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Infantile hemangioma is the most common childhood cancer, the incidence rate of about 3%. The proliferating hemangioma can occur in a variety of complications, such as ulcers, bleeding, infection, thrombocytopenia, heart failure. Clinical treatment, including surgery, laser, freezing, radiation therapy, intratumoral drug injection have certain side effects. With the development of molecular biology and pathogenesis of hemangioma may have a close relation with the high estrogen. According to literature, citrate tamoxifen as an estrogen receptor antagonist, hemangioma treatment. This thesis citrate tamoxifen as a model drug, developed a skin external aqueous gel, to provide a new clinical drug formulations for the treatment of infant skin hemangioma. UV spectrophotometric spectrophotometric and HPLC determination of tamoxifen citrate content in the gels; established HPLC determination of in vitro percutaneous penetration test citrate Tamoxifen content and precision, stability, recovery, and other methodological study, are in line with the Chinese Pharmacopoeia. Vitro percutaneous penetration test, and the test screening citrate tamoxifen gelling agent penetration enhancers. Vitro percutaneous penetration test using a drug the transdermal diffusion tester vertical Franze diffusion cell osmotic membrane dialysis membrane used to accept liquid selection of 50% ethanol saline. In the steady state permeation rate of Js, Delay T and enhanced permeability ratio ER as an indicator, the three transdermal promoting agent of propylene glycol (10% ~ 25%), Azone (1% to 5%), and oleic acid (1% ~ 5%) for screening. The results show that the effect of penetration enhancers of the 15% propylene glycol is preferably, the steady state permeation rate of Js is 72.389μg/cm2/h Delay T is 1.835h enhanced permeability ratio ER 1.73. Therefore, the choice of 15% propylene glycol as penetration enhancers. Cumulative permeation amount on the basis of the single factor index, orthogonal design method the tamoxifen gel citrate prescription and preparation process to optimize the prescription and preparation process; their traits , such as pH, viscosity, content, and in vitro release rate for a quality inspection, as a white, translucent, gelatinous, semi-solid substances, the appearance of uniform fine, has a good spreadability, pH of about 6.2, a viscosity of 70 -80Pa · S, citric tamoxifen content between about 10mg / g, the in vitro cumulative permeation amount is between 300 ~ 400μg/cm2. Impact factor test (including high-temperature test, a test of high humidity and glare test), accelerated testing and long-term test for stability studies. The results showed that the heat and glare of citrate tamoxifen gel greater impact, the need to avoid the high temperature from light, high humidity had no effect on their basic; accelerated test within six months and long-term test 6 month citrate tamoxifen gel inspect the project was no significant change in quality is stable. Further long-term trials are still in progress. Rabbit skin irritation test conducted a safety study, the results showed that the citrate tamoxifen gel is non-irritating to rabbit skin. Further safety studies should also the allergic test evaluation. This thesis develops citrate tamoxifen gel, prescription and preparation process is reasonable and feasible, stable, stable the gels quality obtained, no skin irritation, the need to avoid high temperature, protected from light, for the treatment of a novel pharmaceutical preparations for infant skin hemangioma.
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