Method for controlling quality of Jinji preparation

A quality control method and preparation technology, applied in the field of content determination of Jinji preparations, can solve problems such as difficulty in effectively ensuring product quality, poor separation of chromatographic peaks and miscellaneous peaks, and inability to effectively remove interfering impurities

Active Publication Date: 2010-06-09
广西葛洪堂药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In the standard of Jinji Capsules, there are too few index components for content determination, and the only determination component is berberine hydrochloride, which is difficult to effectively guarantee product quality, so it is necessary to establish multiple index components for quality control
The patent with the application number 200510200479.4 discloses the content determination method of andrographolide and dehydroandrographolide in Jinji capsules, but this method cannot effectively remove interfering impurities, and the separation of chromatographic peaks and miscellaneous peaks is not good

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0068] The content determination of palmatine hydrochloride and berberine hydrochloride in Jinji capsules in embodiment 1

[0069] Chromatographic conditions and system suitability test: Octadecylsilane bonded silica gel is used as filler; acetonitrile-0.05mol / L potassium dihydrogen phosphate buffer solution (adjust pH value to 3.0 with phosphoric acid) (30:70) is used as mobile phase ; The detection wavelength is 265nm; The number of theoretical plates is greater than 2000 based on palmatine hydrochloride and berberine hydrochloride.

[0070] Preparation of reference substance solution Take an appropriate amount of palmatine hydrochloride reference substance and berberine hydrochloride reference substance, weigh them accurately, add acetonitrile-water (30:70) mixed solution to make every 1ml containing palmatine hydrochloride 20 μg, containing hydrochloric acid A mixed reference solution of 15 μg of berberine was obtained.

[0071] Preparation of the test solution Take 2 g of ...

Embodiment 2

[0073] Determination of Andrographolide and Dehydroandrographolide in Example 2 Jinji Capsules

[0074] Chromatographic conditions and system suitability test: octadecylsilane bonded silica gel is used as filler; methanol-water (50:50) is used as mobile phase; the detection wavelength of andrographolide is 225nm, and the detection wavelength of dehydroandrographolide is 254nm; The number of theoretical plates is greater than 3000 based on andrographolide and dehydroandrographolide.

[0075] Preparation of reference substance solution Accurately weigh the appropriate amount of andrographolide reference substance and dehydroandrographolide reference substance, add methanol to make a reference substance solution containing 30 μg of andrographolide and 60 μg of dehydroandrographolide per 1 ml.

[0076] Preparation of the test solution Take about 3g of the contents of Jinji Capsules, accurately weighed, put in a stoppered Erlenmeyer flask, accurately add 50ml of methanol, weigh, so...

Embodiment 3

[0078] The content determination of palmatine hydrochloride and berberine hydrochloride in embodiment 3 Jinji capsules

[0079] Chromatographic conditions and system suitability test: Octadecylsilane bonded silica gel was used as filler; acetonitrile-0.02mol / L sodium dihydrogen phosphate buffer (adjusted to pH 3.0 with phosphoric acid) (25:75) was used as mobile phase ; The detection wavelength is 260nm; The number of theoretical plates is greater than 2000 based on palmatine hydrochloride and berberine hydrochloride.

[0080] Preparation of Reference Substance Solution Take an appropriate amount of palmatine hydrochloride reference substance and berberine hydrochloride reference substance, accurately weighed, add acetonitrile-water (25:75) mixed solution to make every 1ml containing palmatine hydrochloride 10 μg, containing hydrochloric acid A mixed reference solution of 10 μg of berberine was obtained.

[0081] Preparation of the test solution Take 0.2 g of the contents of ...

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Abstract

The invention discloses a method for controlling quality of a Jinji preparation. The method adopts the high performance liquid chromatography, has good precision, stability and reproductivity and can effectively control the quality of the Jinji preparation products.

Description

field of invention [0001] The invention relates to a quality control method of a pharmaceutical preparation, in particular to a method for determining the content of a golden rooster preparation for treating gynecological diseases. Background technique [0002] Jinji Capsule is a marketed drug with approval number Z45020293. It has the functions of clearing heat and detoxifying, invigorating the spleen and dehumidification, dredging collaterals and activating blood circulation, and is used for adnexitis caused by damp-heat betting. This product is extracted and refined from medicinal materials such as Rosa root, Millipede Spatholobus, Qianjinba, Gongluomu, LMianzhen, andrographis paniculata. Gonglaomu has the effect of clearing away heat and dampness, purging fire and detoxifying. It is commonly used in folks for clearing away heat, detoxifying, and treating colds. Its main active ingredients are alkaloids, mainly berberine hydrochloride, palmatine hydrochloride and jatrorrh...

Claims

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Application Information

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IPC IPC(8): A61K36/758A61P15/00G01N30/02
Inventor 黄园荣燕李梁月钊陈晓军
Owner 广西葛洪堂药业有限公司
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