Progesterone nanocrystal injection and preparation method thereof
A progesterone and nanocrystal technology, which can be used in pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., can solve problems such as large side effects, slow absorption, and accumulation of medicinal liquids.
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[0018] A preparation method for progesterone nanocrystal injection, comprising the following steps:
[0019] S1, preparing oil-in-water emulsion;
[0020] The progesterone injections in the prior art use oil as a solvent, but the surface tension of oil molecules is large, and the tissue absorption is slow, which easily causes the accumulation of the liquid medicine in the tissue. After long-term high-dose injection, it is easy to cause skin redness, pain and induration at the injection site, and the patient's compliance is poor.
[0021] Therefore, the present invention provides an injection with water as the dispersion medium, which reduces adverse reactions to the injection site after administration, improves drug safety, and improves patient tolerance.
[0022] Specifically, the progesterone raw material is mixed with an emulsifier, an oil phase, and a water phase and then ultrasonically emulsified. The progesterone raw material is a poorly soluble drug with poor solubilit...
Embodiment 1
[0051] This embodiment provides a preparation method of progesterone nanocrystal injection, comprising the following steps:
[0052] S1, preparing oil-in-water emulsion;
[0053] The progesterone raw material is mixed with Tween 80, methylene chloride and n-butanol to obtain a mixture, wherein the volume ratio of methylene chloride and water is 1:10, the amount of n-butanol added is 5%, and the amount of n-butanol is 5%. The added amount is 0.2%, and the concentration of progesterone is 5 mg / mL.
[0054] For phacoemulsification, the probe is penetrated into the liquid surface of the mixture by 10 mm, the temperature of the mixture is 4°C during ultrasonication, the ultrasonic power is 30% of the maximum ultrasonic power, and the ultrasonic time is 10 minutes.
[0055] Then, the ultrasonicated liquid is evenly mixed with a stabilizer and a lyoprotectant. The stabilizing agent is polyvinylpyrrolidone, and its addition amount is 10 mg / mL, and the lyoprotectant is mannitol, and ...
Embodiment 2-3
[0065] The preparation method of the progesterone nanocrystal injection provided in Example 2-3 is basically the same as the preparation method of the progesterone nanocrystal injection provided in Example 1, except that the specific operating conditions are changed.
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