Preparation method of nonoxinol foamable composition and its quality control method

Abstract

The invention discloses a preparation method of nonoxinol foamable composition and its quality control method, wherein nonoxinol is used as raw material, and right amount of methyl glycol, polyvidon K3O, stearic acid, wool grease are used as auxiliary material, the quality control method includes an identification method and a content determination method, wherein highly effective liquid item chromatography is employed for color spectrum identification for the main constituents, and absolute ethyl alcohol is used as the dissolvent, as the results, the chromatogram is more clear, the position of the characteristic peak is made more evident, the content of the active ingredients can be controlled better.

Description

technical field

[0001] The invention relates to a pharmaceutical preparation, in particular to a preparation method and a quality control method of a foam preparation for contraception. Background technique

[0002] Because oral contraceptives often interfere with endocrine effects, causing side effects such as nausea, vomiting, and even irregular vaginal bleeding, the scope of use is limited. However, contraceptives for external use do not interfere with endocrine function and are reversible. Therefore, the research work of external contraceptives has been paid attention to. In 1964, the International Planned Parenthood Federation approved the use of a vaginal spermicide called "nonoxynol ether": the chemical name of nonoxynol ether [Nonoxynol-9] (abbreviated NP-9) is nonylphenol polyoxygen vinyl ether. NP-9 is a good spermicide, which has the advantages of safety, high efficiency and small systemic side effects. It is suitable for contraception in all stages of women o...

Examples

Embodiment Construction

[0026] Example. Get raw materials according to the following weight ratio, nonoxynol 750g, propylene glycol 2160g, povidone K30 43.2g, stearic acid 540g, lanolin 54g, purified water 23452.8g; make 1000 bottles altogether. Preparation method: mix nonoxynol ether with the prescribed amount of povidone K30, propylene glycol and other emulsifiers, and purified water in a water bath at 75°C; fully dissolve emulsifiers such as stearic acid and lanolin in a water bath at 77°C ,well mixed. Mix the two parts of the uniformly mixed emulsion in a 60°C water bath, stir evenly, add purified water to 27000g, mix well, pack separately, press into propellant, make 1000 bottles, and get ready.

[0027] Identification: Take 1 bottle of this product, shake it vigorously, place the propeller on the valve, press the valve, the foam will fill the propeller, inject the foam in the propeller into the conical flask with a stopper, and repeat this many times until After all the contents are sprayed o...

technical field

[0001] The invention relates to a pharmaceutical preparation, in particular to a preparation method and a quality control method of a foam preparation for contraception. Background technique

[0002] Because oral contraceptives often interfere with endocrine effects, causing side effects such as nausea, vomiting, and even irregular vaginal bleeding, the scope of use is limited. However, contraceptives for external use do not interfere with endocrine function and are reversible. Therefore, the research work of external contraceptives has been paid attention to. In 1964, the International Planned Parenthood Federation approved the use of a vaginal spermicide called "nonoxynol ether": the chemical name of nonoxynol ether [Nonoxynol-9] (abbreviated NP-9) is nonylphenol polyoxygen vinyl ether. NP-9 is a good spermicide, which has the advantages of safety, high efficiency and small systemic side effects. It is suitable for contraception in all stages of women o...

Examples

Embodiment Construction

[0026] Example. Get raw materials according to the following weight ratio, nonoxynol 750g, propylene glycol 2160g, povidone K30 43.2g, stearic acid 540g, lanolin 54g, purified water 23452.8g; make 1000 bottles altogether. Preparation method: mix nonoxynol ether with the prescribed amount of povidone K30, propylene glycol and other emulsifiers, and purified water in a water bath at 75°C; fully dissolve emulsifiers such as stearic acid and lanolin in a water bath at 77°C ,well mixed. Mix the two parts of the uniformly mixed emulsion in a 60°C water bath, stir evenly, add purified water to 27000g, mix well, pack separately, press into propellant, make 1000 bottles, and get ready.

[0027] Identification: Take 1 bottle of this product, shake it vigorously, place the propeller on the valve, press the valve, the foam will fill the propeller, inject the foam in the propeller into the conical flask with a stopper, and repeat this many times until After all the contents are sprayed o...

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