Prescription technique for improving stability of desogestrel
A desogestrel and stability technology, applied in the field of prescription technology for desogestrel stability, can solve the problem of drug stability and increase the difficulty of large-scale production
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[0014] Example: 1 million tablets of desogestrel and ethinyl estradiol are prescribed, the lubricant is magnesium stearate and the dosages are as follows:
[0015] Element Batch size (kg) weight percentage desogestrel 0.150 0.150% Ethinyl Estradiol 0.030 0.030% Vitamin E 0.500 0.500% Chloroform (volatile during the process) 10.000 0.000% medical supplements 98.820 98.820% Magnesium stearate 0.500 0.500% batch weight 100.000 100.000%
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[0016] The specific implementation mode of the present invention comprises the following steps:
[0017] A. Dissolve 0.15 kg of desogestrel, 30 g of ethinyl estradiol and 500 g of vitamin E in 10 kg of chloroform, stir until completely dissolved, so that desogestrel, ethinyl estradiol and vitamin E are in molecular distribution state solution, each active drug molecule is surrounded and protected by multiple antioxidant molecules;
[0018] B. Add 98.820 kg of pharmaceutical excipients into the fluidized bed granulator, use purified and heated high-pressure air to make the medicinal excipients "boiling" in the fluidized bed, and at the same time, process step A containing antioxidant The active drug solution of the agent is sprayed on the "boiling" pharmaceutical excipients at a specified speed (50-300 g / min). After the drug is sprayed, continue to use purified and heated high-pressure air to dry the excipient particles containing the active drug ;
[0019] C, the dried granu...
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