Part II Of The Mother Particle Pharmaceutical Research And Preliminary Efficacy Studies

Cough is a common kind of clinical diseases, cough frequently would seriously affect patients’ living and working quality. Traditional Chinese Medicine has a deep and sysmatic thinking of the causes of cough. By according to the overall concept and thinking about the different time, place and patient, TCM give different prescriptions and treatments to patients for the syndrome differentiation, which shows an obvious advantage.Ermu Powder, which was made of equal volume of powder of Bulbus Fritillariae Cirrhosae and Rhizoma Anemarrhenae, firstly recorded in Ji Jiu Xian Fang on volume6, is a classical traditional Chinese medicine prescription that is widely applied to the clinical treatment of heat and sputum stagnated in lung caused cough with curative effect. Because of large surface area of the powder, it is easy to absorb moisture and mildew, which is not so convinent to be stored, carried and used. In order to ensure its quality and suit for its industrialized production, meanwhile to make it more convinent for storage, carrying-about and usage, expand its clinical use, the project intended to change Ermu Powder into Ermu Granule according to physical and chemical properties and functions of the prescription, and also the industrialized principle of "three little, three effect and five convinent". The preparation parameter was optimized and the granule’s quality standard was studied, and also its fingerprint was studied, which could further value its quality and preparation procedure. Besides, the pharmacodynamic changes before and after its form improvement study were researched, so as to clarify scientificity of form improvement study and rationality of preparation procedure through its preliminary pharmacodynamics studies, which could also provide a reference for controlling its quality comprehensive.Firstly, in pharmaceutical research, extraction process, the kind of pharmaceutic adjuvant and shaping process were studied by using single factor test combineing with orthogonal experiment. The parameters of each key procedure were determined:Bulbus Fritillariae Cirrhosae should be crushed into fine powder, and Rhizoma Anemarrhenae should be boiled for three times with6times valume of water for30minutes per time. Combineing the decoction of Rhizoma Anemarrhenae, filtrated and vacuum concentrated to thick paste with a relative density of1.35(60℃), then join the powder of Bulbus Fritillariae Cirrhosae and dextrin in Rhizoma Anemarrhenae extract and mixed them, adding65%alcohol to adjust the humidity of soft material, pelletized and dryed. In accordance with the regulations of Chinese Pharmacopoeia (2010edition) of first volume, ErMu granule’s quality standard was studied. Ten batches of ErMu granule were made according to the preparation procedure, and HPLC-ELSD method was used to study the fingerprint of "raw material-intermediate-product" of them,10common peaks were demarcated, the similarity of each batch sample was0.960to0.998, which further clarified that the preparation procedure was stabilized and the quality of product could be ensured from the angle of chemistry.Secondly, in preliminary pharmacodynamics study:The model of cough induced by ammonia liquor spray to mice and the model of phenel red excretion in mice were used to observe the antitussive and expectorant effect of ErMu granule. By comparing with effect of ErMu powder, the conclusion was made that ErMu Granule and its traditional dosage form ErMu powder both have the antitussive and expectorant effect, which points out that the improvement of its dosage form is feasible.The study showed that the form change of ErMu powder to ErMu granule was scientific and feasible, the optimized preparation procedure was stable and steerable. The research of fingerprint and preliminary pharmacodynamics study could futher value the preparation procedure and control its quality. The feature of the study were:①Study on the form improvement (from the form of powder to the form of granule) of famous prescription origined from Ji Jiu Xian Fang, and combine pharmacy study, fingerprint study and preliminary pharmacodynamics study to reflect the rationality of form changing and production parameter optimizing.②Follow the continue idea of "raw material-intermediate-product" to study the rationality of production procedure based on the concept of the whole of TCM, which had innovation and could provide a reference for the whole procedure controlling of TCM patent drugs, and also provide a new drug selection to the clinical cough treatment caused by heat and sputum stagnated in lung.