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Quality control method of capsule preparation for treating gastric ulcer

A quality control method and gastric ulcer technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve problems such as difficult to effectively control quality, and not provide effective chemical components for quality control, so as to achieve scientific and reasonable quality control methods and ensure clinical Good curative effect and reproducible effect

Active Publication Date: 2019-08-30
GUIZHOU MEDICAL UNIV
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Liangjiang Weiyang Capsule is a compound preparation composed of Miao medicine iron chopsticks, Evodia rutaecarpa, Diwupao, etc. It has the effects of warming the stomach and dispelling cold, regulating qi and relieving pain. Noisy acid reflux, clinically used for the treatment of gastric ulcer and duodenal ulcer, the drug is a traditional Chinese medicine compound preparation, only the content of evodiamine and evodiamine is determined, it is difficult to effectively control its quality
Although Patent No. CN01108570.3 discloses a capsule for treating stomach diseases, it is obtained by extracting, concentrating, adding volatile oil, and whole grains with iron chopsticks, Evodia rutaecarpa, Diwupao, galangal, and Huoxiang. Diseases such as intestinal ulcers have good curative effects, but there is no quality control method and effective chemical composition, which makes the quality assurance of Liangjiang Weiyang Capsules particularly important

Method used

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  • Quality control method of capsule preparation for treating gastric ulcer
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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] The quality control method of Liangjiang Weiyang Capsules for treating gastric ulcer is mainly content determination, and the contents of 7 components in Liangjiang Weiyang Capsules are determined simultaneously by HPLC method;

[0057] Chromatographic conditions and system suitability test: use octadecylsilane bonded silica gel as filler; methanol (A)-0.1% formic acid water (B) as mobile phase; gradient elution (0-8min, 10%-21% A; 8~14min, 21%A; 14~20min, 21%~29%A; 20~29min, 29%A; 29~35min, 29%~55%A; 35~42min, 55%A~73% A; 42~60min, 73%~100%A); the detection wavelength is 267nm (evodiamine) and 344nm (scopoletin, dehydroevodiamine, scopoletin, isoxapidine, evodiamine, evodiamine base), the number of theoretical plates should not be less than 5000 based on the evodiamine peak;

[0058] Preparation of reference solution: Accurately weigh 12.91 mg of scopoletin, 8.04 mg of dehydroevodiamine, 6.51 mg of scopoletin, 9.99 mg of isoxazinidine, 5.75 mg of evodiamine, 6.90 mg o...

Embodiment 2

[0066] The quality control method of the capsule preparation for the treatment of gastric ulcer, using the HPLC method to determine the content of scopoletin, dehydroevodiamine, scopoletin, isoxazinidine, evodiamine, evodiamine, and evodiamine in Liangjiang Weiyang capsules content;

[0067] The method comprises the following steps: taking the test substance and the reference substance of Galangal Weiyang Capsules for detection, and the chromatographic conditions for the detection are: chromatographic column: octadecylsilane bonded silica gel; mobile phase: methanol (A)-0.1% formic acid aqueous solution (B); flow rate: 1mL / min; column temperature: 30°C; detection wavelength: 267 and 344nm; elution gradient: 0-8min, 10%-21% (A); 8-14min, 21% (A) ;14-20min, 21%-29%(A); 20-29min, 29%(A); 29-35min, 29%-55%(A); 35-42min, 55%-73%(A); 42-60min, 73%-100% (A).

Embodiment 3

[0069] The quality control method of the capsule preparation for the treatment of gastric ulcer specifically comprises the following steps:

[0070] (1) Preparation of the reference solution: Accurately weigh 12.91 mg of scopoletin, 8.04 mg of dehydroevodiamine, 6.51 mg of scopoletin, 9.99 mg of isopyridine, 5.75 mg of evodiamine, 6.90 mg of evodiamine, Evodicarpine 5.00mg, with methanol as solvent, prepared to concentrations of 0.5164mg / mL, 0.2251mg / mL, 0.1302mg / mL, 0.2398mg / mL, 0.1093mg / mL, 0.1794mg / mL, 0.0500mg / mL Mix the reference substance solution, shake well, and store in a 4°C refrigerator for later use;

[0071] (2) Preparation of the test solution: Weigh 0.5 g of the contents of the same batch of capsules, put them into a flat-bottomed flask, add 25 mL of methanol with a volume concentration of 90%, weigh the weight, heat and reflux for 0.5 h, cool to room temperature, and use The volume concentration is 90% methanol to make up the weight, shake well, and filter to ...

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Abstract

The invention belongs to the technical field of capsule preparation quality control, and particularly relates to a quality control method of a capsule preparation for treating gastric ulcer. The quality control method is characterized in that the contents of scopolin, dehydroevodiamine, scopoletin, isofraxidin, rutaecarpin, evocarpine and evodiamine in galangal gastric ulcer capsules are determined by a HPLC (High Performance Liquid Chromatography) method, thereby building a quality control method of a galangal gastric ulcer capsule preparation for treating gastric ulcer. The adopted quality control method is scientific and reasonable, has high accuracy and high reproducibility, can comprehensively and effectively control the quality of the galangal gastric ulcer capsule preparation for treating duodenal ulcer, and can ensure the clinical effect of the preparation.

Description

technical field [0001] The invention belongs to the technical field of quality control of capsule preparations, in particular to a quality control method of capsule preparations for treating gastric ulcer. Background technique [0002] Gastric ulcer (Gastric ulcer, GU) is a common disease of the digestive system with long-term recurrent periodic and rhythmic epigastric pain as the main clinical manifestation. According to relevant research statistics, the annual incidence of gastric ulcer in the world exceeds 2.5%. [0003] Duodenal ulcer is a common type of peptic ulcer. It is a mucosal defect caused by various reasons. The defect can be round or oval. The three common symptoms are: pantothenic acid, stomach fullness and pain. Clinically, it manifests as recurrent rhythmic stomach pain, often accompanied by belching, acid reflux, noise, etc., and in severe cases, it is also accompanied by symptoms such as nausea, vomiting, hematemesis, and blood in the stool. Helicobacter...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 何迅肖耀华王海波曹晓军徐国波雷丹丹廖尚高关焕玉黄甫静
Owner GUIZHOU MEDICAL UNIV
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