CN1660332A - Drop pills preparation of dual goldthread root and preparation method - Google Patents
Drop pills preparation of dual goldthread root and preparation method Download PDFInfo
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- CN1660332A CN1660332A CN 200410155556 CN200410155556A CN1660332A CN 1660332 A CN1660332 A CN 1660332A CN 200410155556 CN200410155556 CN 200410155556 CN 200410155556 A CN200410155556 A CN 200410155556A CN 1660332 A CN1660332 A CN 1660332A
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Abstract
A Chinese medicine 'Shuanghuanglian dripping pill' is composed of the medicinal core prepared from honeysuckle flower, scutellaria root and forsythia fruit through extracting volatile oil, and the surface layer prepared mainly from the fine powder of their extracted dregs.
Description
Technical field: the present invention is a kind of SHUANGHUANLIAN drop pill preparation and preparation thereof, belongs to technical field of medicaments.
Background technology: 'Shuang Hualian ' is the pure Chinese medicinal preparation of raw material production by Flos Lonicerae, Radix Scutellariae and Fructus Forsythiae, and Flos Lonicerae is the dry flower of caprifoliaceae plant Radix Ophiopogonis LonicerajaponicaThunb., Flos Lonicerae Lonicerahypoglauca Miq., Flos Lonicerae LoniceraconfusaDC. or hair style Radix Ophiopogonis Loniceradasystyla Rehd. or the flower that band is just opened.Heat-clearing and toxic substances removing, wind-heat dissipating is used for the carbuncle furuncle, sore throat, erysipelas, warm blood fulminant dysentery, wind heat; Fructus Forsythiae is the dry fruit of Oleaceae plant Fructus Forsythiae Forsythiasuspensa (Thunb.) Vahl, heat-clearing and toxic substances removing, and dispersing swelling and dissipating binds is used for carbuncle, scrofula, acute mastitis, erysipelas, anemopyretic cold, epidemic febrile disease is from the beginning of, warm joining the army, the hyperpyrexia excessive thirst, coma is sent out speckle, the pyretic stranguria urine retention; Radix Scutellariae is the dry root of labiate Radix Scutellariae Scutellariabaicalensis Georgi, heat clearing and damp drying, and eliminating fire and detoxication, hemostasis, antiabortive, be used for hygropyrexia, fever disease in summer vomiting and nausea uncomfortable in chest, damp and hot feeling of fullness, dysentery, jaundice, cough due to lung-heat, the hyperpyrexia excessive thirst, heat in blood is told nosebleed, carbuncle sore tumefacting virus, frequent fetal movement.Confirm that according to modern pharmacological research and zoopery these three kinds of Chinese medicines all have antibacterial action, and staphylococcus aureus, streptococcus pneumoniae, Hemolytic streptococcus, dysentery bacterium etc. are had certain inhibitory action.Three medicines share makes SHUANGHUANLIAN, have relieving the exterior syndrome with drugs of pungent in flavor and cool in nature, the effect of heat-clearing and toxic substances removing, can heat-clearing and toxic substances removing, gently declare expelling pathogenic factors from the exterior, be used for the treatment of the rheumatism heresy and defend or wind heat is closed the cold or diseases such as aversion to cold, the tachypnea of coughing, the yellow skin of coughing up phlegm, the red and swollen pain of pharynx not of heating, micro evil wind that lung causes at lung, and upper respiratory tract infection, acute bronchitis, acute tonsillitis, light-duty pneumonia etc.SHUANGHUANLIAN has multiple dosage form, comprise: aerosol, syrup, tablet, chew sheet, SHUANGHUANLIAN soft capsule, SHUANGHUANGLIAN KOUFUYE, SHUANGHUANGLIAN KELI, SHUANGHUANGLIAN ZHUSHEYE, mixture medicine of honeysuckle, forsythia and scutellaria baicalensis, SHUANGHUANLIAN bolt, SHUANGHUANGLIAN JIAONANG, SHUANGHUANGLIAN FENZHENJI, eye drop of double rhizoma coptidis, ZHUSHEYONG SHUANGHUANGLIAN lyophilizing etc., on the Chinese patent communique, also can retrieve many patent applications that relates to 'Shuang Hualian '; SHUANGHUANGLIAN KELI, SHUANGHUANGLIAN KOUFUYE have been listed version " Chinese pharmacopoeia (an one) in 2000 in, in the 'Shuang Hualian ' commonly used clinically now, with SHUANGHUANGLIAN ZHUSHEYE, SHUANGHUANGLIAN KOUFUYE, SHUANGHUANGLIAN KELI is many, wherein, SHUANGHUANGLIAN ZHUSHEYE patient uses inconvenience, anaphylaxis appears in individual patients, is difficult to accept for the patient; The preparation method of SHUANGHUANLIAN oral (granule) quality standard is that water decocts with the Radix Scutellariae section, adds hydrochloric acid solution adjusting pH value and makes precipitation, and precipitation washes with water, continue to be washed till pH value to 7.0 with 70% ethanol, and cold drying, standby; Flos Lonicerae, Fructus Forsythiae decoct with water, and are concentrated into thick paste, add ethanol and make and contain alcohol amount and reach 75%, fully stir, left standstill 12 hours, and the leaching supernatant, and be condensed into clear paste, and drying under reduced pressure is ground into fine powder with Radix Scutellariae extract, and refabrication becomes finished product.According to Chen Guangyao, people such as Long Jihong＜new Chinese medicine and clinical pharmacology the 15th the 2nd phase of volume of March in 2004 reports " seeing the Chinese medicine Study on Modernization from the SHUANGHUANLIAN preparation series ", " SHUANGHUANLIAN preparation series extraction process all is to continue to use the reppd method of water cooking liquid of former local standard, does not have the improvement of matter.And the modern study result shows, the active component of resisiting influenza virus mainly is a flavone aglycone in the Radix Scutellariae, and especially with 5,7,4 '-trihydroxy-8-methoxy flavone drug effect is the most obvious, and has tangible amount-result relation; Antibiotic and antiviral activity composition in the Fructus Forsythiae is the volatile oil in the seed.So for Radix Scutellariae and Fructus Forsythiae, the extraction process of employing decocting in water is obviously improper to the antibiotic and antiviral activity composition that extracts in the two ".Volatile ingredient in the prescription and other effective ingredient do not extract, " circulating a notice of Flos Lonicerae and pharmacological action thereof biology " report according to 2004 the 39th the 5th phases of volume, volatile ingredient in the Flos Lonicerae, linalool is arranged, methyl linoleate, phenethanol, eugenol, alpha-terpineol, tens of kinds of geraniol and phenethanol etc., these physical and chemical compositions are to staphylococcus aureus, Staphylococcus albus, Hemolytic streptococcus, pneumobacillus, meningococcus, Bacillus typhi, escherichia coli, multiple pathogenic microorganism such as dysentery bacterium and Bacillus proteus has resistant function; Antitoxin, antiinflammatory, refrigeration function are arranged; Can regulate body immunity; Blood fat reducing and antifertility etc.SHUANGHUANGLIAN KOUFUYE (granule), advantage is to be convenient to absorb, drug effect is rapid, bioavailability is better, but lose owing to volatile ingredient volatilizees in leaching process, the effective ingredient in the product reduces, thereby influences the curative effect of final products, oral liquid is placed the generation precipitation for a long time and is influenced its curative effect, makes the patient produce the situation of refusing to obey simultaneously.Though SHUANGHUANGLIAN JIAONANG has solved long-term placement and has produced sedimentary problem, make patient acceptant, extracted volatile oil on technology, still, it is after the volatile ingredient of medical material is extracted, directly be added in the fine powder of the water extracting component of medical material or alcohol extraction composition, make finished product, because the sealing of capsule is very poor, volatile ingredient overflows easily to loose and volatilizees, reduce the effective ingredient in the product, thereby also influence the curative effect of medicine.
Summary of the invention: the object of the present invention is to provide a kind of SHUANGHUANLIAN drop pill preparation and preparation thereof, to solve the problem that existing product exists; Preparation method provided by the invention can instruct enterprise effectively with its preparation; The present invention constitutes like this: SHUANGHUANLIAN drop pill preparation is to use Flos Lonicerae 1500g, Radix Scutellariae 1500g, Fructus Forsythiae 3000g is prepared from, it is made of medicine nuclear and integument, medicine nuclear is wrapped in the middle of the integument, wherein: medicine nuclear is to be made by volatile oil that extracts with Flos Lonicerae and Fructus Forsythiae and substrate, is its diameter 1? millimeter, integument is by other medical material: Radix Scutellariae and Flos Lonicerae, the fine powder that Fructus Forsythiae extracts the extract preparation of the medicinal residues extraction that obtains behind the volatile oil adds suitable adjuvant fine powder composition, shell is thick to be 0.5? millimeter, this product cross-section center is faint yellow, and integument is a sepia, be round body shape, is diameter 2? 7 millimeters; Can also outside integument, wrap up a coatings again.The substrate of making drop pill is water-soluble base and water-insoluble substrate, comprise: polyethylene glycols, the polyoxyethylene monostearate class, glycerin gelatine, sodium stearate, carbamide, water-soluble base and stearic acid such as poloxamer, glyceryl monostearate, insect wax, hydrogenated vegetable oil, octadecanol, the water-insoluble substrate of hexadecanol, the medicinal substances extract of integument can be Radix Scutellariae and Flos Lonicerae, Fructus Forsythiae extracts water extract or the Radix Scutellariae and the Flos Lonicerae of the medicinal residues that obtain behind the volatile oil, Fructus Forsythiae extracts the fine powder of the alcohol extract of the medicinal residues that obtain behind the volatile oil, preferably adopt Radix Scutellariae and Flos Lonicerae, Fructus Forsythiae extracts the alcohol extract of the medicinal residues that obtain behind the volatile oil and the fine powder of water extract, 80? 50 orders, can in integument, add conventional pharmaceutic adjuvant, the ratio of using is to mix 5～50% of the mixed powder gross weight that obtains with adjuvant by medicinal substances extract, and pharmaceutic adjuvant comprises starch, dextrin, Icing Sugar, lactose, mannitol, microcrystalline Cellulose, micropowder silica gel, pregelatinized Starch, calcium sulfate, calcium carbonate, calcium hydrogen phosphate, low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone, the chitin element.Its preparation method is: with Flos Lonicerae, Fructus Forsythiae pulverize separately, it is standby to extract volatile oil, and medicinal residues and Radix Scutellariae adopt prior art for preparing to get extract powder, add a certain amount of pharmaceutic adjuvant, and mix homogeneously gets mixed powder, and is standby; Get volatile oil, drop pill manufacture method with routine is prepared into drop pill, drop pill is inserted in the coating pan, spray wetting agent, wetting agent can select for use 0.1～50% binding agent to comprise solution of cellulose derivative, povidone solution, gelatin solution, gumwater, syrup, the mixture of starch slurry and G ﹠ W or Different concentrations of alcohol, be sprinkled into the extract powder that obtained and the mixed powder of pharmaceutic adjuvant, pill is increased, finish using until mixed powder, spray coating solution, coating solution comprises Gonak, hydroxypropyl cellulose solution, methocel solution, ethyl cellulose solution, polyglycol solution, the stomach dissolution type polyacrylic acid solution, povidone solution, Opadry solution, cellulose acetate phthalate ester solution, polyvinyl alcohol phthalate ester solution, methacrylic acid copolymer solution, cellulose acetate benzenetricarboxylic acid ester solution, hydroxypropyl cellulose phthalate ester solution, acrylic resin soln, promptly.Concrete method is: Flos Lonicerae, Fructus Forsythiae pulverize separately are become fine powder, extract volatile oil, volatile oil device is in addition collected, and standby, medicinal residues are standby; Medicinal residues and Radix Scutellariae are used soak with ethanol 12 hours, the reflux secondary, and each 2 hours, merge reflux extracting liquid, filter, medicinal residues are standby, and decompression filtrate recycling ethanol to there being the ethanol flavor, gets the alcohol extraction thick paste, and is standby; Medicinal residues heating evaporation ethanol makes medicinal residues not have the ethanol flavor, decocts with water then twice, each 1 hour, collecting decoction left standstill, filter, filtrate decompression is condensed into thick paste, merges with the alcohol extraction thick paste, drying under reduced pressure is ground into 120 order fine powders, gets extract powder, add low-substituted hydroxypropyl cellulose, addition be extract powder mix the mixed powder gross weight that obtains with low-substituted hydroxypropyl cellulose 7%, mix homogeneously, standby; The polyethylene glycol 6000 that takes by weighing 2.0 times of amounts of volatile oil fully stirs 60～100 ℃ of water-baths, to there not being bubble, 49～60 ℃ of water-baths are put in fusion fully then, and the volatile oil that extracts is added, fully stir, finish full-fusing to depletion of QI, splash into temperature and be in 0～5 ℃ the liquid paraffin, drip and make ball, promptly get drop pill, the about 2mm of diameter; Wipe the liquid paraffin on drop pill surface, insert in the coating pan, the coating pan temperature is controlled at 50～60 ℃, sprays 85% alcoholic solution as wetting agent, be sprinkled into mixed powder, pill is increased, powder to be mixed is finished using, the about 12mm of diameter, spray Opadry solution, coating promptly gets product.Alleged conventional preparation method or prior art etc. are meant disclosed textbook or disclosed methods such as national standard, provincial standard among the present invention.
Compared with prior art, SHUANGHUANLIAN drop pill provided by the invention, drawn both length of capsule and oral liquid (granule), the curative effect that has kept " SHUANGHUANGLIAN ZHUSHEYE ", for clinical application provides new selection: have taking convenience, safety, characteristics of high efficiency, improved extraction process, three flavors are contained antibiotic in the Chinese medicines, antiviral and antipyretic active component extract to greatest extent, increase antibiotic and antiviral composition in the product, raising is to bacillary and curative effect viral infection, with existing extracting method the volatile ingredient in the medical material is extracted earlier, the extract of volatile ingredient is made drop pill with suitable substrate, the extract that contains volatile ingredient is dissolved in the substrate, and volatile ingredient is molecularity in substrate, absorbs easily, effect is rapid, solved that existing oral liquid (granule) does not extract volatile ingredient and the drawback that reduces curative effect of medication has also solved oral liquid to produce precipitation and influence its curative effect, made the patient produce the problem of refusing to obey simultaneously.Having prevented that volatile ingredient in the common capsule from overflowing looses and makes the generation of phenomenon such as effective ingredient reduction.The water extracting component of medical material or alcohol extraction composition are wrapped in outside the drop pill, increase outer field integument, can effectively prevent overflow loosing of volatile ingredient, prevent light and air, moisture content destruction the character labile drug, stability of drug is increased, and the effectiveness of medicine strengthens.Drop pill disintegrate provided by the invention is very rapid, has shortened the disintegration of pill relatively; After measured in 20 minutes with regard to disintegrate, bioavailability is high.
Technological core of the present invention is that the volatile ingredient with medical material extracts and at first makes drop pill, outside parent nucleus is wrapped in the mixed powder of the fine powder of other medicinal substances extract and adjuvant, makes the SHUANGHUANLIAN drop pill again.
The SHUANGHUANLIAN drop pill is compared with oral liquid with capsule, and drop pill has been got the advantage of capsule and oral liquid, has overcome their deficiencies separately, makes the dosage form optimization.Do the heart with drop pill, extracted the volatile ingredient that contains in the prescription, drug effect is enhanced, improve bioavailability; Other medicinal substances extract is done adjuvant directly to be wrapped in outside the drop pill, prevent that overflowing of volatile ingredient is diffusing, reached the purpose of ensuring the quality of products, improving curative effect, reduce consumption, simultaneously, owing to increase outer field integument, can effectively prevent light and air, moisture content destruction to the character labile drug, stability of drug is increased, the effectiveness of medicine strengthens, and makes that medicine is easier to be taken, and allows the patient accept; The modern outstanding feature of Chinese medicine preparation should be " safe, effective, controlled, stable ", this is people in the industry's a basic Consensus, the existing pharmaceutical preparation that appears as of SHUANGHUANLIAN drop pill has increased a kind of new dosage form, reach the unification of preparation and clinical efficacy, this dosage form can better meet the needs in society, market, preparation method provided by the invention can be prepared a heart preparation that needs preferably, and technology is simple, reasonable; Reach the purpose of invention, solved the problem that the existing product preparation exists.
Be the contrast situation of three kinds of dosage forms below, from comparing result: product provided by the invention more rationally, advantage is obvious.
| Dosage form | Character | Disintegration or bioavailability |
| Capsule | Do not extract volatile ingredient, the medicinal material extract effective ingredient is incomplete, it is few that unit volume contains the medicine effective ingredient, and volatile ingredient overflows easily and looses. | Disintegrate is general, in 30 minutes.The difficult absorption, effect is slow, weak effect. |
| Oral liquid | Do not extract volatile ingredient, the medicinal material extract effective ingredient is incomplete, it is few that unit volume contains the medicine effective ingredient, the adjuvant amount is few, volatile ingredient is volatile, puts for a long time to produce precipitation. | Easily absorb, effect is fast, and it is poor to act on. |
| Drop pill | Extracts active ingredients is complete, and the adjuvant amount is few, and it is many that unit volume contains the medicine effective ingredient, and volatile ingredient is not volatile. | Disintegrate is fast, in 20 minutes.Easily absorb, effect is fast. |
The drop pill substrate of using in preparation medicine when nuclear among the present invention comprises water-soluble base and water-insoluble substrate, and commonly used have water-soluble basees such as polyethylene glycols, polyoxyethylene monostearate class, glycerin gelatine, sodium stearate, carbamide, poloxamer; Water-insoluble substrate has stearic acid, glyceryl monostearate, insect wax, hydrogenated vegetable oil, octadecanol, hexadecanol etc.The present invention's usefulness water solublity mixes the substrate as drop pill with water-insoluble substrate, meltage in the time of can increasing drug melt, two kinds of substrate that dissolubility is different, have the polarity and the dielectric constant that differ bigger, can be adjusted to polarity and the dielectric constant close mutually with medicine, thereby increase the meltage of medicine, play the effect that double solvents improves dissolubility, mixed-matrix also can loose the time limit in order to regulate dissolution rate or solution.Condensed fluid must be safe and harmless, and commonly used have liquid Paraffin, vegetable oil, methyl-silicone oil, Different concentrations of alcohol and a water etc.
In order to confirm the effectiveness of SHUANGHUANLIAN drop pill, the applicant has carried out relevant experiment, proves advance, reasonability and the effectiveness of this product: select for use SHUANGHUANLIAN drop pill, SHUANGHUANGLIAN KELI to carry out the antibacterial action comparative experiments:
The antibacterial action of SHUANGHUANLIAN drop pill
Purpose: the antibacterial action of observing the SHUANGHUANLIAN drop pill.Method: observe the SHUANGHUANLIAN drop pill to the vitro antibacterial activities of 6 kinds of antibacterials such as golden Portugal bacterium and to the protective effect of golden Portugal bacterium infecting mouse.The result: the SHUANGHUANLIAN drop pill has in various degree inhibitory action to 6 kinds of antibacterials such as golden Portugal bacterium, and golden Portugal bacterium infecting mouse is had protective effect.Conclusion: middle dosage and high dose SHUANGHUANLIAN drop pill group and SHUANGHUANGLIAN KELI group relatively have therapeutical effect preferably to the mice of bacterial infection.
1 experiment material
1 medicine: the SHUANGHUANLIAN drop pill, Ma Cuiping provides.During test drop pill is ground into powder, is made into desired concn with distilled water.SHUANGHUANGLIAN KELI, commercially available.
1.2 bacterial strain: golden Portugal bacterium, Diplococcus pneumoniae, bacillus pyocyaneus, escherichia coli, Bacillus typhi, Candida albicans etc. are clinical isolates, are provided by Guiyang Medical College.All by the well-established law preparation, constant temperature is preserved standby for ordinary broth, plain agar flat board, blood agar flat board.
2 methods and result
2.1 external bacteriostasis: SHUANGHUANLIAN drop pill and SHUANGHUANGLIAN KELI are prepared into 15% medicinal liquid (containing crude drug 150mg/ml) respectively as stock solution, adopt 2 times of dilution methods of test tube, medicine is done 1: 2,1: 4,1: 8 with broth bouillon ... dilution (PH no change), every pipe is 2.0ml, inoculation bacterium liquid 0.1ml (about 105CFU/ml～107CFU/ml), cultivate 18h～24h for 37 ℃ behind the abundant mixing, other establishes blank pipe (pastille does not contain bacterium) and own control pipe (not containing the bacterium pastille), and each bacterial strain is all done parallel test (seeing Table 1).
Table 1 SHUANGHUANLIAN drop pill bacteriostatic experiment result
| Experimental strain | Bacterial strain number (strain) | The antibacterial contrast | Own control | ?????????????MIC(mg/ml) | |
| SHUANGHUANGLIAN KELI | The SHUANGHUANLIAN drop pill | ||||
| Staphylococcal pneumonia coccus escherichia coli bacillus pyocyaneus Bacillus typhi Candida albicans | ????20 ????20 ????20 ????10 ????10 ????20 | ????+ ????+ ????+ ????+ ????+ ????+ | ????- ????- ????- ????- ????- ????- | ????9.38 ????35.5 ????4.69 ????75.0 ?????- ????9.38 | ????7.31 ????30.5 ????3.58 ????55.0 ????10.12 ????9.38 |
Experimental result shows, except that Bacillus typhi, SHUANGHUANLIAN drop pill and SHUANGHUANGLIAN KELI all have in various degree vitro inhibition effect to the growth of other 6 kinds of experimental bacteria, and wherein the growth to golden Portugal bacterium, escherichia coli, Candida albicans has stronger inhibitory action, its minimal inhibitory concentration (MIC, mg/ml) be respectively 3.58 and 7.31, next is a Candida albicans, and MIC is 9.38, Bacillus typhi, MIC is 10.12, to the bacteriostasis of bacillus pyocyaneus a little less than.The bacteriostasis of SHUANGHUANLIAN drop pill and SHUANGHUANGLIAN KELI is similar, and the SHUANGHUANLIAN drop pill is strong than SHUANGHUANGLIAN KELI.
2.2 vivo bacteria corrosion action: bacterium liquid preparation: get the bacterium culture and be inoculated in the 2ml fluid medium in vitro, cultivate 18h for 37 ℃, culture is standby with the bacteria suspension that the gastric Mucin suspension is diluted to suitable concentration.Get 100 of mices, male and female half and half are divided into 5 groups at random, 20 every group.Every mouse peritoneal injection 109CFU/ml gold bacterium 0.2ml/10g of Portugal (causing the amount of bacteria of mice 80%～100% death), gavage distilled water (blank), SHUANGHUANGLIAN KELI 10g/kg (containing crude drug), SHUANGHUANLIAN drop pill 5g/kg, 10g/kg, 20g/kg (containing crude drug) behind the 1h respectively, capacity is 0.2ml/10g; 1d1 time, successive administration 3d writes down mouse invasion and death condition every day, observes 7d continuously, statistics mouse death rate (table 2).
The influence of table 2 pair infection staphylococcus aureus mouse death rate
| Group | Dosage (g/kg) | Number of animals (only) | Existence number (only) | Death toll (only) | ||
| Blank group SHUANGHUANGLIAN KELI group SHUANGHUANLIAN drop pill group | ???? ????10.0 ????5.0 ????10.0 ????20.0 | ????20 ????20 ????20 ????20 ????20 | ????3 ????12 ????10 ????12 ????14 | ????17 ????8 ????10 ????8 ????6 | 85 40 *50 *40 *30 * | ??????? ?52.9 ?41.2 ?52.9 ?64.7 |
* compare with the blank group: * P＜0.05, * * P＜0.01
Other gets 100 of mices, and grouping, medication and experimental technique are the same, and mice is lumbar injection 106CFU/ml Diplococcus pneumoniae (causing the amount of bacteria of mice 80%～100% death) 0.2ml/10g (table 3) respectively.
The influence of table 3 pair infection staphylococcus aureus mouse death rate
| Group | Dosage (g/kg) | Number of animals (only) | Existence number (only) | Death toll (only) | ||
| Blank group SHUANGHUANGLIAN KELI group SHUANGHUANLIAN buccal tablet group | ???? ????10.0 ????5.0 ????10.0 ????20.0 | ??20 ??20 ??20 ??20 ??20 | ??4 ??14 ??11 ??14 ??15 | ????16 ????7 ????9 ????6 ????5 | 80 35** 55** 30** 25** | ???????? 56.3 43.8 62.5 68.8 |
Experimental result shows, after the mice that infects above-mentioned 2 kinds of antibacterials was taken SHUANGHUANLIAN, its mortality rate was starkly lower than distilled water blank group mice and shows after SHUANGHUANLIAN drop pill and SHUANGHUANGLIAN KELI are to mouse infection staphylococcus aureus and Diplococcus pneumoniae all have protective effect.
3, conclusion
SHUANGHUANLIAN is traditional prescription of China's Chinese medicine, uses for many years clinically.Be widely used at present various infection that antibacterial, virus cause clinically and by the heating due to infecting, clinical common dosage forms mainly contains SHUANGHUANGLIAN KOUFUYE, tablet and granule.Novel form SHUANGHUANLIAN drop pill of the present invention has and uses conveniently, and the medical material extracts active ingredients is complete, characteristics such as single dose substrate concentration height.Above result of the test shows: the SHUANGHUANLIAN drop pill has certain inhibitory action to 6 kinds of antibacterials such as staphylococcus aureus, Diplococcus pneumoniaes.In the interior bacteriostatic test of SHUANGHUANLIAN drop pill body, can obviously reduce and infect staphylococcus aureus, Diplococcus pneumoniae mouse death rate, showing that at middle dosage and high dose group the therapeutic effect of SHUANGHUANLIAN drop pill is better than the SHUANGHUANGLIAN KELI agent, is an effective antibiotic new drug, has the good clinical using value.
The specific embodiment
Embodiments of the invention 1: take by weighing Flos Lonicerae 1500g, Radix Scutellariae 1500g, Fructus Forsythiae 3000g
Flos Lonicerae, Fructus Forsythiae pulverize separately are become fine powder, CO
2Supercritical fluid extraction volatile oil, volatile oil device are in addition collected, and standby, medicinal residues are standby; Medicinal residues and Radix Scutellariae are used soak with ethanol 12 hours, the reflux secondary, and each 2 hours, merge reflux extracting liquid, filter, medicinal residues are standby, and decompression filtrate recycling ethanol to there being the ethanol flavor, gets the alcohol extraction thick paste, and is standby; Medicinal residues heating evaporation ethanol makes medicinal residues not have the ethanol flavor, decocts with water then twice, each 1 hour, collecting decoction left standstill, filter, filtrate decompression is condensed into thick paste, merges with the alcohol extraction thick paste, drying under reduced pressure is ground into 120 order fine powders, gets extract powder, add low-substituted hydroxypropyl cellulose 70g, mix homogeneously gets mixed powder, and is standby; The polyethylene glycol 6000 that takes by weighing 3.0 times of amounts of volatile oil fully stirs 60～100 ℃ of water-baths, to not having bubble, fusion fully, put 49～60 ℃ of water-baths then, the volatile oil that extracts is added, fully stir, finish full-fusing to depletion of QI, splash into temperature and be in 0～5 ℃ the liquid paraffin, drip and make ball, about 2000, collect drop pill with white oil, promptly get drop pill, the about 3mm of diameter; Wipe the liquid paraffin on drop pill surface, insert in the coating pan, the coating pan temperature is controlled at 50～60 ℃, sprays 85% alcoholic solution as wetting agent, be sprinkled into mixed powder, pill is increased, and powder to be mixed is finished using, and the parcel bed thickness is 2.5mm, spray Opadry solution, coating promptly gets product, the about 8mm of diameter.
Embodiments of the invention 2: take by weighing Flos Lonicerae 1500g, Radix Scutellariae 1500g, Fructus Forsythiae 3000g; Flos Lonicerae, Fructus Forsythiae pulverize separately are become fine powder, use steam distillation, extract volatile oil, volatile oil device is in addition collected, and is standby, and medicinal liquid, medicinal residues are standby; Medicinal residues evaporate to dryness moisture content is used soak with ethanol 12 hours with Radix Scutellariae, the reflux secondary, and each 2 hours, merge reflux extracting liquid, filter, medicinal residues are standby, and decompression filtrate recycling ethanol to there being the ethanol flavor, gets the alcohol extraction thick paste, and is standby; Medicinal residues heating evaporation ethanol makes medicinal residues not have the ethanol flavor, decocts with water then twice, each 1 hour, collecting decoction and the remaining medicinal liquid of extraction volatile oil left standstill, filter, filtrate decompression is condensed into thick paste, merges with the alcohol extraction thick paste, drying under reduced pressure is ground into 120 order fine powders, gets extract powder, add carboxymethyl starch sodium 50g, mix homogeneously gets mixed powder, and is standby; The polyethylene glycol 6000 that takes by weighing 5.0 times of amounts of volatile oil fully stirs 60～100 ℃ of water-baths, to not having bubble, fusion fully, put 49～60 ℃ of water-baths then, the volatile oil that extracts is added, fully stir, finish full-fusing to depletion of QI, splash into temperature and be in 0～5 ℃ the liquid paraffin, drip and make ball, about 1000, collect drop pill with dimethicone, promptly get drop pill, the about 7mm of diameter; Wipe the dimethicone on drop pill surface, insert in the coating pan, the coating pan temperature is controlled at 50～60 ℃, spray 3% Eudragit E solution, as wetting agent, be sprinkled into mixed powder, pill is increased, powder to be mixed is finished using, the parcel bed thickness is 5mm, sprays 3% Eudragit E solution, coating, promptly get product, the about 17mm of diameter.
Embodiments of the invention 3: take by weighing Flos Lonicerae 1500g, Radix Scutellariae 1500g, Fructus Forsythiae 3000g; Flos Lonicerae, Fructus Forsythiae pulverize separately are become fine powder, extract volatile oil, volatile oil device is in addition collected, and is standby, and medicinal liquid, medicinal residues are standby; Medicinal residues evaporate to dryness moisture content is used soak with ethanol 12 hours with Radix Scutellariae, the reflux secondary, and each 2 hours, merge reflux extracting liquid, filter, medicinal residues are standby, and decompression filtrate recycling ethanol to there being the ethanol flavor, gets the alcohol extraction thick paste, and is standby; Medicinal residues heating evaporation ethanol makes medicinal residues not have the ethanol flavor, decocts with water then twice, each 1 hour, collecting decoction and the remaining medicinal liquid of extraction volatile oil left standstill, filter, filtrate decompression is condensed into thick paste, merges with the alcohol extraction thick paste, drying under reduced pressure is ground into 120 order fine powders, gets extract powder, add carboxymethyl starch sodium 50g, mix homogeneously gets mixed powder, and is standby; The polyethylene glycol 6000 that takes by weighing 1.0 times of amounts of volatile oil fully stirs 60～100 ℃ of water-baths, to not having bubble, fusion fully, put 49～60 ℃ of water-baths then, the volatile oil that extracts is added, fully stir, finish full-fusing to depletion of QI, splash into temperature and be in 0～5 ℃ the liquid paraffin, drip and make ball, about 4000, collect drop pill with dimethicone, promptly get drop pill, the about 1mm of diameter;
4. wipe the dimethicone on drop pill surface, insert in the coating pan, the coating pan temperature is controlled at 50～60 ℃, spray 3% Eudragit E solution, as wetting agent, be sprinkled into mixed powder, pill is increased, powder to be mixed is finished using, the parcel bed thickness is 0.5mm, sprays 3% Eudragit E solution, coating, promptly get product, the about 2mm of diameter.
Claims (5)
1. SHUANGHUANLIAN drop pill preparation, it is characterized in that: use Flos Lonicerae 1500g, Radix Scutellariae 1500g and Fructus Forsythiae 3000g are prepared from, it is made of medicine nuclear and integument, medicine nuclear is wrapped in the middle of the integument, wherein: medicine nuclear is to be made by volatile oil that extracts with Flos Lonicerae and Fructus Forsythiae and substrate, is its diameter 1? millimeter, integument is by other medical material: Radix Scutellariae and Flos Lonicerae, the fine powder that Fructus Forsythiae extracts the extract preparation of the medicinal residues extraction that obtains behind the volatile oil adds suitable adjuvant fine powder composition, shell is thick to be 0.5? millimeter, the product cross-section center is faint yellow, and integument is a sepia, be round body shape, is diameter 2? 7 millimeters.
2. according to the described SHUANGHUANLIAN drop pill of claim 1 preparation, it is characterized in that: outside integument, wrap up a coatings again.
3. according to the described SHUANGHUANLIAN drop pill of claim 1 preparation, it is characterized in that: the substrate that preparation medicine nuclear uses is water-soluble base or water-insoluble substrate, comprise: polyethylene glycols, the polyoxyethylene monostearate class, glycerin gelatine, sodium stearate, carbamide, water-soluble base that poloxamer is such or stearic acid, glyceryl monostearate, insect wax, hydrogenated vegetable oil, octadecanol, the water-insoluble substrate that hexadecanol is such, the medicinal substances extract of integument can be Radix Scutellariae and Flos Lonicerae, Fructus Forsythiae extracts water extract or the Radix Scutellariae and the Flos Lonicerae of the medicinal residues that obtain behind the volatile oil, Fructus Forsythiae extracts the fine powder of the alcohol extract of the medicinal residues that obtain behind the volatile oil, 80? 50 orders, can in integument, add conventional pharmaceutic adjuvant, the ratio of using is to mix 5～50% of the mixed powder gross weight that obtains with adjuvant by medicinal substances extract, and pharmaceutic adjuvant comprises starch, dextrin, Icing Sugar, lactose, mannitol, microcrystalline Cellulose, micropowder silica gel, pregelatinized Starch, calcium sulfate, calcium carbonate, calcium hydrogen phosphate, low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone, the chitin element.
4. the preparation method of SHUANGHUANLIAN drop pill preparation as claimed in claim 1 or 2 is characterized in that: with Flos Lonicerae, Fructus Forsythiae pulverize separately, it is standby to extract volatile oil, medicinal residues and Radix Scutellariae adopt prior art for preparing to get extract powder, add a certain amount of pharmaceutic adjuvant, mix homogeneously, get mixed powder, standby; Get volatile oil, drop pill manufacture method with routine is prepared into drop pill, drop pill is inserted in the coating pan, spray wetting agent, wetting agent can select for use 0.1～50% binding agent to comprise solution of cellulose derivative, povidone solution, gelatin solution, gumwater, syrup, the mixture of starch slurry and G ﹠ W or Different concentrations of alcohol, be sprinkled into the extract powder that obtained and the mixed powder of pharmaceutic adjuvant, pill is increased, finish using until mixed powder, spray coating solution, coating solution comprises Gonak, hydroxypropyl cellulose solution, methocel solution, ethyl cellulose solution, polyglycol solution, the stomach dissolution type polyacrylic acid solution, povidone solution, Opadry solution, cellulose acetate phthalate ester solution, polyvinyl alcohol phthalate ester solution, methacrylic acid copolymer solution, cellulose acetate benzenetricarboxylic acid ester solution, hydroxypropyl cellulose phthalate ester solution, acrylic resin soln, promptly.
5. according to the preparation method of the described SHUANGHUANLIAN drop pill of claim 4 preparation, it is characterized in that: concrete method is: Flos Lonicerae, Fructus Forsythiae pulverize separately are become fine powder, extract volatile oil, volatile oil device is in addition collected, and standby, medicinal residues are standby; Medicinal residues and Radix Scutellariae are used soak with ethanol 12 hours, the reflux secondary, and each 2 hours, merge reflux extracting liquid, filter, medicinal residues are standby, and decompression filtrate recycling ethanol to there being the ethanol flavor, gets the alcohol extraction thick paste, and is standby; Medicinal residues heating evaporation ethanol makes medicinal residues not have the ethanol flavor, decocts with water then twice, each 1 hour, collecting decoction left standstill, filter, filtrate decompression is condensed into thick paste, merges with the alcohol extraction thick paste, drying under reduced pressure is ground into 120 order fine powders, gets extract powder, add low-substituted hydroxypropyl cellulose, addition be extract powder mix the mixed powder gross weight that obtains with low-substituted hydroxypropyl cellulose 7%, mix homogeneously, standby; The polyethylene glycol 6000 that takes by weighing 2.0 times of amounts of volatile oil fully stirs 60～100 ℃ of water-baths, to there not being bubble, 49～60 ℃ of water-baths are put in fusion fully then, and the volatile oil that extracts is added, fully stir, finish full-fusing to depletion of QI, splash into temperature and be in 0～5 ℃ the liquid paraffin, drip and make ball, promptly get drop pill, diameter 2mm; Wipe the liquid paraffin on drop pill surface, insert in the coating pan, the coating pan temperature is controlled at 50～60 ℃, sprays 85% alcoholic solution as wetting agent, be sprinkled into mixed powder, pill is increased, powder to be mixed is finished using, the about 12mm of diameter, spray Opadry solution, coating promptly gets product.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410155556 CN1660332A (en) | 2004-12-22 | 2004-12-22 | Drop pills preparation of dual goldthread root and preparation method |
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200410155556 CN1660332A (en) | 2004-12-22 | 2004-12-22 | Drop pills preparation of dual goldthread root and preparation method |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103919859A (en) * | 2014-03-19 | 2014-07-16 | 吉林修正药业新药开发有限公司 | Liver protection and choleresis traditional Chinese medicine composition and preparation method thereof |
| CN113116997A (en) * | 2021-04-30 | 2021-07-16 | 贵州汉方药业有限公司 | Preparation method of storax pills |
| CN113413369A (en) * | 2021-04-30 | 2021-09-21 | 贵州汉方药业有限公司 | Preparation method of flexible rejuvenation pills for children |
| CN113633733A (en) * | 2021-04-30 | 2021-11-12 | 贵州汉方药业有限公司 | A kind of preparation method of gynecological rejuvenation pill |
-
2004
- 2004-12-22 CN CN 200410155556 patent/CN1660332A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103919859A (en) * | 2014-03-19 | 2014-07-16 | 吉林修正药业新药开发有限公司 | Liver protection and choleresis traditional Chinese medicine composition and preparation method thereof |
| CN113116997A (en) * | 2021-04-30 | 2021-07-16 | 贵州汉方药业有限公司 | Preparation method of storax pills |
| CN113413369A (en) * | 2021-04-30 | 2021-09-21 | 贵州汉方药业有限公司 | Preparation method of flexible rejuvenation pills for children |
| CN113633733A (en) * | 2021-04-30 | 2021-11-12 | 贵州汉方药业有限公司 | A kind of preparation method of gynecological rejuvenation pill |
| CN113116997B (en) * | 2021-04-30 | 2022-10-21 | 贵州汉方药业有限公司 | Preparation method of storax pills |
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