Pharmaceutical Research Of Hospital Preparation On HeZe Granules

Heze granules from hubei province hospital pediatric clinical effective experience side, composed of Lotus leaf, Rhizome, Rhizoma alismatis and other eight kinds of Chinese medicine, with invigorating spleen to remove dampness, Qi digestion Runchang, has obvious curative effect on simple obesity patients. In the clinical curative effect of the foundation, the proposed in accordance with the State Food and Drug Administration "medical establishment preparation registered management approach(Trial)"(Decree No. 20 of the Bureau) requirements, to carry out the preparation process, quality standard and stability studies on particle system of Heze, the development to lay the foundation for the hospital preparation.By adopting the combination of modern and traditional preparation technology, extraction and preparation of heze grains molding process has carried on the system research. Single factor investigation to determine the volatile oil of rhizoma atractylodis, acid-insoluble ash, the best extraction process, orthogonal experiment has established the best water decoction extraction process, heze particles obtained reliable technical parameters; Using modern technology the inclusion process of volatile oil was studied, and carries on the experiment fields.therefore, prove that the formation of the new object of inclusion; Preparation of heze grain types of molding process of the auxiliary materials, auxiliary materials consumption, concentration and type of adhesive, granules of critical relative humidity and so on has carried on the system research, determine the reasonable preparation technology of heze particles; The pilot enlarge test, but the transition to industrialization production.By using modern analysis method of heze, thin layer identification of the characteristics of particles, a variety of effective component content determination, granularity, melted, and heavy metals, arsenic salt, water, systemic research on the microbial limit inspection, etc, established the perfect quality standard, hospital preparations can effectively control the immanent quality of heze particles. Thin layer identification in quality standard research, under the lotus leaf, rhizoma atractylodis, adjuvant acid-insoluble ash has carried on the qualitative identification; Determination of content of study, the gentleman medicine in the lotus lotus leaf alkali and adjuvant of rhubarb phenol content in cassia seed.According to the 2015 edition of "Chinese pharmacopoeia" in four general principles of the "guidelines" raw material medicine and preparation stability test requirements, to the heze grain quality standard draft for the test, accelerated stability test of heze particles and room temperature sample preliminary stability test. Investigation results show that various examining indexes has no obvious change, show the heze particles within the inspection period of stable quality, to determine the validity of clinical application for its provide the experimental basis.