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Preparation method of propofol medium/long-chain fat emulsion injection

A technology of long-chain fat emulsion and propofol, which is applied in the fields of emulsion transportation, medical preparations of non-active ingredients, and pharmaceutical formulas, etc. It can solve the problems of low propofol content and high methoxyaniline value, and achieve protection Content, improve stability, reduce the effect of content

Inactive Publication Date: 2016-06-01
HUAREN PHARMACEUTICAL CO LTD
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Problems solved by technology

This causes the propofol emulsion to be destroyed and decomposed during the preparation process. This method leads to a lower content of the main drug propofol, impurities 2,6-diisopropyl-1,4-benzoquinone and 3,3',5 , 5'-Tetraisopropylbiphenol is higher, methoxyaniline is higher

Method used

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  • Preparation method of propofol medium/long-chain fat emulsion injection
  • Preparation method of propofol medium/long-chain fat emulsion injection
  • Preparation method of propofol medium/long-chain fat emulsion injection

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specific Embodiment approach

[0032] Propofol medium / long chain fat emulsion injection prescription:

[0033] 2% strength prescription

[0034]

[0035]

[0036] 1.1 Preparation of oil phase: Take a 500ml three-hole flask, evacuate, fill with nitrogen, and replace 3 times. Continue to pass nitrogen on the surface, put soybean oil and medium chain triglyceride MCT in recipe quantity, add propofol in recipe quantity, put in water bath, be warmed up to 55 ℃ and put in recipe quantity lecithin, oleic acid 400mg, shear evenly ( 10min). After the oil phase is prepared, fill it with nitrogen and place it in an airtight place;

[0037] 1.2 Aqueous phase preparation: Take a 1000mL three-hole flask, continuously pass nitrogen, add 80% of the prescribed amount of water for injection, 55 ° C, add the prescribed amount of glycerin and stir well, add 97% of calcium and sodium edetate 8ppm, control the dissolved oxygen at 5 % or less, add 8 to 12 drops of 1 mol / L sodium hydroxide solution;

[0038] 1.3 Under ni...

experiment example

[0048] 1. The first group of comparative tests: batch BBF1403002 was added with 8ppm of Ethylenediamine-tetraacetic acid, dicalcium salt, 97%, pure (97% calcium sodium edetate) in the prepared water phase to prevent oxidation of the main drug and emulsion by metal ions effect, BBF1403001 batch does not add EDTA (other process conditions are the same as BBF1403002 batch); by comparing the test results of BBF1403001 and BBF1403002 batches in Appendix 1, it can be concluded that after adding EDTA, the methoxyaniline value and impurity 2, The contents of 6-diisopropyl-1,4-benzoquinone and 3,3',5,5'-tetraisopropylbiphenol were significantly reduced.

[0049]2. The second set of comparative experiments: the whole process of preparation of the water phase and oil phase of batch BBF1404002 was filled with nitrogen protection, and the oxidation effect of oxygen on the main drug propofol and emulsion was imitated, and batch BBF1404001 was not protected by nitrogen (other process conditio...

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Abstract

The invention relates to the field of technics and preparation of medicine carrying emulsion, in particular to a preparation method of a propofol medium / long-chain fat emulsion injection. According to the method, 8ppm of 97-percent sodium calcium edentate is added into the prepared water phase; nitrogen gas is inflated for protection in the whole preparation process of a water phase and an oil phase, and the preparation temperature is 55 DEG C; a 121 DEG C and 15min moist heat sterilization method is used for sterilization; and an excessive killing method is used. The preparation method of the propofol medium / long-chain fat emulsion injection has the advantages that the content of main medicine of propofol is protected; the contents of impurities of 2,6-diisopropyl-1,4-benzoquinone and 3,3',5,5'-tetraisopropyl xenol are reduced; the anisidine value content is reduced; and the stability of the medicine carrying emulsion is improved.

Description

technical field [0001] The invention relates to the technical preparation field of a drug-loaded emulsion, in particular to a preparation method of a propofol medium / long-chain fat emulsion injection. Background technique [0002] Propofol Medium / Long Chain Fat Emulsion Injection is suitable for induction of anesthesia and maintenance of intravenous general anesthesia. The emulsion injection of propofol significantly reduces the pain and other adverse reactions of the patient during injection. [0003] Propofol medium / long-chain fat emulsion injection is composed of propofol, soybean oil for injection, medium-chain triglyceride for injection, lecithin for injection, glycerol for injection, oleic acid for injection, and water for injection in a fixed proportion. It consists of an emulsion injection, the main drug propofol is carried in the small oil droplets of the emulsion. [0004] The preparation process is the production process of large emulsion infusion. Weighing → p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K31/05A61K47/12A61P23/00
Inventor 祖庆庆李继仁叶芳
Owner HUAREN PHARMACEUTICAL CO LTD
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