CN1256100C - Artificial bear gall - Google Patents
Artificial bear gall Download PDFInfo
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- CN1256100C CN1256100C CNB031337716A CN03133771A CN1256100C CN 1256100 C CN1256100 C CN 1256100C CN B031337716 A CNB031337716 A CN B031337716A CN 03133771 A CN03133771 A CN 03133771A CN 1256100 C CN1256100 C CN 1256100C
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- fel ursi
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Abstract
The present invention relates to an artificial bear gall for the field of traditional Chinese medicinal plants, which is prepared from cow-bezoar sodium ursodexoxycholate, chicken gall paste and bilirubin. The preparation method of the present invention comprises the steps that the synthesis of effective components and the sieving of substrates of the artificial bear gall use ursodeoxycholic acid as raw material by three steps of reactions of acylation, acyl chloride treatment and condensation to synthesize cow-bezoar sodium ursodexoxycholate; the chicken gall paste is sieved to be used as the substrates; the bilirubin, the cow-bezoar sodium ursodexoxycholate and the chicken gall paste are mixed, sieved and blended by an equivalent dilution method to prepare the finished product, and the product is qualified by quality inspection. The present invention has the advantages of scientific and unique prescription, easy acquirement of the raw material, simple technology, low cost, strict quality control and no three wastes, guarantees the consistency of treatment effect, protects wild animals and is an ideal substitute of a natural bear gall.
Description
Technical field: the artificial manufactured goods that the present invention relates to a kind of artificial Fel Ursi-natural Fel Ursi in the precious in great shortage Chinese medicine material field.
Background technology: natural Fel Ursi is the dry gallbladder of ursidae animal black bear or brown bear.In China's clinical practice the history in more than 1,000 year is arranged, the scope of application is very wide, relates to each section such as inside and outside, woman, youngster, oral cavity, treats more than 30 kind of disease.Have heat clearing away, suppressing the hyperactive liver, make eye bright, ease pain, detoxifcation, sterilization, lung moistening, be good for the stomach, effect such as parasite killing.It is one of primary raw material in the tens of kinds of Chinese medicine prescriptions.Ursus is prohibited hunting and is watched for animals, and natural Fel Ursi medicine source is broken off.National corporation of medical herbs held valuable medicinal production in 1981 and uses meeting, required to carry out as early as possible the research of succedaneum.Nineteen eighty-three is added up again and announces medical material quantity in short supply, requires again to carry out the research of succedaneum as early as possible, otherwise will influence production and clinical practice.August nineteen eighty-three, upright topic began to develop artificial Fel Ursi for this reason.The guiding theory of development: 1, according to national new drug approval method, artificial Fel Ursi belongs to new drug Chinese medicine one class." the artificial manufactured goods of Chinese crude drug ", research are that strictness is undertaken by the requirement of national new drug approval method.2, use bionics principle, the science and the suitability be arranged, Fel Ursi is a Chinese crude drug, and China's ancient Chinese medicine doctor is particular about " authentic medicinal herbs ".Artificial Fel Ursi is to use the modern analysis method, analyzed the high-quality natural Fel Ursi after, in conjunction with documents and materials,,, make the composition of artificial Fel Ursi and chemical constitution and natural Fel Ursi approximate through formulation selection many times with the method for bionical natural Fel Ursi.Guarantee the feature of " authentic medicinal herbs ", guaranteed the concordance of curative effect.3, to guarantee technical feasibility, consider in the research that raw material is easy to get, technology is simple, technical feasibility such as with low cost, strict control of quality, the no three wastes.Artificial Fel Ursi is in the function of effective ingredient and content thereof, physical behavior, physicochemical property, stability, pharmacology, pharmacodynamics, toxicology, clinical trial and cure mainly effectiveness and aspect such as safety all is similar to natural Fel Ursi, is the ideal succedaneum of natural Fel Ursi.Although it is not have a lot of people also the composition bibliographical information of natural Fel Ursi to be arranged also at present, as contain ursodesoxycholic acid, chenodeoxycholic acid and a spot of cholic acid etc., comprehensive at the research artificial Fel Ursi; The synthetic route document of TUDCANa also has report, but also not detailed.Therefore the artificial manufactured goods of developing a kind of artificial Fel Ursi one natural Fel Ursi are new scientific research tasks anxious to be solved both at home and abroad always.
Summary of the invention: the objective of the invention is to be achieved through the following technical solutions: its formula for a product is 50 kilograms of TUDCANas, 49.2 kilograms of Fel Gallus domesticus cream, 0.2 kilogram of bilirubin; Its preparation method is, synthetic effective ingredient of artificial Fel Ursi and screening substrate be with the ursodesoxycholic acid be raw material through acidylate, chloride, the synthetic TUDCANa of condensation three steps reflection, screening substrate is Fel Gallus domesticus cream; With bilirubin and TUDCANa, Fel Gallus domesticus plaster material, mix by the equivalent dilution method, sieve, mixing, that is, it is qualified to pass through the quality inspection product; Natural Fel Ursi is analyzed its technical specification and authentication method is, the natural Fel Ursi of determining with modern analysis methods such as thin layer chromatography, thin slice scan, infrared, ultraviolet, nuclear-magnetism, amino acid analysis, plasma, high performance liquid chromatography, gas chromatograies contains conjunction type TUDCANa 40-60%; Conjunction type Taurochenodeoxycholic Acid sodium 5-30% and a small amount of cholic acid, each seed amino acid and trace element etc.Main points of the present invention are its formula for a product and preparation method.Its pharmacodynamics, pharmacology, toxicology principle are: use bionics principle, the science and the suitability are arranged, the artificial Fel Ursi of preparation is pressed above-mentioned authentication method analytical proof with natural Fel Ursi under identical condition: contained active chemical of artificial Fel Ursi and chemical constitution thereof, content and natural Fel Ursi unanimity.And all contain 18 seed amino acids, 17 kinds of trace element.Physical behavior, color and luster, physicochemical property zero difference.Pharmacodynamic study proves: artificial Fel Ursi all has tangible fungistatic effect to Bacillus typhi, escherichia coli, Diplococcus pneumoniae, modification bacillus, staphylococcus aureus, Staphylococcus albus etc.And having spasmolytic, calmness, function of gallbladder promoting, analgesic, antiinflammatory, anti-strychnine causes and faints from fear and the protective effect of carbon tetrachloride hepatic injury.Pharmaceutical research proves: artificial Fel Ursi is to cat breathing, blood pressure, electrocardiogram, and to hemodynamics, to all no abnormal influence of central nervous system, all are normal.Toxicologic study proves: artificial Fel Ursi LD50 is 3.3390 ± 0.3415 (g/Kg), and natural Fel Ursi LD50 is 3.1422 ± 0.2373 (g/Kg), the two no significant difference; High, medium and low three the dosage groups of acute toxicity are not seen intoxicating phenomenon; The AMES experiment is negative; White mice bone marrow of sternum micronucleus test is negative; To male sex-cell chromosomal aberration influence experiment, the result does not have influence; The long term toxicity test result of Canis familiaris L. does not all have obvious influence to the tissue morphology of hemogram, liver, renal function and main organs.The proof artificial Fel Ursi is a non-toxic and safe.Its research step is: 1, the technical specification and the authentication method of analysis natural Fel Ursi.The natural Fel Ursi of determining with modern analysis methods such as thin layer chromatography, thin slice scan, infrared, ultraviolet, nuclear-magnetism, amino acid analysis, plasma, high performance liquid chromatography, gas chromatograies contains conjunction type TUDCANa 40-60%; Conjunction type Taurochenodeoxycholic Acid sodium 5-30% and a small amount of cholic acid, each seed amino acid and trace element etc.2, synthetic effective ingredient and screening substrate.With the ursodesoxycholic acid is that raw material synthesizes TUDCANa through acidylate, chloride, condensation three steps reflection, and screening substrate is Fel Gallus domesticus cream.3, determine the prescription and the preparation artificial Fel Ursi of artificial Fel Ursi.4, carrying out study of pharmacy proof artificial Fel Ursi and natural Fel Ursi is similar to.5, carrying out clinical trial proves that artificial Fel Ursi is identical with the natural Fel Ursi curative effect, proves that artificial Fel Ursi is a safe and effective medicine.The artificial manufactured goods of artificial Fel Ursi one natural Fel Ursi compared with prior art; have that scientific formulation uniqueness, raw material are easy to get, technology is simple, with low cost, strict control of quality, the no three wastes, guarantee curative effect concordance, save the wild animals, be the advantages such as ideal succedaneum of natural Fel Ursi, will be widely used in the Chinese medicine material field.
The specific embodiment:
Synthetic effective ingredient of artificial Fel Ursi and screening substrate are, are that raw material goes on foot the synthetic TUDCANa of reflection through acidylate, chloride, condensation three with the ursodesoxycholic acid, and screening substrate is Fel Gallus domesticus cream; With 0.2 kilogram of bilirubin and 50 kilograms of TUDCANas, 49.2 kilograms of spices of Fel Gallus domesticus cream, mix by the equivalent dilution method, sieve, mixing, that is, it is qualified to pass through the quality inspection product; Natural Fel Ursi is analyzed its technical specification and authentication method is, the natural Fel Ursi of determining with modern analysis methods such as thin layer chromatography, thin slice scan, infrared, ultraviolet, nuclear-magnetism, amino acid analysis, plasma, high performance liquid chromatography, gas chromatograies contains conjunction type TUDCANa 40-60%; Conjunction type Taurochenodeoxycholic Acid sodium 5-30% and a small amount of cholic acid, each seed amino acid and trace element etc.
The clinical experiment report of artificial Fel Ursi: artificial Fel Ursi is by the star institute of materia medica development of Shenyang China, and its composition and pharmacological action and natural Fel Ursi basically identical have heat-clearing and toxic substances removing, the effect of heat clearing away suppressing the hyperactive liver.According to Ministry of Public Health bureau of drug administration (90) ZL08 gist of a document, artificial Fel Ursi is carried out clinical trial.Now that the clinical trial situation report is as follows:
One, case is selected
295 routine tonsillitis patients, artificial Fel Ursi wanying troche 205 examples, natural Fel Ursi wanying troche 90 examples.
1, sex: male 148 people, women 147 people.
2, the age: 32 people below 20 years old, 21-30 year 127 people, 31-40 year 103 people, 41-50 year 14 people, 19 people more than 50 years old.
3, diagnostic criteria:
(1) body temperature is more than 38 ℃, the heating of feeling cold.
(2) pharyngalgia, headache, systemic pain.
(3) the congested enlargement of tonsil.
(4) tip hemogram, numeration of leukocyte increases.
4, choice criteria: allly meet above-mentioned diagnostic criteria, and possess following condition, elect the object of observation as.
(1) children over five or adult.
(2) morbidity was not used antibiotic or other febrifuge to going to a doctor.
(3) there are not other serious complication persons.
(4) except the patient that can not follow up a case by regular visits to.
Two, test method
1, get single blind random packet counter point, and according to compound recipe (replacement) the controlled trial method of stipulating in " new drug reviewing method " relevant clinical trial specification requirement.
This test is the treatment group with the artificial Fel Ursi wanying troche, and the natural Fel Ursi wanying troche is a matched group.The stratified random principle is adhered in grouping, to allogenic disease dissimilar should all have enter at random two groups may.
2, the dosage and the course of treatment
The treatment group: 205 examples, take the artificial Fel Ursi wanying troche, each 5, day clothes three times serve on 5-7 days.
Matched group: 90 examples, take the natural Fel Ursi wanying troche, each 5, day clothes three times serve on 5-7 days.
Three, curative effect is judged
1, clinical recovery: medication is after three days, and temperature recovery is normal, and pharyngalgia disappears, 5 days whole clinical symptom disappearance, and toposcopy: inflammation disappears substantially, and it is normal that numeration of leukocyte is recovered.
2, produce effects: medication is after 5 days, and temperature recovery is normal, and pharyngalgia disappears, and other symptoms all disappear after the week, and the toposcopy inflammation all disappears, and it is normal that numeration of leukocyte is recovered.
3, effective: medication is after 5 days, and body temperature is near normal, and pharyngalgia disappears, and swallows freely, and the toposcopy inflammation disappears to some extent, and all backs temperature recovery is normal, local mild inflammation, and other symptoms disappear substantially.
4, invalid: medication is after 5 days, and above-mentioned symptom is not seen and alleviated or increase the weight of.
Four, clinical test results
1, the obvious effective rate and the total effective rate of artificial Fel Ursi wanying troche and natural Fel Ursi wanying troche treatment acute tonsillitis are respectively 76.10%, 96.10%; 72.22%, 94.44%.The comparison that two medications are imitated is through X 2 test difference nonsignificance (P＞0.05).
2, the comparison of two kinds of medicine antipyretic effects:
Before the administration, there was no significant difference on two groups of patient temperature rising degree distribution.
Administration after three days body temperature obviously descend, two medicine antipyretic effects are remarkable, but both zero differences.
3, the comparison of two kinds of medicine reduction numeration of leukocyte effect:
Before the administration and after the administration three days, the check numeration of leukocyte relatively, it is obvious and action intensity is close that two medicines reduce the numeration of leukocyte effect.
Five, brief summary
1, artificial Fel Ursi wanying troche treatment acute tonsillitis is evident in efficacy, and obvious effective rate is 76.10%, and total effective rate is 96.10%, compare with the natural Fel Ursi wanying troche, and through X 2 test, both there was no significant differences.
2, bring down a fever, reduce numeration of leukocyte, pain relieving, antiinflammatory all have tangible effect.
3, side effect is slight, and is safe and reliable.
4, take simple, convenience.
The development of artificial Fel Ursi will benefit extensive patients for exploitation Fel Ursi preparation series has crucial meaning, and very big social benefit and economic benefit are arranged.
Six, model case
1, model case one
Name Chen Shou treasured, sex woman, 38 years old age, professional workman, admission number first visit on March 20 in 95242,1991 year.Main suit: pharyngalgia heating two days.Headache, weak, thirsty, dry stool, yellowish urine are arranged, do not used antibiotic and antipyretic.Check: the heating flushed complexion, spirit is weak, red tongue, tonsil is congested red and swollen, and the surface has a lamellar yellow-white exudate to cover 38.5 ℃ of body temperature, 10300/ cubic millimeter of leukocyte.Diagnosis: acute tonsillitis.After being admitted to hospital, only adopt the artificial Fel Ursi wanying troche to treat each 5, day clothes three times serve on three days, 37.6 ℃ of body temperature, 7200/ cubic millimeter of blood leukocytes, pharyngalgia obviously alleviates, and tonsil hyperemia is obviously disappeared, continuous taking medicine two days, symptom and sign all disappears, light red tongue, drug withdrawal.Efficacy determination: produce effects.
2, model case two
Patient Chen Qingjun, man, 29 years old, workman, flat firmly-No. 035 of admission number people, first visit on May 26 in 1991.The main suit: have a sore throat, had a fever three days, thirsty, big dry stool, yellowish urine had not been used the treatment of antibiotics and antipyretic before examining.Have a medical check-up: 38.9 ℃ of body temperature, tonsil hyperemia, yellow fur is thick, 18000/ cubic millimeter of leukocyte, income institute adopts the treatment of artificial Fel Ursi wanying troche.30 minutes 6 pms were obeyed 5 artificial Fel Ursi wanying troches first, obeyed for the second time for late 10, and obey for the third time second day morning, has no adverse reaction after taking medicine.May 27, patient's sense is brought down a fever, and whole body is brisk, 37 ℃ of body temperature, but pharynx is painful, thirsty, yellowish urine, and tonsil hyperemia continues to take medicine.May 28, patient felt that pharynx is painful still to exist, and thirsty yellowish urine disappears, 36 ℃ of body temperature, and pulse condition is gentle, and glossopharyngeum is thin, tonsil hyperemia, 5200/ cubic millimeter of leukocyte continues to take medicine.May 29,36 ℃ of body temperature, the painful and tonsil exudate disappearance of pharynx, transference cures such as thirsty dry stool and yellowish urine continue to take medicine.May 30,36 ℃ of body temperature, the symptomatology transference cure, recovery from illness is left hospital.Efficacy determination: produce effects.
Claims (2)
1, a kind of artificial Fel Ursi is characterized in that being made up of for 0.2 kilogram 50 kilograms of TUDCANas, 49.2 kilograms of Fel Gallus domesticus cream, bilirubin.
2, a kind of artificial Fel Ursi according to claim 1, it is characterized in that synthetic effective ingredient of artificial Fel Ursi and screening substrate are is that raw material synthesizes TUDCANa through acidylate, chloride, condensation three-step reaction with the ursodesoxycholic acid, screening substrate is Fel Gallus domesticus cream; With bilirubin and TUDCANa, Fel Gallus domesticus plaster material, mix by the equivalent dilution method, sieve, mixing, that is, it is qualified to pass through the quality inspection product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB031337716A CN1256100C (en) | 2003-07-22 | 2003-07-22 | Artificial bear gall |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB031337716A CN1256100C (en) | 2003-07-22 | 2003-07-22 | Artificial bear gall |
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| Publication Number | Publication Date |
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| CN1513480A CN1513480A (en) | 2004-07-21 |
| CN1256100C true CN1256100C (en) | 2006-05-17 |
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| CNB031337716A Expired - Fee Related CN1256100C (en) | 2003-07-22 | 2003-07-22 | Artificial bear gall |
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| CN103040869B (en) * | 2013-01-25 | 2014-10-29 | 成都康奥药物研究所 | Artificial bear gall powder and preparation method thereof |
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Owner name: SHANDONG RUIYANG HUAXING PHARMACEUTICAL ENTERPRISE Free format text: FORMER OWNER: HUAXING MATERIA MEDICA INST., SHENYANG CITY Effective date: 20130827 |
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Free format text: CORRECT: ADDRESS; FROM: 110016 SHENYANG, LIAONING PROVINCE TO: 256100 ZIBO, SHANDONG PROVINCE |
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Effective date of registration: 20130827 Address after: 256100 Shandong city of Zibo province Yiyuan County medicine Bolu No. 2 Patentee after: Shandong Rui Ying Huaxing Pharmaceutical Enterprise Management Co., Ltd. Address before: 110016 retired office of Shenyang Pharmaceutical University, 103 Wenhua Road, Shenhe District, Liaoning, Shenyang, Zhou Jie Patentee before: Huaxing Materia Medica Inst., Shenyang City |
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Granted publication date: 20060517 Termination date: 20200722 |
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| CF01 | Termination of patent right due to non-payment of annual fee |