Pharmaceutical composition containing berberine hydrochloride tablets and preparation process thereof

A technology of berberine hydrochloride and composition, which is applied in the field of pharmaceutical composition for the treatment of gastroenteritis, can solve the problems of toxic and side effects, non-significant therapeutic effect, etc., and achieve good therapeutic effect, not easy to relapse, and wide range of drug sources

Inactive Publication Date: 2016-08-24
仁和堂药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Its purpose is to solve the problem of treating gastroenteritis, overcome the toxic and side effects of western medicine and the insignificant therapeutic effect, and achieve the goal of treating both symptoms and root causes

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040]A pharmaceutical composition containing berberine hydrochloride, which includes the following raw materials:

[0041] 25kg of berberine hydrochloride, 25kg of Chinese herbal medicine components, 3kg of sodium starch glycolate, 18kg of purified water, 1,000,000 tablets were prepared according to conventional methods.

[0042] Described berberine hydrochloride adopts commercially available or following method preparation:

[0043] 1) Take three needle root coarse powders, pass through a 20-mesh sieve, add 0.5% sulfuric acid aqueous solution with a concentration of 3 times the weight to submerge the medicine surface, soak for 5 hours, and filter with absorbent cotton;

[0044] 2) Add milk of lime to the filtrate of step 1) to neutralize excess sulfuric acid, adjust the pH to 7, and let stand;

[0045] 3) Add 3 times the weight of 95% (volume ratio) ethanol to the filtrate prepared in step 2), stir and heat to 75°C and reflux for 20-30min, then add an equal amount of ethano...

Embodiment 2

[0065] Acute Toxicity Study

[0066] Healthy rats and mice were given the pharmaceutical composition of the present invention by oral gavage respectively, and the gavage dose was 100 times of the intended clinical dosage. After the administration, the mice showed a slight decrease in activity and returned to normal in about 1 hour. After the administration was observed continuously for 7 days, no animal died. Their general conditions, diet, water intake, urination and weight growth were normal, and no obvious acute symptoms appeared. Toxic reactions did not cause animal death. Mice did not show obvious acute toxicity, but rats showed loose stools and decreased activity, and the target organs of acute toxicity were liver and spleen. It is suggested that the drug has low acute toxicity and is safe for clinical use.

Embodiment 3

[0068] clinical experiments

[0069] Case selection:

[0070] Select 103 patients with confirmed gastroenteritis for clinical observation. The patients are randomly divided into treatment group and control group. There are 52 cases in the treatment group and 51 cases in the control group. No significant difference, comparable.

[0071] Drug choice:

[0072] The treatment group took the pharmaceutical composition of the present invention, orally, 3 times a day, 1 tablet each time;

[0073] The control group took commercially available berberine hydrochloride tablets, orally, 3 times a day, 1 tablet each time.

[0074] Take it with warm water after meals; 3 days is a course of treatment, and in severe cases, follow the doctor's advice to increase the dosage.

[0075] Judgment of curative effect:

[0076] (1) Cure: Abdominal pain, nausea, vomiting, fever, loss of appetite, weight loss, profuse sweating, clammy skin, muscle pain or joint stiffness all disappear and the body r...

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PUM

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Abstract

The invention relates to a pharmaceutical composition containing berberine hydrochloride tablets. The pharmaceutical composition is prepared from the following raw materials: 50kg of berberine hydrochloride tablets, 3kg of carboxymethyl starch sodium and 18kg of purified water to prepare 1 million tablets by a conventional method. The compound berberine hydrochloride tablet medicine composition can be used for treating both symptoms and root cause of enterogastritis, is not toxic or harm to human bodies, does not have side effect, is low in price and simple in preparation, and has a wide application prospect.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a Chinese and western medicine preparation for treating gastroenteritis, in particular to a medicinal composition for treating gastroenteritis, which is supplemented by western medicine berberine hydrochloride as a main Chinese herbal medicine component. Background technique [0002] Gastroenteritis is usually caused by microbial infection, but it can also be caused by chemical poisons or drugs. Typical clinical manifestations are diarrhea, nausea, vomiting and abdominal pain. In healthy adults, gastroenteritis usually causes only discomfort and inconvenience without serious consequences, but can lead to life-threatening dehydration and electrolytes in very ill, debilitated, young or elderly patients disorder. The type and severity of gastroenteritis symptoms depend on the type and amount of the microorganism or toxin. The most common symptom of gastroenteritis i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4375A61K36/9068A61P1/00A61P1/04C07D455/03A61K35/64
CPCA61K31/4375A61K9/2059A61K35/63A61K36/076A61K36/185A61K36/195A61K36/232A61K36/238A61K36/284A61K36/288A61K36/315A61K36/346A61K36/355A61K36/47A61K36/484A61K36/488A61K36/575A61K36/62A61K36/66A61K36/68A61K36/704A61K36/71A61K36/714A61K36/752A61K36/756A61K36/855A61K36/8945A61K36/899A61K36/8994A61K36/9068A61K2236/331A61K2236/39A61K2236/51A61K2236/53C07D455/03A61K2300/00
Inventor 林凡儒聂昌盛杨川川
Owner 仁和堂药业有限公司
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