A kind of detection method of alprostadil injection

A technology of dil injection and alprostadil, which is applied in the field of medicine, can solve the problems of unsatisfactory, high cumulative release rate, and difficulty in convenient and quick detection, and achieves good reproducibility, good stability and high precision Effect

Active Publication Date: 2022-04-22
浙江长典药物技术开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the cumulative release rate of the liposome released in vitro is high and unsatisfactory
[0009] On the other hand, since the above-mentioned alprostadil injections are mostly special pharmaceutical preparations, the detection method recorded in the Chinese Pharmacopoeia is difficult to detect it conveniently, quickly and with high sensitivity.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] Dissolve 5 mg of alprostadil in 100 mL of PBS buffer at pH=7.4, add 21 mg of hydroxypropyl-β-cyclodextrin, stir for 2 hours, and mix well; filter through a 0.45 μm microporous membrane, and freeze-dry to obtain alprostadil clathrate. Dissolve alprostadil inclusion compound, 600mg hydrogenated soybean lecithin, 50mg cholesterol and 25mg cholesteryl sulfate sodium salt in 10mL chloroform, remove solvent by rotary evaporation at 40°C, form lipid film, continue rotary evaporation for 10min; add 200mL 7.5wt% Aqueous sucrose solution, hydrated at room temperature, and homogenized under high pressure for 3 times under 5000psi pressure to obtain alprostadil inclusion compound liposome suspension; filter with 0.45μm microporous membrane, pack in 1 mL / branch into vials, and freeze Dry to obtain the alprostadil inclusion complex liposome. When in use, take 1 branch of alprostadil inclusion complex liposome, add 1 mL of 5% glucose injection for hydration and reconstitution, and le...

Embodiment 2

[0057] Dissolve 5 mg of alprostadil in 100 mL of PBS buffer at pH=7.4, add 19 mg of hydroxypropyl-β-cyclodextrin, stir for 1 h, and mix well; filter through a 0.45 μm microporous membrane, and freeze-dry to obtain alprostadil clathrate. Dissolve the alprostadil inclusion compound, 500mg hydrogenated soybean lecithin, 40mg cholesterol and 20mg cholesteryl sulfate sodium salt in 10mL chloroform, remove the solvent by rotary evaporation at 40°C, form a lipid film, continue rotary evaporation for 5min; add 200mL 5wt% sucrose Aqueous solution, hydrated at room temperature, and homogenized under high pressure for 3 times under 3000psi pressure to obtain alprostadil inclusion compound liposome suspension; filter with 0.45μm microporous membrane, pack in vials with 1mL / branch, freeze-dry , to obtain the alprostadil inclusion complex liposome. When in use, take 1 branch of alprostadil inclusion complex liposome, add 1 mL of 5% glucose injection for hydration and reconstitution, and le...

Embodiment 3

[0059] Dissolve 5 mg of alprostadil in 100 mL of PBS buffer with pH=7.4, add 23 mg of hydroxypropyl-β-cyclodextrin, stir for 3 hours, and mix well; filter through a 0.45 μm microporous membrane, and freeze-dry to obtain alprostadil clathrate. Dissolve the alprostadil inclusion compound, 700mg hydrogenated soybean lecithin, 60mg cholesterol and 30mg cholesteryl sulfate sodium salt in 10mL chloroform, remove the solvent by rotary evaporation at 40°C, form a lipid film, continue rotary evaporation for 30min; add 200mL 15wt% sucrose Aqueous solution, hydrated at room temperature, and homogenized under high pressure for 3 times under 8000psi pressure to obtain alprostadil inclusion compound liposome suspension; filter with 0.45μm microporous membrane, pack in vials with 1mL / branch, freeze-dry , to obtain the alprostadil inclusion complex liposome. When in use, take 1 branch of alprostadil inclusion compound liposome, add 1mL 5% glucose injection for hydration and reconstitution, a...

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PUM

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Abstract

The invention discloses a detection method of alprostadil injection. The method comprises: taking 20 μL of alprostadil reference substance solution for HPLC sample analysis; Used for HPLC injection analysis; calculate the encapsulation efficiency of alprostadil injection according to the external standard method. The detection method of the invention has high precision, good reproducibility and good stability, and can accurately measure the encapsulation efficiency of the alprostadil injection.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to a detection method of alprostadil pharmaceutical preparations, in particular to a detection method of alprostadil injection. Background technique [0002] Alprostadil is an endogenous physiologically active substance, which belongs to natural prostaglandin substances, also known as prostaglandin E 1 . Alprostadil was approved for marketing by the US FDA in 1981, and three scientists, Bergstrom, Sami Elsson and Wan En, won the Nobel Prize in Physiology or Medicine in 1982 for their research on the pharmacological mechanism of alprostadil. [0003] The chemical name of alprostadil is: 11a, 15(S)-dihydroxy-9-carbonyl-13-antiprostaglandin, and its molecular weight is 354.5. Alprostadil is white needle-like crystal or crystalline powder, easily soluble in ethanol, slightly soluble in water, soluble in phosphate buffer (pH 7.4-8.0). Alprostadil for injection and alprostadil raw materi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
Inventor 陈宇东
Owner 浙江长典药物技术开发有限公司
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