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Alprostadil freeze-dried emulsion composition for injection

A technology of alprostadil and freeze-dried emulsion, which is applied in the field of medicine, can solve problems such as not meeting drug safety requirements, being unfavorable for drug promotion and use, and poor clinical compliance, so as to ensure the quality of the emulsion, less injection adverse stimulation, and stability Good results

Active Publication Date: 2016-08-10
ZHEJIANG CHANGDIAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In order to promote the oil phase and the water phase to form a relatively stable phase system when preparing the alprostadil emulsion, it is usually necessary to add more emulsifiers and co-emulsion agents; in order to improve the chemical stability of the alprostadil emulsion, it is necessary to add additional Preservatives, stabilizers, antioxidants, etc., the more inactive ingredients are introduced, the more uncertain factors in drug use, and the less they meet the safety requirements of drug production
At the same time, in order to improve the encapsulation efficiency of alprostadil emulsion and reduce the harm of degraded substances to the human body, high-frequency shearing and high-pressure homogenization are mostly required in the preparation process, which increases energy consumption in the preparation and increases pharmaceutical costs. Not conducive to the promotion and use of drugs to the general public
In particular, the current alprostadil emulsion usually has more adverse reactions in use, and the clinical compliance is poor.

Method used

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  • Alprostadil freeze-dried emulsion composition for injection
  • Alprostadil freeze-dried emulsion composition for injection
  • Alprostadil freeze-dried emulsion composition for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] A kind of alprostadil freeze-dried emulsion composition for injection, its composition is as follows:

[0038]

[0039]

[0040] The steps of preparation are:

[0041] a. Prepare the mixed oil of soybean oil and safflower seed oil according to the quality and ratio, stir and mix evenly, add alprostadil and DHA of the formula amount, stir to make it fully dissolve, and obtain the oil phase;

[0042] b. Dissolve the glycerin for injection of the formula amount in an appropriate amount of water for injection, stir to make it fully mixed, and obtain an aqueous phase;

[0043] c. Mix the above-mentioned oil phase and water phase, stir, then add soybean lecithin in a formula amount, stir to obtain colostrum, and add water for injection to 1000ml of colostrum;

[0044] d. adjust the pH of the obtained colostrum to 5.0, and homogenize under high pressure to obtain essence milk;

[0045] e. Aseptically filter the obtained concentrated milk, fill it, and freeze-dry it.

Embodiment 2

[0047] A kind of alprostadil freeze-dried emulsion composition for injection, its composition is as follows:

[0048]

[0049]

[0050] The steps of preparation are:

[0051] a. Prepare the mixed oil of soybean oil and safflower seed oil according to the quality and ratio, stir and mix evenly, add alprostadil and DHA of the formula amount, stir to make it fully dissolve, and obtain the oil phase;

[0052] b. Dissolve the glycerin for injection of the formula amount in an appropriate amount of water for injection, stir to make it fully mixed, and obtain an aqueous phase;

[0053] c. Heat the oil phase and water phase to 55°C for mixing, stir at 300rpm for 25min, then add egg yolk lecithin according to the formula, and stir at 3000rpm for 30min to obtain colostrum, add water for injection to 1000ml ;

[0054] d. adjust the pH of the obtained colostrum to 5.2, homogenize under high pressure, the pressure of the homogenizer is 18000psi, repeat high pressure homogenization ...

Embodiment 3

[0057] A kind of alprostadil freeze-dried emulsion composition for injection, its composition is as follows:

[0058]

[0059] The steps of preparation are:

[0060] a. Prepare the mixed oil of soybean oil and safflower seed oil according to the quality and ratio, stir and mix evenly, add alprostadil and DHA of the formula amount, stir to make it fully dissolve, and obtain the oil phase;

[0061] b. Dissolve the glycerin for injection of the formula amount in the water for injection, stir to make it fully mixed, and obtain the water phase;

[0062] c. Heat the oil phase and water phase to 60°C for mixing, stir at 400rpm for 20min, then add the formula amount of soybean lecithin, then stir at 2500rpm for 25min to obtain colostrum, add water for injection to 1000ml of colostrum ;

[0063] d. adjust the pH of the obtained colostrum to 5.5, homogenize under high pressure, the pressure of the homogenizer is 16000psi, repeat high pressure homogenization 4 times, and obtain esse...

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PUM

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Abstract

The invention belongs to the technical field of medicine, and discloses an alprostadil freeze-dried emulsion composition for injection. The alprostadil freeze-dried emulsion composition comprises alprostadil, an oil phase, a water phase and an emulsifying agent, wherein the oil phase is prepared from soybean oil and safflower seed oil according to the weight ratio of 11:1-6:1; the alprostadil freeze-dried emulsion composition further comprises 1-3 parts by weight of DHA. According to the alprostadil freeze-dried emulsion composition, addition of inactive ingredients is reduced, and the advantages of being uniform in particle size, high in encapsulation rate, good in stability and few in adverse injection effect are achieved.

Description

technical field [0001] The invention relates to a freeze-dried emulsion composition of alprostadil for injection, which belongs to the technical field of medicine. Background technique [0002] Alprostadil, also known as prostaglandin E1, its chemical name is (1R,2R,3R)-3-hydroxy-2-[(E)-(3S)-3-hydroxy-1-octenyl]-5-oxo Cyclopentane heptanoic acid is a highly active endogenous physiological substance that can be synthesized in every tissue cell of the human body. [0003] Alprostadil has a variety of pharmacological effects, and has very significant effects and effects in the treatment of various diseases, so the research on alprostadil has important medical application value. [0004] Alprostadil has poor water solubility and poor chemical stability, is unstable to water and heat, and is prone to degradation. It is easily metabolized and inactivated in the gastrointestinal tract, so it is not suitable for oral administration, and it is usually administered by intravenous in...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/5575A61K9/19A61K47/44
CPCA61K9/19A61K31/202A61K31/5575A61K47/44A61K2300/00
Inventor 钟正明
Owner ZHEJIANG CHANGDIAN PHARMA
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