| Since ancient times,traditional Chinese medicine has played an irreplaceable role in the prevention and treatment of diseases.High quality medicinal materials are an important prerequisite for building high-quality products and ensuring the healthy development of traditional Chinese medicine industry.Schisandra chinensis,known as "Schisandra chinensis",is a Magnoliaceae plant Schizandra chinensis(Turcz.)Baill.The dried and mature fruit of is listed as the top grade in the book of Shennong materia medica.It is a common tonic and tranquilizer.As a traditional Chinese medicine,it has rich chemical components and pharmacological effects,and is widely added to food and health products as "medicine and food homology".Due to its wide application range and high frequency,its development and utilization degree is increasing,and the wild resources are decreasing.Moreover,according to the 2020 edition of Chinese Pharmacopoeia,only the content of schisandrin A is determined,and the quality control of Schisandra chinensis is not perfect.In addition,dihydromyricetin silymarin Schisandra chinensis capsule,a health food with Schisandra chinensis extract as the main raw material,is a health product independently developed by Shaanxi Jiahe Pharmaceutical Co.,Ltd.,which has the effects of anti-oxidation,anti-inflammatory and liver protection,but the quality standard has not been fully established.In order to improve the quality standard of Schisandra chinensis and meet the clinical needs of health food with Schisandra chinensis as raw material,the quality control of Schisandra chinensis and its related products needs to be improved.Objective: To evaluate the raw material quality of Schisandra chinensis by constructing the fingerprint of traditional Chinese medicine,optimize the best extraction process of lignans of Schisandra chinensis,prepare dihydromyricetin silymarin Schisandra chinensis capsule and improve the preparation quality standard,realize the quality control mode of Schisandra chinensis from the original medicine to the end product,and provide scientific basis for improving the quality standard of Schisandra chinensis and the further development and utilization of Schisandra chinensis.Methods: 1)quality evaluation of Schisandra chinensis from different producing areas:select 10 batches of Schisandra chinensis from different batches and different producing areas,establish the fingerprint of Schisandra chinensis by high performance liquid chromatography(HPLC),and evaluate the similarity of the fingerprint.At the same time,determine the contents of schisandrin a,schisandrin B,schisandrin a ester a,schisandrin a,schisandrin B and schisandrin to optimize the best producing area.2)Optimization of extraction and preparation process of lignans from Schisandra chinensis: supercritical carbon dioxide extraction,ethanol extraction and ethyl acetate extraction were selected to prepare lignans from Schisandra chinensis.Orthogonal experimental design was used in supercritical carbon dioxide extraction to optimize extraction pressure,extraction temperature and extraction time;The orthogonal experiment was used to design the solvent extraction concentration,extraction temperature and extraction time.In ethyl acetate extraction method,orthogonal test was used to design solvent dosage,extraction temperature and extraction time.Taking the lignan content of each method as the evaluation index,the best extraction method and conditions for preparing lignan from Schisandra chinensis were selected.3)Study on preparation quality standard: preliminarily establish the quality standard of Dihydromyricetin silymarin Schisandra chinensis capsule,a self-developed health food with Schisandra chinensis extract as the main drug,and study the quality control from the aspects of capsule properties,TLC identification of three components,water,weight difference,disintegration time limit,ash,heavy metals and solvent residue.4)Study on the improvement of preparation quality standard: establish the fingerprint of traditional Chinese medicine and multi-component content determination of the preparation by HPLC to improve its quality standard.Results: 1)quality evaluation of Schisandra chinensis from different producing areas:the fingerprint similarity of 10 batches of Schisandra chinensis from different producing areas is between 0.3-0.9,which is less than 0.9,indicating that there are great differences in the quality of Schisandra chinensis from different producing areas.The contents of schisandrin a,schisandrin B,schisandrin ester a,schisandrin a,schisandrin B and schisandrin in 10 batches of producing areas are detected,and the total content of Schisandra chinensis in 10 batches is calculated,They are 1.203,1.237,1.217,1.190,1.189,1.195,1.184,1.180,1.095 and 1.096 respectively.The lignan content of Jixi in Heilongjiang is 1.237%,which is the highest,which is the best origin of Schisandra chinensis.2)Optimization of extraction and preparation process of total lignans from Schisandra chinensis: the influencing factors of supercritical carbon dioxide extraction orthogonal test results from high to low are extraction pressure,extraction temperature and extraction time.The optimum process conditions are pressure 30 MPa,temperature 60 ℃and extraction time 120 min.The average yield of extract is 17.5% and the content of total lignans is 12.47%.The influencing factors of orthogonal test results of ethanol extraction method are extraction time,solvent concentration and extraction temperature from high to low.The optimum technological conditions are that 90% concentration of ethanol is extracted at 60 ℃ for 60 min.The average yield of the extract is 30.8% and the content of total lignans is 4.59%.The influencing factors of the orthogonal test results of ethyl acetate extraction method are extraction time,solvent dosage and extraction temperature from high to low.The optimum process conditions are 8 times the amount of solvent and extracted at65 ℃ for 60 min.The average yield of the extract is 17.9% and the content of total lignans is 7.49%.The content of total lignans in the three preparation conditions was compared.Combined with the feasibility of the process,supercritical carbon dioxide extraction was the best extraction scheme of total lignans.3)Study on the quality standard of the preparation: according to the results of the thin-layer test of the preparation,the capsule appears the same spots of dihydromyrica rubra extract,silymarin extract and Schisandra chinensis extract as the control and the control medicine.Moisture results are less than 9%.The content of capsules is 0.3g,and the difference range of 20 capsules is ± 0.0225 g.The disintegration time limit was within 15 minutes,and the number of bacteria,molds,yeasts,Salmonella and Staphylococcus aureus were not detected.Ash content is less than 10%.The heavy metal lead(PB)is less than 3 mg / kg,arsenic(as)is less than 2 mg / kg,cadmium(CD)is less than 1 mg / kg and mercury(Hg)is less than 0.1 mg / kg.The detection results of ethanol residue were less than 0.5%.4)Study on improving the quality standard of the preparation: the average content of dihydromyricetin in the preparation is0.4151,the content of silybin is 0.0517,and the total content of Schisandra chinensis is6.73%.The similarity evaluation of 10 batches of Dihydromyricetin silymarin Schisandra chinensis capsules was greater than 0.93,indicating that the quality of the preparation was uniform and stable.Conclusion: the quality control and evaluation of traditional Chinese medicine and related preparations is not only the key to the modernization of traditional Chinese medicine,but also the difficulty and focus to limit its application.Based on the lack of quality control of Schisandra chinensis,this paper uses traditional Chinese medicine fingerprint to evaluate the quality of Schisandra chinensis from the same origin and the determination of total lignans,and optimize the best extraction method and process of Schisandra chinensis lignans,prepare dihydromyricetin silymarin Schisandra chinensis capsule and improve the preparation quality standard,so as to supplement and improve the quality control and evaluation mode for the clinical application of Schisandra chinensis and related preparations,In order to provide scientific experimental basis for quality control and evaluation for the development of traditional Chinese medicine. |
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