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CN1465384A - Artificial bear gall and making method thereof - Google Patents

Artificial bear gall and making method thereof Download PDF

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Publication number
CN1465384A
CN1465384A CNA021342997A CN02134299A CN1465384A CN 1465384 A CN1465384 A CN 1465384A CN A021342997 A CNA021342997 A CN A021342997A CN 02134299 A CN02134299 A CN 02134299A CN 1465384 A CN1465384 A CN 1465384A
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China
Prior art keywords
fel ursi
artificial
fully
artificial fel
aminoacid
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CNA021342997A
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CN1264523C (en
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江崇波
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  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

The present invention relates to a artificial bear gall and its preparation method. Its composition includes sodium taurodeoxycholate, mixed bile pigments, amino acid, mineral elements, rice bean oil, cholesterol and lecithin. Said invented artificial bear gall can be substituted for natural bear gall.

Description

Artificial Fel Ursi and manufacture method thereof
Technical field
The present invention relates to the manufacture method of a kind of artificial Fel Ursi and artificial Fel Ursi thereof.
Background technology
Fel Ursi is traditional rare Chinese medicine, effect such as have heat clearing away, suppressing the hyperactive liver, make eye bright.Recent two decades comes the exploitation of artificial drainage bear gall to change in the past to kill Bears to get cholic history, is the protection black bear, enlarges the medicine source and has made contribution.Along with development of technology, adopt at present no Tube Drain art, replace complicated gallbladder to make leakage art, only constantly getting under the cholic state harm of the physiological function that causes because of a large amount of losses of bile yet but can not change Bears.Because interests order about, increasing wild Bears is taken in the artificial drainage bear gall processing space, and What is more, and a large amount of bear cubs are held in captivity, and back to nature again, not only this way throughout one's life can not be protected wild Bears, impels wild Bears to quicken extinction on the contrary.
As far back as 1902, people just began Fel Ursi is carried out intensive research.Up to the present, the Main Ingredients and Appearance of Fel Ursi is fully aware of.It contains four kinds of main bile acid compositions such as ursodesoxycholic acid, chenodeoxycholic acid, deoxycholic acid, cholic acid, and these compositions are many to exist with taurine, the bonded form of glycine.In addition, also contain compositions such as lipid, cholesterol, each seed amino acid, micro-bile pigments, trace element.Artificial Fel Ursi is the succedaneum of natural Fel Ursi, is a kind ofly both can alleviate the clinical application demand, can protect the best approach of wild Bears class resource again up hill and dale, always extremely insider's great attention.
Late nineteen eighties Shenyang Pharmacy College once carried out a large amount of careful research work to artificial Fel Ursi.People such as Wang Yongjin have delivered " chemical research of artificial Fel Ursi " literary composition (" Shenyang Pharmacy College's journal ", 286,8 (4), 1991).Introduced the artificial Fel Ursi main component of simulation natural Fel Ursi, as tauroursodeoxycholic acid, Taurochenodeoxycholic Acid, a small amount of taurocholic acid, bilirubin, trace element, aminoacid etc., these compositions are respectively with the form compatible combination of monomeric substance.This artificial Fel Ursi is very feasible from chemical composition, yet because the synthetic difficulty of these monomeric substances, the source is rare, finally makes the cost of artificial Fel Ursi be higher than the price of drainage bear bile powder, and appearance character and Fel Ursi powder are also inconsistent, are difficult to allow the consumer acceptance.
Summary of the invention
The purpose of this invention is to provide a kind of Fel Ursi powder quality standard that meets, technology is simple, and is with low cost, can replace the artificial Fel Ursi and the manufacture method thereof of natural Fel Ursi.
The component and the percentage by weight of the artificial Fel Ursi of the present invention are as follows:
TUDCANa 28~30
Mixed gallbladder extract 60~65
Aminoacid 3~5
Mineral element 1~2
Testa oryzae oil 1.6~2.1
Cholesterol 0.5~1.0
Lecithin 0.5~1.0.
Its manufacture method is as follows: fully dissolve TUDCANa, mixed gallbladder extract, aminoacid, mineral element with the distilled water heated and stirred, and filtered while hot, filtrate is stand-by., after 70 ℃ of following heated and stirred are fully with lecithin, cholesterol dissolving, slowly add in the Testa oryzae oil that is preheated to 80 ℃ with ethanol, constantly stir, treat fully emulsified after, add in the above-mentioned filtrate, after the emulsifying fully, filtered while hot, the filtrate vacuum drying promptly gets described artificial Fel Ursi.
Wherein the preparation method of mixed gallbladder extract is with the fragmentation of fowl gallbladder, and filtered through gauze is collected bile, 0-4 ℃ of cold preservation is spent the night, and behind the extraction oil slick, crosses the 40# screen cloth and gets clean bile, regulate pH to 2.0 with 0.1mol/L hydrochloric acid, be heated to 80 ℃ of postcooling rapidly, be quickly cooled to room temperature with tap water, after treating that precipitate is separated out fully, with the centrifugal 5min of 2100r/min, draw supernatant with the vacuum suction filter device, get thick mixed gallbladder extract, behind the reuse dissolve with ethanol, add 1% active carbon, 80 ℃ are heated 20min down, and kieselguhr helps filter, sucking filtration takes off charcoal, after the decolouring, filtrate recycling ethanol is regulated pH to 7.4 with the 0.1mol/L sodium hydroxide, be evaporated to thick paste, 65 ℃ are drying to obtain mixed gallbladder extract.The gallbladder element of Chu Liing mainly is to keep the conjugated bile acids composition like this, as chenodeoxycholic acid, cholic acid, deoxycholic acid and glycine, the bonded conjugated bile acids composition of taurine.Contain micro-bile pigments, a small amount of lipid material in addition.
Described aminoacid is meant the mixture of taurine, aspartic acid, glutamic acid, alanine, serine, threonine and glycine.
Described mineral element is meant calcium lactate, magnesium oxide, copper sulfate, zinc lactate, ferrous sulfate, manganese sulfate, the Rich chromium yeast of seven kinds of metallic elements such as containing calcium, magnesium, copper, zinc, ferrum, manganese, chromium.
Testa oryzae oil in the prescription mainly contains lubricant components such as oleic acid, linoleic acid, stearic acid, palmitic acid, arachidic acid; contain a large amount of vitamin Es in addition; can protect the not oxidized destruction of artificial Fel Ursi fatty acid in the course of processing; guarantee that fatty acid can not go rancid and become sour in the storage, thereby increase stability.Employing lecithin is emulsifying agent, has both added effective ingredient phospholipid, has reduced oil water interfacial tension again, makes oil water mixture become stable emulsion.
Description of drawings
The specific embodiment
Embodiment 1
Get TUDCANa 280g, mixed gallbladder extract 645g, taurine 7.5g, aspartic acid 6g, glutamic acid 4.5g, alanine 4.5g, serine 3g, threonine 3g, glycine 1.5g, calcium lactate 5g, magnesium oxide 2g, copper sulfate 1g, zinc lactate 0.5g, ferrous sulfate 0.5g, manganese sulfate 0.5g, Rich chromium yeast 0.5g, Testa oryzae oil 25g, cholesterol 5g, lecithin 5g.With water-soluble substanceses such as 5L dissolved in distilled water TUDCANa, several amino acids, mineral element, mixed gallbladder extracts, 80 ℃ are stirred down, fully after the dissolving; behind 100# industrial filter cloth sucking filtration; reuse distilled water flushing sucking filtration container is diluted to 7L with filtrate, and filtrate is stand-by.With Lecithin and cholesterol, add in 50ml 95% ethanol under stirring, heat about 70 ℃, after treating fully dissolving, slowly add in the Testa oryzae oil of 80 ℃ of preheatings, constantly stir, treat fully emulsified after, slowly add in the above-mentioned 7L filtrate, after the emulsifying fully, emulsion is put in the porcelain dish that is covered with the terylene film, liquid level 0.5cm, level is put in the vacuum drying oven, 50 ℃ of temperature, under pressure-0.08MPa, dry 18 hours, dial and get artificial Fel Ursi 985g from dacron membrane.Through medicine inspection department check, tauroursodeoxycholic acid content 26.5%, moisture 1.2%, the sundry item assay all meets the become a full member regulation of the ten WS3-09 (B-09)-96 (Z) of Ministry of Health of the People's Republic of China's new drug.
The artificial Fel Ursi that the present invention produces is with wide material sources; cheap fowl gallbladder is a base starting material; separate and remove deproteinize; polysaccharide; impurity components such as lipid; keep and the same or analogous active component of natural Fel Ursi, add components such as the distinctive TUDCANa of a certain amount of Fel Ursi, aminoacid and a small amount of lipid component, trace element again, embodied the multiformity and the concertedness of artificial Fel Ursi composition.In physical behavior, diagnostic characteristics, color abnormal smells from the patient, physicochemical property, aspects such as main component content all meet every regulation of Fel Ursi powder ministry standard, can realize suitability for industrialized production, and reasonable price, be easy to be accepted by extensive patients, on medical industry, can replace natural Fel Ursi.
The physical behavior of gained artificial Fel Ursi of the present invention is dark-brown or faint yellow irregular fragment, tool hyaloid gloss, translucent, matter is crisp, easily the moisture absorption, extremely bitter Hui Tian distinguishes the flavor of, refrigerant sense is arranged, the phenomenon of in water, flying in circles, yellow line does not vertically loose, calcination is bubbled in the fire does not have the burnt smoke of sticking with paste, with artificial drainage bear gall and natural Fel Ursi indifference.
The animal toxicity test of artificial Fel Ursi is as follows: 3 groups every group 10 of mices, press 10g/kg dosage ig administration, and observe and do not have death in 7 days, the result shows that artificial Fel Ursi is minimum to the acute toxicity of mice, its LD 50Greater than 10g/kg, be equivalent to 120 times of clinical consumption.
Long term toxicity test shows, the conventional no abnormal variation of the hematuria of the trimestral rat of administration, organizing of liver,kidney,spleen, stomach all do not had influence.
The stability of synthetic Fel Ursi: reserved sample observing carried out appearance character after 10 months, and the qualitative, quantitative test of main component does not have significant change with original assay.

Claims (4)

1, a kind of artificial Fel Ursi is characterized in that following component and percentage by weight composition:
TUDCANa 28~30
Mixed gallbladder extract 60~65
Aminoacid 3~5
Mineral element 1~2
Testa oryzae oil 1.6~2.1
Cholesterol 0.5~1.0
Lecithin 0.5~1.0.
2, artificial Fel Ursi according to claim 1 is characterized in that described aminoacid is meant the mixture of taurine, aspartic acid, glutamic acid, alanine, serine, threonine and glycine.
3, artificial Fel Ursi according to claim 1 is characterized in that described mineral element is meant calcium lactate, magnesium oxide, copper sulfate, zinc lactate, ferrous sulfate, manganese sulfate, the Rich chromium yeast of seven kinds of metallic elements such as containing calcium, magnesium, copper, zinc, ferrum, manganese, chromium.
4, the manufacture method of artificial Fel Ursi according to claim 1 is characterized in that with the distilled water heated and stirred, fully dissolves TUDCANa, mixed gallbladder extract, aminoacid, mineral element, filtered while hot, and filtrate is stand-by; , after 70 ℃ of following heated and stirred are fully with lecithin, cholesterol dissolving, slowly add in the Testa oryzae oil that is preheated to 80 ℃ with ethanol, constantly stir, treat fully emulsified after, add in the above-mentioned filtrate, after the emulsifying fully, filtered while hot, the filtrate vacuum drying promptly gets described artificial Fel Ursi.
CNB021342997A 2002-07-04 2002-07-04 Artificial bear gall and making method thereof Expired - Fee Related CN1264523C (en)

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CN1264523C CN1264523C (en) 2006-07-19

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Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102836175A (en) * 2012-05-23 2012-12-26 杭州宝积生物科技有限公司 Artificial bear bile
CN106038601A (en) * 2016-05-26 2016-10-26 重庆大易科技投资有限公司 Preparation method of high-content, high-purity and low-fishy-smell bear gall powder
CN108578433A (en) * 2018-07-14 2018-09-28 齐光伟 For preventing or treating gall stone cholecystitis and improve the bear gall powder of gallbladder function
CN108578434A (en) * 2018-07-14 2018-09-28 齐光伟 Prevent or treat method and the bear gall powder used of eye conjunctivitis and eyelid herpes zoster
CN108635375A (en) * 2018-07-14 2018-10-12 齐光伟 Prevent or treats hepatopathy and liver fibrosis and improve the bear gall powder and purposes of liver function
CN108653332A (en) * 2018-07-14 2018-10-16 齐光伟 Inhibition thrombosis and platelet aggregation and the bear gall powder and purposes for preventing cerebral ischemia
CN108743622A (en) * 2018-07-14 2018-11-06 齐光伟 Immunity of organisms and muscle power are improved using bear gall powder and alleviate the method for organism fatigue
CN108785328A (en) * 2018-07-14 2018-11-13 齐光伟 Prevent or treat method and the bear gall powder used of entity tumor and hematological system tumor
CN114748509A (en) * 2021-10-14 2022-07-15 黑龙江野宝药业有限公司 Refined biological bear gall powder and production method thereof

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102836175A (en) * 2012-05-23 2012-12-26 杭州宝积生物科技有限公司 Artificial bear bile
CN102836175B (en) * 2012-05-23 2015-02-11 杭州宝积生物科技有限公司 Artificial bear bile
CN106038601A (en) * 2016-05-26 2016-10-26 重庆大易科技投资有限公司 Preparation method of high-content, high-purity and low-fishy-smell bear gall powder
CN108578433A (en) * 2018-07-14 2018-09-28 齐光伟 For preventing or treating gall stone cholecystitis and improve the bear gall powder of gallbladder function
CN108578434A (en) * 2018-07-14 2018-09-28 齐光伟 Prevent or treat method and the bear gall powder used of eye conjunctivitis and eyelid herpes zoster
CN108635375A (en) * 2018-07-14 2018-10-12 齐光伟 Prevent or treats hepatopathy and liver fibrosis and improve the bear gall powder and purposes of liver function
CN108653332A (en) * 2018-07-14 2018-10-16 齐光伟 Inhibition thrombosis and platelet aggregation and the bear gall powder and purposes for preventing cerebral ischemia
CN108743622A (en) * 2018-07-14 2018-11-06 齐光伟 Immunity of organisms and muscle power are improved using bear gall powder and alleviate the method for organism fatigue
CN108785328A (en) * 2018-07-14 2018-11-13 齐光伟 Prevent or treat method and the bear gall powder used of entity tumor and hematological system tumor
CN114748509A (en) * 2021-10-14 2022-07-15 黑龙江野宝药业有限公司 Refined biological bear gall powder and production method thereof

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