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Novel painless diluent, dilution compatibility method and application of alprostadil fat emulsion preparation

A technology of dil fat and alprostadil, which is applied in the field of diluents of new painless alprostadil fat emulsion preparations, can solve problems such as the harm of preparation stability and not a dilution method, and achieve the effect of reducing pain

Active Publication Date: 2011-04-06
XIAN LIBANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, the dilution of fat emulsion with sugar and salt water has certain harm to the stability of the preparation, and it is not an ideal diluent, let alone an ideal dilution method.

Method used

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  • Novel painless diluent, dilution compatibility method and application of alprostadil fat emulsion preparation
  • Novel painless diluent, dilution compatibility method and application of alprostadil fat emulsion preparation
  • Novel painless diluent, dilution compatibility method and application of alprostadil fat emulsion preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0094] Embodiment 1: Physiological saline, injection glucose water and blank fat emulsion are investigated as diluents

[0095] Take 10ml each of physiological saline, glucose water for injection and 10% long-chain fat emulsion and mix with 2ml of alprostadil fat emulsion (5μg / ml) respectively. Place the container containing the mixed liquid in a water bath at 25°C, take samples according to the specified time, and measure the particle size of the mixed liquid. Such as figure 1 Shown, no matter diluting alprostadil fat emulsion with that diluent, the particle size of solution after mixing all still meets quality standard requirement. However, when glucose water and normal saline were used as diluents for a long time, the particle size of the mixture tended to increase, while when the blank fat emulsion was used as the diluent, the particle size of the mixture remained basically unchanged despite being left for 24 hours. It shows that it is more stable and reasonable to dilut...

Embodiment 2

[0096] Embodiment 2: the investigation of blank fat emulsion, 10%, 20% and 30% commercially available fat emulsion as diluent

[0097] Take 10ml each of homemade blank fat emulsion and 10%, 20% and 30% commercially available long-chain fat emulsion and mix with 2ml of alprostadil fat emulsion (5 μg / ml) respectively. Place the container containing the mixed liquid in a water bath at 25°C, take samples according to the specified time, and measure the particle size of the mixed liquid. Such as figure 2 As shown, the particle size of the blank fat emulsion prepared by ourselves in this experiment is basically the same as that of the alprostadil lipid microspheres, so after mixing, the particle size of the mixed solution is consistent with that of the initial alprostadil lipid microspheres , while the particle size of commercially available fat emulsions is relatively large, and the diluent accounts for the majority of dilution, so the particle size after mixing is similar to tha...

Embodiment 3

[0098] Example 3: Investigation of 20% long-chain and 20% medium-long-chain blank fat emulsion as diluent

[0099] 10 ml of commercially available 20% long-chain fat emulsion and 20% medium-long-chain fat emulsion were respectively mixed with 2 ml of alprostadil fat emulsion (5 μg / ml). Place the container containing the mixed liquid in a water bath at 25°C, take samples according to the specified time, and measure the particle size of the mixed liquid. Such as image 3 As shown, the changes and differences in the oil phase composition of fat emulsions have no essential difference for their use as diluents for alprostadil lipid microspheres. The particle size did not change significantly after dilution.

[0100] The second part, experimental investigation on the adsorption of free prostaglandin in water phase by blank fat emulsion

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Abstract

The invention discloses a painless alprostadil fat emulsion composition and a preparation method thereof. The fat emulsion composition is prepared from alprostadil fat emulsion and blank fat emulsion according to the minimum ratio of 1:5. By taking active adsorption, physical isolation and protection of the stability of the preparation as strategies, a novel preparation diluting method is established, injection stimulation and injection pain caused by the alprostadil fat emulsion preparation can be removed or obviously reduced, and the treatment tolerance of a patient is improved.

Description

1. Technical field [0001] The invention belongs to the series of medical medicines, and relates to a diluent, a dilution formula and use of a new drug preparation, in particular to a diluent, a dilution compatibility method and application of a new painless alprostadil fat emulsion preparation. 2. Background technology [0002] Alprostadil (prostaglandin E1, PGE1), a member of the prostaglandin family, is a new generation of broad-spectrum endogenous drugs internationally recognized today. Oxidation product of oleic acid) has the effects of significantly dilating blood vessels, increasing blood flow, inhibiting platelet aggregation, and preventing thrombosis, and has obvious curative effects on cardiovascular diseases. Its pharmacological effects include: dilating blood vessels, improving peripheral circulation; inhibiting platelet aggregation; inhibiting platelet synthesis of thromboxane A2 (TXA2), preventing thrombosis; protecting platelet cells to prolong their life; inhi...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K31/5575A61P9/00A61P7/02A61P9/10
Inventor 陈涛惠民权王汝涛傅经国尚斌
Owner XIAN LIBANG PHARMA
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