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A method for determining the fingerprint of Tongluohuatan Capsules

A technology of fingerprint spectrum and determination method, which is applied in the field of determination of the fingerprint spectrum of traditional Chinese medicine preparation Tongluo Huatan Capsule, can solve the problems of incomplete drug quality and inability to reflect the integral characteristics of traditional Chinese medicine compound preparations.

Active Publication Date: 2022-04-22
SHANDONG WOHUA PHARMACEUTICALS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, Tongluo Huatan Capsule is a compound preparation, and it is obviously not comprehensive to control the quality of its drug simply by measuring the quantity of an index component, nor can it reflect the overall characteristics of traditional Chinese medicine compound preparations.

Method used

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  • A method for determining the fingerprint of Tongluohuatan Capsules
  • A method for determining the fingerprint of Tongluohuatan Capsules
  • A method for determining the fingerprint of Tongluohuatan Capsules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0095] 1) Take about 0.5g of the contents of 10 batches of qualified Tongluo Huatan Capsules (batch number 20191001-20191010) respectively, weigh them accurately, put them in a 50mL Erlenmeyer flask with a stopper, add 10mL of methanol precisely, weigh, and ultrasonically ( 700W, 50kHz) for 30min, let it cool, make up the lost weight with methanol, pass through a 0.22μm microporous membrane, and take the subsequent filtrate as the test solution.

[0096] 2) Preparation of reference substance solution:

[0097] Take tauroursodeoxycholic acid, gastrodin, danshensu sodium, tanshinone Ⅱ A, salvianolic acid B, protocatechualdehyde, ginsenoside Rb1, ginsenoside Rg1, notoginseng saponin R1, emodin, and rhein reference substances Appropriate amount, accurately weighed, add methanol to make mixed reference substance solutions with concentrations of 245.5, 582.3, 492.5, 302.7, 517.4, 447.1, 383.6, 298.5, 469.1, 517.4, 483.5 μg / mL.

[0098] 3) inject the need testing solution and refere...

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Abstract

The present invention relates to a method for determining the fingerprint of Tongluo Huatan Capsules. The steps of the method are as follows: (1) Preparation of the test solution: take the content of Tongluo Huatan Capsules, add methanol, ultrasonically extract, filter, Take the continued filtrate to obtain the test solution; (2) Preparation of the reference solution: take tauroursodeoxycholic acid, gastrodin, danshensu sodium, tanshinone ⅡA, and salvianolic acid B dried under reduced pressure to constant weight. , protocatechualdehyde, ginsenoside Rb1, ginsenoside Rg1, notoginseng saponin R1, emodin, rhein reference substance, respectively add methanol to make reference substance solution; (3) determination: precision measure the test solution and The reference substance solution is injected into a high-performance liquid chromatograph for measurement, and the chromatogram is recorded; (4) according to the chromatogram and the standard control fingerprint, it is compared, and if it is consistent, it is a qualified product.

Description

technical field [0001] The invention relates to a detection method of a medicinal preparation, in particular to a detection method of a fingerprint of a traditional Chinese medicine preparation Tongluo Huatan Capsule. Background technique [0002] Cerebrovascular disease is one of the three major diseases that endanger human health in the world today. It is a frequently-occurring disease among middle-aged and elderly people with a high mortality rate. Cerebrovascular disease accounts for the second cause of death in my country. According to domestic reports, the mortality rate of cerebral hemorrhage is 38-43%. About 50%-70% of the survivors have severe sequelae and cannot take care of themselves. Not only the patients suffer great pain, but also bring burdens to families and society. [0003] Traditional Chinese medicine has its advantages in the treatment of cerebrovascular diseases. For example, the traditional Chinese medicine Tongluo Huatan Capsules, whose formula and pr...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/86G01N30/02G01N30/34
CPCG01N30/8679G01N30/02G01N30/34G01N2030/047
Inventor 王炯程世娟周万辉曾英姿王冬梅赵磊
Owner SHANDONG WOHUA PHARMACEUTICALS CO LTD
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