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Determination method of capsule fingerprint spectrum for dredging collaterals and reducing phlegm

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 overall characteristics of traditional Chinese medicine compound preparations.

Active Publication Date: 2020-03-27
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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  • Determination method of capsule fingerprint spectrum for dredging collaterals and reducing phlegm
  • Determination method of capsule fingerprint spectrum for dredging collaterals and reducing phlegm
  • Determination method of capsule fingerprint spectrum for dredging collaterals and reducing phlegm

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 invention relates to a determination method of a capsule fingerprint spectrum for dredging collaterals and reducing phlegm, which comprises the following steps: (1) test solution prepartion: taking capsule contents for dredging collaterals and reducing phlegm, adding methanol, carrying out ultrasonic extraction, filtering, and taking the subsequent filtrate to obtain the test solution; (2) preparation of reference substance solutions: taking tauroursodeoxycholic acid, gastrodin, sodium tanshinol, tanshinone IIA, salvianolic acid B, protocatechuic aldehyde, ginsenoside Rb1, ginsenoside Rg1,notoginsenoside R1, rheum emodin and rheinic acid reference substances which are dried under reduced pressure to constant weight, and respectively adding methanol to prepare the reference substance solutions; (3) determination: precisely measuring the test solution and the reference solution respectively, injecting the solutions into a high performance liquid chromatograph for determination, andrecording chromatograms; and (4) performing comparison according to the chromatogram and the standard comparison fingerprint, and determining that the product is qualified if the chromatogram and thestandard comparison fingerprint are consistent.

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 Applications(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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