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Stable pharmaceutical preparation and preparation method thereof

A technology for pharmaceutical preparations and medicines, applied in the field of stable pharmaceutical preparations and their preparation, can solve the problems of complex process, inability to prepare preparations, poor stability, etc., and achieve the effects of reducing complexity, being convenient to use, and increasing stability

Inactive Publication Date: 2011-12-07
WENZHOU MEDICAL UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Pharmaceutical solid preparations are relatively stable, but the process is more complicated
At present, many promising drugs cannot be prepared into preparations due to poor stability

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Embodiment 1: recombinant human interferon solution

[0024] Preparation of recombinant human interferon solution: dissolve 0.5g hydroxyethyl starch 130 / 0.4, 50mg poloxamer 188, 100mg trehalose, 0.09g sodium chloride in 9ml distilled water, add 1ml 1.0×10 6 IU / ml recombinant human interferon α-2b solution, mixed evenly, prepared into a total volume of 10ml recombinant human interferon α-2b solution, encapsulated in 15ml ampoules, and made stable recombinant human interferon solution (1.0×105IU / ml ). Recombinant human interferon solutions without hydroxyethyl starch, poloxamer 188, and trehalose were prepared in the same way as the control group, namely: control group A (without hydroxyethyl starch), and control group A (without hydroxyethyl starch). B (without poloxamer 188), control group C (without trehalose).

[0025] Determination of biological activity (potency) of recombinant human interferon: according to the content determination method stipulated in "China Bi...

Embodiment 2

[0030] Embodiment 2: Recombinant human interferon freeze-dried product

[0031] Preparation of recombinant human interferon freeze-dried product: 0.5g hydroxyethyl starch 130 / 0.4, 40mg Tween 80, 100mg trehalose, 0.09g sodium chloride dissolved in 9ml distilled water, add 1ml1.0×10 6 IU / ml recombinant human interferon α-2b solution, mixed evenly, prepared into a total volume of 10ml recombinant human interferon α-2b solution, added 300mg macromolecular skeleton support agent polyethylene glycol 4000, transferred to the vial, -20 ℃ for 1 h, freeze-dried (5×10 -4 Pa, 20h) to obtain a stable recombinant human interferon freeze-dried product. Prepare the recombinant human interferon freeze-dried products without hydroxyethyl starch, Tween 80, and trehalose respectively in the same way as the control group, namely: control group A (without hydroxyethyl starch), control group A (without hydroxyethyl starch), B (without Tween 80), control group C (without trehalose).

[0032] Recom...

Embodiment 3

[0036] Embodiment 3: tea polyphenol solution

[0037] Preparation of tea polyphenol solution: Dissolve 100mg hydroxyethyl starch 40, 10mg Tween 80, 50mg trehalose, and 10mg propylene glycol in 10ml distilled water, add 20mg tea polyphenols, mix well, prepare a stable tea polyphenol solution, and encapsulate in In 15ml ampoules. Prepare tea polyphenol solutions without hydroxyethyl starch, Tween 80, and trehalose respectively in the same way as the control group, namely: control group A (without hydroxyethyl starch), control group B (without containing Tween 80), control group C (without trehalose).

[0038] Temperature and light experiment: The stable tea polyphenol solution and the control solution were placed under the following conditions: 1) High temperature experiment: 45°C constant temperature, placed in a dark place; 2) Lighting experiment: 25°C, 4000lx strong light irradiation. Take regular samples and use a clarity detector to check whether the solution remains colo...

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PUM

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Abstract

The invention relates to a stable pharmaceutical preparation and a preparation method thereof. The stable pharmaceutical preparation contains trehalose, polyoxyethylene non-ionic surface active agent and hydroxyethyl starch. By utilizing the liquid pharmaceutical preparation prepared in the invention, phenomena such as oxidization, inactivation, flocculation, gathering, deposition and the like of pharmaceutical preparation due to physical and chemical changes can be restricted, and the physical stability, chemical stability and biological stability of the pharmaceutical preparation are enhanced; solid preparations can be also prepared by a spray drying method or a freeze drying method by utilizing the liquid pharmaceutical preparation prepared with the invention, thereby being convenient for transport and storage of the pharmaceutical preparation. The method of the invention is applied to various pharmaceuticals, and the range of the applicable preparation is wide.

Description

【Technical field】 [0001] The invention belongs to the field of pharmaceutical preparations, more specifically, the invention relates to a stable pharmaceutical preparation and a preparation method thereof. 【Background technique】 [0002] With the rapid development of modern separation technology, synthesis technology and biotechnology, various compounds with high efficiency and high activity are constantly being discovered, especially the powerful and low-toxic peptides and proteins obtained by using biotechnology are attractive drugs. develop potential. Among them, polypeptide and protein biotechnology drugs have complex structures, and maintaining the spatial structure of such drugs is crucial to maintaining drug activity. Maintaining the biological activity of peptide and protein drugs and improving their formulation stability have always been the bottlenecks that plague the formulation and application of macromolecular drugs. [0003] In order to maintain the activity ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/36A61K47/26A61K47/34A61K47/10
Inventor 赵应征李校堃鲁翠涛周志彩
Owner WENZHOU MEDICAL UNIV