CN1112439A - Chinese medicine for diabetes and its preparation - Google Patents

Abstract

A preparation for diabetes consists of animal pancreas, balsom pear, pumpkin, root of astragalus membranaceus and rhizome of dioscorea, in which the pancreas is smashed and dried, balsom pear, pumpkin and root of astragalus membranaceus are extracted with water or alcohol, then the materials are mixed with the dioscorea powder, and has effect of improving immunocompetence, promoting insulin secretion and reducing the blood sugar.

Description

Chinese medicine for diabetes and its preparation

The present invention relates to a kind of production method for the treatment of Chinese medicine and this Chinese medicine thereof of diabetes.

Diabetes are a kind of whole body chronic progressive diseases, modern medicine thinks that its cause of disease is because pancreatic secretion, the absolute shortage of insulin or relative deficiency and due to the carbohydrate metabolism disturbance that causes, so at its etiological study with released many Western medicine, as metformin, diamicron, plain tablet of Chlorpropamidum and insulin injection etc., the weak point that these Western medicine exist is a complex manufacturing, cost is higher, and Western medicine is temporary transient blood sugar lowering for the effect for the treatment of diabetes mostly, can not effect a radical cure, the side effect in addition that has, many people rely on Western medicine and injection for a long time, development that can not disease controlling, in case disconnected medicine, blood glucose again can very fast risings, the dose of use is increasing.

China's tradition Chinese medicine also had many records to diabetes (diabetes), think that the symptom that diabetes occur is that thirsty polydipsia, rapid digestion of food are easily hungry, frequent micturition and sweet, body sees gradually and becomes thin that reason is YIN fluid deficiency, production of dryness-heat in the interior, is this with the deficiency of YIN, scorching for marking, also adopted some prescriptions and therapeutic scheme in some Chinese medicine handbooks and Chinese medicine textbook, but some compatibility of medicines in a prescription are reasonable not enough, effect is not satisfactory.

The purpose of this invention is to provide and a kind ofly make, can prevent, control, support medicine and this medicine production method of three bonded effective treatment diabetes with natural Chinese medicine.

The present invention is the proved recipe that treatment of diabetes basis is proposed according to Chinese medicine and makes a kind of Chinese patent medicine that its composition and content, production method, the mechanism of action and clinical practice are discussed below:

One, Main Ingredients and Appearance and content (by dried medical material weight %):

The pancreas 20-45 of pig or cattle, sheep

Fructus Momordicae charantiae 18-32

Rhizoma Dioscoreae 10-28

Fructus Cucurbitae moschatae 15-25

Radix Astragali 10-26

Two, production method

1, the pancreas of getting pig or cattle, sheep is cleaned, and removes fat and connective tissue, rubs with meat grinder, in 50-80 ℃ of drying under reduced pressure, is ground into powder again, and is standby.

2, get dried Frutus Momordicae Charantiae, dried pumpkin, Radix Astragali chopping, mix, employing water extraction or separating out alcohol method extraction active ingredient are called water extract or alcohol is analysed thing, and water extraction is mixture to be added water 5-6 doubly earlier, soaked 4-8 hour, decoct secondary, each 1 hour, collecting decoction, filter, filtrate is evaporated to the clear paste that relative density is 1.2-1.4 60-80 ℃ temperature.Separating out alcohol method is that the solution that leaches steams ethanol, obtains the solution I with mixture alcohol solution dipping 4-10 hour with 2-3 70-80% doubly; Filtering residue discards residue with 2 times of water boils 1 hour, obtains the solution II, and solution I and solution II are merged, and is evaporated to the clear paste that relative density is 1.2-1.4.

3, get Rhizoma Dioscoreae clean, dry, be ground into middle powder after expanded, standby.

4, getting the above-mentioned pig that makes, cattle, Pancreas caprae seu ovis powder mixes with spissated clear paste and Rhizoma Dioscoreae powder, the antiseptic such as sorbic acid or the sorbate etc. that add 0.3-0.5%, stir, the low-temperature reduced-pressure drying, pulverize 100 mesh sieves, sterilization, made tablet or capsule, obtained product (declaration nomenclature of drug " blood sugar lowering is happy "), also can be with pig, cattle, Pancreas caprae seu ovis powder, Rhizoma Dioscoreae powder, the extracting solution of an amount of antiseptic and dried pumpkin, dried Frutus Momordicae Charantiae, the Radix Astragali is made the paste product.

Three, usage

Take above-mentioned " blood sugar lowering happy " tablet that makes or electuary, unguentum for the patient of diabetes after diagnosing, each 2-4 gram, every day 3-4 time, pass through provincial hospital and medical university's clinical verification, prove that this Chinese patent medicine has supplementing QI for promoting the production of body fluid, spleen invigorating is moisturized, the taste lung reinforces the kidney, the function of nourishing YIN to lower pathogenic fire has significant blood sugar lowering effect.

Four, the present invention " blood sugar lowering happy " prevents and treats diabetes mechanism

1, the pancreas of animal pancreas, particularly pig, cattle, sheep, the property sugariness is flat, has nourishing yin and moistening dryness.In the Compendium of Material Medica that Ming Dynasty's Li Shizhen (1518-1593 A.D.) is shown, once introduced the effect that to treat diabetes, the meaning that " dirty with dirty benefit " arranged, the modern biochemistry analysis result, be rich in trypsin, Chymotrypsin in the animal pancreas, kallikrein, elastoser, glucagon isoreactivity composition so Chinese medicine of the present invention is Main Ingredients and Appearance with the animal pancreas, can play the effect of treatment diabetes.

2, (China's the South and the North all has cultivation to Fructus Momordicae charantiae, go into greengrocery), its bitter in the mouth is cold in nature, clearing away heat-fire is arranged, the Detoxication of promoting the production of body fluid, analyze the Charantin that includes through the inventor similar insulin-like material is arranged, tangible blood sugar reducing function is arranged, also prove in pharmacological evaluation, rabbit normal and the alloxan hyperglycemia gavages Succus Momordicae charantiae, blood glucose is obviously reduced, the rat that subcutaneous injection anterior pituitary extractum causes hyperglycemia, the water extract that gavages Succus Momordicae charantiae also has the blood sugar lowering effect, but gives the oral Charantin blood sugar lowering of rabbit model of action similar to tolbutamide and stronger, so the present invention as accessory drugs, acts on bigger with Fructus Momordicae charantiae.

3, Fructus Cucurbitae moschatae, cucurbitaceous plant (Cucurbita moschata), sweet in the mouth, warm in nature, invigorating the spleen and replenishing QI is arranged, the effect of anti-inflammatory analgetic and promotion insulin secretion, the inventor analyzes, be rich in trace element cobalt in the Fructus Cucurbitae moschatae, can make insulin secretion normal, diabetics is produced effect, in medicine, add and to play the collaborative blood sugar reducing function that strengthens, and the tonification effect of Fructus Cucurbitae moschatae, can enhancing human body immunity function, add and be used as medicine, play auxiliary principal agent performance pharmacological action.

4, Rhizoma Dioscoreae, have another name called Rhizomadioscoreae, nature and flavor are sweet flat, tool spleen invigorating, tonifying the lung, reinforce the kidney the merit of benefit essence, disease such as control diarrhea due to hypofunction of the spleen, chronic dysentery, asthenia, quench one's thirst, modern pharmacological research shows that the Chinese yam polysaccharide composition is in methanol one water, and extract can play the effect that reduces mouse blood sugar concentration.

5, the Radix Astragali, Radix Astragali beginning is stated from Shennong's Herbal, nature and flavor are sweet, tepor, nontoxic, go into lung, spleen channel, and benefit defends consolidating superficial resistance, inducing diuresis to remove edema, detoxification, functions such as granulation promoting, disease such as control spontaneous perspiration, blood low, floating lung, internal injury strain, deficiency of vital energy blood prostration, quench one's thirst.Modern study shows, the Radix Astragali and polysaccharide, can resist immunosuppressant, the immunologic function of activate immunity organ significantly improves antibody forming cell's number, strengthen humoral immune function, enhancing antibody is synthetic, promotes nucleus ribosomal ribonucleic acid and protein metabolism, can improve the content of secreting type immune protein A, stimulate lymphocyte transformation, improve adrenal cortex function.

Though the Radix Astragali hot dryness-fire warm in nature.But add the bitter cold of Fructus Momordicae charantiae antidotal restriction is arranged in being used as medicine, thereby avoid the scorching fraud of the Radix Astragali, help to make the property of medicine gentle, obey for a long time and do not have a hot side effect.

The present invention has supplementing QI for promoting the production of body fluid through selected above-mentioned five tastes medicine, and spleen invigorating is moisturized, the nourishing YIN to lower pathogenic fire effect, and the human body immunity improving function is arranged, promote insulin secretion, the effect of blood sugar lowering.Compare with Western medicine, Western medicine is blood sugar lowering and the interim interior insulin of body that increases temporarily, can not impel the function of pancreas itself to improve, and promptly a lot of Western medicine can only take stopgap measures, and can not effect a permanent cure.And the present invention can take stopgap measures, and can effect a permanent cure again.And medicine composition of the present invention is natural materials, and the source is wide, and cost is low, medicine-food two-purpose, no side effects.

Five, embodiments of the invention:

1, medicine pretreatment

Get pig, cattle, the Pancreas caprae seu ovis, clean of fresh or refrigerated no pathological changes, remove fat and connective tissue, rub,, be ground into fine powder again in 50-80 ℃ of drying under reduced pressure with meat grinder, standby.

Get fresh pumpkin, Fructus Momordicae charantiae, enucleation, thinly slice, dry or use the drying machine drying naturally.

Gather Rhizoma Dioscoreae, remove mud, cleaning, drying are ground into powder after expanded.

Gather the Radix Astragali, clean, chip drying is ground into middle powder.

2, medication preparation embodiment:

Embodiment one

Get dried pumpkin 250 grams, dried Frutus Momordicae Charantiae 220 grams, the Radix Astragali 130 grams, adding water earlier soaked 6 hours for 2 liters, decocted 1 hour, solution poured in the container stock, adding 1.5 liters in water again boiled 1 hour, solution and primary solution are mixed, be evaporated to the clear paste that relative density is 1.2-1.4, get Pancreas Sus domestica powder 250 grams, Rhizoma Dioscoreae powder 150 grams, potassium sorbate 0.3 gram (the most handy low amounts of water dissolving) and clear paste mixing, drying under reduced pressure was pulverized 100 mesh sieves, sterilized 3-5 minute, incapsulate, be " blood sugar lowering is happy " oral capsule.

Embodiment two, get dried pumpkin 200 grams, dried Frutus Momordicae Charantiae 240 grams, astragalus membranaceus powder 180 grams add 2 liters in water, soak 1 hour after-filtration of decoction in 4 hours and go out medicinal residues, add 2 premium on currency again and boil 1 hour collecting decoction, filtrate decompression is concentrated into the clear paste that relative density is 1.2-1.4, and other gets Pancreas Bovis seu Bubali powder 280 grams, Rhizoma Dioscoreae powder 100 grams, sorbic acid 0.35 gram, with the clear paste mixing, drying under reduced pressure, pulverize, sieve, sterilize 5 minutes, be pressed into tablet, be " blood sugar lowering happy " oral tablet.

Embodiment three, get dried pumpkin 150 grams, dried Frutus Momordicae Charantiae 180 grams, the Radix Astragali 180 grams, the method for pressing embodiment one and embodiment two is soaked the back and is decocted at twice with 3 premium on currency, the filtrate decompression that merges is concentrated into the clear paste that relative density is 1.2-1.4, gets Pancreas caprae seu ovis powder 350 grams again, Rhizoma Dioscoreae powder 140 grams, potassium sorbate 0.4 gram (the most handy low amounts of water dissolving) is with clear paste mix homogeneously, drying under reduced pressure, pulverized 100 mesh sieves, sterilized 3 minutes, and incapsulated, obtain " blood sugar lowering is happy " oral capsule.

Embodiment four, get dried pumpkin 170 grams, dried Frutus Momordicae Charantiae 280 grams, astragalus mongholicus tablet or powder 220 grams add 3.5 liters in water, decoct at twice as stated above, filtrate decompression is concentrated into the clear paste that relative density is 1.2-1.4, gets Pancreas Sus domestica powder 240 grams again, Rhizoma Dioscoreae powder 100 grams, sodium sorbate 0.5 gram, with the clear paste mixing, put into vial, seal, sterilization gets " blood sugar lowering is happy " oral cream.

Embodiment five, get dried pumpkin 180 gram, dried Frutus Momordicae Charantiae 250 grams, and astragalus mongholicus tablet 200 grams, chopping, with 1.5 liter 75% alcohol solution dipping 5 hours, the solution that leaches steamed ethanol earlier, and (ethanol is recyclable) obtains the solution I; Filtering residue boiled 1 hour with 2 premium on currency, discarded residue, obtained the solution II, and solution I and solution II are merged, be evaporated to the clear paste that relative density is 1.2-1.4, get Pancreas Bovis seu Bubali powder 220 grams again, Rhizoma Dioscoreae powder 110 grams, sorbic acid 0.4 gram, with clear paste mixing, drying under reduced pressure, pulverize, make capsule.

Six, the test of medicine of the present invention and clinical

1. pharmacodynamics test

Guangxi treatment and prevention of tumour institute in the May, 1994-intend June with the happy treatment of blood sugar lowering diabetes, clinical consumption is each 4 capsules, 3 times on the one, every capsules 0.5g, TDD are 6g, with adult's weighing machine of 50kg, then its dosage is 0.12g cream/kg.d.Cure mainly and new Chinese medicine pharmacological research guide according to this medicine function, design blood sugar lowering pleasure is to the influence of intact animal and hyperglycemia model animal blood glucose, and the detection of animal carbohydrate tolerance test and serum insulin content thes contents are as follows:

A. experiment material

(1) medicine: the blood sugar lowering pleasure is made up of plant medicated powder (Fructus Momordicae charantiae, Fructus Cucurbitae moschatae, Radix Astragali water extract or alcohol are analysed thing and the composite medicated powder of Rhizoma Dioscoreae) and animal medicated powder (pig or cattle, Pancreas caprae seu ovis powder), plant medicated powder is chocolate brown powder, animal medicated powder is the taupe powder, faces to grind after the time spent, the two was mixed in proportion to be made into suspension.Insoral, Jintan, Jiangsu Province county pharmaceutical factory, lot number: 881116, glyburide, Guangzhou brilliance pharmaceutical factory, lot number: 930703.

(2) reagent: blood glucose test kit, Taiwan are marked good company limited, lot number: 40101.Glucose (A.R), reagent purchasing station, Shanghai, lot number: 7805150, insulin test kit, research institute of atomic energy sciences of the Chinese Academy of Sciences, lot number: 940810.Alloxan, this institute is synthetic.

(3) food: the BT2245-ARCD full automatic biochemical apparatus, Italy produces.The automatic r immunity of FJ-2003/50G calculating instrument, Plant No. 262.

(4) animal: NIH is a mice, and ♂ ♀ has concurrently, body weight 20 ± 2g, regular grade: SD is a rat, ♂ ♀ dual-purpose, body weight 180 ± 20g, regular grade, all available from Guangxi Chinese medicine institute animal housing,, in the Rotating Stainless Steel Cage tool, raise with pellet and put 26 ± 1 ℃ of air-conditioner temperatures by the sex sub-cage rearing, under relative temperature 60 ± 5% conditions, all animals are equal fasting 12h before getting hematometry, but can't help water.

B. experimental technique and result

(1) to the influence of normal mouse blood sugar, insulin and carbohydrate tolerance

Choose 80 of NIH mices, evenly be divided into 8 groups by sex, body weight layering, 10 every group, ♂ ♀ half and half.Establish the happy high dose group of blood sugar lowering (6g/kg.BW) respectively, low dose group (0.6g/kg, BW), animal medicated powder high dose group (4.4g powder/kg, BW), low dose group (0.4g powder/kg, BW), animal medicated powder high dose group (1.56 powder/kg.BW), low dose group (0.16 powder/kg.BW), positive controls (glyburide 50mg/kg), and blank group (distilled water 20ml/kg), the administration volume is 0.2ml/10g, BW, by above-mentioned dosage ig every day administration 1 time, continuous 10 days, 1h behind the last medicine, the eyeball rear vein beard is got blood, separation of serum is measured serum glucose value (glucose oxidase method) and insulin level (radioimmunology).After taking a blood sample, each Mus gives glucose 2.5g/kg, BW, ig measure again to after the sugar 0.5, the serum level of glucose (carbohydrate tolerance) of 1h and 2h.Other gets 80 NIM mices, as stated above, and repeated trials.2 batches of experiment glyburide can obviously reduce normal mouse blood glucose insulin level and not have significant difference as a result, see Table 1, table 2.

(2) to the influence of normal rat blood sugar, insulin and carbohydrate tolerance

Choose 80 of SD rats, the animal grouping, administrated method, dosage, observation index are all with experiment 1.Each group of result does not have obvious influence to normal rat blood sugar and insulin level.The happy high dose of blood sugar lowering, plant medicated powder high dose and the carbohydrate tolerance test of glyburide treated animal when 120min, its G/W on average significantly is lower than the distilled water group.See Table 4.Show that the blood sugar lowering pleasure can increase carbohydrate tolerance.

(3) to the influence of alloxan hyperglycemia mouse blood sugar, insulin and carbohydrate tolerance.

Choosing NIH is 120 of white mice, and ♂ surveys empty stomach 10h blood glucose 2 times, after 2 days, leaves and takes 10 mices and makes blank, the equal iv alloxan of all the other animals 80mg/kg moulding at interval.Measure blood glucose behind the moulding 48h.Choose 80 confession tests of mice that blood glucose is higher than 10mmol/L, be divided into 8 groups at random, every group 10, administrated method, dosage and observation index are with experiment 1, but positive controls gives insoral 100mg/kg.BW, successive administration 10 days, 1h behind the last medicine, the eyeball rear vein beard is got blood, and separation of serum is measured serum glucose and insulin level.Get the equal ig glucose of each treated animal 2.5g/kg.BW behind the blood, survey anti-sugar amount according to preceding method.According to the method described above, other gets 80 of the mices that blood glucose is higher than 10mmol/L, repeated trials.Administration as a result 10 days, the happy and plant amedica part of blood sugar lowering, the insulin level that can obviously raise, blood sugar lowering level (see Table 5, table 6); Happy and the plant amedica part of blood sugar lowering, the animal drugs part can obviously improve carbohydrate tolerance (seeing Table 7).

(4) to the influence of alloxan hyperglycemic rat blood glucose, insulin and carbohydrate tolerance

Choosing SD is 120 of rat, the grouping of ♂ animal, dosage approach, method and observation index are with experiment 3, but the used alloxan dosage of moulding 45mg/kg.BW, the obvious amount of the liter insulin level (table 9) of the happy and plant amedica part of blood sugar lowering, animal drugs part as a result, blood sugar lowering level (table 8), and increase carbohydrate tolerance (table 10)

Table 1 blood sugar lowering pleasure is to the influence of normal mouse blood sugar and insulin level (n ± 10, X ± SD)

Dosage blood glucose mmol/L insulin (ZU/L)

(g/kg) behind the medicine prodrug behind the medicine prodrug

A collection of:

Happy (height) 6.00 5.73 ± 1.20 5.42 ± 0.97 15.25 ± 3.67 17.07 ± 2.52 of blood sugar lowering

Happy (low) 0.60 5.80 ± 1.02 5.49 ± 1.43 15.16 ± 3.04 15.41 ± 3.32 of blood sugar lowering

Plant medicated powder (height) 4.40 6.05 ± 1.27 5.56 ± 1.15 14.61 ± 3.50 15.60 ± 3.40

Plant medicated powder (low) 0.44 6.11 ± 1.11 6.00 ± 1.06 14.89 ± 3.26 15.16 ± 3.84

Animal medicated powder (height) 1.56 5.76 ± 1.41 5.46 ± 1.04 15.52 ± 4.07 16.39 ± 3.08

Animal medicated powder (low) 0.16 5.98 ± 1.06 5.55 ± 1.00 15.31 ± 4.17 15.55 ± 3.10

Glyburide 0.05 5.59 ± 0.84 4.06 ± 1.07** 14.91 ± 4.26 14.40 ± 4.45

Distilled water 20ml 6.14 ± 1.58 5.76 ± 1.15 15.03 ± 2.40 15.24 ± 2.27

Two batches:

Happy (height) 6.00 5.805 ± 1.20 5.60 ± 1.41 13.80 ± 2.91 16.31 ± 3.30 of blood sugar lowering

Happy (low) 0.60 5.82 ± 1.02 5.63 ± 1.11 13.90 ± 2.71 14.63 ± 3.33 of blood sugar lowering

Plant medicated powder (height) 4.40 5.81 ± 0.54 6.22 ± 0.85 13.08 ± 2.61 15.33 ± 3.14

Plant medicated powder (low) 0.44 6.08 ± 1.06 5.92 ± 0.89 12.41 ± 2.45 13.51 ± 2.90

Animal medicated powder (height) 1.56 5.77 ± 0.78 5.63 ± 0.76 14.02 ± 3.04 14.21 ± 2.82

Animal medicated powder (low) 0.16 5.81 ± 0.79 5.71 ± 0.69 15.08 ± 3.31 15.73 ± 2.60

Glyburide 0.05 5.80 ± 0.44 4.22 ± 0.71** 15.22 ± 3.32 15.20 ± 2.27

Distilled water 20ml 5.66 ± 1.23 5.53 ± 1.42 14.70 ± 3.33 14.87 ± 2.90

Compare with blank group (distilled water group).＊＊P＜0.05 ＊＊P＜0.01

Table 2 blood sugar lowering pleasure is to the influence of normal mouse carbohydrate tolerance (n ± 10, X ± SD)

Dosage carbohydrate tolerance (blood glucose mmol/L)

120min behind the 60min medicine behind the 20min medicine behind the g/kg medicine

A collection of

Happy (height) 6.00 6.39 ± 2.79 6.21 ± 2.52 5.48 ± 1.83 of blood sugar lowering

Happy (low) 0.60 6.53 ± 2.34 6.37 ± 2.25 5.68 ± 2.16 of blood sugar lowering

Plant medicated powder (height) 4.40 7.31 ± 1.71 6.88 ± 2.04 6.09 ± 1.45

Plant medicated powder (low) 0.44 7.89 ± 1.79 7.55 ± 1.61 6.65 ± 1.25

Animal medicated powder (height) 1.56 7.15 ± 1.48 6.48 ± 1.26 5.83 ± 0.95

Animal medicated powder (low) 0.16 8.63 ± 2.36 7.48 ± 1.60 6.63 ± 1.15

Glyburide 0.05 5.73 ± 1.03** 5.89 ± 1.20* 6.07 ± 1.56

Distilled water 20.0ml 8.27 ± 2.10 7.41 ± 1.90 6.29 ± 2.16

Two batches

Happy (height) 6.00 7.00 ± 1.30 6.80 ± 1.20 6.53 ± 1.20 of blood sugar lowering

Happy (low) 0.60 7.40 ± 1.20 7.40 ± 0.09 7.01 ± 1.61 of blood sugar lowering

Plant medicated powder (height) 4.40 7.21 ± 1.05 6.91 ± 1.20 6.81 ± 1.11

Plant medicated powder (low) 0.44 7.81 ± 1.63 7.51 ± 0.84 7.33 ± 1.12

Animal medicated powder (height) 1.56 7.32 ± 1.14 7.15 ± 1.23 7.13 ± 0.88

Animal medicated powder (low) 0.16 7.94 ± 1.16 7.43 ± 1.15 7.23 ± 1.57

Glyburide 0.05 5.40 ± 1.03*** 6.01 ± 1.31** 6.00 ± 1.02*

Distilled water 20.0ml 8.14 ± 1.23 7.93 ± 1.35 7.46 ± 1.28

Compare * P＜0.05 * * P＜0.01 * * * P＜0.001 with blank group (distilled water group)

Table 3 blood sugar lowering pleasure is to the influence of normal rat blood sugar and insulin level (n=10, X ± SD)

Dosage blood glucose mmol/L insulin (IU/L)

(g/kg) behind the medicine prodrug behind the medicine prodrug

A collection of:

Happy (height) 6.00 4.74 ± 0.92 4.76 ± 0.76 41.36 ± 9.74 44.66 ± 11.05 of blood sugar lowering

Happy (low) 0.60 4.94 ± 0.78 5.36 ± 0.60 38.86 ± 8.85 42.81 ± 8.91 of blood sugar lowering

Plant medicated powder (height) 4.40 5.16 ± 0.67 5.34 ± 0.61 39.07 ± 9.06 41.90 ±

8.99

Plant medicated powder (low) 0.44 5.18 ± 0.99 5.36 ± 0.86 39.15 ± 9.97 43.08 ± 10.04

Animal medicated powder (height) 1.56 4.85 ± 0.95 5.27 ± 0.59 42.83 ± 10.06 43.35 ± 10.89

Animal medicated powder (low) 0.16 4.92 ± 0.80 5.22 ± 0.85 40.36 ± 10.66 39.31 ± 7.65

Glyburide 0.05 5.07 ± 1.04 4.74 ± 0.89 42.46 ± 10.94 38.56 ± 9.02

Distilled water 20ml 5.15 ± 0.99 5.42 ± 0.85 42.04 ± 10.05 41.32 ± 9.94

Two batches:

Happy (height) 6.00 5.10 ± 1.03 4.90 ± 0.82 19.60 ± 3.74 23.6 ± 5.23 of blood sugar lowering

Happy (low) 0.60 5.21 ± 1.22 5.44 ± 1.11 17.64 ± 5.73 17.81 ± 5.03 of blood sugar lowering

Plant medicated powder (height) 4.40 4.76 ± 0.78 4.23 ± 1.24 20.91 ± 4.15 21.22 ± 9.06

Plant medicated powder (low) 0.44 5.30 ± 0.93 4.91 ± 0.66 18.31 ± 2.96 19.17 ± 3.77

Animal medicated powder (height) 1.56 4.63 ± 1.25 4.23 ± 0.98 18.53 ± 4.14 19.34 ± 3.66

Animal medicated powder (low) 0.16 5.15 ± 1.27 5.44 ± 1.08 18.55 ± 1.96 18.47 ± 3.50

Glyburide 0.05 4.87 ± 1.28 3.20 ± 1.06* 20.66 ± 4.43 25.00 ± 5.61*

Distilled water 20ml 4.51 ± 1.72 4.63 ± 1.29 18.11 ± 3.85 19.80 ± 4.93

Compare * P＜0.05 with blank group (distilled water group)

Table 4 blood sugar lowering pleasure is to the influence of normal rat carbohydrate tolerance (n=10 X ± SD)

Dosage carbohydrate tolerance (blood glucose mmol/L)

120min behind the 60min medicine behind the 20min medicine behind the g/kg medicine

A collection of

Happy (height) 6.00 7.16 ± 2.03 6.22 ± 1.65 4.21 ± 1.34* of blood sugar lowering

Happy (low) 0.60 7.70 ± 2.62 6.98 ± 2.49 4.94 ± 2.14 of blood sugar lowering

Plant medicated powder (height) 4.40 7.35 ± 2.05 6.52 ± 1.64 4.61 ± 1.58*

Plant medicated powder (low) 0.44 7.65 ± 2.26 6.88 ± 2.19 5.07 ± 0.19

Animal medicated powder (height) 1.56 7.96 ± 2.11 6.73 ± 1.26 5.08 ± 0.15

Animal medicated powder (low) 0.16 7.76 ± 2.13 6.88 ± 1.50 5.55 ± 0.14

Glyburide 0.05 6.84 ± 2.92 5.79 ± 2.25 4.67 ± 2.05*

Distilled water 20.0ml 8.28 ± 2.68 6.88 ± 2.00 6.60 ± 1.80

Two batches

Happy (height) 6.00 7.91 ± 1.44 9.23 ± 2.76 8.71 ± 3.67 of blood sugar lowering

Happy (low) 0.60 9.33 ± 2.93 9.65 ± 2.84 9.53 ± 2.11 of blood sugar lowering

Plant medicated powder (height) 4.40 8.34 ± 2.19 9.60 ± 1.67 8.86 ± 2.08

Plant medicated powder (low) 0.44 9.66 ± 2.39 10.91 ± 1.77 9.43 ± 2.47

Animal medicated powder (height) 1.56 8.78 ± 3.08 9.99 ± 2.18 9.04 ± 1.83

Animal medicated powder (low) 0.16 9.83 ± 2.55 11.11 ± 1.85 9.56 ± 2.07

Glyburide 0.05 7.44 ± 3.26 8.50 ± 2.71**, 7.50 ± 2.31**

Distilled water 20.0ml 11.05 ± 5.43 12.96 ± 3.88 11.42 ± 3.56

Compare * P＜0.05 * * P＜0.01 * * * P＜0.001 with blank group contrast (distilled water group)

Table 5 blood sugar lowering pleasure is to the influence of hyperglycemia mouse blood sugar (n=10, X ± SD)

Dosage blood glucose (mmol/L)

Before the g/kg moulding behind the moulding 48h medicine 10 days

A collection of:

Happy (height) 6.00 5.28 ± 0.75 17.99 ± 2.59 12.46=4.2* of blood sugar lowering

Happy (low) 0.60 5.02 ± 1.01 19.47 ± 2.18 14.82=2.76 of blood sugar lowering

Plant medicated powder (height) 4.40 4.51 ± 0.86 18.39 ± 2.78 12.32=3.92**

Plant medicated powder (low) 0.44 5.41 ± 0.74 17.91 ± 2.75 11.48=5.02**

Animal medicated powder (height) 1.56 5.38 ± 0.74 17.36 ± 3.02 11.73=4.34**

Animal medicated powder (low) 0.16 5.28 ± 1.18 17.93 ± 2.54 15.24=3.93

Insoral 0.10 5.35 ± 0.68 18.31 ± 2.52 10.76=1.92**

Moulding contrast water 20ml 5.39 ± 1.09 19.66 ± 3.39 17.37=4.62

Distilled water water 20ml 5.19 ± 1.10 5.19 ± 0.74 5.31=0.74

Two batches:

Happy (height) 6.00 5.10 ± 1.00 19.50 ± 3.06 13.71=3.31*** of blood sugar lowering

Happy (low) 0.60 5.11 ± 1.00 19.36 ± 3.66 16.90=2.81 of blood sugar lowering

Plant medicated powder (height) 4.40 5.63 ± 0.77 20.51 ± 4.80 14.20=1.21***

Plant medicated powder (low) 0.44 5.41 ± 0.99 19.77 ± 3.13 18.31=3.64

Animal medicated powder (height) 1.56 5.60 ± 1.34 19.14 ± 3.34 15.91=2.21*

Animal medicated powder (low) 0.16 5.61 ± 0.74 19.83 ± 2.76 19.22=3.11

Insoral 0.10 5.33 ± 1.14 19.97 ± 2.68 11.34=2.23***

Moulding contrast water 20ml 5.60 ± 1.22 19.65 ± 4.05 20.17=5.28

Distilled water 20ml 5.10 ± 1.11 5.23 ± 1.10 5.50=0.95

Compare * P＜0.05 * * P＜0.01 * * * P＜0.001 with the moulding matched group

Table 6 blood sugar lowering pleasure is to the influence of the plain level of hyperglycemia mouse islets (n=10, X ± SD)

Dosage insulin (IU/L)

Before the g/kg moulding behind the moulding 48h medicine 10 days

A collection of:

Happy (height) 6.00 17.81 ± 2.02 3.38 ± 0.76 5.98 ± 1.56** of blood sugar lowering

Happy (low) 0.60 16.13 ± 2.42 3.84 ± 0.68 4.34 ± 1.04 of blood sugar lowering

Plant medicated powder (height) 4.40 16.93 ± 2.07 3.82 ± 1.11 6.70 ± 3.02

Plant medicated powder (low) 0.44 17.00 ± 3.21 3.83 ± 0.86 4.99 ± 1.83

Animal medicated powder (height) 1.56 17.30 ± 2.38 3.59 ± 0.79 4.88 ± 1.01

Animal medicated powder (low) 0.16 16.74 ± 2.52 3.45 ± 0.96 4.45 ± 0.90

Insoral 0.10 17.51 ± 1.95 3.79 ± 1.18 7.10 ± 0.83**

Moulding contrast water 20ml 16.11 ± 2.71 3.25 ± 0.74 4.04 ± 1.12

Distilled water 20ml 17.43 ± 3.09 17.68 ± 2.18 16.99 ± 1.74

Two batches:

Happy (height) 6.00 18.60 ± 2.91 5.00 ± 0.83 8.71 ± 1.11*** of blood sugar lowering

Happy (low) 0.60 18.34 ± 2.22 4.93 ± 1.12 7.11 ± 2.40*** of blood sugar lowering

Plant medicated powder (height) 4.40 17.80 ± 2.81 4.90 ± 1.11 6.22 ± 1.54**

Plant medicated powder (low) 0.44 18.33 ± 3.07 4.93 ± 0.99 5.43 ± 0.99

Animal medicated powder (height) 1.56 17.11 ± 3.13 5.14 ± 1.68 6.14 ± 1.89

Animal medicated powder (low) 0.16 19.54 ± 2.34 5.22 ± 1.19 5.95 ± 1.58

Insoral 0.10 18.00 ± 2.70 5.11 ± 1.43 10.02 ± 2.34***

Moulding contrast water 20ml 18.60 ± 2.61 5.00 ± 1.33 4.61 ± 1.11

Distilled water 20ml 18.51 ± 2.56 18.02 ± 2.04 17.66 ± 2.63

Table 7 blood sugar lowering pleasure is to the influence of hyperglycemia mice carbohydrate tolerance (n=10, X ± SD)

Dosage carbohydrate tolerance (blood glucose mmol/L)

120min behind the 60min medicine behind the 20min medicine behind the g/kg medicine

A collection of

Happy (height) 6.00 13.40 ± 4.74*** 11.86 ± 1.33** of blood sugar lowering 8.99 ± 3.64**

Happy (low) 0.60 17.69 ± 3.37 14.65 ± 3.17 12.36 ± 2.43* of blood sugar lowering

Plant medicated powder (height) 4.40 14.91 ± 3.34** 12.86 ± 5.03* 10.24 ± 4.21**

Plant medicated powder (low) 0.44 15.83 ± 2.89** 13.80 ± 4.62 12.51 ± 2.47*

Animal medicated powder (height) 1.56 15.94 ± 2.83** 13.23 ± 4.37* 4.38 ± 3.35**

Animal medicated powder (low) 0.16 19.27 ± 3.73 14.82 ± 5.23 12.87 ± 3.54

Insoral 0.10 12.86 ± 3.38** 10.80 ± 3.74** 7.40 ± 2.05**

Moulding contrast water 20.0ml 20.04 ± 3.51 17.43 ± 4.44 13.27 ± 3.49

Distilled water 20ml 8.27 ± 2.10 7.41 ± 1.90 6.92 ± 2.16

Two batches

Happy (height) 6.00 17.50 ± 1.73** 13.91 ± 2.94*** of blood sugar lowering 13.85 ± 2.51***

Happy (low) 0.60 19.22 ± 2.94 18.11 ± 2.46* 17.64 ± 1.83 of blood sugar lowering

Plant medicated powder (height) 4.40 18.24 ± 3.11 17.91 ± 2.20**, 14.50 ± 2.33***

Plant medicated powder (low) 0.44 19.40 ± 2.61 18.53 ± 2.25* 17.20 ± 2.14

Animal medicated powder (height) 1.56 18.50 ± 2.67 18.23 ± 2.41*, 16.27 ± 1.95***

Animal medicated powder (low) 0.16 19.73 ± 3.09 18.84 ± 2.07 17.55 ± 1.73

Insoral 0.15 13.90 ± 2.91*** 12.70 ± 1.87*** 10.60 ± 2.61***

Moulding contrasts little 20.0ml 20.66 ± 2.21 20.70 ± 1.87 18.77 ± 1.85

Distilled water 20ml 8.10 ± 1.20 7.93 ± 1.32 7.45 ± 1.24

Table 8 blood sugar lowering pleasure is to the influence of hyperglycemic rat blood glucose (n=10, X ± SD)

Dosage blood glucose (mmol/L)

Before the g/kg moulding behind the moulding 48h medicine 10 days

A collection of

Happy (height) 6.00 6.12 ± 1.14 18.87 ± 2.85 13.11 ± 2.31* of blood sugar lowering

Happy (low) 0.60 6.22 ± 1.13 18.29 ± 3.01 14.65 ± 1.18 of blood sugar lowering

Plant medicated powder (height) 4.40 5.55 ± 1.13 19.47 ± 2.22 12.63 ± 3.10*

Plant medicated powder (low) 0.44 5.81 ± 1.72 19.70 ± 3.33 15.66 ± 2.54

Animal medicated powder (height) 1.56 5.84 ± 1.43 17.90 ± 2.64 13.00 ± 3.79*

Animal medicated powder (low) 0.16 5.65 ± 1.15 18.45 ± 2.41 15.26 ± 2.55

Insoral 0.10 6.34 ± 1.33 18.08 ± 4.87 11.28 ± 2.57**

Moulding contrast water 20.0ml 5.74 ± 1.02 17.99 ± 3.39 16.51 ± 3.25

Distilled water 20ml 5.53 ± 0.87 5.69 ± 1.30 5.65 ± 1.23

Two batches

Happy (height) 6.00 5.41 ± 0.55 20.60 ± 3.23 15.77 ± 4.70** of blood sugar lowering

Happy (low) 0.60 5.22 ± 0.64 20.11 ± 2.94 18.30 ± 4.33 of blood sugar lowering

Plant medicated powder (height) 4.40 5.24 ± 0.66 20.10 ± 3.44 15.90 ± 4.40**

Plant medicated powder (low) 0.44 5.24 ± 0.55 19.30 ± 3.07 18.22 ± 2.76

Animal medicated powder (height) 1.56 5.25 ± 0.50 20.00 ± 2.46 17.11 ± 3.03*

Animal medicated powder (low) 0.16 5.30 ± 0.44 19.11 ± 2.87 19.05 ± 4.04

Insoral 0.10 5.47 ± 0.73 19.71 ± 5.18 15.83 ± 3.81***

Moulding contrast water 20.0ml 5.30 ± 0.77 20.50 ± 1.68 20.24 ± 2.16

Distilled water 20ml 5.33 ± 0.78 5.33 ± 0.83 5.35 ± 1.13

Compare * P＜0.05 * * P＜0.01 * * * P＜0.001 with moulding

Table 9 blood sugar lowering pleasure is to the influence of hyperglycemic rat insulin (n=10, X ± SD)

Dosage insulin (IU/L)

Before the g/kg moulding behind the moulding 48h medicine 10 days

A collection of

Happy (height) 6.00 17.26 ± 2.52 3.96 ± 0.81 6.44 ± 1.41** of blood sugar lowering

Happy (low) 0.60 17.37 ± 2.03 3.65 ± 1.03 5.19 ± 1.73** of blood sugar lowering

Plant medicated powder (height) 4.40 16.73 ± 2.02 3.45 ± 0.89 6.60 ± 1.33**

Plant medicated powder (low) 0.44 17.49 ± 2.40 3.66 ± 1.62 5.14 ± 0.99**

Animal medicated powder (height) 1.56 16.24 ± 1.63 3.67 ± 0.99 5.36 ± 1.40**

Animal medicated powder (low) 0.16 16.44 ± 2.40 3.25 ± 0.69 4.70 ± 0.75**

Insoral 0.10 17.08 ± 2.79 3.55 ± 0.87 8.23 ± 1.57**

Moulding contrast water 20.0ml 17.33 ± 3.22 3.83 ± 0.87 3.25 ± 0.80

Distilled water 20ml 17.83 ± 1.94 17.04 ± 2.53 17.32 ± 2.63

Two batches

Happy (height) 6.00 18.60 ± 3.11 5.53 ± 1.76 9.66 ± 1.52*** of blood sugar lowering

Happy (low) 0.60 18.15 ± 2.93 4.89 ± 0.87 7.90 ± 2.20*** of blood sugar lowering

Plant medicated powder (height) 4.40 17.83 ± 2.36 5.27 ± 1.13 8.70 ± 1.83***

Plant medicated powder (low) 0.44 18.77 ± 3.24 5.06 ± 1.28 7.50 ± 2.73*

Animal medicated powder (height) 1.56 18.33 ± 2.36 4.78 ± 1.36 6.60 ± 1.85*

Animal medicated powder (low) 0.16 18.56 ± 2.87 5.06 ± 1.26 5.66 ± 2.07

Insoral 0.10 19.40 ± 2.46 5.16 ± 1.07 10.31 ± 2.93**

Moulding contrast water 20.0ml 18.44 ± 2.93 5.00 ± 1.34 5.07 ± 1.15

Distilled water 20ml 19.17 ± 4.08 20.11 ± 2.59 18.66 ± 2.83

Table 10 blood sugar lowering pleasure is to the influence of hyperglycemic rat carbohydrate tolerance (n=10, X ± SD)

Dosage carbohydrate tolerance (blood glucose mmol/L)

120min behind the 60min medicine behind the 20min medicine behind the g/kg medicine

A collection of

Happy (height) 6.00 13.29 ± 2.45*** 11.74 ± 2.11*** of blood sugar lowering 10.38 ± 2.05***

Happy (low) 0.60 15.00 ± 2.88*** 14.14 ± 2.22*** of blood sugar lowering 12.63 ± 1.17***

Plant medicated powder (height) 4.40 14.42 ± 3.08*** 13.69 ± 2.24*** 11.78 ± 2.10***

Plant medicated powder (low) 0.44 14.93 ± 2.54*** 13.98 ± 1.98*** 13.04 ± 1.20***

Animal medicated powder (height) 1.56 16.38 ± 2.97 15.35 ± 2.22*, 13.64 ± 1.62*

Animal medicated powder (low) 0.16 17.20 ± 0.39 15.83 ± 3.63* 14.46 ± 3.07

Insoral 0.10 11.20 ± 5.21*** 10.23 ± 4.27*** 8.59 ± 3.55***

Moulding contrast water 20.0ml 19.26 ± 3.39 18.34 ± 3.18 15.94 ± 2.72

Distilled water 20ml 8.28 ± 2.68 6.88 ± 2.01 6.60 ± 1.84

Two batches

Happy (height) 6.00 16.55 ± 2.10*** 16.13 ± 2.44*** of blood sugar lowering 15.00 ± 2.11***

Happy (low) 0.60 18.00 ± 3.64** 18.64 ± 2.72* of blood sugar lowering 16.20 ± 2.13**

Plant medicated powder (height) 4.40 18.71 ± 2.95* 16.43 ± 2.42*** 15.93 ± 2.92**

Plant medicated powder (low) 0.44 19.33 ± 2.56* 17.82 ± 3.55*** 17.00 ± 2.14

Animal medicated powder (height) 4.56 18.81 ± 3.20* 17.05 ± 3.26** 16.14 ± 2.93*

Animal medicated powder (low) 0.16 19.35 ± 3.46 18.54 ± 3.28* 17.39 ± 2.48

Insoral 0.10 15.77 ± 4.53*** 14.84 ± 2.03*** 14.06 ± 1.67***

Moulding contrasts little 20.0ml 21.76 ± 2.66 21.49 ± 2.95 18.95 ± 2.86

Distilled water 20ml 11.02 ± 5.48 12.98 ± 3.83 11.44 ± 3.57

Compare * P＜0.05 * * P＜0.01 * * * P＜0.001 with matched group

C. brief summary

To normal mouse, the happy and plant amedica part of blood sugar lowering, the animal drugs part blood glucose insulin level that all can not raise can not improve carbohydrate tolerance, can not blood sugar lowering content, but can use a large amount of after obvious raising carbohydrate tolerance during 120min.To alloxan hyperglycemia mice, the happy and plant part of blood sugar lowering can obviously reduce the plain level in island, blood sugar lowering is happy, the plant amedica part, and the animal drugs part obviously blood sugar lowering content, obviously increase carbohydrate tolerance.To the alloxan hyperglycemic rat, blood sugar lowering pleasure and plant amedica thereof, animal drugs part all can obviously increase insulin level, improve carbohydrate tolerance, blood sugar lowering level.

2. toxicity test

Medicine of the present invention carried out the acute toxicity test of white mice in 1994 through the institute for drug control, Guangxi, conclusion be " this product toxicity is low; fail to measure its LD50, and the maximum tolerated dose that mice gavages this product is greater than the quite clinical plan of this dosage of 30g/kg(600 times with daily dose).”

3, clinical trial

In JIUYUE, 1994-November, first Affiliated Hospital of Colleges Of Traditional Chinese Medicine Of Guangxi, second Affiliated Hospital, No.1 Hospital Attached to Guangxi Medical Univ. carries out clinical trial to diabetics, treatment group and contrast be totally 160 examples, 60 examples are observed by one attached institute of Colleges Of Traditional Chinese Medicine Of Guangxi, 60 examples are observed by two attached institutes of Colleges Of Traditional Chinese Medicine Of Guangxi, and 40 examples are observed by one attached institute of Guangxi Medical University.

A. physical data

The object of observation of being included in is 18-65 year, meets the diabetics of WHO tentative standard in 1980.100 examples are organized in treatment, use the happy capsule of blood sugar lowering, and matched group 60 examples are used Guangxi Medical Univ. Pharmaceutical Plant's production XIAOKE JIANGTANG JIAONANG, and treatment group and matched group sex, age distribution all do not have significant difference (P＞0.05), see Table 11.

B. diagnostic criteria:

(1) the Western medicine diagnose standard adopts WHO tentative standard (venous plasma method) in 1980, allly meets that one of following condition person is diagnosable to be diabetes:

(1) diabetic symptom is arranged, any time blood glucose 〉=11.1mmol/L(200mg/dl), or fasting blood 〉=7.8mmol/L(149mg/dl).

(2) diabetic symptom is arranged and blood glucose does not reach above-mentioned standard, carry out 75g oral glucose tolerance test (OGTT), 2 hours blood glucose 〉=11.1mmol/L(200mg/dl).

(3) as the non-diabetic symptom, except that above-mentioned standard, add a standard in addition, be OGTT1 hour blood glucose 〉=11.1mmol/L(200mg/dl), or another time OGTT2 hour blood glucose 〉=11.1mmol/L(200mg/dl), or another time fasting blood 〉=7.8mmol/L(140mg/dl).

(2) tcm diagnosis standard; All have a thirsty polydipsia, and rapid digestion of food is easily hungry, and frequent micturition and sweet, body see that gradually patient such as become thin can make a definite diagnosis.

C. observational technique

Observe 160 examples altogether, be divided into 2 groups at random, 100 examples are organized in treatment, use the happy capsule of blood sugar lowering, each 4, every day 3 times, serve on for 4 weeks.Matched group 60 examples, the XIAOKE JIANGTANG JIAONANG of using Guangxi Medical Univ. Pharmaceutical Plant to produce, each 5,2 hours ante cibum warm water delivery service, every day 3 times, 4 weeks of logotype.Conventional before the test experimenter is made detailed physical examination, surveys fasting glucose, glucose in urine (treat preceding 4 weeks, surveyed fasting glucose, glucose in urine 1 time every 10 days, continuous 3 times, with 3 averages as treating preceding control value).Weekly with examining 1 time, inquire the situation of taking medicine after the test, 1 empty stomach and 2 hours after the meal blood glucose are surveyed in the record state of an illness and side effect.The variation of traditional Chinese medical science witness is evaluated with scoring method, and the curative effect judgement is directly made by the observer.Viewing duration is generally without other similar medicines, to the insulin patient of difficulty recklessly that stops using, can observe the therapeutic effect after the decrement.

D. result

Efficacy assessment standard:

(1) produce effects: treatment back symptom disappears substantially, fasting glucose＜7.2mmol/L(130mg/dl), 2 hours after the meal blood glucose＜8.3mmol/L(150mg/dl), twenty-four-hour urine sugar quantitatively＜10.0g; Or blood glucose, twenty-four-hour urine sugar quantitatively descends more than 30% before the treatment.

(2) effective: treatment back symptom is obviously improved, fasting glucose＜8.3mmol/L(150mg/dl), 2 hours after the meal blood glucose＜10.0mmol/L(180mg/dl), twenty-four-hour urine sugar quantitatively＜25.mg; Or blood glucose, twenty-four-hour urine sugar sugar quantitatively descends more than 10% before the treatment; Or use and can reduce insulin dosage behind this medicine and keep fasting glucose＜7.2mmol/L, 2 hours after the meal blood glucose＜8.3mmol/L, twenty-four-hour urine sugar quantitatively＜10.0g.

(3) invalid: treatment back symptom does not have obvious improvement, and blood glucose, glucose in urine descend and do not reach above-mentioned standard.

Therapeutic outcome:

(1) compares before and after the treatment of witness integration: see Table 12.

(2) compare before and after the physico-chemical examination treatment: see Table 13.

(3) treatment group and matched group are treated relatively: see Table 14.

Table 11 treatment group and matched group sex, age ratio are

The sex age

Men and women's age bracket X ± SD

56 44 42-65 50.39 ± 10.78 are organized in treatment

Matched group 31 29 32-65 50.12 ± 10.98

Table 12 compares (X=SD) before and after seeing the treatment of disease integration

Treatment group matched group

After treating before the preceding treatment of the n treatment back n treatment

Thirsty polydipsia 100 4.53 ± 1.06 1.68 ± 1.07 60 4.41 ± 1.04 2.01 ± 1.19

Polyorexia 100 4.24 ± 1.05 1.53 ± 1.21 60 3.97 ± 1.24 1.80 ± 1.22

Urinary micturition 100 4.44 ± 1.53 2.16 ± 1.15 60 4.45 ± 1.30 1.99 ± 1.13

Emaciated physique 82 3.39 ± 1.26 2.84 ± 1.12 38 3.12 ± 1.16 2.81 ± 1.19

Annotate: relatively, the P value all＜0.01 before and after the treatment

Compare (Ridit analysis) before and after the table 13 physico-chemical examination treatment

Treatment group matched group

After treating before the preceding treatment of the n treatment back n treatment

Fasting glucose 100 10.86 ± 2.18 7.71 ± 2.12 60 11.00 ± 2.35 6.83 ± 2.58

2h blood glucose 96 13.57 ± 2.66 10.53 ± 2.36 57 13.37 ± 2.50 10.53 ± 4.12 after the meal

Annotate: relatively, the P value all＜0.01 before and after the treatment

Table 14 treatment group and matched group curative effect be (Ridit analysis) relatively

N produce effects enabledisable R U P

Treatment organizes 100 32 48 20 0.4758

1.0267 >0.05

Treatment back 60 25 23 12 0.5242

E. side effect

100 examples are organized in treatment, and matched group 60 examples are not all found obvious adverse reaction and toxic and side effects at viewing duration.

F. discuss and sum up

(1) the happy capsule of blood sugar lowering has certain therapeutic effect to diabetes, the thirsty polydipsia of energy control of diabetes patient after the medication, and polyorexia, clinical symptoms such as urinary micturition point out this medical instrument to have the supplementing QI for promoting the production of body fluid spleen invigorating to moisturize, and grow lung and reinforce the kidney the effect of nourishing YIN to lower pathogenic fire.(seeing Table 12).

(2) this organizes 100 examples, matched group 60 examples, treatment back patient's fasting glucose and after the meal 2h blood glucose obvious decline (P＜0.01 sees Table 12) is all arranged, the happy capsule of prompting blood sugar lowering can control of diabetes patient blood glucose.

(3) this organizes 100 examples, and total effective rate is 80%.Matched group 60 examples, total effective rate are 80%.Two groups are compared no significant difference (P＞0.05 sees Table 14).

(4) this product is safe and reliable, no obvious adverse reaction and toxic and side effects.

In JIUYUE, 1994 to November first Affiliated Hospital of Colleges Of Traditional Chinese Medicine Of Guangxi the happy capsule of new drug blood sugar lowering has been carried out clinical verification:

A. clinical data

Accept diabetics 60 examples for medical treatment.30 examples are organized in treatment, use the happy capsule of blood sugar lowering, inpatient's 7 examples wherein, outpatient service 23 examples.Matched group 30 examples: the XIAOKE JIANGTANG JIAONANG of using Guangxi Medical Univ. Pharmaceutical Plant to produce, wherein inpatient's 7 examples: outpatient service 23 examples.Two groups of sexes, age distribution do not have significant difference (P＞0.05).See Table 15.

Case selection, diagnostic criteria, observational technique, curative effect judging standard and statistical procedures method are all carried out according to proof scheme.

B. therapeutic outcome

(1) to the influence of various symptoms, sign: see Table 16.

(2) to the influence of blood glucose: see Table 16.

Table 15 treatment group and matched group sex, age ratio are

The sex age

Routine number divides into groups

Men and women X ± SD minimax

Treatment organizes 30 15 15 54.2 ± 11.1 65 42

Matched group 30 17 13 54.57 ± 9.36 65 32

Annotate: two groups of sexes, distributions are compared, and P all＞0.05

Table 16 compares (X before and after seeing the treatment of disease integration ^-± SD)

Treatment group matched group

See disease and blood glucose

After treating before the preceding treatment of the n treatment back n treatment

Thirsty polydipsia 30 4.93 ± 1.14 2.18 ± 1.38* 30 4.32 ± 0.96 2.59 ± 1.37*

Polyorexia 30 4.13 ± 0.90 1.47 ± 1.28* 30 3.43 ± 0.98 2.15 ± 1.12

Urinary micturition 30 4.33 ± 1.06 2.26 ± 1.14* 30 4.46 ± 1.45 2.13 ± 1.24

Emaciated physique 24 3.25 ± 1.54 2.25 ± 1.22 24 2.96 ± 1.31 2.42 ± 1.18

Fasting glucose 30 9.16 ± 1.82 7.95 ± 1.91** 30 9.0 ± 1.64 8.2 ± 2.3

(mmol/L)

Post-prandial glycemia 26 14.28 ± 2.28 11.2 ± 2.07 27 13.36 ± 2.35 12.33 ± 5.21

(mmol/L)

Annotate: front and back relatively, * represents＜0.01, * * represents P＜0.05, all the other represent P＞0.05

The comparison of (3) treatment group and matched group curative effect: see Table 17.

Table 17 treatment group and matched group curative effect be (Ridit analysis) relatively

Routine digital display effect enabledisable total effective rate R U P divides into groups

Treat 30 10 16 4 86.67% 0.5278

0.7459 >0.05

Contrast 30 10 11 9 70% 0.4722

Annotate: two groups of curative effect of medication do not have significant difference (P＞0.05)

C. discuss and brief summary

(1) the happy capsule of blood sugar lowering has supplementing QI for promoting the production of body fluid, spleen invigorating and moisturizes, grows that lung reinforces the kidney, the effect of nourishing YIN to lower pathogenic fire, can significantly improve clinical symptoms such as the common thirsty polydipsia of diabetics, polyorexia, urinary micturition, simultaneously the unusual higher fasting blood of diabetics and 2 hours after the meal blood glucose also there is tangible reduction effect, this clinical verification total effective rate is 86.67%, and curative effect and matched group do not have significant difference.

(2) the happy capsule formulation of blood sugar lowering is reasonable, and taking convenience is safe and reliable, does not see obvious adverse reaction.

In sum, this medicine meets new drug safety, effectively requirement.

4, model case:

Example 1, Zhang, male 38 years old.Because of thirsty, polydipsia, fatigue and weakness 1 year were gone to a doctor on October 20th, 1994.Card is seen: thirst and liking drink, and fatigue and weakness, spontaneous sweating, breathe hard lazy speech, dysphoria with feverish sensation in the chest palms and soles, palpitation and insomnia, constipation, corpulent tongue is big, thin fur, thready and rapid pulse.Fasting glucose 13.96mmol/L, 2h blood glucose 12.85mmol/L after the meal.Tcm diagnosis: diabetes (syndrome of deficiency of both qi and yin).Western medicine diagnose: diabetes (II type).Give the happy capsule of blood sugar lowering, each 4, every day 3 times.Take medicine after 1 week, thirst and liking drink, dysphoria with feverish sensation in the chest palms and soles, diseases such as cardiopalmus, insomnia are obviously improved.Symptom disappears substantially after 4 weeks.Fasting glucose 6.45mmol/L, 2h blood glucose 660mmol/L after the meal, efficacy evaluation: produce effects.

Example 2, the week * *, the man, 54 years old, because of " polydipsia polyuria repeatedly 5 years companion fatigue and weakness February " in JIUYUE in 1994 prescription on individual diagnosis on the 20th.Readme: thirst and liking drink, urinary micturition, polyorexia, breathe hard lazy speech, dysphoria with feverish sensation in the chest palms and soles, palpitation and insomnia.Inspection is seen: emaciated physique, spiritlessness and weakness, red tongue, yellow and thin fur, stringy and thready pulse.Control 3 times that the fasting glucose average is 8.5mmol/L, mean blood glucose was 12.8mmol/L in 3 times 2 hours after the meal.Tcm diagnosis: quench one's thirst (type of deficiency of both QI and YIN).Western medicine diagnose: non-insulin-dependent diabetes mellitus.Give the happy capsule for treating of blood sugar lowering, every day 3 times, each 4.After 1 week of medication, polyuria begins to alleviate, and fasting glucose is 8.2mmol/L, 2 hours after the meal blood glucose 8.8mmol/L.To the 3rd week, thirsty, polyphagia, easy hungry the alleviation; Fasting glucose 8.1mmol/L, 2 hours after the meal blood glucose 8.5mmol/L.To the 4th week, disappearances such as polydipsia polyuria, only surplus slight easily famine and emaciated physique symptom, check fasting glucose 7.23mmol/L, 2 hours after the meal blood glucose 7.8mmol/L, efficacy evaluation: produce effects.

Claims (5)

1, a kind of Chinese medicine for the treatment of diabetes is characterized in that Main Ingredients and Appearance is: pancreas of pig or cattle, sheep and Fructus Momordicae charantiae, Fructus Cucurbitae moschatae, the Radix Astragali, Rhizoma Dioscoreae.

2, Chinese medicine according to claim 1 is characterized in that each composition of this Chinese medicine by the weight % content of dried medical material is:

The pancreas 20-45 of pig or cattle, sheep

Fructus Momordicae charantiae 18-32

Rhizoma Dioscoreae 10-28

Fructus Cucurbitae moschatae 15-25

Radix Astragali 10-26

3, a kind of production method for the treatment of the Chinese medicine of diabetes, it is characterized in that earlier the pancreas of pig or cattle, sheep is rubbed, drying under reduced pressure is pulverized the composition end again, and is standby, other gets, and the water extract of Fructus Momordicae charantiae, Fructus Cucurbitae moschatae, the Radix Astragali or alcohol are analysed the Rhizoma Dioscoreae of thing, dry expanded pulverizing and pig or cattle, the Pancreas caprae seu ovis powder mixes is even, add antiseptic and mix, low-temperature reduced-pressure drying and crushing, sterilization, make tablet, capsule or unguentum.

4, the production method of Chinese medicine according to claim 3, the water extract that it is characterized in that Fructus Momordicae charantiae, Fructus Cucurbitae moschatae, the Radix Astragali is earlier dried Frutus Momordicae Charantiae, dried pumpkin, the Radix Astragali to be mixed, add 5-6 times of water, soaked 4-8 hour, decoct secondary, each 1 hour, collecting decoction, filter, filtrate is evaporated to the clear paste that relative density is 1.2-1.4 50-80 ℃ temperature.

5, the production method of Chinese medicine according to claim 3, it is that Fructus Momordicae charantiae, Fructus Cucurbitae moschatae, the Radix Astragali are mixed chopping that the alcohol that it is characterized in that Fructus Momordicae charantiae, Fructus Cucurbitae moschatae, the Radix Astragali is analysed thing, with alcohol solution dipping 4-10 hour of 2-3 70-80% doubly, the solution that leaches steams ethanol, obtains the solution I, and filtering residue was with 2 times of water boils 1 hour, discard residue, obtain the solution II, solution I and solution II are merged, be evaporated to the clear paste that relative density is 1.2-1.4.