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Sodium ozagrel freeze-dried powder for injection and preparation method of sodium ozagrel freeze-dried powder

A technology of ozagrel sodium and freeze-dried powder, which is applied in the field of ozagrel sodium freeze-dried powder for injection and its preparation, and can solve the problem of unstable quality of ozagrel sodium freeze-dried powder for injection and non-standardized step control process , Increase the risk of clinical use and other issues, to achieve the effect of improving the safety of clinical use, suitable for promotion, and high safety in clinical use

Inactive Publication Date: 2015-02-18
HAINAN GENERAL & KANGLI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, ozagrel sodium for injection is mainly stored in the form of lyophilized powder. However, in the preparation process of ozagrel sodium lyophilized powder for injection, the step control process is not very standardized, and the parameter control is not accurate enough. The quality of the obtained ozagrel sodium freeze-dried powder for injection is not stable, so the shelf life has a large fluctuation range, and the risk of clinical use is relatively high. In addition, in order to improve the stability of drug performance, the side effects caused by adding various excipients are also Increased risk of clinical use

Method used

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  • Sodium ozagrel freeze-dried powder for injection and preparation method of sodium ozagrel freeze-dried powder
  • Sodium ozagrel freeze-dried powder for injection and preparation method of sodium ozagrel freeze-dried powder
  • Sodium ozagrel freeze-dried powder for injection and preparation method of sodium ozagrel freeze-dried powder

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Effect test

Embodiment 1

[0042] The invention provides a freeze-dried powder of ozagrel sodium for injection, which comprises 70 g of ozagrel, 150 g of mannitol and 10 g of sodium hydroxide in parts by weight.

[0043] The preparation method of ozagrel sodium freeze-dried powder for injection comprises the following steps:

[0044] S1 formula preparation;

[0045] S2 liquid preparation:

[0046] S2-1: Disperse ozagrel in water for injection, slowly add sodium hydroxide while stirring, and stir until ozagrel is completely dissolved to obtain a clear liquid;

[0047] S2-2: Add mannitol and stir until completely dissolved;

[0048] S2-3: Adjust the pH value to 8.2 with sodium hydroxide solution, which effectively inhibits the hydrolysis of the formula and improves the stability of the drug;

[0049] S2-4: Add medicinal activated carbon, stir for 30 minutes to make it evenly dispersed, successively pass through a 0.45 μm microporous membrane for filtration decarbonization, and pass through a 0.22 μm mi...

Embodiment 2 Embodiment 9

[0064] In Example 1 to Example 9, the composition formula of ozagrel sodium freeze-dried powder for injection is shown in Table 1, and its preparation method is the same as that of Example 1. Continue to carry out the stability study, as can be seen from the data in Table 1, the obtained ozagrel sodium freeze-dried powder for injection has high quality, good stability, low water content in the finished product, and a shelf life of more than 30 months. Especially in Example 1, when the composition formula of ozagrel sodium lyophilized powder for injection is ozagrel 70g, mannitol 150g and sodium hydroxide 10g, the stability of the obtained ozagrel sodium lyophilized powder for injection is the best , the retention period can reach 36 months.

[0065] Table 1 Ozagrel Sodium Freeze-Dried Powder for Injection with Different Formulations

[0066]

[0067]

Embodiment 10 Embodiment 12

[0069] The composition and formula of the ozagrel sodium freeze-dried powder for injection in the tenth to the twelveth embodiment are all the same as in the first embodiment, and the preparation method is to reduce the pH value in the step S2-3, and the cooling in the step S4-1 to S4-4. , the first temperature rise, the temperature rise rate of the second temperature rise, the holding temperature, the holding time and the vacuum degree are replaced with the values ​​shown in Table 2, and the stability research of the obtained finished product is continued at room temperature, and the results are shown in Table 2 As shown in, compared with the prior art, the method of the present invention adopts the vacuum low-temperature freeze-drying process to prepare the medicine in an airtight container, so as to ensure that the medicine is not easy to oxidize and deteriorate, and overcome the problem of medicine decomposition caused by high temperature in the production process, and the o...

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Abstract

The invention provides sodium ozagrel freeze-dried powder for injection. The sodium ozagrel freeze-dried powder comprises formula components in parts by weight as follows: 60-80 parts of ozagrel, 120-150 parts of mannitol and 10-20 parts of sodium hydroxide. The sodium ozagrel freeze-dried powder has simple formula and fewer auxiliary materials and is applicable to popularization, side effects caused by excessive addition of auxiliary materials are avoided, and the safety of clinical use is improved. The invention further provides a preparation method of the sodium ozagrel freeze-dried powder for injection. Through accurate control on parameters such as the heating speed, the holding temperature, the holding time, the pressure and the like of freeze-drying process steps, the obtained sodium ozagrel freeze-dried powder for injection is more normative in preparation course, good in product quality and high in stability.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a freeze-dried powder of ozagrel sodium for injection and a preparation method thereof. Background technique [0002] Sodium ozagrel, chemical name: trans-3-4-(1H-imidazolyl-1-methyl)phenyl-2-propenoic acid sodium. This product is a thromboxane (TX) synthase inhibitor, which can prevent prostaglandin H2 (PGH2) from generating thromboxane A2 (TXA2), and promote the transfer of PGH2 derived from platelets to endothelial cells. Endothelial cells are used to synthesize PGI2, thereby improving the abnormal balance of TXA2 and prostaglandin PGI2. In theory, it can inhibit the aggregation of platelets and dilate blood vessels. This product can improve the movement disorder in the acute stage of cerebral thrombosis, improve the circulation disorder in the acute stage of cerebral ischemia and improve the abnormal energy metabolism in cerebral ischemia. Animal experiments have shown that intrave...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4174A61K47/26A61P7/02A61P9/10
Inventor 王志涛林小雪张丽华
Owner HAINAN GENERAL & KANGLI PHARMA
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