The Manufacture And Quality Standard Of The Huangbei Ointment

Huangbei hemorrhoid ointment is a kind of Chinese medicine compound preparation, which consist of six herbs such as coptis, Ampelopsis, gall.after clinical practice observation, the prescription has the function of heat hemostatic, anti-phlogistic check hurts.It is indicated for the treatment of hemorrhoids, mixed hemorrhoids caused by bowel inflammation, bleeding, anal discharge, anal bulge, pain and other clinical manifestations.Under the guidance of the theories of Traditional Chinese Medicine and Pharmacy, and with the help of the modern pharmaceutical technology, Huangbei hemorrhoid ointment has been researched on pre—clinical pharmacy. On the basis of the function and treatment as well as the characters of the effective component of the herbs, the preparation process was designed to study the essential oil extraction and water extraction. the optimum extract conditions about water-extract were selected by using orthogonal design which used quite a few assessing norms to evaluate them comprehensively. At the same time the optimal condensing and moulding conditions were screened. So that the preparation of Huangbei hemorrhoids ointment was determined.The quality standard was set up.which included thin layer chromatograph y identification of four Chinese herbs in the prescription.the content of berbe rine was determined by HPLC.which accomplished systematic methodology. The results were in line with requirements. according to the results of batches of samples, the limits of berberine hydrochloride were developed which me aned that each gram contained berberine not less than 22.67mg temporarily.The preliminary stability was fulfilled. The research indicated that the technique of preparation was reasonable and practical, the standard was controllable and the quality of the sample was steady as well.