Research And Development For Zhuyuan Jianpi Zhitong Wan Of Preparations In Medical Institutions

The direction of this research is directed towards development of new formulations of traditional Chinese medicine(TMC)for local hospitals.The new formulations and preparations of TMC approved by the Provincial Food and Drug Administration play important roles in our local medical and health care system,which provides the needs for local hospitals due to the lack of market supply,thus ensuring the proper clinical treatment for patients.The aim of this study was to develop a simple and new formulation for water pills from a prescription of traditional Chinese medicine that has been long used in our hospital.The original prescription of “Zhuyuan Jiapi Zhitong Wan",which is obtained from Spleen and Stomach Disease Section of Fangzi District and used in the long-term clinical practice as effective therapy,has been well received by patients.However,it is inconvenient for patients because of its large quantity as herbal prescriptions and a long-term use for chronic diseases.To meet the needs of patients,we carried out experimental improvements from the original prescriptions by preparing the water-dissolvable pellets for application of new preparations of medical institutions.The prescription of medical establishment formulations comes from our hospital clinical based on many years of clinical use and experience,which requires less restrictions through simplified process in the application of new formulation.According to the “Dispensing Registration Measures for the Administration of Medical Institutions”in Shandong Province(trial)and detailed rules for the implementation of the related technical requirements,the market supply situation and the status of water pill preparation as well as the relevant laws,regulations and policies were analyzed to initiate this project.Preparation of prescriptions,and summary of the clinical usage of nearly 5years and analysis were studied;and new formulation of water pills was determined using optimized preparation techniques,and the three batches of test samples were produced.We also tested the stability of the new formulation,and the formulation satisfying the quality standard was finalized.Although the condition of pharmaceutical preparation in medical institutions at local hospital level is limited,the development of new formulation plays an important role inproviding the basic needs for medical treatment and health care for patients.The formulation from this study will be used for a user-friendly treatment for functional dyspepsia with stable quality and reasonable price,thus providing useful information for relevant preparations of traditional Chinese medicines.At the present,the quality standards of pharmaceutical preparations are generally too low.This improved new formulation was based on the new "China pharmacopoeia"(2015 edition)development of the technology,and one third of critical ingredients were identified using HPLC method,thus providing a guideline for further improvement of formulation standards and serving as technical references for similar formulation at medical institutions in the future.