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Alprostadil preparation and its making method

A technology for alprostadil and preparations, applied in the field of preparation of alprostadil preparations, can solve the problems of complex preparation process, vascular irritation and the like, and achieve the effects of simple process, improved stability and improved lifespan

Active Publication Date: 2007-04-04
BEIJING SAISHENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The preparation process of this invention is relatively complicated, and the absolute ethanol used will cause irritation to blood vessels.

Method used

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  • Alprostadil preparation and its making method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0070] Figure 1 is a flowchart of the dissolution of alprostadil by supercritical carbon dioxide (reference: Hou Yucui, Sun Junhong, Solubility of Egg Oil in Supercritical Carbon Dioxide and Its Simulation, 2000, 14(3), 62-67).

[0071] First put 10g of alprostadil (Biochemical Branch of Bethune Medical University Pharmaceutical Factory) into the extractor, open the inlet valve of the extractor, and introduce CO 2 , so that CO 2 The pressure is equilibrated and the CO is turned on 2 Metering pump, when the pressure of the extractor reaches the required pressure, open the regulating valve at the outlet of the extractor to maintain the required pressure, periodically release alprostadil through a special nozzle at the bottom of the separator, and weigh and calculate. The temperature is controlled by a water bath with an accuracy of 0.5°C; the pressure is controlled by a throttle valve with an accuracy of 0.5MPa; the flow rate is controlled by CO 2 Metering pump control, the ma...

Embodiment 2

[0082] 2. Preparation process

[0083] 500mg of alprostadil is loaded into the extractor, the temperature is constant at 30°C, the pressure is 30MPa, CO 2 The flow rate is kept constant at 150-200L / min for 90 minutes. After alprostadil is dissolved in supercritical carbon dioxide, open the outlet regulating valve of the extractor, keep the pressure at 30MPa, open the nozzle at the bottom of the separator, so that alprostadil is ejected in the form of ultrafine particles, and weigh 20mg, 30mg, and 100mg respectively , respectively add 1000ml of water for injection, 50ml of phosphate buffer saline and 300ml of auxiliary material 10% dextran mixed in proportion in advance, and stir evenly. Sterilize by filtration with a 0.2 μm pore size filter membrane, and fill it after checking the clarity. Each 1000 vials of the drug solution were divided into vials and freeze-dried. Check the packaging.

Embodiment 3

[0086] 2. Preparation process

[0087] Alprostadil 500mg is loaded into the extractor, the temperature is constant at 35°C, the pressure is 30Mpa, CO 2 The flow rate is kept constant at 150-200L / min for 90 minutes. After alprostadil is dissolved in supercritical carbon dioxide, open the outlet regulating valve of the extractor, keep the pressure at 30MPa, open the nozzle at the bottom of the separator, so that alprostadil is ejected in the form of ultrafine particles, and weigh 20mg, 30mg, and 100mg respectively, Add 1000ml of water for injection, 50ml of phosphate buffer saline and 300ml of auxiliary material 10% dextran which have been mixed in proportion in advance, and stir evenly. Sterilize by filtration with a 0.2 μm pore size filter membrane, and fill it after checking the clarity. Each 1000 vials of the drug solution were divided into vials and freeze-dried. Check the packaging.

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Abstract

A prostaglandin El medicine in the form of superfine particles used for preparing the injection of prostaglandin El is prepared through dissolving prostaglandin El in supercritical CO2 to obtain supercritical solution, and fast expanding to become superfine particles.

Description

technical field [0001] The invention relates to a method for preparing alprostadil preparations. [0002] The present invention also relates to an alprostadil preparation prepared by the method. Background technique [0003] Supercritical fluids have solubility for many solid solutes and this solubility can be adjusted with temperature and pressure, which constitutes a new preparation technology for ultrafine particle materials. There are two ways, namely the rapid expansion process (RESS) and the anti-solvent process (GAS). The process of rapid expansion of supercritical fluid solution (Rapid Expansion from Supercritical Solution, RESS process) is composed of two mutually opposite steps. First, the supercritical solution is formed by extracting the target solid substance with the supercritical fluid, and the supercritical solution containing the extracted solid component is then extracted. Rapid expansion through a special nozzle (hole diameter tens of μm), due to the ext...

Claims

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Application Information

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IPC IPC(8): A61K31/5575A61K9/19A61K9/14A61K9/10A61P9/04A61P9/10A61P3/10A61P25/02A61P1/18
Inventor 马骉单连慧王天燕宋梦薇
Owner BEIJING SAISHENG PHARMA
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