Preparation And Quality Control Study Of Tazarotene Ingredient And Cream

Psoriasis is a clinically characterized lesion of the skin, inflammatory, excessive proliferation of skin diseases. Every year, the incidence rate of new cases is 0.47%, and the incidence is 150 thousand. However, due to the large population base, the projections of China has 6,500 thousand patients, and there is a gradual upward trend.Tazarotene as the third generation of retinoic acid-multi aromatic retinoic acid drug, applicable to ordinary type plaque psoriasis.This topic mainly carried on the following research work:-To develop the synthetic route of tazarotene,and the structure of the tazarotene was confirmed.-To optimize the formulation of the tazarotene with the index of character, assay, PH, oil-water separation by using the homemade tazarotene. determine the reasonable prescription developed with small particle size, uniform distribution, good coating, stability and is suitable for industrialized production of tazarotene cream formulation technology.-Combined with tazarotene medicinal properties and cream of quality requirements, establish the quality standard of tazarotene cream, including character, identification, content, grain size, microbial limit, assay and related substances determination quality control project.-According to established standards of quality, of tazarotene cream were influencing factors test (light, temperature,wet), tazarotene cream selection of packaging materials and storage conditions to improve the basis, accelerated test and long-term test were carried out to test three batches of samples, further verify the stability of the product.-Using homemade tazarotene cream transdermal absorption test, can draw drug cortex and drug retention through the cortex of the drug is 0, indicating that the drug did not enter the blood, to avoid the side effects of drugs. At the same time the skin irritation and sensitization of safety evaluation test, to ensure the safety of drug use. The results showed that tazarotene cream to the skin of rabbits, and no obvious irritation, on guinea pig no obvious allergic reaction.-In summary, in this paper, the system of tazarotene synthesis route and cream preparation process, quality standard, preparation stability and transdermal absorption, irritation, allergy and so on were studied and the preparation of control of science and technology, the quality of comprehensive safety evaluation test and transdermal absorption to ensure safe and effective medication.