CN104840777A

CN104840777A - Diabetes treating traditional Chinese medicine preparation and preparation method thereof

Info

Publication number: CN104840777A
Application number: CN201410052627.1A
Authority: CN
Inventors: 夏文; 蒋坤; 孙小军; 安斯扬; 潘玉杰; 李星
Original assignee: GUIZHOU BAILING GROUP PHARMACY CO Ltd
Current assignee: GUIZHOU BAILING GROUP PHARMACY CO Ltd
Priority date: 2014-02-17
Filing date: 2014-02-17
Publication date: 2015-08-19
Anticipated expiration: 2034-02-17
Also published as: CN104840777B

Abstract

The present invention discloses a diabetes treating traditional Chinese medicine preparation and a preparation method thereof. The preparation method comprises: weighting Keyaoluoqu, plantago depressa willd, agrimonia pilosa ledeb, and lonicera confusa dc according to a weight ratio, adding 6-10 times the amount of water, soaking for 30-120 m, boiling for 1-2 h, filtering, and taking the filtrate for spare; adding 6-10 times the amount of water to the drug residue, boiling for 1-2 h, and filtering; and merging the two filtrates, filtering, concentrating, drying, crushing, and adding an auxiliary material to prepare the corresponding traditional Chinese medicine preparation. According to the present invention, the diabetes treating traditional Chinese medicine preparation prepared according to the Miao medicine secret recipe has characteristics of significant blood glucose lowering and good treatment effect; and the prescription is derived from the folk effective medical prescription, has been used more than 50 years, and is summarized by clinical practice, the diabetes treating traditional Chinese medicine preparation has effects of body consolidating, yin nourishing, turbid fluid eliminating, blood circulation promotion, fluid production promoting, and thirst quenching, and especially provides significant blood glucose lowering effects for diabetes caused by qi and yin deficiency, and the blood glucose lowering effect is not completely dependent on pancreatic B cell secretion promotion.

Description

A kind of Chinese medicine preparation for the treatment of diabetes and preparation method thereof

Technical field

The present invention relates to a kind of Chinese medicine preparation for the treatment of diabetes and preparation method thereof, belong to technical field of Chinese medicines.

Background technology

Diabetes are common frdquently encountered diseases of serious harm human health, and the bran urine patient of current China increases year by year, and exceeded more than 2,000 ten thousand people, global diabetics has exceeded 100,000,000 people, and already, diabetes have become a worldwide problem.Distribution of diabetes is only second to malignant tumor and cardiovascular disease, is the third-largest disease jeopardizing human life.

China is in treatment diabetes for thousands of years, have accumulated rich experience.In recent years, there is the Chinese medicine formula application of many treatment diabetes patent of invention, such as application number has been 201010259466.5 disclosed " medicines of radical cure diabetes and preparation method thereof ", application number is 201110346174.X disclosed " a kind of Chinese medicine for the treatment of type 2 diabetes mellitus insulin resistant ", application number has been 201110048889.7 disclosed " a kind of medicines for the treatment of type 2 diabetes mellitus insulin resistant " etc.But these existing antidiabetic drug effects are not remarkable, do not reach good therapeutic effect.Thus need people to continue to excavate Chinese material medicine resource, develop more efficiently medicine.

Summary of the invention

The object of the invention is to, provide a kind of Chinese medicine preparation for the treatment of diabetes and preparation method thereof, described Chinese medicine preparation hypoglycemic effect is remarkable, can obtain better therapeutic effect.

For solving the problems of the technologies described above, the present invention adopts following technical scheme: a kind of Chinese medicine preparation for the treatment of diabetes, calculates by weight, and it is prepared from by following crude drug:

Section dies young Luo Qu 400 ~ 550 portions of Herba Plantaginiss 300 ~ 400 parts of Herba Agrimoniaes 300 ~ 400 parts of native Radix Ophiopogoniss 300 ~ 400 parts; Described section dies young Luo Qu, calculate by weight, by the fresh Fructus Trichosanthis of medical material 2 parts, fresh Caulis Spatholobi 2 parts and fresh Herba Sedi 1 part of mixture formed after squeezing extracting juice, the dry fine powder of medicinal residues mixes with flour 2 parts, 1 part, wheat bran again, add medicine juice, carry out zymolysis through song system and form.

Described native Radix Ophiopogonis is the dry flower of caprifoliaceae plant largeflower-like honeysuckle flower Lonicera macranthoides Hand.-Mazz. or is with the flower just opened, and is a kind in " Chinese Pharmacopoeia " version one in 2010 28 pages " Flos Lonicerae ".

Preferably, calculate by weight, it is prepared from by following crude drug:

Section dies young Luo Qu 480 portions of Herba Plantaginiss 350 parts

Herba Agrimoniae 335 parts native Radix Ophiopogonis 335 parts.

Preferably, the mixture of the dry fine powder of described medicinal residues and flour and wheat bran, adds medicine juice and stirs evenly and make soft material, steams thoroughly, maintenance temperature is 18 ~ 26 DEG C, humidity is 45% ~ 65%, adds bent essence fermentation 20 days ~ 30 days, taking-up, dry, pulverize, Ji get section dies young Luo Qu.

Aforementioned section dies young in the preparation method of Luo Qu, also can add water while adding whole medicine juice.

A kind of preparation method of the Chinese medicine preparation for the treatment of diabetes of the present invention, calculates by weight, and the section of taking dies young Luo Qu, Herba Plantaginis, Herba Agrimoniae and soil Radix Ophiopogonis, adds 6 ~ 10 times of water gagings, soaks 30 ~ 120 minutes, decoct 1 ~ 2 hour, filtration, and it is for subsequent use to get filtrate; Medicinal residues add 6 ~ 10 times amount soak by water 1 ~ 2 hour, filter; Merge twice filtrate, filter, concentrated, dry, pulverize, add adjuvant, make corresponding Chinese medicine preparation, to obtain final product.

Preferably, described preparation method comprises: calculate by weight, and the section of taking dies young Luo Qu, Herba Plantaginis, Herba Agrimoniae and soil Radix Ophiopogonis, Herba Plantaginis and Herba Agrimoniae is cut into 1.0cm section, adds 8 times of water gagings, soaks 30 minutes, decoct 2 hours, filtration, and it is for subsequent use to get filtrate; Medicinal residues add 6 times amount soak by water 1 hour, filter, merge twice filtrate, and filter, the relative density being condensed into 60 DEG C is the clear paste of 1.2 ~ 1.3, under the condition of temperature 55 ~ 75 DEG C, vacuum 0.08 ~ 0.1Mpa, clear paste drying under reduced pressure is become dry cream; Pulverize, add adjuvant, make corresponding Chinese medicine preparation, to obtain final product.

Preferred, described preparation method comprises: calculate by weight, and the section of taking dies young Luo Qu, Herba Plantaginis, Herba Agrimoniae and soil Radix Ophiopogonis, Herba Plantaginis and Herba Agrimoniae is cut into 1.0cm section, adds 8 times of water gagings, soaks 30 minutes, decoct 2 hours, filtration, and it is for subsequent use to get filtrate; Medicinal residues add 6 times amount soak by water 1 hour, filter, merge twice filtrate, and filter, the relative density being condensed into 60 DEG C is the clear paste of 1.2, under the condition of temperature 65 DEG C, vacuum 0.1Mpa, clear paste drying under reduced pressure is become dry cream; Pulverize, granulate, adds the silicon dioxide of 0.37% of dry cream gross weight, and mixing, incapsulates, obtain capsule.

In order to ensure effect of the present invention, the applicant has carried out series of experiments to select the preparation technology of pharmaceutical preparation provided by the invention, ensures science, reasonable, feasible.Specific as follows:

Experimental example 1: the selection of dosage form

This product by section die young Luo Qu, Herba Plantaginis, Herba Agrimoniae, soil Radix Ophiopogonis four Chinese medicine form, on the basis in conjunction with the Empirical formula of Seedling doctor Long-term clinical utilization, combine with dialectical to debate disease, according to the Therapeutic Method of " treatment through spleen diabetes " and the Seedling medical knowledge opinion of " two sick two guiding principles ", cold outer heat symptom-complex in diabetes and complication belong to, need heat coldly take into account medication to establish method for the treatment of, carry out selecting medicine prescription.Fang Zhongke die young Luo Qu carbon be Seedling doctor peculiar, tool replenishing QI to invigorate the spleen, the effect of quenching one's thirst of promoting the production of body fluid, function of spleen and stomach regulating, beneficial liquid fills as the medicine of a warm nature, enters cold warp, owner's medicine; Herba Agrimoniae astringing to arrest bleeding, preventing the attack (or recurrence) of malaria, dysentery relieving, removing toxic substances; Herba Plantaginis clearing away heat and promoting diuresis, eliminates the phlegm, removing heat from blood, removing toxic substances; The removing toxic substances of soil Radix Ophiopogonis dispelling wind, stomach function regulating promotes the production of body fluid; Rear three tastes all belong to cold medicine and enter hot warp, are accessory drugs altogether; All medicine 5 use, play altogether and consolidate yin nourishing, change turbidly to promote blood circulation, effect of promoting the production of body fluid to quench thirst.Capsule is compared with tablet, and capsule is plus-pressure not, so medicine is fast in gastrointestinal tract disintegrate, thus soon effective, good absorbing; In addition, capsule is light tight, photosensitive medicine and meet wet heat-labile medicine, after incapsulating, can protect medicine by the impact of the oxygen in dampness and air and light, thus can improve its stability.Therefore, in the feature that decoction is directly taken after as far as possible retaining Chinese medicine traditional decoction, the dosage form of consideration capsule, and the least possible add adjuvant to carry out technical study wherein.

Experimental example 2: Study on Preparation

For making the composition of prescription Chinese crude drug extract as far as possible, take paste-forming rate as inspection target, to process of preparing Chinese medicine length, the amount of water of medical material, soak time, decocting time, decoction number of times are investigated respectively, and its result is as follows:

(1) process of preparing Chinese medicine length of prescription Chinese crude drug is on the impact of paste-forming rate

Herba Plantaginis, Herba Agrimoniae are concocted into different length, and the soil decoction pieces of Radix Ophiopogonis and the section Luo Qu that dies young directly feeds intake, and takes recipe quantity medical material, with 10 times of water gagings, medical material is infiltrated 30 minutes, decoct 2 times, each 2 hours, filter, merging filtrate, concentrated, carry out paste-forming rate mensuration, the results are shown in Table 1:

Table 1 medicinal material processing length is on the impact of paste-forming rate

As shown in Table 1: the paste-forming rate of medicinal material coarse powder is the highest, but after medicinal material coarse powder extraction, medicinal liquid is difficult to filter, and during experiment, the method for machinery used drains medicinal residues, is not suitable for large commercial production; And the paste-forming rate cutting into 1.0cm section is close with it, therefore Herba Plantaginis, Herba Agrimoniae is cut into 1.0cm section and carry out being extracted as good.

(2) soak time is on the impact of paste-forming rate

Herba Plantaginis, Herba Agrimoniae are concocted into 1.0cm section, and the soil decoction pieces of Radix Ophiopogonis and the section Luo Qu that dies young directly feeds intake, and takes recipe quantity medical material, with 10 times of water gagings, medical material is infiltrated different time, decoct 2 times, each 2 hours, filter, merging filtrate, concentrated, carry out paste-forming rate mensuration, the results are shown in Table shown in 2:

The different soak time of table 2 is on the impact of paste-forming rate

As shown in Table 2: different soak times, little on the paste-forming rate impact of medical material, from the consideration that saves time and cost, to infiltrate 30 minutes for good.

(3) different amount of water, decocting time and extraction time are on the impact of paste-forming rate

Herba Plantaginis, Herba Agrimoniae are concocted into 1.0cm section, the soil decoction pieces of Radix Ophiopogonis and the section Luo Qu that dies young directly feeds intake, and takes recipe quantity medical material, with different amount of water, soak 30 minutes, extract with different decocting times and extraction time, filter, filtrate, concentrated, carry out paste-forming rate mensuration, specifically investigate with the scheme in following table 3, result of the test is as shown in table 4:

The extraction scheme that table 3 is different

The different extraction scheme of table 4 is on the impact of extractum yield

From table 3, table 4: prescription medicinal material extract 2 times, first time adds 8 times amount water soaking 30 minutes, decocts 2 hours, and second time added 6 times amount soak by water after 1 hour, extractum yield almost no longer increases, consider from energy savings and time cost, concoct into 1.0cm section with Herba Plantaginis, Herba Agrimoniae, the decoction pieces of soil Radix Ophiopogonis and the section Luo Qu that dies young directly feeds intake, take recipe quantity medical material, decoct 2 times, medical material is infiltrated 30 minutes with 8 times of water gagings by first time, decocts 2 hours; Second time 6 times amount soak by water 1 hour, filtration, the technique of merging filtrate is good.

The concrete grammar that described paste-forming rate measures is: getting and being concentrated into relative density is that 1.2 ~ 1.3(measures temperature 60 C) clear paste, shift and be settled in 1000ml volumetric flask, shaking up; Precision measures 20ml, and be placed in the evaporating dish of constant weight respectively, water-bath volatilizes, and residue, in 105 DEG C of dryings 3 hours, takes out, and puts in exsiccator and places 30 minutes, weigh, and calculates.

(4) concentrated and drying process research

Adopting (the 300 order filter cloth) method of filtration to carry out in crude extract test, for preventing effective ingredient for a long time by heat damage, in conjunction with industrial process conditions, adopting triple effect concentrating under reduced pressure equipment to concentrate.Result shows: the filtrate reduced in volume of merging become relative density be 1.2 ~ 1.3 clear paste, measuring tempeature is 60 DEG C; Drying condition is simultaneously: temperature 55 ~ 75 DEG C, during vacuum 0.08 ~ 0.1Mpa, effect is best.

(5) screening of lubricant and consumption

Dried extractum is beaten powder and crosses 60 orders, direct filled capsules, find that the mobility of powder is too poor, affect loading amount, therefore consider to add lubricant.Through preliminary experiment, draw and make lubricant best results with silicon dioxide; Take powder flowbility as inspection target, investigate the addition of silicon dioxide, result is as shown in table 5:

The addition experiment investigation result of table 5 silicon dioxide

As shown in Table 5: when the addition of silicon dioxide is 0.27% of crude drug total amount, powder flowbility is general, and when adding 0.47% of 0.37% and total amount of total amount, powder flowbility is all better, from the viewpoint of saving cost, to add the silicon dioxide of total amount 0.37% for optimum selection.

(6) section dies young the preparation method research of Luo Qu:

Research shows, section dies young, and to prepare effect better for sieve Qu Caiyong following methods:

The fresh Fructus Trichosanthis of medical material, fresh Caulis Spatholobi and fresh Herba Sedi is taken, squeezing extracting juice by proportioning, for subsequent use; After medicinal residues drying, be ground into fine powder; Take flour and wheat bran by proportioning, flour and wheat bran and medicinal residues fine powder are mixed, add medicine juice and water and stir evenly and make soft material, steam thoroughly, keep that temperature is 18 ~ 26 DEG C, humidity is 45% ~ 65%, add bent essence fermentation 20 ~ 30 days, take out, dry, pulverize, to obtain final product.

Section dies young in the preparation method of Luo Qu:

One,

1, leaven embryo arrangement pitch :) under the palm bar of 3-4cm(side freely;

2, fermentation culture origin temp 23-25 DEG C (summer is more low better);

3, room culture require Caulis et Folium Oryzae depending on season, winter: pad and lid reach 3 centimeters thick; Summer: pad and lid reach 2 centimeters thick;

4, fermentation culture, the most Gao Shida 56 DEG C of product temperature (latter three days will according to the suitable humidity discharging of weather);

5, upper wallette requires as just rectangular row, height 4-7 layer;

6, later stage fermentation cultivation temperature 28-30 DEG C, and carry out ventilation;

7, ferment complete, upper big-wall height 6-8 layer.

Two, fermentation management:

1, in primary fermentation 2-3 days, insulation, water conservation, make its normal fermentation;

2, in ferment middle 4-7 days, ventilation humidity discharging is proper, keeps bent embryo surface humidity, moist, cracking;

3, turn over and bent upper and lowerly change face, as temperature is too high, pull open the distance between bent embryo.

Three, critical process:

1, cultivation in early stage:

Along with the difference of season and room temperature, bent embryo heats up also different, and summer heats up hurry up, and winter more slowly, when rising gradually along with temperature, bent aqueous humor vapour increases, humid, and bent room temperature is raised to 30-45 DEG C, bent embryo surface has mycelia (when presenting white dot, should spare no effort to check, and according to indoor temperature, humidity condition, carry out humidity discharging).If bent embryo surface moisture content is evaporated to a certain degree, and band is hard, tack-free, can carry out turning over song, its method is by above translating into bottom knee-piece, surrounding turn over to centre, middle turns over to surrounding, according to the distance determining knee-piece season, and build one deck Caulis et Folium Oryzae, insulation of closing the doors and windows.

2, middle term management:

1. after turning over song, close the doors and windows, bent room temperature can rise gradually, and when temperature rises to more than 45-50 DEG C, (depending on medium and high temperature Qu Erding) carries out second time and turn over song, closes the doors and windows after having turned over.

2. when temperature continues again to rise to 35-45 DEG C, open door and window, and want humidity discharging, regulate temperature, when temperature drops to 30 DEG C, (summer is as the criterion with room temperature) is carried out second time and is turned over song.

3. according to ramp case, the degree of drying of bent embryo, turns over bent 4-6 time; Often turn over once, knee-piece height one deck after upper wallette, at the end of bent room heats up substantially, when having obvious Qu Xiangqi taste, knee-piece is mature on the whole.

3, final-period management:

Depending on difference in season, when bent room temperature is down to 10-35 DEG C gradually, can above big-wall, namely the knee-piece be mature on the whole is concentrated gradually and be deposited in a room, require that pendulum is real, be close to (ground will add backing plate).Whole fermentation time, at 16-25 days, wets without amassing in requiring, mildew is good, moisture≤20.0%; Store three months and use later, physical and chemical index: moisture≤14.0%.

In addition, section is died young Luo Qu:

Check: moisture must not cross 9.0%(" Chinese Pharmacopoeia " version in 2010 annex Ⅸ H first method); Acid-insoluble ash must not cross 1.0%(" Chinese Pharmacopoeia " version in 2010 annex Ⅸ K);

Character: for irregular fine powder or fine particle shape become thoroughly decomposed thing, surperficial canescence is to micro-yellow, and coarse, matter is crisp frangible, and gas is fragrant;

Nature and flavor with return through sweet, acrid, warm; Return spleen, stomach warp;

Function with cure mainly: replenishing QI to invigorate the spleen, promote the production of body fluid and quench one's thirst, function of spleen and stomach regulating, beneficial liquid fill.For thirst and liking drink, polyphagia, polyuria, become thin, breathe hard, fatigue and asthenia;

Usage and consumption: 3 ~ 6g;

Storage: put shady and cool dry place, mothproof.

Experimental example 3: to the physical property research of the capsule preparations for the treatment of diabetes of the present invention

1. character: with 3 batches of formulation samples for foundation describes dosage form color, profile, abnormal smells from the patient etc., as shown in table 6:

The character description of table 6 three batch sample

Conclusion: by the shape description to three batch samples, illustrates that the character of this medicine is stablized, and determines that the character of this medicine is hard capsule; Aobvious brown to sepia after removing softgel shell, bitter in the mouth.

Wherein, the die young character of Luo Qu of section is as shown in table 7:

Table 7

2. bulk density: take constant weight conforming particle, loads in 10ml graduated cylinder, falls for several times (controlled condition is consistent as far as possible) with certain altitude, and make degree of tightness appropriateness, obtain bulk density with weight divided by volume, result is as shown in table 8:

Table 8 granular pile density measurement result

3. the mensuration of angle of repose: get conforming particle and flow down through funnel and be cone shape, measure its angle of repose, result is as shown in table 9:

Table 9 granule measurement result angle of repose

As shown in Table 9: the angle of repose of granule, lower than 45.0 °, has good mobility, is suitable for the requirement of filled capsules.

4. the critical relative humidity of granule measures, and as shown in table 10, table 11, critical relative humidity measures curve as shown in Figure 3:

The relative humidity table of table 10 different solutions

Table 11 critical relative humidity determination data

Can be tried to achieve by the sucting wet curve of Fig. 3, critical relative humidity is about 58%; In conjunction with production, should relative humidity be controlled below 55% when playing powder, mixing, filling and storing, to reduce the impact of moisture on pharmaceutical properties and stability.

Experimental example 4: scale up test is tested

According to preparation technology of the present invention, carry out the engineer testing of pilot-scale, feed intake 3 batches altogether, three batches of pilot product detection data are as shown in table 12, and assay is as shown in table 13:

Table 12 three batches of pilot plant test data

Table 13 three batches of pilot sample assays

Carry out the checking of three batches of scale up test, as table 12, table 13, result shows: the technique of the Chinese medicine preparation for the treatment of diabetes of the present invention is rational, feasible.

Experimental example 5: determination of extractives

This product is not containing toxic medical material, assay really acquires a certain degree of difficulty, the mensuration of this project is increased according to " Guizhou Province's Preparation in medical units Technical Review main points-Chinese medicine ethnic drug " (trying), assay method is measured according to " Chinese Pharmacopoeia " version in 2010 annex Ⅹ A Extract mensuration hot dipping, test agent extract content in testing 3 batches, the results are shown in following table 14:

The determination of extractives of table 14 the present invention 3 batches of Chinese medicine preparation

Therefore this product water-soluble extractives content is fixed tentatively as being not less than 50.0%.

Experimental example 6: pharmacodynamics test

One, Chinese medicine preparation of the present invention is on the impact of db/db Spontaneous Diabetic mice

1. instrument and reagent

1.1 Chinese medicine preparation of the present invention

Chinese medicine preparation of the present invention (lot number: 20130401, specification: 0.3g/ grain are equivalent to 1.5g crude drug/grain, and people's consumption is each 3, every day 3 times, is provided by Braun Guizhou Pharmaceutical Enterprise Group Co).

3 dosage groups are established in test: low dose group (4 times of clinical equivalent dosage) 1.8g/kg, middle dosage group (8 times of clinical equivalent dosage) 3.6g/kg, high dose group (16 times of clinical equivalent dosage) 7.2g/kg, and animals administer volume is 0.1ml/10g body weight; Therefore Pharmaceutical formulations concentration is respectively 7.2g/kg/10ml=0.72g/ml, 3.6g/kg/10ml=0.36g/ml, 1.8g/kg/10ml=0.18g/ml.

Compound method: capsule every is 0.3g, therefore get 24,12,6 respectively at every turn, it is stand-by that adding distil water is mixed with 10ml.

2.2 metformin hydrochloride tablet

Metformin hydrochloride tablet produces (lot number: 1303107) by Shanghai Shi Guibao pharmaceutical Co. Ltd of Sino-U.S.; Indication: hyperinsulinemia, type 2 diabetes mellitus.Usage and dosage: the initial dose of this product (metformin hydrochloride tablet) is 0.5 gram usually, and every day 2 times, dosage on the one is 1g.Body weight for humans calculates according to 60kg, and being converted to animals administer dosage is 120mg/kg; Animals administer volume is 0.1ml/10g body weight; Therefore Pharmaceutical formulations concentration is 120mg/kg/10ml/kg=12mg/ml.

Compound method: tablet format is 0.5g, therefore gets 1 at every turn, and it is stand-by that adding distil water is mixed with 41.70ml.

2.3. reagent and instrument

Glucose, purchased from Beijing Chemical Plant's (lot number: 20121205); Four items of blood lipid tests CHO(lot number: 120971), TG(lot number: 125161), HDL(lot number: 120331), LDL(lot number: 120411), test kit is purchased from high-tech trade (Shanghai) Co., Ltd. of Hitachi; Mouse islets element ELISA kit (lot number: 13061201), purchased from American Crystal Chem company; 3462320) and steady bold and unconstrained type blood glucose meter (lot number:, purchased from Johnson (Shanghai) Medical Appliance Co., Ltd. for steady bold and unconstrained type blood sugar test paper; Microplate reader, agree (Shanghai) company purchased from Supreme Being; Hitachi 7080 full automatic biochemical apparatus, purchased from FDAC Co., Ltd.; Electronic balance, purchased from Mei Teletuo benefit instrument (Shanghai) Co., Ltd..

3. animal and rearing conditions

3.1 experimental animals: SPF level Spontaneous Diabetic mouse model C57BL/KsJ-db/db mice (being called for short db/db mice), 6 ~ 8 week age, body weight 45 ~ 55g, male; Thered is provided by Shanghai Experimental Animal Center/Shanghai Slac Experimental Animal Co., Ltd. of the Chinese Academy of Sciences.

3.2 rearing conditions: carry out animal feeding in China Medical Sciences Academy Medical Plants Institute's animal center, animal facility continues to keep barrier environment standard.The span of control of main environment index: room temperature 20 ~ 26 DEG C, temperature difference per day≤4 DEG C; Relative humidity 40% ~ 70%; Minimum air changes 15 times/hour; Optical illumination: dark=12h, bright=12h.Animal feeding is in base box, and 5, every box, its cultured space meets the regulation about minimum space needed for laboratory animal in National Standard of the People's Republic of China GB14925-2010.All animals carry out feeding and management by the qualified personnel of training, keep animal diet followed freedom of movement in whole feeding process.

3.3 quarantines and domestication process: 3 ~ 5 days animal quarantine phases newly received.Observe drinking water for animals at quarantine, ingest and health status, and whether there is disease and intimations of mortality.Healthy animal fur is smooth, be quick on the draw, secretions without exception etc.Find that any abnormal phenomena all needs, to thematic director and clinical veterinarian report, under veterinary instructs, to confirm through thematic director, reject ill animal, replace by healthy animal.Confirm that animal health is anosis, can use.Can test after Animal adaptability raises 1 week.

4 test methods

4.1 impacts on db/db mice fasting glucose

Age in week, C57/BL male mice was blank group together, 25 male db/db mices are divided into 5 groups at random, 6-8 week age, test is respectively dosage group, Chinese medicine preparation low dose group of the present invention in model group, metformin hydrochloride group, Chinese medicine preparation high dose group of the present invention, Chinese medicine preparation of the present invention, totally 5 groups, often organize 5.After all giving standard particle feedstuff adaptability nursing 14d, blood glucose value gives pharmaceutical intervention more than starting after 13.9mmol/L, respectively organizes gastric infusion, every day 1 time, gavage volume 0.1ml/10g, successive administration 35 days, the wherein drinking water of blank group and model group gavage 0.1ml/10g every day.After water 5h is can't help in animal fasting, measure mouse tail vein blood blood glucose value by full-automatic blood glucose meter, during administration, measure weekly once.

4.2 impacts on db/db mouse glucose tolerance

Age in week, C57/BL male mice was blank group together, 25 male db/db mices are divided into 5 groups at random, be respectively dosage group, Chinese medicine preparation low dose group of the present invention in model group, metformin hydrochloride group, Chinese medicine preparation high dose group of the present invention, Chinese medicine preparation of the present invention, totally 5 groups, often organize 5.After all giving standard particle feedstuff adaptability nursing 14d, blood glucose value all gives pharmaceutical intervention more than starting after 13.9mmol/L, respectively organizes gastric infusion, every day 1 time, gavage volume 0.1ml/10g, successive administration 35 days, the wherein drinking water of blank group and model group gavage 0.1ml/10g every day.Water is can't help in animal fasting, and after 5h, after 2.5g/kg glucose gavage, the full-automatic blood glucose meter of 0min, 30min, 60min, 90min, 120min measures tail vein blood glucose value.

4.3 impacts on db/db mice serum insulin level

Administration and process the same 4.2, water is can't help in animal fasting, and after measuring fasting glucose and carbohydrate tolerance after 5h, Animal Anesthesia, ventral aorta is taken a blood sample the centrifugal 15min of 500 μ L, 3500rpm, gets supernatant, and insulin ELISA kit detects serum insulin.

The impact of 4.4 pairs of db/db lipid of mices four CHO, TG, HDL, LDL

Administration and process the same 4.2, water is can't help in animal fasting, and after measuring fasting glucose and carbohydrate tolerance after 5h, Animal Anesthesia, ventral aorta is taken a blood sample the centrifugal 15min of 500 μ L, 3500rpm, gets supernatant, and full automatic biochemical apparatus detects four items of blood lipid tests.

5 experimental results

5.1 impacts on db/db mice general state

Compare with C57/BL matched group, db/db model group build is fat, and body weight significantly increases, movable minimizing, and other states are as hair color, and diet is unchanged; Compare with db/db model, metformin and Chinese medicine preparation of the present invention change without significance db/db mice build, activity, hair color, diet.Chinese medicine preparation group body weight of the present invention is partially light, but no difference of science of statistics.

5.2 impacts on db/db mice fasting glucose

Result shows, gives drug treating after 1 week, compares the trend that fasting glucose has reduction with model group, but no difference of science of statistics; Give drug treating after 2 weeks, compare the trend that fasting glucose has reduction with model group, Chinese medicine preparation high dose group of the present invention has significant difference.Give drug treating after 4 weeks, positive drug and Chinese medicine preparation group of the present invention compare fasting glucose with model group all has significant difference, Chinese medicine preparation group dosage of the present invention and hypoglycemic effect amount effect relationship; Give drug treating after 5 weeks, positive drug and Chinese medicine preparation group of the present invention compare fasting glucose with model group all has significant difference, Chinese medicine preparation group dosage of the present invention and hypoglycemic effect amount effect relationship.Chinese medicine preparation high dose group of the present invention is variant with model group fasting glucose after administration 2 weeks, in, low dose group administration 4 weeks afterwards and model group fasting glucose variant.After 2 weeks, blood glucose value is close to normal (lower than 13.9mmol/L) in administration for high dose group, and after this fasting glucose maintains this level always.Low dose group is along with the prolongation of administration time, and hypoglycemic effect is strengthened gradually, and comparing with model group in 4th week has significant difference.The results are shown in Table 15:

Table 15 metformin and Chinese medicine preparation of the present invention on the impact of db/db mice fasting glucose (mmol/L, n=5)

^*, p < 0.05; ^*, p < 0.01, and compare with time point db/db model group.

5.3 impacts on db/db mouse glucose tolerance

Result shows, compares with C57 Normal group, and the blood glucose of model group different time points all significantly raises.Administration group after taking glucose each time point blood glucose value all raise, comparing with model group has reduction trend, all but no difference of science of statistics, in table 16:

Table 16 metformin and Chinese medicine preparation of the present invention on the impact of db/db mouse glucose tolerance (different time points blood glucose value, mmol/L, n=5)

^*, p < 0.05, compares with Normal group.#, p < 0.05; ##, p < 0.01, compares with model group.

Compare with C57 Normal group, after model group takes glucose, under blood glucose-time graph, area (AUC) all significantly raises.Compare with model group, after administration group takes glucose, under blood glucose-time graph, area (AUC) reduces, and compares have significant difference with model group, in table 17: table 17 metformin and Chinese medicine preparation of the present invention are on the impact (area under curve of db/db mouse glucose tolerance, AUC, minmmol/L n=5)

^*, p < 0.05, compares with Normal group; #, p < 0.05; ##, p < 0.01, compares with model group.

5.4 impacts on db/db mice serum insulin

Result shows, with C ₅₇normal group compares, and db/db mouse model group serum insulin declines, but does not have significant difference, and compare with db/db mouse model group, administration group can increase serum insulin, but does not have significant difference, in table 18:

Table 18 metformin and Chinese medicine preparation of the present invention on the impact of db/db mice serum insulin ( n=5)

5.5 impacts on db/db lipid of mice four

Result shows, compares with C57 Normal group, and db/db mouse model group CHO declines, and it is obvious that TG raises trend, but do not have significant difference; Compare with db/db mice, administration group TG downward trend is obvious, does not have significant difference; The change of other indexs is not obvious, in table 19:

Table 19 metformin and Chinese medicine preparation of the present invention on the impact of four items of blood lipid tests ( n=5)

6. conclusion

Give drug treating after 5 weeks, compare with model group, positive drug and Chinese medicine preparation group fasting glucose of the present invention significantly reduce; Chinese medicine preparation group dosage of the present invention and hypoglycemic effect amount effect relationship.Chinese medicine preparation high dose group of the present invention, compares with model group after 2 weeks in administration, and fasting glucose significantly reduces; In, low dose group after administration 4 weeks fasting glucose significantly lower than model group.After 2 weeks, fasting blood sugar is close to normal (lower than 13.9mmol/L) in administration for high dose group, and after this fasting glucose maintains this level always.Low dose group is along with the prolongation of administration time, and hypoglycemic effect manifests gradually, in 4th week fasting glucose significantly lower than model group.On this model (db/db), Chinese medicine preparation of the present invention shows blood sugar lowering and improves the effect of carbohydrate tolerance, comparatively early there is hypoglycemic effect in higher dosage, low dosage administration certain hour (4 weeks) also shows good hypoglycemic effect, and the blood sugar reducing function continued appears in the performance of this medicine.Chinese medicine preparation of the present invention is in the impact test of db/db mice serum insulin, four items of blood lipid tests, have rising trend to serum islet, TG has reduction trend, because size of animal is less, compare with db/db mouse model, the effect there was no significant difference of Chinese medicine preparation of the present invention.

Have good hypoglycemic activity by above-mentioned result of the test preliminary proof Chinese medicine preparation of the present invention, high dose group is slightly better than metformin group, is significantly improved effect for carbohydrate tolerance simultaneously; Thus this Chinese medicine preparation has good DEVELOPMENT PROSPECT.

Two, Chinese medicine preparation of the present invention is to the experimentation of type 2 diabetes mellitus rat blood sugar reducing function

1. materials and methods

1.1 material

1.1.1 animal cleaning grade male SD rat, body weight 150 ~ 180g, is purchased from Chongqing and rises prosperous Bill's laboratory animal sale company limited, animal credit number SCXK (Chongqing), 2012-0006.

1.1.2 medicine and reagent

1.1.2.1 Chinese medicine preparation of the present invention: provided (hereinafter referred to as TNTL) by Braun Guizhou Pharmaceutical Enterprise Group Co, adult's clinical dosage is 0.045g/kg, and rat dose,equivalent and people are scaled 7 times of people's clinical dosages.Face the used time content (brown powder) the taking-up pure water of Chinese medicine preparation is prepared.During test, rat TNTL low dose group is 0.63g/kg(bis-times of clinical dosages), high dose group is 1.26g/kg(tetra-times of clinical dosages).

1.1.2.2 streptozotocin (Streptozotocin STZ), Beijing is won Alto and is reached Science and Technology Ltd., lot number: 040M1367.

1.1.2.3 rat insulin test kit: Manufactured by Mercodia AB, Sylveniusgatan8A, SE-75450Uppsala, Sweden.Lot number: 20518, used time by specification operation.

1.1.2.4 rat C peptide reagent box: upper sea blue base Science and Technology Ltd., lot number: 20130617.Used time by specification operation.

1.1.2.5 metformin: be Tian An board Dimethyldiguanide hydrochloride enteric solubility tablet, adult's clinical dosage is 0.03g/kg every day, is scaled rat equivalent 0.21g/kg.

1.1.2.6 normal diet, is purchased from Chongqing and rises prosperous Bill's laboratory animal sale company limited.

1.1.2.7 high-sugar-fat-diet makes: white sugar, Adeps Sus domestica, egg are all purchased from supermarket, and egg boils only with egg yolk, and normal diet is broken into powder.Feed formula: sell company limited containing normal diet 35g(Chongqing Teng Xin Bill laboratory animal in every 100g high lipid food), Adeps Sus domestica 15g, white sugar 25g, egg yolk 25g, feeding animals 20 days.

1.2 animal grouping and medications

1.2.1 give TNTL in advance to test the impact of type Ⅱdiabetes mellitus rat: rat is divided into 3 groups, be respectively normal group, model group, TNTL group.Normal group gives normal diet, model group and TNTL group high-sugar-fat-diet are fed, TNTL group gavage every day gives Chinese medicine preparation of the present invention (0.63g/kg, 1 times/day), after 20 days simultaneously, model group and TNTL group lumbar injection STZ(face the used time and prepare with citrate buffer, pH value 4.2,30mg/kg, completed injection in 30 minutes), manufacture diabetes model, filter out modeling successful rat normal diet and feed 12 days (the omnidistance administration of TNTL group 32 days).

1.2.2TNTL the impact of type 2 diabetes mellitus rat is tested: rat is divided into 5 groups, normal group, model group, metformin group, TNTL low dose group, TNTL high dose group.Normal group gives normal diet, and other 4 groups of high-sugar-fat-diets feed modeling (the same) after 20 days, and the successful rat of modeling is used normal diet instead and feeds, and each group starts administration, 2 times/d, each 1 time of upper and lower noon simultaneously.Metformin group ig0.21g/kg, TNTL low dosage ig0.63g/kg, (two times of clinical dosages), TNTL high dose ig1.26g/kg(tetra-times of clinical dosages).Omnidistance administration 27 days.

1.2.3TNTL test with the impact of Western medicine conbined usage on type 2 diabetes mellitus rat and normal rat: rat is divided into 4 groups, normal group, model group, metformin+TNTL low dose group, normal+TNTL high dose group.Normal group and normal+TNTL high dose group give normal diet, model group, metformin+TNTL low dose group high lipid food feed modeling (the same) after 20 days, and the successful rat of screening modeling is used normal diet instead and feeds, and each group starts administration simultaneously, 2 times/d, each 1 time of upper and lower noon.Metformin+TNTL low dose group first gives metformin 27 days (ig, 0.21g/kg), then changes TNTL low dosage (ig, 0.63g/kg, two times of clinical dosages) 21 days into.Normally+TNTL high dose group was to TNTL high dose (ig, 1.26g/kg, four times of clinical dosages) 21 days.

1.3 detection methods and instrument

1.3.1 insulin, C peptide all detect by ELISA method, detecting instrument Biotek Synergy2 fluorescence microplate reader, U.S. Biotek Products.

1.3.2 blood-sugar detecting instrument and reagent paper: U.S.'s Roche Products, ACCU-CHEK Pertorma.

1.4 check pathological section rat limosis are after 16 hours, and sacrificed by decapitation, gets pancreas and be placed in the fixing preservation of neutral formalin liquid, do pathology detection.This detection completes in Pathology Deparment of No. 2 Affiliated Hospital of Guiyang College of Traditional Chinese Medicine.Be divided into normal and atrophy according to the atrophy degree after pancreas is damaged, carry out statistics (card side) and check by often organizing atrophy and normal number of elements and process.

1.5 statistical method: use SPSS17.0 statistical software, measurement data with express, enumeration data is with percentage expression, and after group, measurement data compares with T inspection, and enumeration data compares with X 2 test.

2. result

2.1 give the impact of TNTL on type Ⅱdiabetes mellitus rat in advance

2.1.1 carbohydrate tolerance: rat limosis is after 16 hours, gives glucose solution (gavage, 20g/100mL, 3mL/ are only), measures empty stomach, 1h, 2h, 3h blood glucose value of rat, the results are shown in Table 20, Fig. 4:

Table 20 gives Chinese medicine preparation of the present invention on the impact of type 2 diabetes mellitus rat carbohydrate tolerance in advance

Note: compare with normal group, ^*p<0.05, ^*p<0.01; Compare with model group, ^#p<0.05, ^##p<0.01

Be starkly lower than model group (P<0.05) from the blood glucose value of table 20, Fig. 4, TNTL group 3h, other two time points also have reduction.

2.1.2 pancreatic tissue check pathological section

Pathology detection result point out, in advance to TNTL group comparatively model group Pancreas pathology damage obviously alleviate.In table 21, Fig. 5-Fig. 7:

Table 21 gives Chinese medicine preparation of the present invention on the impact (unit: only) of type 2 diabetes mellitus pancreas in rat in advance

Note: compare with normal group, ^*p<0.05; Compare with model group, ^#p<0.05

2.2TNTL is on the impact of type 2 diabetes mellitus rat

2.2.1 body weight

TNTL significantly can improve the body weight that diabetes rat reduces, and the results are shown in Table 22, Fig. 8:

Table 22 Chinese medicine preparation of the present invention is on the impact of type 2 diabetes mellitus rat body weight

2.2.2 carbohydrate tolerance

Rat limosis, after 16 hours, gives glucose solution (gavage, 20g/100mL, 3mL/ are only), uses Roche blood glucose meter to measure empty stomach, 1h, 2h, 3h blood glucose value.The results are shown in Table 23, Fig. 9:

Table 23 Chinese medicine preparation of the present invention is on the impact of type 2 diabetes mellitus rat carbohydrate tolerance

Note: compare with normal group, ^*p<0.05, ^*p<0.01; Compare with model group, #p<0.05, ##p<0.01

From table 23, Fig. 9, the fasting glucose of each group rat does not have significant difference, the blood glucose value of TNTL low dosage and each time point of high dose all lower than model group, difference significance (p<0.01), but still variant with normal group.There was no significant difference between Chinese medicine TNTL low dose group and Chinese medicine TNTL high dose group.

2.2.3 insulin and C peptide

Rat limosis, after 16 hours, gets blood centrifuging and taking supernatant, uses rat insulin ELISA kit (Mercodia), rat C peptide ELISA kit (BluGene), detects the OD value at 450nm wavelength place, the results are shown in Table 24:

Table 24 Chinese medicine preparation of the present invention is on the impact of type 2 diabetes mellitus rat limosis insulin, C peptide

By shown in table 24, the insulin of model group is significantly lower than normal group, and TNTL high and low dose group insulin comparatively model group has increase trend, but still is starkly lower than normal group.C peptide result shows, and model group decreases, and TNTL high and low dose group comparatively model group has and slightly increases trend.

2.2.4 Pancreas pathology inspection

Gather pancreas and be placed in that neutral formalin liquid is fixing to be preserved, check pathological section, the results are shown in Table 25, Figure 10-Figure 14:

Table 25 Chinese medicine preparation of the present invention is on the impact (unit: only) of type 2 diabetes mellitus pancreas

Note: compare with normal group, ^*p<0.05; Compare with model group, #p<0.05

2.3TNTL and metformin conbined usage are on the impact of type 2 diabetes mellitus rat

2.3.1 carbohydrate tolerance:

Rat limosis, after 16 hours, gives glucose solution (gavage, 20g/100mL, 3mL/ are only), measures empty stomach, 1h, 2h, 3h blood glucose value of rat.The results are shown in Table 26, Figure 15:

Table 26 drug combination is on the impact of type 2 diabetes mellitus rat carbohydrate tolerance

From table 26, Figure 15, metformin+TNTL low dose group fasting glucose is significantly lower than model group, and normal+TNTL high dose group and normal group carbohydrate tolerance value do not have difference, illustrate that this TNTL does not affect blood glucose level normal.

2.3.2 Pancreas pathology inspection

Gather pancreas and be placed in that neutral formalin liquid is fixing to be preserved, do pathology detection, the results are shown in Table 27, Figure 16-Figure 19:

Table 27 drug combination is on the impact (unit: only) of pancreas in rat check pathological section

Note: compare with normal group, ^*p<0.05

This first 3 groups of test compares, and result metformin+TNTL low dose group has certain protective role to rat Langerhans islet, but does not have statistical significance.Normally+TNTL high dose group compares with normal group, does not have diversity between two groups, and the TNTL of high dose does not affect normal pancreas in rat.

Conclusion:

This experiment male SD rat, feeds with high calorie and adds the classical way of half amount streptozotocin partial destruction B cell, successfully construct type 2 diabetes mellitus rat model.

This research finds, it is no matter the method with the method for administration in advance or conventional therapy administration, no matter be individually dosed method or the method with metformin administering drug combinations, no matter be observe with carbohydrate tolerance or observe with conventional blood sugar, TNTL all obviously can reduce type 2 diabetes mellitus rat blood sugar (the equal <0.05 of P value), shows the obvious blood sugar reducing function of TNTL tool.

This research also finds, after TNTL acts on type 2 diabetes mellitus rat, while blood glucose obviously reduces, its fasting insulin and C peptide there is no obvious change, point out this blood sugar reducing function mechanism not necessarily B cell is short and secrete effect, may be relevant with improving the factors such as insulin resistant (IR).

This research observes the change of the Neo-Confucianism of the Pancreas Disease after TNTL effect, finds that its atrophy number is starkly lower than the model group (P<0.05) without TNTL effect, shows that TNTL is to the islets of langerhans protective effect to a certain degree of type 2 diabetes mellitus rat tool.

TNTL is acted on normal SD rats by this research, and it found that the blood glucose of normal SD rats is unchanged before and after TNTL effect, and its pancreas, also without pathological change, shows TNTL to normal rat without blood sugar influence, also has no significant effect its islets of langerhans.This result also points out the blood sugar reducing function of TNTL may not realize mainly through promotion B cell excreting insulin further.

Experimental example 7: acute toxicity test

1.1 medicine

Chinese medicine preparation of the present invention, is provided by Braun Guizhou Pharmaceutical Enterprise Group Co, lot number: 20130106.Face the used time is mixed with desired concn suspension oral gavage administration with distilled water.

1.2 animal

Kunming mouse, male and female half and half, body weight 20 ± 2g, is provided by Military Medical Univ No.3, P.L.A's Experimental Animal Center, the quality certification number: SCXK(changes) 2012-0003.

1.3 feedstuff

Feedstuff is full-valence pellet feed, is provided by above-mentioned unit.

1.4 zoopery places

Guiyang College of Traditional Chinese Medicine's pharmacological toxicology laboratory ventilation is good, and sanitation and hygiene, temperature, humidity all reach the requirement of new drug pharmacological research.

1.5 key instrument

ALC-210.3 type electronic balance, upper current chart level instruments and meters company limited.

1.6 statistical procedures

The poor opposite sex between data acquisition group, with represent, carry out t inspection.

2 experimental techniques and result

2.1 prerun tests

With the Chinese medicine preparation aqueous solution of the present invention of Cmax 23%, 0.3ml/10g body weight gavage gives mice, observes 7 days.Result: have no animal dead, shows to measure its LD ₅₀, therefore measure the maximum dosage-feeding of Chinese medicine preparation of the present invention.

2.2 formal test

Get Kunming mouse 40, be divided into blank group, Chinese medicine preparation group of the present invention at random, often organize 20, male and female half and half.Before experiment, water 12h is can't help in fasting, and Chinese medicine preparation group gavage of the present invention gives the Chinese medicine preparation aqueous solution 0.3ml/10g body weight of the present invention of mice 23%, and a twice-daily, is equivalent to 13.8g/kg body weight, is 400 times of clinical plan dosage 0.0345g/kg body weight; Blank group with mutually commensurability normal saline gavage, a twice-daily.Continuous Observation 14d after administration, record animal has body weight change before and after non-toxic reaction and experiment, not produce dead dosage for maximum dosage-feeding.

Result: after Kunming mouse gavage Chinese medicine preparation aqueous solution of the present invention 13.8g/kg, grow healthy, fleshiness, glossy by Mao Mi, bright and flexible, the N/R secretions of eyes, crissum is clean, ingest normal, extremity are healthy and strong, and spontaneous activity is normal, in observation period, body weight increases gradually, compares no significant difference with blank group.Animal dead and toxicity is had no in 14d.At the end of experiment, naked eyes become celestial and have no obvious pathological change.Experimental result is in table 28:

Table 28 Chinese medicine preparation of the present invention on the impact of Mouse Weight (g) ( n=10)

Note: Chinese medicine preparation group of the present invention is female compares P>0.05 with blank group is female; Chinese medicine preparation group of the present invention is male compares P>0.05 with blank group is male.

Conclusion: Kunming mouse gavage Chinese medicine preparation of the present invention, with Cmax 0.23g/ml, administration volume 0.3ml/10g body weight, a twice-daily administration, is equivalent to 13.8g/kg body weight, is 400 times of clinical plan dosage." it is generally acknowledged that the maximum tolerated dose of mice is according to the weight equivalent to people's consumption more than 100 times then safer " according to bibliographical information, therefore, can think that Chinese medicine preparation of the present invention is very little to the acute toxicity of animal, safety, can clinic trial be provided; In addition, inventor has also carried out long term toxicity test to Chinese medicine preparation of the present invention, and result of the test also shows that Chinese medicine preparation toxicity of the present invention is less, and Clinical practice is safer.

Experimental example 8 long term toxicity test

1. object

Observe larger dose, long period, give rat continuously and repeat gavage Chinese medicine preparation of the present invention 12 weeks, 24 weeks and drug withdrawal 4 weeks to toxic reaction that rat produces, the order of severity and the symptom first occurred; The target organ observing toxic reaction recovers and development, determining nontoxic crude protein, providing foundation for drafting people's safe dose.

2. experiment material

2.1 medicine

Chinese medicine preparation of the present invention, is provided by Braun Guizhou Pharmaceutical Enterprise Group Co, lot number: 20130106.Function cures mainly: yin nourishing is promoted blood circulation, promoting the production of body fluid to quench thirst, clearing away heat-fire.For the diabetes caused by deficiency of both QI and YIN, disease is seen thirst and liking drink, polyphagia, polyuria, becomes thin, is breathed hard, weak, sleep poor, lumbago, feverish sensation in the palms and soles; Type 2 diabetes mellitus is shown in above-mentioned patient.Dosage form: capsule.Usage and dosage: oral, 3 times on the one, a 3-4 grain; Bfore meals.Specification: the heavy 0.3g of every capsules, is equivalent to crude drug amount 1.73g.Adult's body weight calculates according to 60kg, then the clinical Coming-of-Age Day consumption drafted is 0.0345g/kg body weight, is equivalent to 0.19895g crude drug amount/kg body weight.

Face the used time is mixed with desired concn suspension oral gavage administration with distilled water.

2.2 animal

SD rat, male and female half and half, 120, body weight 100g ± 20g, is provided by Military Medical Univ No.3, P.L.A's Experimental Animal Center, the quality certification number: SCXK(changes) 2012-0003.

2.3 key instrument

JY601 type electronic balance, upper current chart level instruments and meters company limited; OLYMPUSBH-2 microscope, Japan; SC-970 Automatic Blood Cell Analyzer, Bei Ken company of Switzerland; Hitachi 7170A automatic clinical chemistry analyzer, Kodak of the U.S.; HPIAS-1000 high-definition color picture and text pathological analysis system, light microscopic.

2.4 experimental data statistics

Experimental data with represent, t inspection between organizing.

3 experimental techniques

3.1 experiment condition

Not every cage 5 group supports of the equal unisexuality of rat before and after administration, feed with full-valence pellet feed, freely drink water, room temperature 20 DEG C ~ 23 DEG C, humidity 55% ~ 65%.First conform before administration, observe 7 days rat general status, change without exception, then the administration that starts to divide into groups is tested.

3.2 grouping and dosage

SD rat 120, male and female half and half, are divided into 4 groups at random, often organize 30, respectively as high, medium and low three the dosage groups of Chinese medicine preparation of the present invention and blank group.Administration group dosage is respectively 2.07g, 1.035g, 0.5175g/kg body weight, and administration concentration is respectively 20.7%, 10.35%, 5.175%, is said preparation and drafts clinical Coming-of-Age Day with 60 times, 30 times, 15 times of dosage 0.0345g/kg body weight.Administration volume is 10ml/kg body weight.

3.3 route of administration and method

Because Chinese medicine preparation clinical administration approach of the present invention is oral administration, so the equal gastric infusion of each treated animal.During 8-10 in morning every day, gastric infusion once, and administration volume is 10ml/kg body weight, continuous 24 weeks; Observe animal general status every day, record weekly each treated animal body weight and food-intake once, increase change according to the weight of animals, adjustment dosage.

3.4 the test period

Testing total cycle is 28 weeks, and first 24 weeks is administration time, drug withdrawal in latter 4 weeks, observes animal different time whether toxic reaction respectively.The administration phase, respectively at administration 12 weeks, 24 weeks time, after last administration, fasting can't help water 12 hours, often group get 10 animals (male and female half and half) weigh after femoral vein get blood, measure animal blood cytology, blood biochemical analysis, put to death animal to carry out system and become celestial simultaneously, observe animal each organs and tissues with or without after hyperemia, enlargement, the ANOMALOUS VARIATIONS such as hemorrhage, get each Mus main organs again to weigh respectively, calculate after organ coefficient and other organs and tissues specimen are carefully peeled off peripheral adipose tissue etc. and immersed 10% formaldehyde and fix, carry out Pathomorphologic inspection.Withdrawal time, all the other animal drug withdrawal routines are raised 4 weeks, and every day carries out general status observation, every journal body weight and food-intake, and fasting be can't help drink and put to death animal in 12 hours, detects above-mentioned indices.

4 inspection items

4.1 overview

Observe the mode of appearance sign, behavioral activity, hair luster, feed, drinking-water, stool etc. of each treated animal every day; Find that intoxicated animals is isolated immediately, primary part observation; Find dead or moribund animals, at once postmortem.Claim the weight of animals weekly, adjust dosage accordingly, record each treated animal feed consumption simultaneously.

4.2 test item

4.2.1 blood cytology Index for examination

Leukocyte (WBC), neutrophilic granulocyte sum (#NEUT), lymphocyte absolute value (#LYMPH), monocyte count (MONO#), acidophil number (#EOS), basophilic leukocyte number (#BASO), Erythrocyte hemoglobin distribution width (RDW), neutrophilic granulocyte percentage ratio (%NEUT), cent lymphocytes (%LYMPH), mononuclear cell percentage ratio (%MONO), acidophil percentage ratio (%EOS), basophilic leukocyte percentage ratio (%BASO), erythrocyte (RBC), hemoglobin (HGB), packed cell volume (HCT), mean corpuscular volume (MCV) (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin (MCHC), platelet (PLT), Mean Platelet Volume (MPV).4.2.2 blood biochemical analysis Index for examination

Potassium (K), sodium (Na), chlorine (CL), glucose (GLU), triglyceride (TG), T-CHOL (CHOL), blood urea nitrogen (BUN), creatinine (CREA), glutamate pyruvate transaminase (ALT), glutamic oxaloacetic transaminase, GOT (AST), alkali phosphatase (AKP), creatine kinase (CK), total protein (TP), albumin (ALB), globulin (GLB), total bilirubin (TBIL).

4.2.3 major organs tissue specimen

The heart, liver, spleen, lung, kidney, adrenal gland, thymus, brain, uterus, ovary, testis, epididymis, weigh respectively, calculates acropetal coefficient; Draw materials in same positions of internal organs such as the heart, liver, spleen, lung, kidney, adrenal gland, thymus, cerebral tissue, thyroid, hypophysis, trachea, esophagus, stomach, intestinal, bladder, pancreas, lymph node, optic nervies and carry out paraffin embedding, section, HE dyes; Put observation by light microscope and carry out internal organs pathological tissue with blank group and compare.First comparison check high dose group and the pathological change of blank treated animal tissue morphology, middle dosage group and low dose group animal organ tissue specimen 10% formaldehyde are fixed for future reference.

4.2.4 pathological examination

Carry out corpse to analyse, and main Organ and tissue 10% formaldehyde is fixed, preserved.The histopathological examination of high dose group and blank treated animal is only carried out when each dosage treated animal corpse is analysed and do not found obvious pathological changes.As found, centering, low dose group animal check pathological changes accordingly again.4.3 index observing times

The general status of all laboratory animals of complete observation every day, animal activity behavior, stool, outward appearance sign, the feedstuff consumption of a week; Weigh weekly once; After administration 12 weeks, 24 weeks last medicines, 12 hours and 4 weeks recovery end of term of drug withdrawal, respectively carry out once above-mentioned project and check comprehensively.

5 experimental results

5.1 Chinese medicine preparation of the present invention are on the impact of rat ordinary circumstance and feed

In successive administration 12 weeks, 24 weeks and drug withdrawal 4 weeks, each administration group compared with blank group, observe animal activity, behavior, diet, stool, hair luster etc., 4 treated animal situations are similar, show no obvious abnormalities change.Interior rat food ration also no significant difference at one time.The results are shown in Table 29, table 30:

Table 29 Chinese medicine preparation successive administration of the present invention 12 weeks, 24 weeks and drug withdrawal during 4 weeks on the impact of female rats Zhou Pingjun food-intake (g)

Note: different time points, each administration group compares with blank group, P>0.05.

Table 30 Chinese medicine preparation successive administration of the present invention 12 weeks, 24 weeks and drug withdrawal during 4 weeks on the impact of male rat Zhou Pingjun food-intake (g)

Result shows, each treated animal week consumes appetite all in increasing trend gradually, and each administration group compares with blank group, no significant difference, P > 0.05.Show the continuous gastric infusion of rat 12 weeks, 24 weeks and drug withdrawal 4 weeks, male and female rat chow week consumption is had no significant effect.

5.2 Chinese medicine preparation of the present invention are on the impact of rat body weight

The high, medium and low Three doses of Chinese medicine preparation of the present invention compares with blank group the body weight after rat successive administration different time, and its difference, without significant change, the results are shown in Table 31, table 32.

The long-term successive administration of table 31 Chinese medicine preparation of the present invention 12 weeks, 24 weeks and drug withdrawal during 4 weeks on the impact of female rats body weight (g)

Note: each administration group compares with blank group, P>0.05; Within 0 week, be medicine early stage, n=15; 1-12 week is the administration phase 1, n=15; 13-24 week is the administration phase 2, n=10; 25-28 week is withdrawal time, n=5.

The long-term successive administration of table 32 Chinese medicine preparation of the present invention 12 weeks, 24 weeks and drug withdrawal during 4 weeks on the impact of male rat body weight (g)

Result shows, in the observation period, each group male and female rat body weight increases all gradually, and growth promoter is good; Each administration group compared with same time period blank group, each time point body weight no significant difference compared with blank group, P > 0.05.Show the continuous gastric infusion of rat 12 weeks, 24 weeks and drug withdrawal 4 weeks, male and female rat body weight is affected without overt toxicity.

5.3 Chinese medicine preparation of the present invention affect rat blood cytology

Chinese medicine preparation of the present invention is to rat oral gavage administration 12 weeks, 24 weeks and drug withdrawal 4 weeks, and each treated animal hematological indices testing result is in table 33 ~ 35.

The impact on rat blood cytology index in 12 weeks of table 33 Chinese medicine preparation successive administration of the present invention ( n=10)

Note: each administration treated animal blood cytology indices numerical value respectively with blank group corresponding index numeric ratio comparatively, P>0.05.

The impact on rat blood cytology index in 24 weeks of table 34 Chinese medicine preparation successive administration of the present invention ( n=10)

The table 35 Chinese medicine preparation drug withdrawal of the present invention impact on rat blood cytology index in 4 weeks ( n=10)

Result shows, the high, medium and low Three doses successive administration of Chinese medicine preparation of the present invention 12 weeks, 24 weeks and drug withdrawal 4 weeks, be showed no appreciable impact to the hemocyte of rat, through statistical procedures, and P > 0.05.Therefore, Chinese medicine preparation larger dose of the present invention, long period (24 weeks) administration and drug withdrawal 4 weeks can be thought, to the hemopoietic function of rat without significant toxic effect.

5.4 Chinese medicine preparation of the present invention are on the biochemical impact of rat blood

Chinese medicine preparation of the present invention is to rat oral gavage administration 12 weeks, 24 weeks and drug withdrawal 4 weeks, and each treated animal blood biochemical analysis Indexs measure the results are shown in Table 36, table 37, table 38.

The impact on rat blood biochemical indexes in 12 weeks of table 36 Chinese medicine preparation successive administration of the present invention ( n=10)

The table 38 Chinese medicine preparation drug withdrawal of the present invention impact on rat blood biochemical indexes in 4 weeks ( n=10)

Result shows, the high, medium and low Three doses successive administration of Chinese medicine preparation of the present invention 12 weeks, 24 weeks and drug withdrawal 4 weeks, appreciable impact is showed no on the blood parameters of rat, every biochemical indicator numerical value such as the liver function of rat and renal function are respectively compared with blank group respective value, have no notable difference, P > 0.05; Therefore show Chinese medicine preparation larger dose successive administration of the present invention 12 weeks, 24 weeks and drug withdrawal 4 weeks to the index such as Liver Function, renal function all without remarkable toxic action.

5.5 Chinese medicine preparation of the present invention are on the impact of rat major organs index

Chinese medicine preparation of the present invention to rat oral gavage administration 12 weeks, 24 weeks and drug withdrawal 4 weeks, system obduction: the form of the internal organs such as brain, heart, liver, spleen, lungs, kidney, adrenal gland, thymus, thyroid, stomach, intestinal, testis, epididymis, prostate, uterus, ovary, size, color all do not find macroscopic change.Each treated animal main organs index testing result in table 39, table 40, table 41, table 42, table 43, table 44.

The impact on female rats main organs index (g/100g) in 12 weeks of table 39 Chinese medicine preparation successive administration of the present invention ( n=5)

Note: each administration treated animal each organ index value respectively exponential quantity corresponding to blank group compares, P>0.05.

The impact on female rats main organs index (g/100g) in 24 weeks of table 40 Chinese medicine preparation successive administration of the present invention ( n=5)

The table 41 Chinese medicine preparation drug withdrawal of the present invention impact on female rats main organs index (g/100g) in 4 weeks ( n=5)

The impact on male rat main organs index (g/100g) in 12 weeks of table 42 Chinese medicine preparation successive administration of the present invention ( n=5)

The table 44 Chinese medicine preparation drug withdrawal of the present invention impact on male rat main organs index (g/100g) in 4 weeks ( n=5)

Result shows, the high, medium and low Three doses successive administration of Chinese medicine preparation of the present invention 12 weeks, 24 weeks and drug withdrawal 4 weeks, obvious toxic effect is had no to rat main organs tissue, the every organ index of each administration group rat compared with blank group all without significant difference, P > 0.05; Therefore show Chinese medicine preparation larger dose successive administration of the present invention 12 weeks, 24 weeks and drug withdrawal 4 weeks to each organs and tissues of rat without remarkable toxic action.

5.6 Chinese medicine preparation of the present invention are on the impact of rat important organ histoorgan pathomorphism

To Chinese medicine preparation successive administration of the present invention 12 weeks, 24 weeks, and the drug withdrawal high, medium and low Three doses group of 4 weeks and blank group three batches, kill and get rat and solution cuts the histoorgan such as the heart, liver, spleen, lung, kidney, adrenal gland, thymus, brain, uterus, ovary, testis, epididymis, prostate, thyroid, trachea, esophagus, stomach, aorta, duodenum, colon, bladder, pancreas, lymph node, optic nerve, sciatic nerve of each group of rat, draw materials in same area, fix by 10% formalin.Chinese medicine preparation high dose group of the present invention and blank group Rats Organs and Tissues specimen are carried out tissue slice, carries out pathological examination, all the other specimen retain with for subsequent use.Result: through checking two treated animal organ specimens, various organ-tissue structure is normal, and cell dyeing is even, without obviously changing.Because the checked organ-tissue of Chinese medicine preparation high dose group animal of the present invention does not occur that medicine causes pathological change, therefore organ-tissue section is not carried out to dosage group in Chinese medicine preparation of the present invention and low dose group.Tested organ-tissue form section photo and pathological section are reported attached.

Pathological observation result shows, the histiocyte of all multi viscera of each administration group rat is harmless, morphology is pointed out this medicine to each organs and tissues free of toxic effects.

6. conclusion

Rat chronic toxicity test result shows, with Chinese medicine preparation 2.07g/kg, 1.035g/kg, 0.5175g/kg of the present invention, be equivalent to 60 times, 30 times, 15 times of clinical dosage for adults 0.0345g/kg body weight, once a day, rat oral gavage administration in continuous 12 weeks, 24 weeks and drug withdrawal 4 weeks, compare with blank group; Each dosed administration is to the general state (mode of appearance, activity, stool shape etc.) of rat, growth promoter (body weight growth), hemopoietic function (hematological examination), Liver and kidney function (blood biochemical analysis), vitals ponderal index, all finds no obvious toxic action; Prove through pathological examination, to histoorgans such as the rat heart, liver, spleen, lung, kidney, adrenal gland, thymus, brain, uterus, ovary, testis, epididymis, prostate, thyroid, trachea, esophagus, stomach, aorta, duodenum, colon, bladder, pancreas, lymph node, optic nerve, sciatic nerves, Chinese medicine preparation high dose group of the present invention and blank group comparative observation, all do not find that obvious toxic damages changes.Because obvious pathological change does not appear in each histoorgan of Chinese medicine preparation high dose group animal of the present invention, therefore dosage group, low dose group in Chinese medicine preparation of the present invention are not carried out to organ-tissue section and detected, its Saving specimen is for subsequent use.So can think that larger dose, the long period oral toxicity giving Chinese medicine preparation of the present invention is lower, Clinical practice safety.

Compared with prior art, the Chinese medicine preparation blood sugar lowering of the treatment diabetes that the present invention is made up of Miao Ethnomedicine secret recipe is remarkable, has better therapeutic effect.This prescription derives from folk remedy, the use history of existing five more than ten years, it is the prescription summed up by clinical practice, have consolidate yin nourishing, change turbidly to promote blood circulation, effect of promoting the production of body fluid to quench thirst, especially for the diabetes caused by deficiency of both QI and YIN and complication, there is obvious blood sugar reducing function, and this blood sugar reducing function not exclusively depends on the secretion of promotion B cell; In addition, Chinese medicine preparation of the present invention has islets of langerhans protective effect to a certain degree to type 2 diabetes mellitus, can improve insulin resistant; It does not have a blood sugar reducing function to normal SD rats; In addition, Chinese medicine preparation quality safety of the present invention is reliable, does not find untoward reaction and toxic and side effects.

Accompanying drawing explanation

Fig. 1 is preparation technology's flow chart that the present invention treats the Chinese medicine preparation of diabetes;

Tu2Shi section dies young preparation technology's flow chart of Luo Qu;

Fig. 3 is that critical relative humidity measures curve chart;

Fig. 4 is rat limosis after 16 hours, gives glucose solution (gavage, 20g/100mL, 3mL/ are only), measures empty stomach, 1h, 2h, 3h blood glucose value result curve of rat;

Fig. 5 is that normal group is to type Ⅱdiabetes mellitus pancreas in rat pathological change schematic diagram;

Fig. 6 is that model group is to type Ⅱdiabetes mellitus pancreas in rat pathological change schematic diagram;

Fig. 7 is that model group is to type Ⅱdiabetes mellitus pancreas in rat pathological change schematic diagram;

Fig. 8 is that Chinese medicine preparation of the present invention affects schematic diagram to type Ⅱdiabetes mellitus rat body weight;

Fig. 9 is that Chinese medicine preparation of the present invention affects schematic diagram to type 2 diabetes mellitus rat carbohydrate tolerance;

Figure 10 is the section schematic diagram of normal rats pancreas;

Figure 11 is the section schematic diagram of model group diabetic rat pancreas;

Figure 12 is that the section of metformin group on diabetic rat pancreas affects schematic diagram;

Figure 13 is that the section of TNTL low dose group on diabetic rat pancreas affects schematic diagram;

Figure 14 is that the section of TNTL high dose group on diabetic rat pancreas affects schematic diagram;

Figure 15 is that drug combination affects schematic diagram to type 2 diabetes mellitus rat carbohydrate tolerance;

Figure 16 is the pancreas schematic diagram of normal rats;

Figure 17 is the pancreas schematic diagram of model group rats;

Figure 18 is that metformin+TNTL low dose group drug combination affects schematic diagram to pancreas in rat;

Figure 19 is that normal+TNTL high dose group affects schematic diagram to pancreas in rat.

Detailed description of the invention

Embodiment 1:

Section dies young the preparation method of Luo Qu: the mixture fresh for medical material Fructus Trichosanthis 2g, fresh Caulis Spatholobi 2g and fresh Herba Sedi 1g formed is after squeezing extracting juice, the dry fine powder of medicinal residues mixes with flour 2g, wheat bran 1g again, add medicine juice and water to stir evenly and make soft material, thoroughly, maintenance temperature is 22 DEG C, humidity is 50% in steaming, adds bent smart fermentation 25 days, take out, dry, pulverize, to obtain final product.Described fresh Fructus Trichosanthis also can be one or more in Semen Trichosanthis, Pericarpium Trichosanthis and Radix Trichosanthis.

The preparation method of capsule for the treatment of diabetes: the section of taking dies young Luo Qu 480g, Herba Plantaginis 350g, Herba Agrimoniae 335g and soil Radix Ophiopogonis 335g, Herba Plantaginis and Herba Agrimoniae is cut into 1.0cm section, adds 8 times of water gagings, soak 30 minutes, decoct 2 hours, filter, it is for subsequent use to get filtrate; Medicinal residues add 6 times amount soak by water 1 hour, filter, merge twice filtrate, and filter, the relative density being condensed into 60 DEG C is the clear paste of 1.2, under the condition of temperature 65 DEG C, vacuum 0.1Mpa, clear paste drying under reduced pressure is become dry cream; Pulverize, granulate, adds 1.13g silicon dioxide, and mixing, incapsulates, i.e. obtained capsule.Instructions of taking: in crude drug powder, 3g/ time, daily 3 times, daily crude drug powder meter 9-12g, bfore meals; In capsule: because medical material inventory is 1500g, paste-forming rate is 20.3%, thus calculates dry cream and is about 304.5g, adjuvant silica 1 .13g again, amount to 305.63g, make 1000, every heavy 0.3056g, namely every is equivalent to raw medicinal herbs 1.5g, on average every is heavily 0.30g, therefore designs each serving with 2-3 grain (0.30 dry cream/grain), every day 3 times, with daily 9-12g crude drug powder is suitable, bfore meals.

Character: this product is hard capsule, content should be brown to tan powder, bitter in the mouth.

Embodiment 2:

Section dies young the preparation method of Luo Qu: the mixture fresh for medical material Fructus Trichosanthis 2g, fresh Caulis Spatholobi 2g and fresh Herba Sedi 1g formed is after squeezing extracting juice, the dry fine powder of medicinal residues mixes with flour 2g, wheat bran 1g again, add medicine juice to stir evenly and make soft material, thoroughly, maintenance temperature is 26 DEG C, humidity is 65% in steaming, adds bent smart fermentation 30 days, take out, dry, pulverize, Ji get section dies young Luo Qu.

The preparation method of tablet for the treatment of diabetes: the section of taking dies young Luo Qu 400g, Herba Plantaginis 300g, Herba Agrimoniae 400g and soil Radix Ophiopogonis 400g, Herba Plantaginis and Herba Agrimoniae is cut into 1.0cm section, adds 10 times of water gagings, soak 120 minutes, decoct 2 hours, filter, it is for subsequent use to get filtrate; Medicinal residues add 10 times amount soak by water 2 hours, filter, merge twice filtrate, and filter, the relative density being condensed into 60 DEG C is the clear paste of 1.3, under the condition of temperature 75 DEG C, vacuum 0.1Mpa, clear paste drying under reduced pressure is become dry cream; Pulverize, add the corresponding adjuvant of tablet, obtain 1000, tablet.Instructions of taking: every day 3 times, each 2, every heavy 0.15g, bfore meals.

Embodiment 3:

Section dies young the preparation method of Luo Qu: the mixture fresh for medical material Fructus Trichosanthis 2g, fresh Caulis Spatholobi 2g and fresh Herba Sedi 1g formed is after squeezing extracting juice, the dry fine powder of medicinal residues mixes with flour 2g, wheat bran 1g again, add medicine juice to stir evenly and make soft material, thoroughly, maintenance temperature is 18 DEG C, humidity is 45% in steaming, adds bent smart fermentation 20 days, take out, dry, pulverize, Ji get section dies young Luo Qu.

The preparation method of granule for the treatment of diabetes: the section of taking dies young Luo Qu 500g, Herba Plantaginis 400g, Herba Agrimoniae 300g and soil Radix Ophiopogonis 300g, Herba Plantaginis and Herba Agrimoniae is cut into 1.0cm section, adds 6 times of water gagings, soak 90 minutes, decoct 1 hour, filter, it is for subsequent use to get filtrate; Medicinal residues add 8 times amount soak by water 1 hour, filter, merge twice filtrate, and filter, the relative density being condensed into 60 DEG C is the clear paste of 1.2, under the condition of temperature 55 DEG C, vacuum 0.08Mpa, clear paste drying under reduced pressure is become dry cream; Pulverize, add the corresponding adjuvant of granule, obtain granule 1000.Instructions of taking: every day 3 times, each 2, every heavy 0.15g, bfore meals.

Embodiment 4:

The preparation method of drop pill for the treatment of diabetes: the section taking preparation in embodiment 1 dies young Luo Qu 550g, Herba Plantaginis 350g, Herba Agrimoniae 300g and soil Radix Ophiopogonis 300g, Herba Plantaginis and Herba Agrimoniae is cut into 1.0cm section, adds 10 times of water gagings, soak 120 minutes, decoct 2 hours, filter, it is for subsequent use to get filtrate; Medicinal residues add 10 times amount soak by water 2 hours, filter, merge twice filtrate, and filter, the relative density being condensed into 60 DEG C is the clear paste of 1.3, under the condition of temperature 75 DEG C, vacuum 0.1Mpa, clear paste drying under reduced pressure is become dry cream; Pulverize, add the corresponding adjuvant of drop pill, obtain drop pill.Instructions of taking: every day 3 times, each 2-3 grain, every heavy 0.3g, bfore meals.

Claims

1. treat a Chinese medicine preparation for diabetes, it is characterized in that, calculate by weight, it is prepared from by following crude drug:

2. the Chinese medicine preparation for the treatment of diabetes according to claim 1, is characterized in that, calculate by weight, and it is prepared from by following crude drug: section dies young Luo Qu 480 portions of Herba Plantaginiss 350 parts of Herba Agrimoniaes 335 parts of native Radix Ophiopogoniss 335 parts.

3. the Chinese medicine preparation for the treatment of diabetes according to claim 1 and 2, it is characterized in that, the mixture of the dry fine powder of described medicinal residues and flour and wheat bran, adds medicine juice and stirs evenly and make soft material, steams thoroughly, maintenance temperature is 18 ~ 26 DEG C, humidity is 45% ~ 65%, add bent essence fermentation 20 days ~ 30 days, take out, dry, pulverize, Ji get section dies young Luo Qu.

4. a kind of preparation method of the Chinese medicine preparation of the arbitrary described treatment diabetes of claims 1 to 3, it is characterized in that, calculate by weight, take section to die young Luo Qu, Herba Plantaginis, Herba Agrimoniae and soil Radix Ophiopogonis, add 6 ~ 10 times of water gagings, soak 30 ~ 120 minutes, decoct 1 ~ 2 hour, filter, it is for subsequent use to get filtrate; Medicinal residues add 6 ~ 10 times amount soak by water 1 ~ 2 hour, filter; Merge twice filtrate, filter, concentrated, dry, pulverize, add adjuvant, make corresponding Chinese medicine preparation, to obtain final product.

5. the preparation method of the Chinese medicine preparation for the treatment of diabetes according to claim 4, it is characterized in that, calculate by weight, take section to die young Luo Qu, Herba Plantaginis, Herba Agrimoniae and soil Radix Ophiopogonis, Herba Plantaginis and Herba Agrimoniae are cut into 1.0cm section, adds 8 times of water gagings, soak 30 minutes, decoct 2 hours, filter, it is for subsequent use to get filtrate; Medicinal residues add 6 times amount soak by water 1 hour, filter, merge twice filtrate, and filter, the relative density being condensed into 60 DEG C is the clear paste of 1.2 ~ 1.3, under the condition of temperature 55 ~ 75 DEG C, vacuum 0.08 ~ 0.1Mpa, clear paste drying under reduced pressure is become dry cream; Pulverize, add adjuvant, make corresponding Chinese medicine preparation, to obtain final product.

6. the preparation method of the Chinese medicine preparation for the treatment of diabetes according to claim 5, it is characterized in that, calculate by weight, take section to die young Luo Qu, Herba Plantaginis, Herba Agrimoniae and soil Radix Ophiopogonis, Herba Plantaginis and Herba Agrimoniae are cut into 1.0cm section, adds 8 times of water gagings, soak 30 minutes, decoct 2 hours, filter, it is for subsequent use to get filtrate; Medicinal residues add 6 times amount soak by water 1 hour, filter, merge twice filtrate, and filter, the relative density being condensed into 60 DEG C is the clear paste of 1.2, under the condition of temperature 65 DEG C, vacuum 0.1Mpa, clear paste drying under reduced pressure is become dry cream; Pulverize, granulate, adds the silicon dioxide of 0.37% of dry cream gross weight, and mixing, incapsulates, obtain capsule.