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Method for controlling antiviral oral liquid

An anti-viral oral liquid and quality technology, applied in the field of medicine, can solve the problems of unstable operation content and inability to accurately reflect the internal quality, and achieve the effects of controlling quality, ensuring curative effect and improving drug quality.

Active Publication Date: 2007-04-04
GUANGZHOU XIANGXUE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The quality control of the final product is carried out according to the standard WS3-49(X-39)-92(Z) promulgated by the Ministry of Health of China, and only the TLC identification and content determination method of forsythin in the standard cannot accurately reflect this Intrinsic quality of the product, especially the content of volatile components
According to literature reports, pharmacodynamic experiments have proved that patchouli alcohol (patchouli alcohol) in antiviral oral liquid has good antipyretic and antibacterial effects. In order to better reflect the internal quality of antiviral oral liquid, it reflects the advanced nature of the process It is imperative to formulate a reasonable detection method for the content of volatile components, especially the content of volatile components is extremely unstable with general process operations

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Take the antiviral oral liquid produced by Guangzhou Xiangxue Pharmaceutical Co., Ltd. with the batch number 20051201 and the production date on December 7, 2005, and test it on December 8, 2005 according to the following conditions:

[0042] A. Chromatographic conditions: the chromatographic column is an elastic quartz capillary column, the temperature of the injection port is 230°C, the temperature of the detector is 250°C, split injection, the temperature is programmed to rise from 70°C to 230°C, the temperature is kept at 230°C for 10 to 15 minutes, and the flow rate is 1ml / min.

[0043] B. The preparation steps of the reference substance solution are as follows:

[0044] Accurately weigh the patchouli alcohol reference substance, add n-hexane to dissolve and make a 0.5 mg / ml solution.

[0045] C. Preparation of the test solution:

[0046] Take 50ml of antiviral oral solution, add 50ml of chloroform, and extract under reflux for 2 hours, take 48ml of chloroform e...

Embodiment 2

[0050] The batch number produced by Guangzhou Xiangxue Pharmaceutical Co., Ltd. is batch 20051201, and the production date is 2005

[0051] The antiviral oral liquid on December 7, 2005 was tested according to the following conditions on December 8, 2005:

[0052] A. The chromatographic conditions are the same as the external standard method.

[0053] B. Determination of correction factor: Accurately weigh an appropriate amount of n-eicosane, make a 5.0 mg / mL solution with n-hexane, and use it as an internal standard solution for future use. In addition, accurately weigh 10 mg of patchouli alcohol reference substance and place it in a 25ml measuring bottle Dissolve in n-hexane, shake well, accurately measure 0.1ml of the above-mentioned patchouli alcohol reference solution, put it in a 1ml measuring bottle, add 0.1ml of internal standard solution precisely, add n-hexane to dilute to 1ml, shake well, draw 1μl, inject Gas chromatograph, calculate correction factor;

[0054] C....

Embodiment 3

[0059] Take the antiviral oral liquid produced by Guangzhou Xiangxue Pharmaceutical Co., Ltd. with the batch number 20051201 and the production date on December 7, 2005, and test it on December 8, 2005 according to the following conditions:

[0060] A. The chromatographic conditions are the same as the external standard method.

[0061] B. Determination of correction factor: the same as in Example 2.

[0062] C. Preparation of the test solution: get 50ml of antiviral oral liquid, add 50ml of chloroform, reflux extraction 2 times, each 2 hours, take off 48ml of the lower layer of chloroform extract, evaporate to dryness at 65°C, and remove the residue Add 1ml of n-hexane to dissolve, ultrasonic treatment for 5min (160W, 40kHz), take the n-hexane solution as the test solution, transfer it to a 1ml volumetric flask, add 100μL internal standard solution, add n-hexane to dilute to 1ml, and use it as the test solution sample solution

[0063] D. with embodiment 2.

[0064] Measur...

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Abstract

A quaility control method for the antiviral oral liquid features that on the basis of existing quality control standards, the gas-phase chromatography method is additionally used to measure the content for patchoulic alcohol to ensure that it is not less than 10 micrograms per 10 ml.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a quality control method of a traditional Chinese medicine composition. Background technique [0002] Antiviral Oral Liquid is a well-known well-known product that has been approved by the state for many years. It is a drug with positive clinical efficacy and has been included in the standards issued by the Ministry of Health of China. The antiviral oral liquid is made from 129g of Radix Radix, 57g of Gypsum, 61g of Reed Root, 32g of Rehmannia, 25g of Curcuma, 25g of Anemarrhena, 25g of Iris, 29g of Patchouli, 46g of Forsythia, 1000ml of auxiliary materials, and purified water. The antiviral oral liquid composition is prepared according to the conventional process for preparing oral liquid from traditional Chinese medicine. The quality control of the final product is carried out according to the standard WS3-49(X-39)-92(Z) promulgated by the Ministry o...

Claims

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Application Information

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IPC IPC(8): A61K36/9066A61P31/12G01N30/02
Inventor 连林生康志英蔡春玲丘鸰原刘国宏符方非
Owner GUANGZHOU XIANGXUE PHARMA CO LTD
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