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Preparation method of vinpocetine freeze-dried powder for injection

A technology of vinpocetine and freeze-dried powder, which is applied in the direction of freeze-dried transportation, making drugs into special physical or taking forms, powder transportation, etc., which can solve the problem of unstable quality of vinpocetine freeze-dried powder for injection, Parameter control is not accurate enough, the process is not very standardized, etc., to achieve the effect of improving the safety of clinical use, standardization of the preparation process, and high safety of clinical use

Inactive Publication Date: 2016-01-06
HAINAN GENERAL & KANGLI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, vinpocetine for injection is mainly stored in the form of lyophilized powder. Due to the non-standardized process and inaccurate parameter control in the preparation process of vinpocetine lyophilized powder for injection, the obtained injection The quality of vinpocetine freeze-dried powder is unstable, so the shelf life has a large fluctuation range, and the risk of clinical use is relatively high

Method used

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  • Preparation method of vinpocetine freeze-dried powder for injection
  • Preparation method of vinpocetine freeze-dried powder for injection
  • Preparation method of vinpocetine freeze-dried powder for injection

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Embodiment 1

[0034] Such as figure 1 As shown in the flow chart, according to the method provided by the present invention, a method for preparing vinpocetine freeze-dried powder for injection includes the steps: S1 formula preparation, S2 liquid medicine preparation, S3 filling, S4 freeze-drying and S5 packaging, wherein ,

[0035] S1 recipe preparation

[0036] For every 1,000 pieces of the vinpocetine freeze-dried powder pharmaceutical composition for injection, the formula is as follows:

[0037]

[0038] The formula of the invention is simple, the auxiliary materials are less, the side effects caused by excessive addition of auxiliary materials are avoided, and the safety of clinical use is improved.

[0039] S2 liquid medicine preparation:

[0040] Such as figure 2 As shown in the flowchart, it includes the following steps

[0041] S2-1. Weigh an appropriate amount of water for injection into the mixing tank and cool it to room temperature. The amount of water for injection added for the firs...

Embodiment 2 3

[0062] The first time injection water consumption in step S2-1, the pH value in S2-3, the first cooling down, the first heating up, the second heating up speed, and the holding temperature in steps S4-1 to S4-4 , The holding time and the degree of vacuum are replaced with the values ​​shown in Table 1, and the stability study of the finished product at room temperature is continued. The results are shown in Table 1. Compared with the prior art, the method of the present invention uses vacuum The low-temperature freeze-drying process ensures that the medicine is not easily oxidized and deteriorated, and overcomes the problem of decomposition of the medicine due to high temperature in the production process. The obtained vinpocetine freeze-dried powder for injection has high quality, good stability, and water content Low, extending the shelf life.

[0063] Table 1 The shelf life of vinpocetine freeze-dried powder for injection prepared under different conditions

[0064]

[0065]

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PUM

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Abstract

The invention provides a preparation method of vinpocetine freeze-dried powder for injection. The preparation method comprises the following steps: S1, preparing raw materials, S2, preparing medicinal liquid, S3, filling, S4, carrying out freeze drying, and S5, packaging. By adjusting the processing steps, such as the accurate control on parameters including the temperature increase rate, the heat preservation temperature, the heat preservation time, the pressure and the like, the control on multi-layer filtration, and the like, the prepared vinpocetine freeze-dried powder for injection is high in quality and stability, the clinic use is high in safety, the preparation process is standard, and the vinpocetine freeze-dried powder is suitable for popularization.

Description

Technical field [0001] The invention relates to the field of pharmacy, in particular to a preparation method of vinpocetine freeze-dried powder for injection. Background technique [0002] Vinpocetine is an indole alkaloid. Since its market in 1978, due to its remarkable clinical effects, safety and tolerability, the scope of clinical application is expanding, and it has become a routine drug in Europe, America and Japan. Vinpocetine is a cerebral vasodilator, which can inhibit phosphodiesterase activity, increase the effect of c-GMP, a messenger of vascular smooth muscle relaxation, and selectively increase cerebral blood flow. In addition, it can inhibit platelet aggregation, reduce human blood viscosity, and enhance Red blood cell deformability improves blood fluidity and microcirculation, and promotes glucose uptake by brain tissue. Increase brain oxygen consumption and improve brain metabolism. [0003] At present, vinpocetine for injection is mainly stored in the form of fr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4375A61P9/08A61J3/02
Inventor 王志涛林密林小雪
Owner HAINAN GENERAL & KANGLI PHARMA
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