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Preparation of fotemustine fat emulsion for injection

A formustine fat emulsion and formustine fat technology are applied in the field of medicine and biology, which can solve the problems of high toxicity and achieve the effects of large drug loading, stable properties and low vascular irritation

Inactive Publication Date: 2011-06-08
刘振平
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method uses an organic solvent, absolute ethanol, as a solvent, which is highly toxic

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Formustine fat emulsion, which consists of:

[0019] Formustine 50mg

[0020] Soybean oil for injection 10g

[0021] Medium chain oil 10g

[0022] Oleic acid 1.0g

[0023] Soy Lecithin 1.0g

[0024] Glycerin 2.0g

[0025] Add water for injection to 100ml

[0026] The preparation method of above-mentioned fat emulsion:

[0027] Weigh the oil phase according to the prescription amount and stir evenly, weigh the recipe amount of formustine, mix soybean lecithin for injection with glycerin and an appropriate amount of water to completely dissolve it into the water phase, and add the oil phase to the water phase under stirring Medium, high-speed shearing to obtain colostrum; adjust the pH to 6.0-8.0, 100mpa emulsion 20 times, the emulsion is filtered with a 0.45μm microporous membrane, the emulsion is filled in an ampoule, and sterilized at 121°C for 20min. . The particle size is between 100-500nm.

Embodiment 2

[0028] Embodiment 2 A kind of formustine fat emulsion is made up of following components:

[0029] Formustine 200mg

[0030] Peanut oil 5g

[0031] Lecithin 1.2g

[0032] Cholic acid 1.0g

[0033] Propylene glycol 0.5g

[0034] water to 100ml

[0035] Weigh the oil phase according to the prescription amount and stir evenly, weigh the water phase containing the drug formustine in the prescription amount, add the oil phase to the water phase under stirring, and shear at high speed to obtain colostrum; adjust the pH to 6.0-8.0 , 100mpa milk for 20 times, the emulsion is filtered with a 0.45μm microporous membrane, the emulsion is filled in an ampoule, and sterilized at 121°C for 20min to obtain the obtained product. The particle size is between 100-500nm.

Embodiment 3

[0036] Embodiment 3 A kind of formustine fat emulsion is made up of following components:

[0037] Formustine 500mg

[0038] Sesame oil 20g

[0039] Poloxamer 2g

[0040] Cholesterol 4g

[0041] Polyethylene glycol 15g

[0042] water to 100ml

[0043] Weigh the oil phase according to the prescription amount and stir evenly, weigh the water phase containing the drug formustine in the prescription amount, add the oil phase to the water phase under stirring, and shear at high speed to obtain colostrum; adjust the pH to 6.0-8.0 , 100mpa milk for 20 times, the emulsion is filtered with a 0.45μm microporous membrane, the emulsion is filled in an ampoule, and sterilized at 121°C for 20min to obtain the obtained product. The particle size is between 100-500nm.

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Abstract

The invention relates to a preparation method for a fotemustine fat emulsion injection. The invention comprises the following steps: putting soybean oil, mid-chain oil, and oleic acid into a container, stirring the mixture to prepare an oil phase; adding a certain amount of water into a mixture of fotemustine, soybean phosphatide, and glycerin to prepare a water phase; adding the oil phase into the water phase, stirring uniformly, performing high-speed shearing, adjusting the pH to be neutral, homogenizing the mixture by a high-pressure homogenizer to prepare a drug-loaded fat emulsion, filtering, filling into an ampoule, injecting nitrogen, performing melt sealing and autoclaving. The injection emulsion of the invention has the advantages of high efficiency, large drug loading amount, no toxic and side effects, good stability, and convenient usage, and the preparation method is rapid and simple, and is applicable to large amount preparation and industrial production.

Description

technical field [0001] The invention relates to a formustine fat emulsion injection and a preparation method thereof, belonging to the field of medical biotechnology. Background technique [0002] Malignant glioma is a common brain tumor. The main treatment methods are surgery and postoperative radiotherapy. Chemotherapy has not received sufficient attention. The main reason is that most chemotherapeutic drugs cannot pass through the blood-brain barrier, so it is difficult to play an anti-tumor effect. Due to the invasive growth of glioma and unclear boundary with normal brain tissue, it is impossible to completely remove it by surgery, and the postoperative recurrence rate is extremely high. Malignant glioma is treated with surgery alone, and the average survival period is only 6 months. After surgery, it is combined with chemotherapy. It is an important means of treating glioma [0003] When chemotherapy and radiotherapy are performed on patients with tumors, malignant t...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K31/662A61P35/00A61P3/02
Inventor 刘振平王起伟刘伟王学军
Owner 刘振平
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