Quality control method of infant spleen tonifying medicament
A technology for invigorating the spleen and medicines for children, which is applied in the field of quality control of the medicines, can solve the problems such as the lack of chemical identification of the constituent medicines and the lack of quantitative determination of the main medicines, and achieve the effects of strong specificity, easy operation and high precision
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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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