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Quality control method of infant spleen tonifying medicament

A quality control method and a technology for strengthening the spleen in children, which are applied in the preparation of test samples, measuring devices, instruments, etc., can solve the problems of chemical identification of constituent drugs and quantitative determination of main drugs, and achieve strong specificity, Easy operation and good reproducibility

Active Publication Date: 2013-06-19
山西振东五和堂制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The above-mentioned quality standards have relatively serious defects: firstly, the standard does not carry out quantitative determination of the content of active ingredients for the main drugs; secondly, more than 50% of the constituent drugs are not chemically identified

Method used

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  • Quality control method of infant spleen tonifying medicament
  • Quality control method of infant spleen tonifying medicament
  • Quality control method of infant spleen tonifying medicament

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Example 1: TLC identification of hawthorn.

[0021] Take 10g of Xiaoer Shenzhu Jianpi Pills, add 5g of diatomaceous earth, grind well, add 40ml of ether, sonicate for 15 minutes, filter, add 40ml of ethyl acetate to the dregs, sonicate for 15 minutes, filter, and evaporate the filtrate to dryness. Dissolve the residue in 2ml of methanol, and use it as the test solution; prepare a negative sample solution in the same way; take another 1.0g of hawthorn reference medicinal material, and prepare a control medicinal solution in the same method; take another ursolic acid reference substance, add methanol to make each 1ml contains 1mg solution, as the reference solution. According to the thin-layer chromatography (Appendix VI B of "Chinese Pharmacopoeia" 2010 edition), draw negative sample solution 10μl, test product solution 10μl, control medicinal material solution 5μl, reference substance solution 2μl, and spot on the same silica gel G thin layer On the board, use toluene-...

Embodiment 2

[0023] Example 2: TLC identification of licorice.

[0024] Take 10g of Xiaoer Shenzhu Jianpi Pills, add 5g of diatomaceous earth, grind well, add 40ml of diethyl ether, sonicate for 15 minutes, filter, add 40ml of ethyl acetate to the dregs, sonicate for 15 minutes, filter, add methanol to the dregs 30ml, heat to reflux for 1 hour, filter, evaporate the filtrate to dryness, add 40ml of water to the residue to dissolve, extract 3 times with n-butanol, 20ml each time, combine the n-butanol liquid, wash with water 3 times, evaporate to dryness, add 5ml of methanol to the residue Make it dissolve, and use it as the test solution; prepare the negative sample solution in the same way; take another 1 g of licorice as the reference drug, and make the reference drug solution in the same way. According to the thin-layer chromatography ("Chinese Pharmacopoeia" 2005 edition, an appendix VI B) test, draw 10 μl of the test solution, 6 μl of the control medicinal material solution, and 10 μl...

Embodiment 3

[0026] Embodiment 3: Determination of hesperidin content.

[0027] Xiaoer Shenshu Jianpi Pills are composed of 13 traditional Chinese medicines such as Codonopsis pilosula, Atractylodes macrocephala, licorice, Gorgon seed, white lentils, yam, lotus seed meat, and tangerine peel. The original standard has no content determination items. In order to better control the quality of the preparation and realize the monitoring of the technological process, hesperidin in orange peel was selected as the content determination index.

[0028] 1. Instruments and reagents.

[0029] Waters2695-2487 high-performance liquid chromatography, chromatographic workstation (Waters, USA); hesperidin reference substance (batch number 0721-200010, China Institute for the Control of Pharmaceutical and Biological Products); methanol: chromatographically pure (Tianjin Siyou Fine Chemicals Co., Ltd.) ; Water: pure water; diatomaceous earth and other reagents are of analytical grade.

[0030] Pediatric Sh...

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Abstract

The invention discloses a quality control method of an infant spleen tonifying medicament. According to the method, hawthorn and licorice in the medicament are identified by using layer chromatography respectively, and the hesperidin content of the medicament is measured by using liquid chromatography. In the established quality control method, the medicinal material identification method is mature, feasible, high in specificity, negative and non-interfering; the content measurement method is easy to operate, high in precision and high in reproducibility; and by adopting the quality control method, the quality of the medicament can be accurately and stably controlled to adapt to industrialized stable production of the medicament.

Description

technical field [0001] The invention relates to a traditional Chinese medicine for invigorating the spleen of children, in particular to a quality control method of the medicine. Background technique [0002] Xiaoer Shenshu Jianpi Pill is a pediatric drug, used for children with weak spleen and stomach, indigestion, yellow complexion, emaciation, and lack of energy. [0003] The current implementation standards of Xiaoer Shenshu Jianpi Pills are included in the fifth volume of the Ministry of Health's drug standards for traditional Chinese medicine preparations. The following are specified in this quality standard. [0004] Take this product and observe it under a microscope: the irregular branched mass is colorless, and dissolves in chloral hydrate solution; the hyphae are colorless or light brown, with a diameter of 4-6 μm. Connecting milk ducts are 12-15μm in diameter and contain fine particles. Pericarp stone cells scattered singly or in small groups, lavender, red or...

Claims

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Application Information

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IPC IPC(8): G01N30/90G01N30/94G01N30/02G01N30/06G01N1/28
Inventor 王六贵吕建英
Owner 山西振东五和堂制药有限公司
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