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Method for testing content in quality control of Bittersweet Herb gel preparation for eliminating rash and relieving itching

The technology of a gel preparation and a detection method, which is applied in the field of medicine, can solve the problems such as the lack of Baiying, and achieve the effects of effective menthol content, perfect quality standard and high stability

Inactive Publication Date: 2008-10-01
东莞劲芳生物医药孵化器有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, there is no report on the determination of the content of active ingredients in Baiying. This invention is the first to formulate and disclose the content determination method of rutin and its menthol, the active ingredient of Baiying Xiaozhen Antipruritic Gel, according to the new drug registration management method.

Method used

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  • Method for testing content in quality control of Bittersweet Herb gel preparation for eliminating rash and relieving itching
  • Method for testing content in quality control of Bittersweet Herb gel preparation for eliminating rash and relieving itching
  • Method for testing content in quality control of Bittersweet Herb gel preparation for eliminating rash and relieving itching

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Embodiment 1

[0027] Example 1: Content Determination of Rutin in Baiying Xiaozhen Zhiitch Gel Preparation

[0028] (1), materials, reagents and instruments:

[0029] Material: Baiying Xiaozhe Antipruritic Gel (provided by Dongguan Jinfang Biomedical Incubator Co., Ltd., batch number: 20050209)

[0030] Reagents: Borax (chemically pure), rutin (standard grade), calcium oxide (chemically pure), hydrochloric acid (chemically pure).

[0031] Instruments: 721-type spectrophotometer, vacuum pump, JJ500 electronic balance (Changshu Shuangjie Testing Instrument Factory), etc.

[0032] (2), preparation of reference substance solution: Accurately weigh 25 mg of rutin reference substance dried under reduced pressure at 120°C to constant weight, place it in a 100ml volumetric flask, add 60ml of 75% ethanol, ultrasonically oscillate to dissolve, add 75% Ethanol to the mark, shake well, it is the rutin reference solution, each 1ml contains 0.25mg of anhydrous rutin.

[0033] (3), determination of mea...

Embodiment 2

[0036] Embodiment 2: Determination of the content of menthol in Baiying Xiaozhen Zhiitch gel preparation

[0037] (1), instruments and reagents:

[0038] HP6890 Gas Chromatograph (Hewlett-Packard, USA), G×300A Nitrogen, Cyclohexanone, Absolute Ethanol (analytical grade); Baiying Xiaozhang Antipruritic Gel (self-made, batch numbers 20050209, 20050218, 20050221).

[0039] (2), measure with gas chromatography, chromatographic condition is:

[0040] PEG-20M elastic quartz capillary column (Supelco-Wax), 30m×0.25mm; FID detector; inlet temperature 230°C; detector temperature 250°C; split injection, split ratio 10:1; column temperature 130°C ;The number of theoretical plates should be no less than 8000 based on the cyclohexane peak; the carrier gas is nitrogen, and the flow rate is 3.3ml / min; the internal standard is cyclohexanone;

[0041] (3) Preparation of the test solution: Take 1.0 g of Baiying Xiaozhen Antipruritic Gel Preparation, weigh it accurately, put it in a beaker, ad...

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Abstract

The invention discloses a content measurement method in the quality control of a solanum dulcamara anthema eliminating and antipruritic gel preparation, in particular a method for measuring the content of rutin and menthol which are effective components in the solanum dulcamara anthema eliminating and antipruritic gel preparation. The solanum dulcamara anthema eliminating and antipruritic gel preparation is a novel compound traditional Chinese medicine, of which solanum dulcamara and menthol are made to the prescription, and takes carbomer and gelatin as gel matrices and is a semi transparent water-soluble gel for humectant glycerol and triethanolamine are added. The medicine is mainly applied to treating chronic eczema, dermatitis, pruritus, etc. The content measurement method disclosed by the invention is accurate and stable, can separate components totally and has the quality of the solanum dulcamara anthema eliminating and antipruritic gel preparation more stable and controllable.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a method for content detection in the quality control of Baiying Xiaozhenzhiqing gel preparation, specifically, the content detection method of the active ingredients rutin and menthol in Baiying Xiaozhenzhiqing gel preparation. Content determination method. technical background [0002] Baiying Xiaozhang Antipruritic Gel is mainly used to treat chronic eczema and dermatitis. It is a new Chinese medicine compound prescription composed of Baiying and menthol. Dermatitis eczema is common disease, frequently-occurring disease of dermatology, often shows effect repeatedly, is difficult to cure, is a kind of allergic skin disease, and sickness rate accounts for about 1 / 4 of skin disease. Solanum Lyratum Thanb (Solanum Lyratum Thanb) is the whole herb of Solanaceae plant Baiying. It mainly contains active ingredients such as steroidal alkaloids and flavonoids such as rutin. This medici...

Claims

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Application Information

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IPC IPC(8): A61K36/81A61K9/00A61P17/00G01N21/31G01N30/02A61K31/045
Inventor 张干元郭可锦邓韵贲彦鸿方芳
Owner 东莞劲芳生物医药孵化器有限公司
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