Study On The Preparation Process And Quality Standards Of Guanjie Tongxiao Granules

Objective:The "Guanjie Tongxiao Prescription" originates from the classic formula of Professor Yang Fengyun,a renowned Chinese medicine practitioner.It has the functions of tonifying the liver and kidney,strengthening muscles and bones,dispersing cold and dehumidifying,and is used for knee osteoarthritis.Symptoms include knee joint pain,poor flexion and extension,increased pain when encountering cold,slightly reduced heat gain,cold sensation in limbs,heavy weight,light daytime and heavy night,fatigue and fatigue,soreness and weakness in the waist and knees,cold body shape and cold limbs,and frequent nocturia.In order to further enhance the efficacy of this formula,ensure the quality of the preparation,and improve the shortcomings of traditional decoction such as easy mold and spoilage,inconvenience in carrying,and large consumption volume,it has been decided to develop it into "Joint Pain Clearing Granules" to improve the quality control level while ensuring the efficacy of traditional Chinese medicine.According to the requirements of relevant laws and regulations,this topic will conduct pharmaceutical research on the preparation of medical institutions,including preparation process research,pilot study,quality standard draft study and stability study.Method:1.Extraction,concentration,and drying process research:Using the transfer rate of salvianolic acid B as an indicator,orthogonal experiments were conducted to investigate the effects of water addition,extraction time,and extraction frequency on the extraction process;Examine the effect of different concentration processes on the transfer rate of salvianolic acid B;Study the effect of different drying processes on the transfer rate of salvianolic acid B.2.Molding process research: Mainly based on the solubility,molding rate,and difficulty of granulation of particles,the type and dosage of excipients and wetting agents in the prescription factors are determined by examining them.The process parameters of the molding process related equipment are determined by examining the process factors,providing a certain reference basis for later pilot production research.3.Pilot study: Conduct pilot study according to the determined process and parameters,verify whether the relevant processes and parameters are suitable for pilot production through pilot study,adjust the relevant parameters if necessary to meet production requirements,form a reasonable,stable and feasible process flow,and provide reliable experimental data for later large-scale production.4.Stability inspection: the stability of Tongtongxiao granules was inspected with reference to the general rule 9001 of the four parts of the Chinese Pharmacopoeia(2020).Result:According to the preliminary research results and orthogonal test results,and taking into account the cost and time factors of industrial production,the optimal extraction process is determined as follows: extract twice,one hour each time,and add 10 times of water,;The drug solution is concentrated by vacuum concentration,and the concentrated solution is dried by vacuum drying process,and the extract powder is obtained after crushing.The wetting agent is 90% ethanol,and the prescription composition is: extract powder: dextrin is 1.5:1.The wet granulator is used for granulation,and then the swing granulator is used for granulation and drying.According to the requirements of the Chinese Pharmacopoeia(2020),the routine test items of Jietongxiao granules meet the requirements.The TLC identification method of prepared rehmannia,licorice,ephedra,and achyranthes bidentata in Jietongxiao granules has been established,and the determination and analysis method of salvianolic acid B content has been established.The analytical method is scientific,stable,and reliable.Three batches of Tongtongxiao granules in the pilot test were stable in the influence factor test,long-term test and accelerated test.Conclusion:The preparation process of Guanjie Tongxiao granule is simple,stable and feasible,and suitable for industrial production;The quality of three batches of pilot particles is stable and reliable,which lays the foundation for later research.