| Shendi granule is a compound preparation composed of 11 Traditional Chinese medicines such as Codonopsis,ripe ground,white peony,tangerine peel and Angelica root.It has the effect of nourishing qi and blood,soothing liver and relieving depression.It is mainly used to prevent deficiency of qi and blood of sows caused by gestation of fetus before and after farrowing and a series of disease syndromes caused thereby.To optimize particle extraction technology and molding process,we planned the extraction process of the granules based on various ingredients contained in the prescription of the chemical composition of the physical and chemical properties and by combining with modern Chinese medicine extraction and preparation technology.At the same time,by adopting orthogonal experiment and the single factor investigation,we optimized the process parameter,so as to determine the scientific and reasonable extraction process and preparation technology.Modern analytical techniques,such as thin layer chromatography(TLC)and high-performance liquid chromatography(HPLC),were used to establish the quality control standards for the preparation.Methods:(1)Optimization of extraction process parameters.Each prescription was divided into volatile oil extraction group and water extraction group according to the physical and chemical properties of the active components.The single factor was used to investigate the effect of extraction time on the extraction rate of total volatile oil and determine the best extraction time.L9(34)orthogonal optimal extraction process was used.(2)Particle molding process optimization.Taking the content of paeoniflorin as the investigation index,and the molding rate and particle appearance characteristics as the index,we screened the dosage of extant and flavor correction agent and optimized the particle molding process.(3)Research on quality control Standards.TLC was used for qualitative identification of radix Paeoniae alba,orange peel and Angelica angelica in the preparation,and HPLC was used to develop the content determination method of paeoniflorin,the main component of Chinese medicinal paeonia lactionis in the preparation,to determine the standard of content determination.Results:(1)The best extraction time of volatile oil was 3h,and the best water extraction process was:add 10 times more water,fry for 1.5h,and cook for 3 times.(2)The optimal molding process was as follows:the liquid was concentrated into wet extract under atmospheric pressure,auxiliary materials were added,wet granulation,drying,whole granulation and spraying volatile oil.Soluble starch was used as excipient,sucrose as flavor modifier,the ratio between extract and excipient was 1:3,among which the ratio between soluble starch and sucrose was 4:1.(3)TLC spots of radix paeoniae alba,orange peel and Angelica sinensis were clear,with strong characteristics,good reproducibility,and negative without interference;HPLC method for the determination of paeoniflorin content was established.The results showed that the ratio between paeoniflorin and paeoniflorin ranged from 4.76 g to 152.20 g and there was a linear relationship between them.The recovery rate was 98.15%(RSD value was 0.26%),the precision RSD was 0.17%,and the stability RSD was 0.46%.Conclusion:(1)The extraction process and molding process of Shendi granules were determined;(2)The method of quality control by TLC qualitative identification and HPLC content determination is stable and feasible,which can effectively control the quality of Shendi granules. |
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