Method for controlling quality of anti-inflammation antibacterial medicament

A quality control method and preparation technology, applied in antibacterial drugs, drug combinations, pharmaceutical formulations, etc., can solve the problems of poor control of product quality, poor specificity, complex components, etc., and achieve easy operation, good separation, Methods with high precision

Active Publication Date: 2009-06-24
贵州省科晖制药有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the complexity of the traditional Chinese medicine ingredients in compound preparations, the original ministerial standards only have microscopic identification of calcium o

Method used

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  • Method for controlling quality of anti-inflammation antibacterial medicament
  • Method for controlling quality of anti-inflammation antibacterial medicament
  • Method for controlling quality of anti-inflammation antibacterial medicament

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0069] A quality control method for Yankening preparations, comprising the following steps:

[0070] (1) Identification:

[0071] a. Identification of rhubarb: Weigh 0.1g of this product powder, add 20ml of methanol, soak for 1 hour, filter, take 5ml of filtrate, evaporate to dryness, add 10ml of water to the residue to dissolve, add 1ml of hydrochloric acid, heat and reflux for 30 minutes, immediately Cool, shake and extract twice with diethyl ether, 20ml each time, combine the diethyl ether solution, evaporate to dryness, add 1ml of chloroform to the residue to dissolve, and use it as the test solution; take another 0.1g of rhubarb reference medicine, and make the same method as the reference medicine solution; test according to thin-layer chromatography (Appendix VI B), draw 4 μl of the above-mentioned test product and 3 μl of the reference medicinal material, respectively spot on the same silica gel G thin-layer plate, and use petroleum ether (30~60°C)-ethyl formate- The ...

Embodiment 2-10

[0081] Same as Example 1

[0082] The results are shown in Table 8

[0083] Table 8 Statistical Table of Sample Baicalin Content Investigation

[0084]

[0085] The content limit of baicalin in Yankening Tablets (mg / g) = the dosage of Scutellaria baicalensis (g) x the content limit of baicalin in Scutellaria baicalensis (mg / g) x average yield (%) ÷ the amount of finished product (g) = 310.3g ×90mg / g×35.27%÷340g=28.97mg / g, namely: 9.85mg / tablet.

[0086] It can be seen that each tablet of this product contains Scutellaria baicalensis and baicalin (C 21 h 18 o 11 ) shall not be less than 9.85mg.

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Abstract

The invention discloses a method for controlling the quality of antipyrotic and antibacterial medicines, which comprises the following steps: firstly, identification: a, identification of rhubarb; and b, identification of phellodendron barks and Coptis chinensis; and secondly, content measurement of scutelloside: a, preparation of a sample solution; b, preparation of a reference solution; c, chromatographic conditions, namely octadecylsilane chemically bonded silica is taken as filler, and methanol and 0.2 percent phosphoric acid with a ratio of 40:60 are taken as mobile phases; the wavelength is controlled to be 280 nanometers; and the theoretical plate number is not less than 3,000 as calculated by the peak value of the scutelloside; and d, content measurement, namely 10 mu 1 of the reference solution and 10 mu 1 of the sample solution are precisely absorbed respectively and injected into a liquid phase chromatograph for measurement, and the content of the scutelloside in a sample is calculated. The method can quantitatively control the product quality of Yankening preparation, and is simple and convenient to operate.

Description

technical field [0001] The invention belongs to the field of quality detection of traditional Chinese medicines, and in particular relates to a quality control method of Yankening preparations. Background technique [0002] The Yankening preparation made from Phellodendron Phellodendron, Rhubarb, Radix Scutellariae, Radix Isatidis, and Coptis chinensis has the functions of clearing heat and purging fire, reducing inflammation and relieving dysentery. For acute tonsillitis, bacterial pneumonia, acute conjunctivitis, otitis media, furuncle carbuncle scrofula, acute mastitis, enteritis, bacillary dysentery and acute urinary tract infection. The effect is obvious. Due to the complexity of the traditional Chinese medicine components in compound preparations, the original ministerial standards only have microscopic identification of calcium oxalate, qualitative identification of flavonoids and alkaloids, but no quantitative indicators. Therefore, this method has poor specificity ...

Claims

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Application Information

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IPC IPC(8): A61K36/756A61P31/04A61P1/12A61P11/00A61P11/04A61P13/02A61P15/14A61P17/02A61P27/02A61P27/16G01N30/02G01N30/90
Inventor 杨迺嘉霍昕刘文炜高玉琼
Owner 贵州省科晖制药有限公司
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