 18112D, 1 pg / ml) was added to the microtiter disk. After 2 hours of reaction, 100 μΐ of avidin-basic phosphate (1: 1000) (Streptavidin-AP, PharMinge 1 3043E) was added to the microtiter plate while shaking for 1 hour. 200 μΐ of phosphatase substrate p-n-phenylphenyl phosphate disodium salt (pNPP, alkaline phosphatase substrate, Sigma N-2770) was added to the microtiter plate to cause a color reaction. The microtiter disk was read with a microtiter disk reader (ELISA reader, Dynex MRX) at a wavelength of 40 5 nm. This paper size applies the Chinese National Standard (CNS) A4 specification (2! 0 '乂 297 mm) (Please read the precautions on the back before filling this page) Ordered by the Intellectual Property Bureau of the Ministry of Economic Affairs and printed by the Consumer Cooperatives -32- A7 1233804 ___ B7_ _____ 5. Description of the invention () 〇 (F) Measurement of lung function (please read the precautions on the back before filling this page) Intravenous injection of phenobarbital (100 mg / ml) in mice Insert a PE50 tube into the trachea. The tube was connected to a breathing meter to measure exhalation and inspiration. Another PE50 tube was inserted into the esophagus to measure the esophageal pressure instead of the pulmonary pressure (TTP). When the pressure signal is transmitted to the physiological recorder BR8000, the signal is amplified and converted into breathing volume and pulmonary pressure to calculate tracheal pressure. In the experiment, a retention needle was inserted into the tail vein of the mouse to inject acetylcholine to change the change in tracheal pressure. 4. Statistics All the data in the experiment are calculated by "mean 値 ± SEM". The change in resistance of trachea caused by acetylcholine was converted to PC 100, and the measured 値 was expressed as mean 値 iS EM. IgE and IgG2a were determined by absorption spectrometry. The significance difference between the groups was determined using the Student's t-test. Statistical significance was expressed as p < 0.05. Example 4: The effect of herbal extracts on IgG and IgE. Various water extraction methods printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs have been tested on American ginseng and pneumoniae to determine which form of aqueous extract is the most suitable herbal composition. . American ginseng was tested in the form of (1) powder, (2) 95% alcohol extract, (3) water extract, and (4) 50% alcohol extract to test its effectiveness in inhibiting IgE and IgG2a. As shown in Figure 6, the 50% alcohol extract of American Ginseng has the best effect on inhibiting IgE, although its effect on reducing IgG2a is not as good as that of 95% alcohol extract. However, because the antigen-mediated immune disorder is a type mainly composed of IgE media, the paper size applies the Chinese National Standard (CNS) A4 specification {210X297 mm)-33- A7 1233804 __ B7

V. Description of the invention (A (please read the precautions on the back before filling out this page), the 50% alcohol extract of American ginseng in the herbal composition appears to provide the best IgE reduction effect of the composition However, if the granules made from American Ginseng extract are added to the granules of other herbs, the granules made from American Ginseng's water extract will inhibit IgE and increase IgG and provide better results. Therefore, the composition of STA-4 The American ginseng is extracted from water. Pneumoniae is tested for its IgE inhibition in the form of (1) powder, (2) 95% alcohol extract, (3) water extract and (4) 50% alcohol extract. The pharmacological effects of IgG2a, IL-4 and IF N-γ. As shown in Fig. 7, a 50% alcohol extraction of pneumonia in bone produced the best IgE and IgG2a inhibitory effect, although the water extract of pneumonia showed an effect on IL- 4 and IFN-γ have the best inhibitory effect. However, it was found that the water extract of pneumoniae caused blood clots in animals during investigation, so it was not considered for use in humans. Example 5 Comparison of STA-36 and STA-4 for IgE and IgG2a , IL-4, IFN-γ and Pulmonary Function Purpose Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs Experiments were conducted to compare the effects of herbal ingredients STA-36 and STA-4 on IgE, IgG2a, IL-4, IFN-γ, and lung function. The results of the study are shown in Figure 8-10. Figure 8 The comparison of the effects of the herbal compositions STA-36 and STA-4 on mouse IgG and IgE is shown. As shown in Figure 8, the comparison of the two herb compounds STA-36 and STA-4 with the control group shows that IgE is inhibited, and this effect is much greater in STA-4 than in STA-36. Compared with the control group, STA-4 shows a statistically significant difference. However, both STA-36 and STA-4 have no inhibitory effect on IgG. In fact, In the two groups of STA-36 and STA-4, IgG was increased. This paper size applies the Chinese National Standard (CNS) A4 specification (210X297 mm)-34- A7 1233804 ______B7______ 5. Description of the invention (4 Figure 9 shows STA Effects of -36 and STA-4 on lung function in mice. Both STA-36 and STA-4 groups have significant improvement in lung function compared with the control group (ρ < 0.05). Between these two groups, STA-4 on lung function The improvement of the function is better than that of STA-36. Although there is no significant difference in the number between STA_4 and STA-36, it may be caused by the insufficient number of animals (η) in each group. Figure 10 Comparing STA-4 and traditional Effect of asthma drugs such as ketotifen, prednisolone and aminophylline on IgE, IgG, IL-4 and IFN-γ. The results showed that only STA-4 showed a significant reduction in IgE and a significant increase in IgG, IL-4 and IFN-γ It shows that STA-4 has better effect on asthma than ketotifen, prednisolone and aminophylline. Figure 10 also shows that the efficacy of STA-4 is different from the general mechanism of first suppressing IL-4 and then indirectly reducing IgE 値. The behavior of this case is that after taking STA-4, both IL-4 and IFN-γ increase significantly, so the decrease in IgE is not due to the decrease in IL-4. In contrast, the amount of IFN-γ (produced by TH1 cells) increased significantly after treatment with STA-4. IFN-γ stimulates β cells to synthesize and secrete IgG2a, which explains why the amount of IgG2a is increased in the treatment of STA-4. Therefore, it is speculated that the effect of STA-4 is partly caused by IgG2a. This IgG2a will interact with the allergen when it is exposed for the second time to reduce the allergic reaction. Example 6 ^ Toxicity test of the pharmaceutical composition STA-36 and STA-4 The toxicity test of the herbal composition is based on the 28-day oral subtoxicity laboratory. The paper size applies the Chinese National Standard (CNS) A4 specification (210 × 297 mm) ( Please read the precautions on the back before filling this page) Order printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs -35-! 233804 A7 ^ -------; ------- B7 V. Description of Invention (^- — Mortality test, eye examination, clinical symptoms and gross anatomy results are shown in Tables 8 to 10. | S ^ Math mortality after taking STA-3 ^^ jTA-4 ~ ———— ------ X Li. _2% T wee η 8 0 Aqueous solution STA-36 STA-4 ^ [Amount (mg / kg / day) 5000 ------- _5000 — Gender-Male-Male-Young Number of rats 10 10 10 — Mortality 0/10 0/10 0/10 (Please read the notes on the back before filling out this page) Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs ^ 9 Mice take STA-36 and STA Ophthalmological examination and clinical symptoms after -4 2% Tween 80 aqueous solution STA-36 STA-4 dosage (mg / kg / day) 5000 5000 _ sex number of male and female mice 10 10 10 (Day 0) 0/10 0/10 0/10 Before gross anatomy (Day 28) 0/10 0/10 0/10 Clinical symptoms 0/10 0/10 0/10 -36- This paper size applies to China National Standard (CNS) A4 specification (2 丨 〇 < 297 mm) 1233804 A7 B7 V. Description of the invention (& Elephant 10 taking STA-36 and 3 Ding Ba-4_ ^ | Spoon gross anatomy 2% T wee η 8 0 Aqueous solution STA-36 STA-4 Dose (mg / kg / day) 5000 5000 Sex Number of male and female mice 10 10 10 Abnormal organs 0/10 0/10 0/10 Tables 8 to 10 show the results. In the study, neither STA-35 nor STA-4 showed symptoms of subtoxicity. After describing the invention in detail and referring to the preferred specific examples, for those skilled in the art, without departing from the scope defined in the appendix of the appended patent application, Modifications and changes are obviously feasible. (Please read the notes on the back before filling out this page) Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs -37-This paper size applies to China National Standard (CNS) A4 specifications (mm )

Claims (1)

A8 B8 C8 D8 1233804 Attachment to the scope of patent application: No. 9 1 1 20752 Chinese Patent Application Amendment Amendment November 29, 1993. A pharmaceutical composition containing: / 叩 ⑽Ker. Gawl) water extract A kind of Pinellia tern at a (Thunb.) Breitenbach water extract, —— Glycyrrhiza uralens is Fischer or Glycyrrhiza glabra Linne Ointment, a 40-60% ethanol / water extract of pneumonia procz / mkws Linn.), And a water extract of American ginseng (Pawax L.), of which Ophiopogon, pinellia, licorice, pneumonia and citi The weight ratio of the ginseng is 2.4-3.6: 1.6-2.4: 0.8-1.2: 0.8-1.2: 0.8-1.2. 2. If the pharmaceutical composition of the first patent application scope, each extract such as Ophiophyllum, Pinellia ternata, Glycyrrhiza uralensis, Pneumonia spp. And American ginseng is filtered and concentrated into Ophiophyllum sylvestris, Pinellia ternata, Licorice, pneumonia Various concentrates such as grass and American ginseng. 3. If the pharmaceutical composition in the second item of the patent application, the concentrates of Pinellia ternata, licorice, pneumonia, and American ginseng are granulated into individual granules, such as Pinellia ternata, licorice, pneumonia, and American ginseng. Individual granules are then mixed with the aspart concentrate to form mixed granules. This paper size applies to China's national standards (CNS> A4 size (210X297 mm) c Please read the Weeping Matters on the back #Fill this Guan], \ st > Printed by the Employees ’Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs 1238804 | D8 6 2. The scope of the patent application 24. If the pharmaceutical composition of the third scope of the patent application, the concentrates such as Pinellia ternata, licorice, pneumonia, and American ginseng are separately prepared before granulation (please read the precautions on the back first) (Fill this page) Add an excipient. 5 · If the pharmaceutical composition in the scope of the patent application No. 4 wherein the excipient is corn starch. 6. If the pharmaceutical composition in the scope of the patent application No. 1 where Maimen The weight ratio of winter, pinellia ternata, licorice, pneumonia, and American ginseng is 3: 2: 1: 1: 107. For example, the pharmaceutical composition of item 1 in the scope of patent application, wherein the extract of pneumonia is the pneumonia 50% alcoholic extract. 8. The pharmaceutical composition according to item 2 of the patent application, wherein the solid content of the concentrate of O. asparagus is 20-30% by weight of O. aspart; the solid form of Pinellia ternate concentrate Material content is 15-25% by weight of Pinellia ternata The solid content of licorice concentrate is 15-25% by weight of licorice; the solid content of ginseng concentrate is 19-2 by 9% by weight of ginseng; the solid content of pneumonia concentrate is 5% of pneumonia -10% by weight. Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs. 9. If the pharmaceutical composition in the third item of the patent application is applied, Pinellia pellets are 20-30% by weight of Pinellia. 16-26% by weight; American ginseng granules are 27-3 7% by weight of American ginseng; Pneumonia granules are 3-7-47% by weight of pneumonia. 1 〇 · As in the first patent application of medicine Composition for treating patients with immunological disorders. 1 1 · The pharmaceutical composition according to item 10 of the patent application scope, wherein the immunological disorders include at least one of the following: allergic rhinitis, allergic tissue paper scales applicable to China National Standard (CNS) A4 specification (210 X 297 mm) > 2- 1233804 A8 B8 C8 D8 3 Patent application scopes Meningitis, allergic asthma, atopic eczema, atopic skin rash, food allergy 'IgE Excessive symptoms and rheumatoid disease 1 2. — A method for manufacturing a pharmaceutical composition such as the patent application for item i, which includes: Weighing the weight ratio of Ophiopogon, Pinellia ternata, Licorice, Pneumoniae, and American Ginseng to 2.4-3.6. 1.6-2.4 · 0.8-1.2: 0.8-1.2: 0.8-1.2, decoction of Ophiopogon asparagus with water, and asparagus water extract is filtered and concentrated to form Ophiopogon condensate; decoction with water to extract Pinellia ternate, Pinellia ternate The water extract is filtered and concentrated to become Pinellia condensate. The pinellia concentrate is spray-dried and granulated. The licorice is extracted by boiling with water. The licorice water extract is filtered and concentrated to become the licorice concentrate. The licorice concentrate is spray-dried and granulated. Extracting American ginseng by decoction with water; American ginseng water extract is filtered and concentrated to make American ginseng concentrate, and American ginseng concentrate is spray-dried for granulation; 40-60% ethanol / water is used to reflux to extract pneumonia; The paste is filtered and concentrated to form a pneumoniae concentrate. The pneumoniae concentrate is made by spray drying. The granules of Pinellia ternata, licorice, American ginseng and pneumoniae are mixed with the concentrate of Ophiopogon. 1 3 · The method according to item 12 of the patent application scope, wherein the extract of pneumonia grass is a 50% alcohol extract of pneumonia grass. 14 · The method according to item 12 of the scope of patent application, wherein an excipient is added to each concentrate of Pinellia ternata, licorice root, ginseng and pneumonia grass to make granules before granulation. This paper size applies Chinese National Standard (CNS) A4 (210X297 mm). A · _A ~ 1 ~~ '(Please read the notes on the back before filling out this page) Order printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economy 1238804 A8 B8 C8 D8 VI. Application for patent scope 4 1 5.靑 The method of item 14 in the patent scope, wherein the excipient is corn starch. (Please read the precautions on the reverse side before filling out this page) 16. If you apply for the method of item 12 of the patent scope, the mixed granules are filled in capsules. 17. The method of claim 12 in the scope of the patent claim, wherein the solid content of the concentrate of O. asparagus is 2 (K30% by weight of O. ascension; the solid content of the pinellia concentrate is Pinellia ternata The solid content of licorice concentrate is 15 to 25% by weight of licorice; the solid content of ginseng concentrate is 19 to 29% by weight of ginseng; pneumonia The solid content of the concentrate is 5-10% by weight of pneumonia. 18. The method according to item 12 of the patent application range, wherein Pinellia granules are 20-30% by weight of Pinellia ternate; Licorice granules It is 16_26% weight ratio of licorice, Huaqishen granules are 2-7-37% by weight of Citimont; pneumonia granules are 3 7-47% by weight of pneumonia. 1 9. Such as the scope of patent application 1 2 The method of item 1, wherein each concentrate is concentrated under reduced pressure at a temperature of about 55 ° C and a pressure of about 30 torr. Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs. The method of item 12, wherein each concentrate is spray-dried with a feed temperature of about 105 ° C and a discharge temperature of 76-77 ° C. This paper size applies to China National Standard (CNS) A4 (210 X 297 mm)