CN100509017C - Medicine for treating biliary tract infection and prepn process thereof - Google Patents

Medicine for treating biliary tract infection and prepn process thereof Download PDF

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CN100509017C
CN100509017C CNB2006100219279A CN200610021927A CN100509017C CN 100509017 C CN100509017 C CN 100509017C CN B2006100219279 A CNB2006100219279 A CN B2006100219279A CN 200610021927 A CN200610021927 A CN 200610021927A CN 100509017 C CN100509017 C CN 100509017C
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medical material
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CN1931279A (en
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朱培庭
陶建生
金若敏
高建平
张祝君
卿光明
李彦
胡德模
秦方云
刘义林
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MEIDAKANG PHARMACEUTICAL CO Ltd SICHUAN PROV
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MEIDAKANG PHARMACEUTICAL CO Ltd SICHUAN PROV
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Abstract

The present invention discloses one kind of medicine for treating biliary tract infection and its preparation process. The medicine is prepared with white peony root, dried old orange peel, fleeceflower root, wolfberry fruit and licorice in certain weight proportion, and through the technological process including extracting, purifying, drying and other steps, and may be prepared into different preparation forms. Clinical experiments show that the medicine has relatively high curative effect on chronic biliary tract infection and cholelithiasis.

Description

Medicine of treatment biliary tract infection and preparation method thereof
[technical field]
The invention belongs to technical field of Chinese medicines, specifically, relate to a kind of medicine for the treatment of biliary tract infection and preparation method thereof.
[background technology]
Chronic biliary tract infection, cholelithiasis are a kind of worldwide commonly encountered diseases, have a strong impact on human beings'health for a long time, and its sickness rate day by day raises in China, and according to many provinces and cities of China findings of the survey, its morbidity is up to 18%, surpass American-European (10%).Brainstrust is thought, calculates by annual 1000000000 populations 5%, has 2,500 ten thousand chronic biliary tract infection, cholelithiasis patient at least in China.
At chronic biliary tract infection, cholelithiasis: mainly adopt biliary tract surgery, endoscopic surgical treatment, the various rubbles in inside and outside abroad, directly pour into Therapeutic Method such as litholytic therapy; Domestic in recent years on western medical treatment method basis,, formed Comprehensive Treatment systems such as " broken, rows, molten, prevent, cut, get " in that oneself obtains than remarkable break-throughs aspect the combination of Chinese and Western medicine non-operative treatment.Internationally recognized oral medicine less (as UDCA, DANTONG etc.), and effect owes desirable.Though there is the medicine of many treatment cholelithiasis in Chinese medicine market, has multiple effect as DANNING PIAN, cholagogic and lithagogue tablet etc., patient is acceptant, and is easy to use, safe, but still can not satisfy dissimilar patients' needs; For the treatment of biliary tract infection, medical circle does not still have ideal Therapeutic Method and medicine except that acute attack stage is adopted the anti-infective therapy for chronic biliary tract infection both at home and abroad.
In recent years, domestic some hospital with Chinese medicine decoction to treat chronic biliary tract infection, cholelithiasis deficiecny of liver-YIN disease patient treats, though better therapeutic effect is arranged, but said preparation is at memory period, the physical behavior poor stability is placed the back and is produced more precipitate, has influenced practical effect, and carry inconvenience, limited promoting the use of clinically.
[summary of the invention]
Goal of the invention
The present invention be directed to and carry out on the basis of the pathogeny of chronic biliary tract infection, cholelithiasis and research, primary purpose provides a kind of medicine for the treatment of biliary tract infection, and this drug main will be treated chronic biliary tract infection, cholelithiasis deficiecny of liver-YIN disease.
Another object of the present invention provides a kind of manufacturing method for above mentioned medicine.The pharmaceutical preparation of this method preparation is at memory period, and physical behavior is stable, and easy to carry, is easy to clinical expansion and uses.
Technical scheme
The medicine of treatment biliary tract infection of the present invention, make the raw material of active ingredient and form by following weight portion:
3~5 parts of the Radix Paeoniae Albas; 2~4 parts of Pericarpium Citri Reticulataes; 1.4~2.6 parts of Radix Polygoni Multiflori;
1.4~2.6 parts of Fructus Lycii; 0.6~1.5 part in Radix Glycyrrhizae.
The formula optimization weight proportion of preparation medicine of the present invention is:
3.5~4.5 parts of the Radix Paeoniae Albas; 2.5~3.5 parts of Pericarpium Citri Reticulataes; 1.6~2.3 parts of Radix Polygoni Multiflori,
1.6~2.3 parts of Fructus Lycii; 0.8~1.2 part in Radix Glycyrrhizae.
The optimum weight proportioning of medicine of the present invention is:
4 parts of the Radix Paeoniae Albas; 3 parts of Pericarpium Citri Reticulataes; 2 parts of Radix Polygoni Multiflori; 2 parts of Fructus Lycii; 1 part in Radix Glycyrrhizae.
The dosage form of this medicine comprises powder, granule, tablet, capsule, soft capsule, pill, injection.
The dosage form of this medicine is granule, tablet, capsule, the soft capsule of being convenient to take.
Pharmacological research shows: Fructus Lycii has anti-fatty liver, promotes liver cell regeneration, improves the effect of liver function; The Radix Paeoniae Alba, Pericarpium Citri Reticulatae have the gallbladder of urging and the effect of row's gallbladder, and the volatile oil of Pericarpium Citri Reticulatae also has litholytic effect concurrently; Radix Glycyrrhizae has detoxifcation, antiinflammatory, suppresses bile B one glucuronic acid enzymatic activity, blood fat reducing, jaundice eliminating and urges the gallbladder effect; Radix Polygoni Multiflori: go into Liver and kidney and benefiting essence-blood is not dry oiliness, the merit that has tonify deficiency to set upright.So prescription of the present invention has effects such as antiinflammatory, function of gallbladder promoting, lithodialysis, anti-stone, anti-hepatic cell fattydegeneration and removing free radical.
The present invention treats the medicine of biliary tract infection, and described medicine is according to comprising that the method for following each processing step obtains:
(1). batching:
Take by weighing corresponding raw materials of traditional Chinese medicinal materials according to said medicine; And concoct Radix Polygoni Multiflori, Radix Glycyrrhizae, Radix Polygoni Multiflori is added decoction of black soybean steam, with the Radix Glycyrrhizae processed with honey;
(2). extraction process
With what head of the Radix Paeoniae Alba, Pericarpium Citri Reticulatae, system, Fructus Lycii, Radix Glycyrrhizae Preparata medicinal raw material, decoct with water three times, amount of water is respectively: be 3~9 times of the medical material amount for the first time, be for the second time 2~6 times of the medical material amount, be 2~6 times of medical material amount for the third time; Each boiling reflux 0.8~1.2 hour, filtration, merging filtrate gets medicinal liquid;
Before decocting for the first time, medical material was soaked 15~60 minutes.
(3). purifying process
Above-mentioned medicinal liquid A is evaporated to the clear paste that medicine liquid volume is 1~2 times of a medical material total amount, is chilled to room temperature, high speed centrifugation separates, the clear paste of relative density 1.20~1.22 when collecting centrifugal liquid and being evaporated to 75~80 ℃;
(4). drying process
Above-mentioned clear paste B drying under reduced pressure is become dry extract, dry extract is pulverized, cross 100 mesh sieves and get fine powder;
(5). preparation process
By existing conventional pharmaceutical methods, fine powder is added acceptable accessories or complementary composition is prepared into various dosage forms, promptly get medicine capsule of the present invention, tablet, granule, soft capsule.
In described step (2) extraction process, medical material decocts with water three times, and amount of water is respectively: be for the first time 6 times of amounts of medical material, be 4 times of amounts of medical material, be 4 times of amounts of medical material for the third time the second time; Before decocting for the first time medical material was soaked 30 minutes.Each boiling reflux 1 hour.
In described step (2) extraction process, medical material decocts with water three times, and amount of water is respectively: be for the first time 6 times of amounts of medical material, be 4 times of amounts of medical material, be 4 times of amounts of medical material for the third time the second time; Before decocting for the first time medical material was soaked 30 minutes.Each boiling reflux 1 hour.
The preparation method of this medicine makes standard compliant each drug form by extraction process, purifying process, drying process, preparation process.
The preparation method of described capsule, in above-mentioned steps (5): fine powder adds the appropriate amount of auxiliary materials mixing, and with purified water spray granulation, drying, granulate, the adding micropowder silica gel is an amount of, and filled capsules gets capsule medicine.The consumption weight proportion of its fine powder and proper auxiliary materials is fine powder: starch or dextrin or lactose: micropowder silica gel=10:1~10:0.01~0.1
The preparation method of described tablet, in above-mentioned steps (5): fine powder adds suitable filler and adhesive (starch, lactose, dextrin, cane sugar powder be one or more combination wherein) mix homogeneously, granulate, granulate, add suitable lubricant (micropowder silica gel or magnesium stearate) again, tabletting gets tablet medicine.The consumption weight proportion of its fine powder and proper auxiliary materials is fine powder D: starch or lactose: dextrin or cane sugar powder: micropowder silica gel or magnesium stearate=1:1~1.5:0.1~0.5:0.01~0.05.
Tablet is conventional tablet or slow-release tablet.This tablet can be plain sheet, also can plain sheet be carried out coating with suitable coating material, makes coated tablet or Film coated tablets.
The preparation method of described granule, in above-mentioned steps (5): fine powder adds the proper auxiliary materials mixing, granulates, and granulate gets granules medicine.The consumption weight proportion of its fine powder and proper auxiliary materials is fine powder: adjuvant=1:0.5~4 (adjuvant is wherein one or more a combination in any of Icing Sugar, lactose, dextrin, mannitol).
Perhaps gained granule behind the granulate is used suitable coating material coating, made coated granule.This granule can be that the plain particles agent also can be a sustained-release granular formulation.
The preparation method of described soft capsule, in above-mentioned steps (five): fine powder adds proper auxiliary materials and makes soft capsule content with ball mill or colloid mill grinding mixing, this content is wrapped in dropping preparation method or pressing in the soft capsule shell made from appropriate materials, gets the soft capsule medicine.The consumption weight proportion of its fine powder and proper auxiliary materials is fine powder: adjuvant (suspending agent, edible vegetable oil)=1:1~2.
Dosage forms such as other powder, pill, oral liquid can make with the method for existing conventional pharmaceutical technology.
Beneficial effect
According to the medicine that the technical program obtains, used the theory of Chinese medical science of nourishing the liver function of gallbladder promoting, can treat chronic biliary tract infection, cholelithiasis deficiecny of liver-YIN disease, total effectively treatment rate reaches 93.11%.Adopt industrial preparation on preparation method, quality is controlled easily, and is easy to operate, and packing back product efficacy stability is easily preserved.
Each the dosage form product that obtains according to the technical program has different advantages: the granule effect is rapid, delicious taste, and volume is little, takes, accumulating is convenient; The capsule disintegrate is fast, and release is rapid, and the bioavailability height can be covered bad smell, easily swallows steady quality; The soft capsule craft science, easy to use, the bioavailability height, rapid-action, the curative effect height can be covered bad smell, and stability is high; Tablet quality is stable, and coated tablet can improve the influence of light, air, moisture commute oxidation deterioration and deliquescence medicine.
Medicine of the present invention solved existing medication decoction instability, be difficult for to preserve, take problem such as inconvenience, and several formulations is to satisfy the selection of clinical different liver-gallbladder disease people medication.
Medicine of the present invention shows through drug effect, toxicity test: hepatic cholagogic effect is preferably arranged, and stronger antiinflammatory, antibiotic, pain relieving, spasmolysis and prevent lithogenous effect help treating the biliary tract infection disease.
[specific embodiment]
Embodiment 1: the preparation of capsule
The according to the form below batching
Figure C200610021927D00081
(1). batching: with the Radix Paeoniae Alba, Pericarpium Citri Reticulatae, Radix Polygoni Multiflori, Fructus Lycii, Radix Glycyrrhizae five tastes medical material by example listed in the above-mentioned table 1.~6. six components (can one of select) prepare burden; And concoct Radix Polygoni Multiflori, Radix Glycyrrhizae: with Radix Polygoni Multiflori section or piece, add decoction of black soybean, mix the back thoroughly and steam, or shine to half-dried to the inside and outside sepia that all is, section, drying, Radix Polygoni Multiflori Preparata (weight portion proportioning, Radix Polygoni Multiflori: decoction of black soybean=1:0.15); Radix Glycyrrhizae section and refined honey are mixed thoroughly, vexed, put in the pot, fry to yellow to buff with slow fire, to take out when tack-free, the cold of drying in the air gets Radix Glycyrrhizae Preparata (weight portion proportioning, Radix Glycyrrhizae: refined honey=1:0.25).(2). extract: with the Radix Paeoniae Alba, Pericarpium Citri Reticulatae, Radix Polygoni Multiflori Preparata, Fructus Lycii, Radix Glycyrrhizae Preparata medical material, decoct with water three times, amount of water is 8 times of medical material amount for the first time, be 4 times of medical material amount the second time, be 4 times of medical material amount for the third time, before decocting the first time medical material was soaked 30 minutes, each boiling reflux 1 hour, filtration merge three filtrates and get medicinal liquid.(3). purification: medicinal liquid A is concentrated into the clear paste that medicine liquid volume is 1.5 times of medical material total amounts at 60 ℃ of vacuum decompressions, is chilled to room temperature, centrifugalize is collected centrifugal liquid and the clear paste of relative density 1.20~1.22 when vacuum decompression is concentrated into 78 ℃ below 80 ℃.(4). drying: the clear paste drying under reduced pressure is become dry extract, dry extract was pulverized 100 mesh sieves get fine powder.(5). preparation: fine powder adds the starch mixing, with purified water spray granulation, drying, granulate, adds micropowder silica gel (10 parts of fine powders, 2 parts of starch, 0.05 part of micropowder silica gel) dress capsule, gets capsule.
Embodiment 2: the preparation of tablet
Step (1), (2), (3), (4) are with above-mentioned embodiment 1, in step (5): get 1 part of fine powder, 1.2 parts of starch: 0.3 part in dextrin: 0.03 part of micropowder silica gel adds starch, dextrin mixing with fine powder, granulate, granulate adds micropowder silica gel again, tabletting gets tablet.
Embodiment 3: the preparation of granule
(1). batching: get Radix Paeoniae Alba 750g, Pericarpium Citri Reticulatae 562.5g, Radix Polygoni Multiflori Preparata 375g, Fructus Lycii 375g, Radix Glycyrrhizae Preparata 187.5g.(2). extract: with the Radix Paeoniae Alba, Pericarpium Citri Reticulatae, Radix Polygoni Multiflori Preparata, Fructus Lycii, Radix Glycyrrhizae Preparata medical material, decoct with water three times, amount of water is 6 times of amounts of medical material for the first time, be 4 times of amounts of medical material for the second time, be 4 times of amounts of medical material for the third time, need before the decoction for the first time medical material was soaked 30 minutes, each boiling reflux 1 hour, filtration merge three filtrates and get medicinal liquid.(3). purification: medicinal liquid is concentrated into the clear paste that medicine liquid volume is 1.5 times of medical material total amounts at 60 ℃ of vacuum decompressions, is chilled to room temperature, centrifugalize is collected centrifugal liquid and the clear paste of relative density 1.20~1.22 when vacuum decompression is concentrated into 78 ℃ below 80 ℃.(4). drying: clear paste B drying under reduced pressure is become dry extract, dry extract is broken into fine powder, the powder 500g that gets dry extract (100 order).(5). granulate: get fine powder 500g, dextrin 300g, fine powder is added the dextrin mixing, granulate, granulate gets granule (100 bags).This granule product is brown granule, mildly bitter flavor, gas perfume (or spice), every bag 8 gram.
The preparation of embodiment 4. soft capsules
Step (1), (2), (3), (4) are with above-mentioned embodiment 1, and in step (five): it is standby that fine powder is crossed 100 mesh sieves; Earlier suspending agent (1 part of oil with hydrogenated soybean, 4 parts of short chain vegetable oil) is added the middle fusion of edible vegetable oil (getting 2 parts of suspending agents, 5 parts of edible vegetable oils) as adjuvant; Again fine powder is added in the adjuvant (adding weight portion: 1 part of fine powder, 1.5 parts of adjuvants) and make soft capsule content with colloid mill grinding mixing, this content is wrapped in dropping preparation method or pressing uses gelatin: in the soft capsule shell that glycerol: distilled water=100:35:80 (weight part ratio) makes, soft capsule.
Below, further specify the beneficial effect of medicine of the present invention by to experiments such as the drug effect of medicinal granule of the present invention, toxicity.
One. medicine stability is investigated
By 18 months ambient stable investigation, the character of medicine of the present invention, the TLC of Radix Polygoni Multiflori Preparata, Pericarpium Citri Reticulatae differentiates and meets the quality standard regulation; Content of paeoniflorin meets the quality standard regulation, reduces with no significant change in 0 month; Granularity, moisture, melting meet the quality standard regulation; Health examination, antibacterial, mycete, pathogenic bacterium meet the quality standard regulation.Show that medicine room temperature preservation of the present invention is more stable.
Two. the drug effect zoopery
1. adopt rat bile secretory volume algoscopy, gavaged administration in continuous 4 days, the result shows: the present invention 2.2~8.6g crude drug/Kg.d (being equivalent to 3~12 times of the clinical consumptions to the greatest extent of people) can obviously increase the rat bile flow in 0.5~2 hour after administration.The present invention 1.8~7.2g crude drug/Kg.d (be equivalent to the clinical consumption per day of people 2.5~10 times) can reduce CCl 4Mice subacute liver injury model animal serum ALT.AST and animal pattern hepatic tissue MDA amount, the S0D activity of rising hepatic tissue.The tectology inspection is as seen: low dose of the present invention can alleviate hepatocyte granular, hydropic degeneration; Middle dosage can alleviate hepatocyte acidophilia degeneration, downright bad and cell infiltration degree; Heavy dose all has clear improvement to multiple pathological changes.The result shows: medicine of the present invention has hepatic cholagogic effect preferably.
2. adopt mice caused by dimethylbenzene xylene ear swelling method and carrageenin to cause the rat paw edema method, gavaged administration in continuous 4 days, the result shows: the present invention 3.6~14.4g crude drug/Kg.d can obviously suppress the mice ear degree when (be equivalent to the clinical consumption per day of people 5~20 times), and suppression ratio is 18.4%~24.5%; 2.2~8.6g crude drug/Kg.d (being equivalent to 3~12 times of the clinical consumption per days of people) can obviously suppress rat paw edema.The employing glacial acetic acid causes mouse writhing and thermostimulation causes two kinds of methods of mice pain, gavaged administration in continuous 4 days, the result shows: the present invention 3.6~14.4g crude drug/Kg.d is equivalent to 5~20 times of the clinical consumption per day of people) time can obviously suppress the mouse writhing reaction, middle dosage can obviously improve the pain threshold of mice.The Cavia porcellus gallbladder test of exsomatizing shows: medicine of the present invention does not have obvious influence to the gallbladder normal tension when concentration 2.5~5.0mg/ml; But no matter be administration after administration in advance or the gallbladder spasm, all can alleviate acetylcholine and cause the effect of gallbladder spasm that suppression ratio is 41.6%~65.8%.The above results shows that medicine of the present invention has stronger antiinflammatory, pain relieving, spasmolysis.
3. medicine antibacterial spectrum of the present invention and antibacterial strength test
(1) direct dose regimen, the result is as follows for the antibacterial activity in vitro of medicine of the present invention (MIC): dysentery bacterium is that 3.1mg/ml, escherichia coli are that 12.5mg/ml, staphylococcus aureus are that 25mg/ml, molten straightforward streptococcus are that 25mg/ml, streptococcus faecalis are that 50mg/ml, pneumobacillus are〉50mg/ml, bacillus pyocyaneus is〉50mg/ml.
(2) antibacterial in the body: as to be inverse ratio principle according to bacterial number in the liquid and its transmittance, adopt colorimetry, after different time is cultivated, detect the friendshipization of culture transmittance with micro-spectrophotometer: if bacterial number increases, the 0D value just raises, to measure the influence to the bacterial growth breeding of drug serum or bile.Rats gavaged medicine 28.8g of the present invention crude drug/kg.d (being equivalent to 40 times of the clinical consumption per days of people) after 3.5 days, gets serum, and the serum dilution is carried out bacteriostatic test for 1 times, surveys the 0D value at wavelength 590nm place with spectrophotometer respectively at 0,6,12,24 hour; Cavia porcellus gavages same dose drug, gets bile after 4 days, carries out bacteriostatic test after the 1:8 dilution, surveys the 0D value at wavelength 590nm place with spectrophotometer respectively at 0,8,24 hour.The result shows: 1.. drug serum of the present invention (being equivalent to 20 times of the clinical consumption per days of people) has certain antibacterial action, wherein acts on the most obvious to escherichia coli, Bacillus proteus, dysentery bacterium.2.. dilution ratio is that the medicine of the present invention (being equivalent to 5 times of the clinical consumption per days of people) of 1:8 can reduce escherichia coli, staphylococcus aureus at 8 hours. the 0D value of dysentery bacterium culture fluid, show that medicine of the present invention has certain antibacterial action, wherein stronger to the staphylococcus aureus effect, at 24 hours 0D value rate of increase to dysentery bacterium was 386%, and other bacterial growth is not had obvious influence.The above results shows that medicine of the present invention has certain antibacterial action.
4. litholytic effect test
External lithodialysis test: medicine of the present invention is directly mixed with three kinds of dissimilar calculus (bilins, cholesterol, mixed type), take by weighing the weight of calculus after 30 days.The result shows: the large and small dosage group of the present invention all can be dissolved (every 100ml contained 0.5 day or 0.25 staggering amount) three types calculus, and it is stronger wherein to dissolve the bilins effect.The lithodialysis test adopts low protein diet to cause Cavia porcellus bilins calculus model in the body, simultaneously continuous 6 weeks gavage medicine, the result shows: medicine 4.3~17.3g crude drug/kg.d of the present invention can obviously reduce the rising of gallstone formation rate and antagonism animal serum ALT, the AST of model Cavia porcellus when (being equivalent to 6~24 times of the clinical consumption per days of people).
The above results shows that medicine of the present invention protects the liver and prevent lithogenous effect, helps treating biliary tract infection.
Above-mentioned test shows: behave 12 times of clinical consumption per day of behave 10 times of clinical consumption per day of medicine mice effective dose of the present invention, rat effective dose.
In sum, medicine of the present invention protects the liver when 2.5~24 times of the clinical consumption per day of people, function of gallbladder promoting, antiinflammatory, analgesia, spasmolytic, antibiotic and litholytic effect, for this medicine provides the modern pharmacology foundation at the chronic biliary tract infection of clinical treatment.
Three, animal toxicity experiment
1. adopt medicine 4g crude drug of the present invention/g dried cream powder.The SD rat, cleaning level, 6 ages in week, male and female half and half.The SD rat is divided into 40 of heavy dose of groups, ig36g crude drug/kg.d (Cmax is equivalent to 50 times of clinical consumptions approximately) at random; 40 of middle dosage groups, ig18g crude drug/kg.d (25 times of quite clinical consumption approximately); 40 of small dose group, ig9g crude drug/kg.d ((12.5 times of quite clinical consumption approximately) approximately; 40 of normal control groups, ig equal solvent distilled water 1ml/100g body weight.Successive administration six months continues after the drug withdrawal to observe for three weeks.Experimental result shows: rat general state all along is good, body weight gain, and food-intake, movable normal is not seen any abnormal symptom or death; Hematology, blood biochemical are learned, pathological examination there is no tangible reaction in administration mid-term (3 months), administration end (6 months) and convalescent period.
Conclusion: 6 months gastric infusion long term toxicity tests of medicine rat of the present invention are not found overt toxicity.
2. medicinal granule acute toxic reaction of the present invention and death condition research
The dried cream powder of medicine of the present invention, every gram dried cream powder contain 4 gram crude drugs.Kunming mouse, cleaning level, body weight 18~22g, male and female half and half.Get 20 of healthy mices, gavage and give 142g crude drug/kg.d (being equivalent to 197 times of clinical consumptions approximately), give at twice.Observe animal activity, breathing state, muscular tension, feed, body weight, fur, defecation after the administration immediately, have or not situations such as death; Administration on the one, the conventional raising and continuous the observation 7.
Experimental result shows: in 2 hours, mice is movable to be reduced after the administration for the first time, and after the administration for the second time, the mice stool is thin, and that night, mice recovered normal, did not see other abnormal response.
Conclusion: the maximum dosage-feeding of medicine mice of the present invention is 142g crude drug/kg, is equivalent to 197 times of the clinical consumption per day of people.

Claims (8)

1. medicine for the treatment of biliary tract infection is characterized in that the raw material of making active ingredient forms by following weight portion:
3~5 parts of the Radix Paeoniae Albas; 2~4 parts of Pericarpium Citri Reticulataes; 1.4~2.6 parts of Radix Polygoni Multiflori;
1.4~2.6 parts of Fructus Lycii; 0.6~1.5 part in Radix Glycyrrhizae.
2. medicine according to claim 1 is characterized in that the weight proportion of each raw material is:
3.5~4.5 parts of the Radix Paeoniae Albas; 2.5~3.5 parts of Pericarpium Citri Reticulataes; 1.6~2.3 parts of Radix Polygoni Multiflori;
1.6~2.3 parts of Fructus Lycii; 0.8~1.2 part in Radix Glycyrrhizae.
3. medicine according to claim 1 is characterized in that the weight proportion of each raw material is:
4 parts of the Radix Paeoniae Albas; 3 parts of Pericarpium Citri Reticulataes; 2 parts of Radix Polygoni Multiflori; 2 parts of Fructus Lycii; 1 part in Radix Glycyrrhizae.
4. according to each described medicine in the claim 1 to 3, it is characterized in that its dosage form comprises capsule, tablet, granule, powder, pill, oral liquid, soft capsule.
5. medicine according to claim 4 is characterized in that described dosage form is capsule, tablet, granule, soft capsule.
6. according to the preparation method of each described treatment biliary tract infection medicine in the claim 1 to 3, it is characterized in that this preparation method comprises the steps:
(1). batching:
Take by weighing corresponding raw materials of traditional Chinese medicinal materials according to each described medicine in the claim 1 to 3; And concoct Radix Polygoni Multiflori, Radix Glycyrrhizae, Radix Polygoni Multiflori is added decoction of black soybean steam, with the Radix Glycyrrhizae processed with honey;
(2). extract
With the Radix Paeoniae Alba, Pericarpium Citri Reticulatae, Radix Polygoni Multiflori Preparata, Fructus Lycii, Radix Glycyrrhizae Preparata five tastes medical material, decoct with water three times, amount of water is respectively: for the first time be 3~9 times of the medical material amount, be for the second time 2~6 times of the medical material amount, be 2~6 times of medical material amount for the third time; Each boiling reflux 0.5~1.5 hour, filtration, merging filtrate gets medicinal liquid;
(3). purification
Above-mentioned medicinal liquid is evaporated to the clear paste that medicine liquid volume is 1~2 times of a medical material total amount, is chilled to room temperature, centrifugalize, the clear paste of relative density 1.20~1.22 when collecting centrifugal liquid and being evaporated to 75~80 ℃;
(4). drying
Above-mentioned clear paste drying under reduced pressure is become dry extract, dry extract is broken into fine powder;
(5). preparation
Pharmaceutical methods adds adjuvant or the complementary composition pharmaceutically accepted with fine powder and is prepared into various dosage forms routinely, promptly gets medicine capsule, tablet, granule, soft capsule.
7. according to the preparation method of the described medicine of claim 6, it is characterized in that in step (2), before decocting for the first time medical material was soaked 15~60 minutes.
8. according to the preparation method of the described medicine of claim 6, it is characterized in that in step (2), medical material decocts with water three times, amount of water be for the first time 6 times of the medical material amount, for the second time for 4 times of the medical material amount, be 4 times of the medical material amount for the third time, each boiling reflux 1 hour.
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Assignee: Sichuan Meida Kangjiale Pharmaceutical Co., Ltd.

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Denomination of invention: Medicine for treating biliary tract infection and its prepn process

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