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Method for testing quality of antiviral oral liquid for treating hand-foot-and-mouth disease

An antiviral oral liquid and quality detection method technology, applied in the field of medicine, can solve the problem of not establishing content determination indicators and the like, and achieve the effect of a simple method

Active Publication Date: 2010-09-29
GUANGZHOU XIANGXUE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the current standard has not established its content determination index

Method used

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  • Method for testing quality of antiviral oral liquid for treating hand-foot-and-mouth disease
  • Method for testing quality of antiviral oral liquid for treating hand-foot-and-mouth disease
  • Method for testing quality of antiviral oral liquid for treating hand-foot-and-mouth disease

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Embodiment 1: the preparation of antiviral oral liquid

[0032] (A) Sample:

[0033] Prescription: Banlangen 129g, gypsum 57g, reed root 61g, rehmannia glutinosa 32g, turmeric 25g, Anemarrhena 25g, Shichangpu 25g, patchouli 29g, forsythia 46g

[0034] Preparation method: add water to extract the above nine medicinal materials twice, add 8 times the amount of water for the first time, decoct for 3 hours, collect volatile oil and volatile oil emulsion at the same time, add hydroxypropyl-β-cyclodextrin for inclusion; Add 6 times the amount of water for the second time, decoct for 1 hour and 20 minutes, combine the decoction liquid, concentrate to a relative density of 1.08 (60°C), add more than 85% ethanol to make the alcohol content reach 70%, let stand for 24 hours, filter Collect the filtrate, recover ethanol from the filtrate under reduced pressure, concentrate to a relative density of 1.10 (60°C), filter, add volatile oil clathrate, honey, sucrose, etc., add purified...

Embodiment 2

[0040] Example 2 Determination of the contents of the four components of (R, S)-Gaoyichun, Forsythin, Forsythiaside, and Forsythialin in the sample (A) of Example 1

[0041] 1. Instruments and reagents

[0042] Instruments and reagents Agilent 1200 high performance liquid chromatography, antiviral oral liquid provided by the applicant, acetonitrile is chromatographically pure, and water is ultrapure water. (R, S)-Gaoyichun, forsythin, forsythiaside A, forsythialin and other control drugs were provided by China National Institute for the Control of Pharmaceutical and Biological Products.

[0043] 2. High performance liquid chromatography

[0044] Chromatographic conditions: use octadecylsilane bonded silica gel as filler; use acetonitrile as mobile phase A, use water (adjust pH value to 2.85 with phosphoric acid) as mobile phase B, carry out gradient elution according to the table below, and the detection wavelength is 236nm. The number of theoretical boards is calculated ac...

Embodiment 3

[0050] Example 3: Determination of the contents of the four components (R, S)-Cuyichun, Forsythin, Forsythiaside and Forsythialin in the sample (B) of Example 1.

[0051] Method steps are with embodiment 2

[0052] See attached figure 2

[0053] Calculated: each antiviral oral solution contains (R, S)-Gaoyichun 68.9μg / bottle, forsythiaside A 1.47mg / bottle, forsythin 0.27mg / bottle, forsythiaside 0.14mg / bottle branch.

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Abstract

The invention discloses a method for testing the quality of antiviral oral liquid for treating the hand-foot-and-mouth disease and relates to the technical field of medicaments. In the method for testing the quality, the quality is tested by using a high performance liquid chromatogram single-test multi-evaluation method. 10 ml of antiviral oral liquid contains no less than 60 mu g of (R,S)-goitrin, no less than 1 mg of forsythoside A, no less than 0.25 mg of forsythin and no less than 0.12 mg of forsythingenin. The method has the advantages that: the method is simple and convenient; the content of four active ingredients of the antiviral oral liquid can be tested at the same time; the quality of the antiviral oral liquid and the curative effect of the antiviral oral liquid on the hand-foot-and-mouth disease can be comprehensively evaluated by establishing a quantitative analysis result of the active ingredients of the antiviral oral liquid, so the antiviral oral liquid has a truly-controllable standard; and simultaneously, the medicinal material basis of a Chinese medicinal preparation, namely, the antiviral oral liquid in the aspect of curing the hand-foot-and-mouth disease is put forward in China for the first time.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to a quality detection method of a Chinese patent medicine, in particular to a quality detection method of an antiviral oral liquid for treating hand, foot and mouth disease. Background technique [0002] The antiviral oral liquid is recorded in the "Ministry of Health of the People's Republic of China Drug Standards New Drug Standard Volume II" WS 3 -(X-39)-92(z), (Compiled by the Pharmacopoeia Commission of the Ministry of Health of the People's Republic of China, published in 1992). It has been included in Pharmacopoeia 1 of the 2010 edition (officially implemented on October 1, 2010). The product is a compound preparation, which is composed of 129g of Radix isatidis, 57g of gypsum, 61g of reed root, 32g of rehmannia glutinosa, 25g of turmeric, 25g of Anemarrhena, 25g of Shichangpu, 29g of patchouli, 46g of forsythia, plus medicinal excipients and Water is made into 1000ml an...

Claims

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Application Information

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IPC IPC(8): A61K36/9066A61K9/00A61P31/14G01N30/02G01N30/36G01N30/06A61K33/06
Inventor 康志英蔡春玲黄洁文张余霞李小妹
Owner GUANGZHOU XIANGXUE PHARMA CO LTD
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