CN1057909C

CN1057909C - Preparation of drained bear bile freeze-dried powder injection

Info

Publication number: CN1057909C
Application number: CN98101235A
Authority: CN
Inventors: 赵风泽; 金正男; 李松雄
Original assignee: Individual
Current assignee: Individual
Priority date: 1998-04-01
Filing date: 1998-04-01
Publication date: 2000-11-01
Anticipated expiration: 2018-04-01
Also published as: CN1191724A

Abstract

The present invention relates to a method for preparing injections with drained bear gall powder as raw material, which comprises the steps that drained bear gall powder is used as basic material to be prepared into injections respectively by utilizing petroleum ether and ethanol by refluxing, concentration, decolorization, adjustment of the pH value, sterilization and freeze drying. The concentration of the medicine in blood and the biological utilization degree is enhanced, the treatment effect is obvious, and thereby, the effective components in bear galls are easy to be absorbed by human bodies. The injection has the efficacy of benefiting the gallbladder, protecting the liver and reducing blood fat, and thereby, the liver functions rapidly return to normal. In addition, the injection of the present invention has the efficacy of resisting arteriosclerosis, reducing low-density lipoprotein and enhancing high-density lipoprotein.

Description

The preparation method of drained bear bile freeze-dried powder injection

The present invention relates to a kind of preparation method of injection, especially is the method for feedstock production injection with the drainage bear bile powder.

At present many is raw material with the drainage bear bile powder, directly is soaked in and makes bear bile wine in the Chinese liquor, or add adjuvant such as Chinese herbal medicine in bear bile wine, make medicated wine, treating relevant disease, but there is active ingredient in Fel Ursi powder shortcoming such as be difficult to be absorbed by the body in it, and does not reach therapeutic purposes.

The object of the present invention is to provide a kind of method of utilizing the artificial drainage bear gall lyophilized powder to prepare injection.

Solution of the present invention, be based on treatment mechanism and the using priciple of motherland's medical science to Fel Ursi powder, achieve with reference to modern pharmacological research, the method that adopts Chinese and western medicine to combine, skim the cream off milk, change drainage bear bile powder into injection, to improve its blood drug level and bioavailability, make Fel Ursi bring into play its due curative effect, through experiment confirm to function of gallbladder promoting, blood fat reducing drug effect according to the drainage bear bile powder drug effect more comparatively fast, stronger.

The object of the present invention is achieved like this: under aseptic condition, take by weighing 1 part of drainage bear bile powder, with 50 parts of petroleum ether water-bath internal reflux 1 hour, reclaim the filtrate petroleum ether through filtering the back, to its residue with 15 parts 80% alcohol reflux 12 hours, reclaim filtrate ethanol through filtering the back, under 5 ℃ condition, place and concentrated and took by weighing its volume in 8 hours, 95% ethanol that thereupon adds 3 times of amounts, under 5 ℃ condition, continue to place 8 hours, after filtering, reclaim filtrate ethanol, under 5 ℃ condition, placed 8 hours, continue to concentrate, take by weighing its volume, add distilled water in 1: 2 ratio, under 5 ℃ condition, placed 8 hours, afterwards with 0.1% Kaolin to its processing of decolouring, filter by microporous filter membrane thereupon, take out filtrate, in filtrate, put into 1.5 parts sodium hydroxide thereupon, adjust its pH value, make pH value reach 6.8-7.0, the distilled water for injection that adds 100 parts at last, be mixed with 1% injection, after sterilization, under-45 ℃ condition, carry out freezing, make its lyophilizing, cooling time is 24 hours, and in the amine bottle of packing at last, its dosage can be divided into 10 milligrams every bottle or 20 milligrams every bottle.

The present invention shows that through animal test results following advantage is arranged:

1, curative effect is fast, and the active ingredient in the Fel Ursi powder is absorbed by the body easily, has improved blood drug level and bioavailability, makes its therapeutic effect of the easier performance of Fel Ursi powder.

2, improve the stability of Fel Ursi powder active ingredient, in preparation process, can protect its active ingredient not to be destroyed, do not needed to add any antioxidant, antiseptic, but long preservation.

3, function of gallbladder promoting protects the liver, the protection hepatocyte, and blood fat reducing makes liver function recover rapidly normal, arteriosclerosis, can reduce low density lipoprotein, LDL, improves high density lipoprotein, can reduce the Hepatic artery hardenability value.

4, can reduce viscosity of blood, it is poly-to suppress platelet erythrocyte flesh, can antithrombotic.

The chemical analysis of artificial drainage bear gall and natural Fel Ursi, physicochemical property and content basically identical, Main Ingredients and Appearance are trace element such as ursodesoxycholic acid, chenodeoxycholic acid, bilirubin, aminoacid, zinc, manganese, silicon.

In order to show therapeutic effect of the present invention, adopt drained bear bile freeze-dried powder injection, oral agents that the rat choleretic effect has been carried out contrast test.Medicine: bear bile freeze-dried powder injection is 1% yellow clear liquor, and oral agents is faint yellow Fel Ursi powder, and with its 1% suspension, water bath shampoo is 1% water bath shampoo during experiment.Animal: male rat, body weight 250-300g.Experimental technique is divided into Fel Ursi injection group with male rat and the oral agents group compares experiment, the experimental result prompting, and artificial drainage bear gall injection, oral agents all have choleretic effect, but the choleretic effect of artificial drainage bear gall injection is stronger than oral agents effect, and the persistent period is short.

Using method: 100 milligrams/time, secondary intravenous injection every day.

Concrete preparation method of the present invention: at first under aseptic condition, take by weighing 1 part of drainage bear bile powder, with 50 parts of petroleum ether water-bath internal reflux 1 hour, reclaim the filtrate petroleum ether through filtering the back, to its residue with 15 parts 80% alcohol reflux 12 hours, reclaim filtrate ethanol through filtering the back, placed 8 hours thereupon, concentrate, laying temperature is 5 ℃, takes by weighing its volume, 95% ethanol that adds 3 times of amounts, placed afterwards 8 hours, laying temperature is 5 ℃, after filtering, reclaim filtrate ethanol, and then leave standstill and continue to concentrate in 8 hours, dwell temperature is 5 ℃, takes by weighing its volume, in concentrated solution, add distilled water in 1: 2 ratio, under 5 ℃ condition, placed 8 hours, and with the processing of decolouring of 0.1% Kaolin, filtered afterwards with microporous filter membrane, take out filtrate, the sodium hydroxide that thereupon adds 1.5 parts in filtrate is adjusted its pH value, makes pH value reach 6.8-7.0, the distilled water for injection that adds 100 parts at last, be mixed with 1% injection, after sterilization, under-45 ℃ condition, carry out freezing, make its lyophilizing, cooling time is 24 hours, and in the amine bottle of packing into, dosage can be divided into 10 milligrams/bottle or 20 milligrams/bottle.

Claims

1, a kind of preparation method of drained bear bile freeze-dried powder injection, it is characterized in that: under aseptic condition, take by weighing 1 part of drainage bear bile powder, with 50 parts of petroleum ether water-bath internal reflux 1 hour, reclaim the filtrate petroleum ether through filtering the back, to its residue with 15 parts 80% alcohol reflux 12 hours, reclaim filtrate ethanol through filtering the back again, under 5 ℃ condition, place and concentrated in 8 hours, take by weighing its volume, 95% ethanol that thereupon adds 3 times of amounts, under 5 ℃ condition, continue to place 8 hours, after filtering, reclaim filtrate ethanol, under 5 ℃ condition, place and continued in 8 hours to concentrate, take by weighing its volume, add distilled water in 1: 2 ratio, under 5 ℃ condition, placed 8 hours, afterwards with 0.1% Kaolin to its processing of decolouring, the reuse microporous filter membrane filters, take out filtrate, in filtrate, put into 1.5 parts sodium hydroxide afterwards, adjust its pH value, make pH value reach 6.6-7.0, the distilled water for injection that adds 100 parts at last is mixed with 1% injection, after sterilization, under-45 ℃ condition, carry out freezing, make its lyophilizing, cooling time is 24 hours, through sealing by fusing promptly.