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Quality control method of Danle capsule

A quality control method and capsule technology, which can be used in capsule delivery, medical preparations containing active ingredients, measuring devices, etc., and can solve the problems of poor repeatability of thin-layer scanning method and low sensitivity of titration method.

Active Publication Date: 2008-12-31
ZHEJIANG YONGNING PHARMA
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  • Summary
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AI Technical Summary

Problems solved by technology

The present invention intends to use high-performance liquid chromatography-evaporative light scattering detector with high sensitivity and good repeatability to measure, so as to overcome the shortcomings of poor repeatability of thin-layer scanning method and low sensitivity of titration method

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Example 1: Determination of Hyodeoxybutanic Acid Content in Danle Capsules

[0030] Instrument: LC-10 chromatograph (Dalian Jiangshen Separation Science and Technology Company) (single pump, VWD detector), evaporative light detector (model SEDEX 55, Dima Company), rotary evaporator (model RE-2000, Shanghai Yarong Biochemical Instrument Factory), water bath (model: SK5200H, Shanghai Kedao Instrument Co., Ltd.); DiamonsilC 18 Chromatographic column (5 μm, 4.6×250mm, NO: 8039884); Milipore ultrapure water device.

[0031] Determination of content according to high-performance liquid chromatography (Chinese Pharmacopoeia 2005 edition of an appendix VI D) determination.

[0032] The system suitability test uses octadecylsilane bonded silicon as a filler; methanol-0.1% formic acid (75:25) is used as mobile phase; evaporative light scattering detector; drift tube temperature is 40°C, detection wavelength is 210nm, flow rate 1.0ml / min; the number of theoretical plates should ...

Embodiment 2

[0036] Embodiment 2: Determination of hyodeoxycholic acid content of porcine bile acid

[0037] Instruments: high performance liquid chromatography Agilent 1100 (quaternary pump, online degassing, automatic sampling, constant temperature box); evaporative light detector (model Aotai 2000, American Aotai); water bath (model: SK5200H, Shanghai Science and Technology Co., Ltd. Guidance Instrument Co., Ltd.); rotary evaporator (model RE-2000, Shanghai Yarong Biochemical Instrument Factory); Kromasil C18 column (5μm, 4.6×250mm, Beijing Analytical Instrument Factory, NO: 22203); Milipore ultrapure water device .

[0038] Chromatographic conditions: methyl alcohol-0.1% formic acid (75: 25) is mobile phase; 85 ℃ of drift tube temperature, flow rate 3.0L / min the preparation of porcine bile acid test sample solution is obtained Zhejiang Yongning Pharmaceutical Co., Ltd. to produce porcine bile acid ( The production batch number is 070602) 0.75g, accurately weighed, put in a stoppered E...

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Abstract

The invention relates to a quality detection and control method of a compound preparation of Danle capsule which is made from traditional Chinese medicinal materials of 75g of hyodeoxycholic acid, 75g of dried tangerine peel, 240g of turmeric root tuber and 600g of longtube ground ivy herb; the method comprises a content measure item which adopts an HPLC-ELSD method to measure the content of hyodeoxycholic acid C24H40O4 in the Danle capsule; and the method is also can be used for measuring the content of the hyodeoxycholic acid C24H40O4 in the hyocholic acid. The method ensures the accuracy and the advanced nature of the quality detection standard of the Danle capsule and is capable of effectively controlling the quality of the Danle capsule, thus the method can be considered as the index of the quality control and the technological stability observation of the Danle capsule.

Description

technical field [0001] The invention relates to a quality control method of a pharmaceutical preparation, in particular to a new quality control method of a traditional Chinese medicine preparation Danle Capsule. Background technique [0002] Danle Capsule is a traditional Chinese medicine preparation made by extracting and processing pig bile acid, tangerine peel, hawthorn, turmeric, and saffron. It has been sold on the market, and its pharmacological effects are anti-inflammatory and analgesic. Functions and indications are: regulating qi and relieving pain, promoting gallbladder and removing stones. For hypochondriac pain and biliary distension caused by liver depression and qi stagnation. Symptoms include distending pain in the hypochondriac ribs, anorexia and yellow urine; chronic cholecystitis and cholelithiasis, see the above syndromes. The formula and quality control methods of Danle Capsules have been included in the "Pharmacopoeia of the People's Republic of China...

Claims

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Application Information

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IPC IPC(8): A61K36/9066A61K9/48G01N30/02A61P1/16A61K35/413
Inventor 方圣敏李建伟叶祥宝叶蔚
Owner ZHEJIANG YONGNING PHARMA
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