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Preparation method of alprostadil injection

A technology of dil injection and alprostadil, which is applied in the field of preparation of alprostadil injection, can solve the problem that sterilization filtration cannot be completed, refractory alprostadil injection sterilization filtration, and unfiltered emulsion cannot reach the surface of filter membrane and other problems, to achieve the effect of reducing the incidence of adverse reactions, reducing the content of degraded impurities and lysophospholipids, and shortening the time.

Active Publication Date: 2011-04-13
辽宁中海康生物制药股份有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] Alprostadil injection dosage form among the present invention is submicroemulsion, and the aseptic filter that conventional injection adopts is difficult to complete the aseptic filtration of alprostadil injection, because the filter surface can adhere to a layer of extremely thick mucus (emulsion) partial concentrate), resulting in the failure of the unfiltered emulsion to reach the surface of the filter membrane, so that the sterile filtration cannot be completed

Method used

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  • Preparation method of alprostadil injection

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Embodiment 1

[0027] For the convenience of examining the process, the present invention proposes a prescription as follows, but the process of the present invention is not limited to adapting to this specific prescription.

[0028] Alprostadil injection prescription

[0029] Alprostadil (PGE 1 ) 5mg

[0030] Refined soybean oil 100g

[0031] Egg yolk lecithin 12g

[0032] Oleic acid 1.8g

[0033] Glycerin 22.5g

[0034] Appropriate amount of sodium hydroxide

[0035] Add water for injection to 1000ml

[0036] Process: (1) Preparation of water phase: add glycerin to water to dissolve, heat to 55-70°C, and set aside;

[0037] (2) Preparation of the oil phase: heat the refined soybean oil to 55-70°C, add egg yolk lecithin, dissolve oleic acid, add alprostadil, stir to dissolve;

[0038] (3) Preparation of colostrum: Add the oil phase of step (2) into the water phase of step (1), at a temperature of 55-70° C., high-speed shear dispersion, with a shear rate of 8000 rpm, for 15 minutes, ...

Embodiment 2

[0043] Embodiment 2: the preparation temperature of colostrum

[0044] Set up three temperature inspection points respectively. Under the same conditions of other processes, emulsification effect, prostaglandin E 1 (PGE 1 ) and the degradation product prostaglandin A 1 (PGA 1 ) content as an index, and the investigation was carried out at 50, 55, 70, and 90°C respectively, and the results are shown in Table 1.

[0045] Table 1 Investigation of emulsifier dispersion temperature (made into 100mL)

[0046]

[0047] The test results show that the emulsification effect at 50°C is poor, and there are obvious oil droplets, which is not suitable for the next step of high-pressure homogenization; the content measurement results show that too high dispersion temperature is not conducive to the stability of the drug. Comprehensive consideration, choose the initial The emulsification temperature of 55-70°C can meet the quality requirements of the product.

Embodiment 3

[0048] Embodiment 3: Selection of high-pressure milk homogenization temperature

[0049] Get the colostrum prepared under the condition of 55 ℃ among the embodiment 2, have investigated the finished product after high-pressure homogenization in two kinds of temperature ranges, with average particle diameter, prostaglandin E 1 and prostaglandin A 1 content as an indicator. The results are shown in Table 2 below.

[0050] Particle size distribution determination method: take a sample, dilute it to 5000 times with purified water (filtered through a 0.22 μm microporous membrane), mix well, and use a dynamic laser scattering particle size analyzer as the test solution.

[0051] Table 2 Investigation of high-pressure milk uniform dispersion temperature (made into 100mL)

[0052]

[0053] The results showed that, compared with 25°C, the high-pressure homogenization temperature at 65°C could obtain a fat emulsion with smaller particle size and uniform distribution, but at the sa...

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Abstract

The invention relates to a preparation method of an alprostadil injection. The alprostadil injection consists of alprostadil, oil for injection, emulsifier, stabilizer and other agents, pH regulator and water for injection. Compared with the commercially available products, the quality standard of the prepared product is significantly improved, and the safety of clinical medication is increased.

Description

technical field [0001] The invention relates to a preparation method of alprostadil injection. Background technique [0002] Alprostadil, also known as prostaglandin E 1 (PGE 1 ), is a highly active physiologically active substance that can inhibit platelet aggregation, thromboxane A 2 generation, atherosclerosis lipid plaque formation and the role of immune complexes, and can expand the pharmacological effects of peripheral and coronary vessels, mainly used for the treatment of chronic arterial occlusion (thromboangiitis obliterans, arteriosclerosis obliterans Etc.) limb ulcers and resting pain in limbs caused by microvascular circulation disorders, improving cardiovascular and cerebrovascular microcirculation disorders and adjuvant treatment of chronic hepatitis. The kind currently on the market is alprostadil injection, and its character is a kind of white milky liquid. Degradation product prostaglandin A in the marketed alprostadil injection 1 The content limit of t...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/107A61K31/5575A61K47/44A61K47/28A61K47/24A61P7/02A61P9/10A61P1/16
Inventor 黄海马红萍宋华先
Owner 辽宁中海康生物制药股份有限公司
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