Preparation Molding Process And Quality Control Of Chaigui Granules

Topic basis: Depression is a disease which is extremely harmful to human physical and mental health.At present,the treatment of depression is still based on drug therapy.Most of the antidepressant drugs that are on the market are mainly chemical drugs,but there are some problems such as effective Low,high recurrence rate and many side effects,so the development of a new type of anti-depressant Chinese medicine with better efficacy and fewer side effects has become the aim of many researchers.In the early stage of the laboratory,on the basis of the classic name “Xiaoyao San”,the compound Chaiguifang with significant antidepressant effect was screened through the clinical observation of decoction,pharmacological efficacy test,chemical composition analysis.And the extraction process,chemical composition and quality standards of the extracts were studied.Based on the above research,we studied the formulation process of Chai Guifang's formulation and optimized the molding process suitable for Chaigui extract.At the same time,three batches of pilot scale experiments have been performed and a set of reasonably plausible quality standards for finished granules was established.With reasonable and feasible quality standards,the stability of three batches of pilot particles was also examined.Objective: To study the formulation of Chaigui granules,optimize the suitable molding process,complete three batches of pilot production,establish the quality standard of the finished granules,and conduct a stability study on the middle sample granules.Methods: Single-factor investigation,orthogonal test design and other methods were used to optimize the formation process of Chaigui granules.Three batches of pilot-scale test were performed to verify the molding process.The quality standards of Chaigui granules were established according to the quality standards of TCM preparations.A comprehensive inspection of the stability of the finished product.Results:(1)Through the process investigation and optimization,the granulation process suitable for Chaigui Granules was selected,the dry granulation technology was adopted,and the dry extract powder: pregelatinized starch=3:2,the granulation parameters were extrusion pressure 20 MPa,extrusion speed 10 rpm,feed rate 14 rpm,and the finished granules were packaged with a polyester/aluminum-coated polyester/polyethylene medical composite film,each bag containing 15 g.(2)According to the pilot production operation procedures,and strictly control the quality of production raw materials,3 batches of pilot production are successfully carried out according to the preferred process flow.According to the test results,the preparation process is feasible,and the quality of the finished products is stable,which is suitable for large-scale production.(3)We established TLC methods for identification of Radix Bupleurum,Radix Angelicae Sinensis,Radix Angelicae Dahuricae and Radix Glycyrrhizae in the granules.The HPLC fingerprint of Chaigui granules was established and 12 chemical components in the granules were identified.HPLC methods for the determination of saikosaponin a,paeoniflorin and ferulic acid in Chaigui Granules were established.And the granules were examined in accordance with the requirements of the Pharmacopoeia.(4)The influencing factors,acceleration and long-term stability of Chaigui granules were studied.Conclusion: Appropriate Chaigui granules molding process was obtained.Three batches of pilot tests were successfully completed.A set of accurate and feasible formulation quality standards was established.The stability study results showed that the stability of this product was good.