Establishment method of HPLC fingerprint of andrographispaniculata and indian stringbush root anti-inflammatory capsule

A technology of Chuanwang Xiaoyan and fingerprints, which is applied in the field of high-performance liquid chromatography to construct fingerprints of Chuanwang Xiaoyan capsule preparations, and can solve the problem that the internal quality of Chuanwang Xiaoyan capsules cannot be truly reflected from batch to batch. , to achieve the effect of ensuring long-term stability, ensuring safety and effectiveness

Active Publication Date: 2014-08-06
JIANGXI POZIN PHARMA
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AI Technical Summary

Problems solved by technology

[0004] With the rapid development of modern medicine, the current quality control standards for Chuanwang Xiaoyan Capsules can no longer truly reflect the internal quality of Chuanwang Xiaoyan Capsules and the consistency of product quality between batches

Method used

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  • Establishment method of HPLC fingerprint of andrographispaniculata and indian stringbush root anti-inflammatory capsule
  • Establishment method of HPLC fingerprint of andrographispaniculata and indian stringbush root anti-inflammatory capsule
  • Establishment method of HPLC fingerprint of andrographispaniculata and indian stringbush root anti-inflammatory capsule

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Experimental program
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Effect test

Embodiment 1

[0068] Instruments: Waters 2695 high performance liquid chromatography; Waters 2996 PAD detector.

[0069] Reagent: Andrographolide reference substance was provided by Jiangxi Puzheng Pharmaceutical Co., Ltd. Reference Substance Division; dehydrated andrographolide reference substance was provided by Jiangxi Puzheng Pharmaceutical Co., Ltd. Reference Substance Division; mobile phase methanol and acetonitrile were chromatographically pure, water Ultrapure water was used, and other reagents were of analytical grade.

[0070] Preparation of the test solution: Accurately weigh 0.4g of the content of Chuanwang Xiaoyan Capsules, add 40ml of methanol, weigh, ultrasonically extract for 20 minutes, cool to room temperature, make up the lost weight with methanol, and filter through a 0.45μm microporous membrane After that, take the continued filtrate to obtain the reference substance solution.

[0071] Preparation of reference substance solution: Accurately weigh 10 mg each of androgra...

Embodiment 2

[0080] A total of 6 different batches of Chuanwang Xiaoyan Capsules were tested using the method described in Implementation 1 (batch numbers: 110601, 110602, 110603, 110701, 110702, 110703).

[0081] Using the "Similarity Evaluation System for Chromatographic Fingerprints of Traditional Chinese Medicine" 2004 Edition to evaluate the similarity of 6 batches of Chuanwang Xiaoyan Capsules, the 6 batches of Chuanwang Xiaoyan Capsules and the control fingerprints (the common pattern generated by the 6 batches of Chuanwang Xiaoyan Capsules) S1) The similarities are all greater than 0.96 (Table 5).

[0082] Table 5 Six batches of Chuanwang Xiaoyan Capsules fingerprint similarity calculation results

[0083]

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Abstract

An establishment method of an HPLC fingerprint of an andrographispaniculata and indian stringbush root anti-inflammatory capsule relates to the Chinese traditional medicine quality control method. The andrographispaniculata and indian stringbush root anti-inflammatory capsule is extracted with methanol solution by ultrasonic; andrographolide and dehydroandrographolide are used as reference substances, indian stringbush root and andrographispaniculata are used as control medicines, and a fingerprint is established according to HPLC; and an elution procedure is gradient elution. According to similarity evaluation, the fingerprint of the andrographispaniculata and indian stringbush root anti-inflammatory capsule provided by the invention has a similarity greater than 0.90 to corresponding control spectrum, can effectively characterize the quality of the products, benefit monitoring of quality products, and effectively ensure the long-term stability of the product quality, so as to guarantee the security and efficacy of curative effect.

Description

technical field [0001] The invention relates to a method for quality control of traditional Chinese medicine preparations, in particular to a method for constructing fingerprints of Chuanwang Xiaoyan capsule preparations by high performance liquid chromatography. Background technique [0002] Chuanwang Xiaoyan Capsules are prepared from Chuanwang Xiaoyan Tablets, and are classified as Class Nine New Drugs of Traditional Chinese Medicine according to the National New Drug Approval Regulations. The prescription of Chuanwang Xiaoyan Capsules is composed of Andrographis paniculata and Liaogewang two traditional Chinese medicines, among which Andrographis paniculata and Andrographis paniculata is a plant of the family Acanthaceae. Andrographis paniculata (Burm . f. ) The dry aboveground part is recorded in "Chinese Pharmacopoeia" and local drug standards. The main active ingredients are diterpenoids and flavonoids such as andrographolide and dehydroandrographolide, which have ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 肖军平康兴东尹文娟杨伟庆刘立鼎
Owner JIANGXI POZIN PHARMA
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