Study On The Quality Standard For High Grade Drug Of Xinshenghua Granule

Xinshenghua granul is processed with seven traditional chinese medicines such as angelica sinensis,rhizoma chuanxiong,peach kernel as bulk drug and brown sugar as auxiliary material.The granule is derived from“Shenghua Decoction",which is known as the "first prescription after childbirth" for activating blood circulation,removing blood stasis and relieving pain.However,the quality control of the national drug standards can no longer meet the needs of industry development,since there are many kinds of traditional Chinese medicines(TCMs)and complex chemical compositions in Xinshenghua granul.Therefore,according to the requirements for high-quality products proposed by the standardization project of TCM,modern analysis technology and evaluation system of TCM are used to assess the research on the quality standard for high grade drug of Xinshenghua granule in the paper.The specific contents are as follows:1.The study on qualitative identification of the preparation was carried out.The method with amygdalin as index component to identify the peach kernel in Xinshenghua granul was established.In addition,Chemical constituents from brown sugar is researched and the main characteristic component is separated and identified.Based on that,trans-aconitic acid was used as the index to establish a qualitative identification method for brown sugar,which is used as supplementary materials.What’s more,examining under 365 nm ultraviolet lamp,11 fluorescent spots before and 13 after chromogenesis were clear shown in the TLC chromatography.The characteristic fluorescence HPTLC chromatography fingerprints of the high quality Xinshenghua granules were built with relative Rf and spot characteristics as indicators.2.The harmful residues in the preparation were studied.Twenty-four heavy metals and harmful elements in Xinshenghua granules were simultaneously determined and analyzed through inductively coupled plasma mass spectrometry(ICP-MS).The risk assessment of Pb,Cd,As,Hg and Cu was assessed and the proposed limits were formulated according to Chinese Pharmacopoeia.Gas chromatography-tandem mass spectrometry(GC-MS)was used to analyze 73 pesticide residues and 6 growth regulator hormones in the product.According to the results,9 pesticide residues detected were limited:pp-DDT,bifenthrin,fenpropathrin≤0.05 ppm,dichlorvos,chlorpyrifos,dimethyl pentaerythrin≤0.1 ppm,permethrin,deltamethrin≤0.5 ppm,diphenylamine≤lppm.Moreover,aflatoxin was detected by HPLC-FLD and results showed it was less than the amount limit required.3.A fingerprint method of wavelength fusion for high-quality preparations of Xinsheng granule was established through 3D channel(200-400 nm)acquisition by HPLC-PDA and there are 28 common peaks in the fingerprint.Similarity and relative peak area are used to evaluate and control the quality.Besides,51 chemical constituents were identified by HPLC-MS preliminarily,and 10 common peaks were determined by the relative time of the standard substance.The common peaks were assigned to corresponding herbal medicines in Xinshenghua granule by means of HPLC-PDA spectral comparison.The quantitative analysis method of multi-component with a single-maker(QAMS)was established to determine the content of Senkyunolide I,with leonurine hydrochloride as internal reference.The content ratio of stachydrine hydrochloride to leonurus hydrochloride,ligustilide I to ferulic acid and stachydrine hydrochloride to ferulic acid were used to monitor the content of components in high-quality preparations of Xinshenghua granule in the base of "composition structure" theory.On basis of the above research,the quality standard for high grade drug of Xinshenghua granule was established,which reflect the information of quality transmission of each herbal medicine in the prescription and excipient.What’ more,the quality standard can distinguish high-quality preparation from ordinary one and provide a reference for quality control of Xinhua Granule.