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Quality standard and detection method of compound fritillaria cirrhosa essence capsules

A compound Chuanbeijing and quality standard technology, applied in the quality standard and detection field of Fufang Chuanbeijing Capsules, can solve problems such as high output value, no spots, unstable ephedrine hydrochloride content determination method, etc., and achieve Good effect and suitable retention time

Inactive Publication Date: 2013-04-24
HANDAN PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Fufang Chuanbeijing Capsules was originally recorded in the national trial standard that the local standard of Hebei Province rose to. The TLC identification method of Schisandra chinensis in the trial quality standard was unstable, resulting in unclear or no spots in the test; ephedrine hydrochloride The content determination method is unstable, sometimes resulting in a higher output value than the input value, and it is difficult to display effective and real data

Method used

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  • Quality standard and detection method of compound fritillaria cirrhosa essence capsules
  • Quality standard and detection method of compound fritillaria cirrhosa essence capsules
  • Quality standard and detection method of compound fritillaria cirrhosa essence capsules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0131] Sample name: Fufang Chuanbeijing Capsules

[0132] Qualitative identification of Schisandra:

[0133] Take 4g of the content of this product, add 15ml of chloroform, ultrasonically treat for 20min, filter, evaporate the filtrate to dryness, add 2ml of ethyl acetate to the residue to dissolve, and use it as the test solution.

[0134] Take 0.5g of the Schisandra reference medicinal material, add 10ml of chloroform, ultrasonically treat for 20min, filter, evaporate the filtrate to dryness, add 1ml of ethyl acetate to the residue to dissolve, and use it as the reference medicinal solution.

[0135] Take schisandrin A reference substance, add ethyl acetate to make a solution containing 1mg per 1ml, as the reference substance solution.

[0136] According to "Chinese Pharmacopoeia" 2010 Edition, Appendix VIB thin-layer chromatography test: draw 10 μl of the test solution, 5 μl of the reference medicinal material solution, and 2 μl of the reference solution, respectively spot...

Embodiment 2

[0138] Sample name: Fufang Chuanbeijing Capsules

[0139] Determination of ephedrine content:

[0140] According to the "Chinese Pharmacopoeia" 2010 edition an appendix VID determination, the specific steps are as follows,

[0141] ① Chromatographic conditions and system adaptability test:

[0142] Octadecylsilane bonded silica gel is used as filler; acetonitrile-0.1% phosphoric acid (9:87) is used as mobile phase; detection wavelength is 207nm. The number of theoretical plates should not be less than 3000 based on the ephedrine hydrochloride peak.

[0143] ② Preparation of reference solution:

[0144] Precisely weigh the ephedrine hydrochloride reference substance and dissolve it in methanol to make a solution with a concentration of 0.1 mg / ml, then dilute it with a mobile phase to a solution with a concentration of 8 μg / ml of ephedrine hydrochloride, shake well, and obtain the reference substance solution.

[0145] ③ Preparation of the test solution:

[0146] Take the c...

Embodiment 3

[0150] Sample name: Fufang Chuanbeijing Capsules

[0151] Qualitative identification of Schisandra:

[0152] According to "Chinese Pharmacopoeia" 2010 edition an appendix VIB thin-layer chromatography determination.

[0153] ①Take 3g of the content of this product, add 10ml of chloroform, ultrasonically treat for 10min, filter, evaporate the filtrate to dryness, add 1ml of ethyl acetate to the residue to dissolve, and use it as the test solution.

[0154] ②Take 0.2g of Schisandra chinensis reference medicinal material, add 5ml of chloroform, sonicate for 10min, filter, evaporate the filtrate to dryness, add 0.5ml of ethyl acetate to dissolve the residue, and use it as the reference medicinal material solution.

[0155] ③ Take schisandrin A reference substance, add ethyl acetate to make a solution with a concentration of 0.5 mg / ml of schisandrin A, as the reference substance solution.

[0156] ④According to the "Chinese Pharmacopoeia" 2010 edition, Appendix VIB thin-layer chr...

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Abstract

The invention provides a quality standard and a detection method of compound fritillaria cirrhosa essence capsules, and improves a thin-layer identification method of schisandra chinensis in a tentative standard and a content determination method of ephedrine hydrochloride. After improvement, the thin-layer identification method of the schisandra chinensis is stable, and clear spots can be reflected in detection; and content detection of the ephedrine hydrochloride is also stable and real. The quality standard and the detection method of the compound fritillaria cirrhosa essence capsules improve controllability of quality of products, and further guarantee drug therapeutic effects.

Description

technical field [0001] The invention belongs to the technical field of drug detection, relates to a quality standard and a detection method of traditional Chinese medicine preparations, in particular to a quality standard and a detection method of a compound Chuanbeijing capsule. Background technique [0002] Compound Chuanbeijing Capsules is a preparation composed of ephedra extract, Chuanbeimu, tangerine peel, platycodon, Schisandra chinensis, licorice extract, Pinellia fragrans, Polygala eight flavors of traditional Chinese medicine. It is used to treat cough, asthma, chest tightness and excessive phlegm caused by wind-cold cough and phlegm. [0003] Fufang Chuanbeijing Capsules was originally recorded in the national trial standard that the local standard of Hebei Province rose to. The TLC identification method of Schisandra chinensis in the trial quality standard was unstable, resulting in unclear or no spots in the test; ephedrine hydrochloride The content determinati...

Claims

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Application Information

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IPC IPC(8): G01N30/90G01N30/02
Inventor 陈致慜李春雷霍志金刘宇
Owner HANDAN PHARMA
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