Studies On Preparation Techonology And Quality Sandard Of Mangzhi Zhining Ointment

Pythonis moluri oil is purification of the oil that come from Python molurus bivittatus. According to Chinese medicine documents, pythonis moluri oil is sweet and flat. It can dispel wind, clear heat and detoxicate, and moisten skin,treatment of anal fistula, chilblain, scald, skin chap and so on. Pharmcodynamics study of pythonis moluri oil, showed that it has notable effect on antiphlogosis, anti-allergy and relieve itching. Followwing the whole view of TCM theory, differentiation of TCM,and combination principle,standing on the important point of the etiology,pathogenesis and symptoms of the hemorrhoids,we determined the formulation of Mangzhi Zhining ointment,include pythonis moluri oil, beeswax, borax and borneol. This subject, on the basis of new drug development, according to the requirements of the Drug Registration Administration and Technical requirements of traditional Chinese drug research,we completed formula optimizing, preparation techonology and quality sandard of Mangzhi Zhining ointment, the results will now be summarized as follows:1. Python moluri oil quality standards.Reference to "Chinese Pharmacopoeia" (2010) and "Standard Chinese herbal medicines in Guangdong Province"(2005),we provide the limit of refractive index, iodine value, acid value and saponification value of python moluri oil. Develop its alcohol insoluble, water and inspection standards for volatile,and set up the method of determination of Oleic acid and Linoleic acid by gas chromatographic.2. The formula optimizing of Mangzhi Zhining ointment. By designed some of different formula, and make the anti-inflammatory effect as evaluation index, we ultimately determined the best ratio of the herbs of Mangzhi Zhining ointment is:50% of pythonis moluri oil,15% beeswax,3% borneol,1.5%borax.3. The preparation techonology of Mangzhi Zhining ointment. By formula analysis, we determine Mangzhi Zhining ointment dosage form for W/O type; by study of a variety of the matrix, we ultimately determined the best ratio of the matrix is:16% Vaseline,7%lanolin,7.5%water. Emulsification conditions are:①Weigh borax and water,mix them, heat and stir them until dissolved, and maintain the system temperature is 75℃.②Weigh python moluri oil, wax, Vaseline, lanolin, mix them,heat and stir them until dissolved,until the temperature is 70℃, addict borneol, stirring and maintain the temperature is 70℃.③In the stirring conditions, add slowly the "②" to"①", maintaining the system temperature is 70℃and stir it until completely emulsified, remove heat and continue stirring the mixture to room temperature.4. The quality sandard of Mangzhi Zhining ointment. The methods of distinguish python moluri oil and borneol were developed by TLC. By gas chromatography, octadecane as internal standard, D-borneol, methyl oleate and methyl linoleate as measurable indicators, the determination of borneol, oleic acid and linoleic acid in Mangzhi Zhining ointment were established.