Study On The Proparation Of Progesterone Cream

Objectives:To set up industry productive preparation technology,quality specification, Local application safety test,peal-rabbit endometrial transformation assay and investigate the stability,to develop local application progesterone cream.Method:1)using the monofactor experiment select base material of progesterone cream;procedure orthogonal design to optimize emulsifying agent;used the cumulative amount and constants of percutaneous rate to select the dosage of enhancers;2)progesterone cream were examined to test the quality of the product and set up the quality standard by HPLC;3) used the description,detection of degradation substance,content,grade size,homogeneity to select packed material of progesterone cream;throught study the cream quality,and stability of progesterone cream was preserved in normal condition and accelerate condition;4)the cream was spread on normal and damaged skin that hairs were cut off in the back of rabbit or cavia cobaya;it was observed whether the cream could induce acute toxicity,irritation,andtheallergyreaction;5)Through ped-rabbit endometfial transforma-tion assay was applied,for detect progestogen activity.Result:1)The constitution of select progesterone cream basis are progesterone of 2%,octadecoic acid of 11%,beeswax of 6%,cetylalcohol of 3%,liquid paraffin of 14%,azone of 2%,dodeca- Alkyl sodium sulfates of 5%,mon-octadecoic acid glycerolipid of 1%,propylene glycol of 5%, glycerine of 16%,ethylparaben of 1%;2)progesterone cream were examined and met the criteria.Determined the content of progesterone and related substance by HPLC not detected other Steroid;3)To select the aluminium-pipe was a progesterone cream packed material;in normal condition and accelerate condition the description,detection of degradation substance,content,grade size,homogeneity of progesterone cream have no marked change;4)There is no irritation,allergia and toxicity of progesterone cream on the skin;5)The pharmacodyna- mics experiment showed that progesterone cream is to bring about distinct progestogen activity.Conclusion:1)The formula of the progesterone cream including the content and the shell selected is well formed and stable and is suitable for Pharmacia production;2)The quality standard of the preparation is feasible and controllable,and the result showed that this method are have good resolving power, high sensibility;3)The initial stability of the preparation is sound and provides evidence for the feasibility of technological and packing materials;4)local application progesterone cream is safe,no evidence of irritation allergia and toxicity;5)The dosage of clinical medication can change ped- rabbit endometrium.and exertion whole-length function,and replenish the progesterone through the skin.