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Quality-control method of a traditional Chinese medicine 'Xuebijing' injection

A quality control method and Xuebijing technology, applied in the field of removing blood stasis and detoxification, can solve problems such as difficulty in effectively controlling the quality of preparations, affecting product production and ensuring quality

Active Publication Date: 2007-08-01
TIANJIN CHASE SUN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to problems such as the stability of traditional Chinese medicine injection products, it is difficult to effectively control the quality of the preparations, which affects the production and quality assurance of products

Method used

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  • Quality-control method of a traditional Chinese medicine 'Xuebijing' injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0080] Preparation of Xuebijing Injection:

[0081] The formula consists of the following:

[0082] 100g of safflower, 100g of red peony root, 100g of Chuanxiong, 100g of salvia miltiorrhiza, 100g of angelica,

[0083] Its preparation method is as follows:

[0084] [Preparation method] the above five flavors, take safflower, according to the percolation method (Appendix 10 of Chinese Pharmacopoeia 2005 edition) under the liquid extract and extract item, use 8 times the amount of 30% ethanol as solvent, soak for 8 hours, soak Filter, collect 5 times the amount of filtrate, add ethanol to process twice, the first time to make the ethanol content reach 70%, the second time to 80%, each time refrigerated at 5 ° C for 48 hours, filter, the filtrate recovers ethanol, concentrates to 5 times the amount, vacuum-dry it into a dry paste, dissolve it with 0.5 times the amount of water for injection, and set aside; add water to decoct the Radix Paeoniae Rubra twice, add 10 times the amo...

Embodiment 2

[0086] The steps to compare the fingerprints of Xuebijing Injection are:

[0087] [Fingerprint] With reference to high-performance liquid chromatography (Appendix VI D of Chinese Pharmacopoeia 2005 Edition), combined with the requirements of fingerprints, it was determined. Proceed as follows:

[0088] 1. Formulate standard control fingerprints;

[0089] 2. Measure the fingerprint of the preparation of the present invention;

[0090] 3. Compare the above fingerprints;

[0091] specifically is:

[0092] Obtain the high performance liquid chromatogram of standard product paeoniflorin with high-performance liquid chromatography, the preparation of standard product paeoniflorin solution Take paeoniflorin (standard reference substance can be purchased in the drug supervision department) reference substance amount, accurately weighed, add methanol to make A solution containing 1.0 mg per 1 ml is available.

[0093] The specific chromatographic conditions are as follows:

[0094]...

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Abstract

The invention discloses a method for controlling quality of Chinese medicinal preparation Xuebijing for injection, which comprises steps of deseription observation, content identification, content examination, fingerprint pattern comparison, and content measurement for the constituents.

Description

Technical field: [0001] The invention relates to a quality control method of pharmaceutical preparations, in particular to a method for removing blood stasis and detoxifying. Quality control method of traditional Chinese medicine Xuebijing injection for infection-induced systemic inflammatory response syndrome. Background technique: [0002] The prescription composition of Xuebijing injection is: 100g of safflower, 100g of red peony root, 100g of Chuanxiong, 100g of salvia miltiorrhiza, and 100g of angelica. Now there are products on the market. Due to problems such as the stability of traditional Chinese medicine injection products, it is difficult to effectively control the quality of the preparations, which affects the production and quality assurance of products. [0003] In order to effectively control product quality, we have established a quality control method for Xuebijing Injection. This quality control method has good precision, sensitivity, and stability, and ca...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/71A61P29/00G01N30/90G01N30/02
Inventor 姚小青
Owner TIANJIN CHASE SUN PHARM CO LTD
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