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A kind of oxaliplatin injection

An oxaliplatin and injection technology, applied in the field of pharmaceutical preparations, can solve the problems of increasing the risk of microbial contamination, sterilization failure, sample precipitation, etc., and achieve the effects of meeting industrial preparation requirements, low manufacturing cost, and simple production process

Inactive Publication Date: 2011-12-14
SHANGHAI ACEBRIGHT PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, such freeze-dried products have some disadvantages: firstly, the freeze-drying process is relatively complicated and the operation is expensive; in addition, the use of freeze-dried products requires the product to be reconstituted when used, which provides a guarantee for selecting a suitable reconstitution solution. chance of error
For example, the misuse of 0.9% NaCl solution, which is an extremely common solution when reconstituting lyophilized products or diluting liquid formulations, in the reconstitution of oxaliplatin lyophilized product will be harmful to the active ingredient, because A rapid reaction will occur, causing not only loss of oxaliplatin, but also precipitation of the sample
Other disadvantages of lyophilized products are: (a) reconstitution of lyophilized products increases the risk of microbial contamination relative to sterile products that do not require reconstitution; (c) lyophilized products have a greater risk of sterilization failure than sterilized solution products; and (c) lyophilized products have the potential for incomplete dissolution when reconstituted, resulting in particles that are not desirable for injectable products
Such impurities are usually present in trace amounts, which cannot be detected by the currently used analytical methods, and therefore cannot be found in the mass detection of oxaliplatin

Method used

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  • A kind of oxaliplatin injection
  • A kind of oxaliplatin injection
  • A kind of oxaliplatin injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Accurately weigh 5g of oxaliplatin into the container, then add 900ml of water for injection at 50°C, stir until the oxaliplatin is completely dissolved, and cool to room temperature; add 10ml of acetic acid-sodium acetate buffer solution, wherein: acetic acid in the buffer solution The molar ratio to sodium acetate is 4:1, and the molar concentrations of acetic acid and sodium acetate are 0.2M and 0.05M respectively; then make up to 1000ml with water for injection; filter, fill, stopper, cover, and finally extinguish with damp heat at 121°C 15 minutes to obtain the oxaliplatin injection of the present invention, which is referred to as preparation 1.

Embodiment 2

[0042] Preparation 4, preparation 5 and preparation 6 were prepared according to the preparation process described in Example 1, and the specific formulations are shown in Table 3.

[0043] table 3

[0044]

[0045] The test results of the content, pH value and the amount of related substances of the above three preparations are shown in Table 4.

[0046] Table 4

[0047]

[0048] It can be seen from Table 4 that when acetic acid or sodium acetate is used alone as a stabilizer, the pH value changes before and after sterilization, and the related substances after sterilization are relatively large; especially when acetic acid is used alone as a stabilizer, the relevant substances after sterilization The growth of substances is particularly obvious; and the oxaliplatin injection prepared by using the buffer solution of acetic acid-sodium acetate as a stabilizer in the present invention has stable and superior quality before and after sterilization.

[0049] Accelerated s...

Embodiment 3

[0054] Preparation 7, preparation 8, preparation 9, preparation 10 and preparation 11 were prepared according to the preparation process described in Example 1, and the specific formulations are shown in Table 6.

[0055] Table 6

[0056]

[0057] The test results of the content, pH value and the amount of related substances of the above five preparations are shown in Table 7.

[0058] Table 7

[0059]

[0060] It can be seen from Table 7 that the oxaliplatin injections prepared from the buffer solution formed with the molar ratio of acetic acid and sodium acetate as 1:1 to 5:1 all have stable quality; especially when the molar ratio of acetic acid and sodium acetate is 3 : 1~5: 1 The oxaliplatin injection prepared by the buffer solution that forms has better quality, the oxaliplatin injection that is 3: 1~4: 1 to form the buffer solution that the mol ratio of acetic acid and sodium acetate prepares has best quality.

[0061] Accelerated stability tests were carried o...

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Abstract

The invention discloses an oxaliplatin injection. The injection comprises oxaliplatin, a buffer solution formed of an effective and stable amount of acetic acid and a pharmaceutically acceptable salt of acetic acid, and a pharmaceutically acceptable carrier. The oxaliplatin injection prepared by using the buffer solution formed by acetic acid and a pharmaceutically acceptable salt of acetic acid as a stabilizer in the present invention has good quality and superior stability, and does not introduce additional impurities that need to be controlled and can cause side effects ; Different from oxaliplatin preparations in freeze-dried powder form, the injection preparation of the present invention has low manufacturing cost and simple production process, and can be used immediately; The industrial preparation requirements of Liplatin injection and the quality requirements as pharmaceutical preparations.

Description

technical field [0001] The invention relates to an oxaliplatin injection, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Oxaliplatin (L-OHP) is a third-generation platinum-based anticancer drug first launched in France in October 1996, which was developed by Debiopharm in Switzerland and produced and sold by Sanofi in France. The molecular structure of oxaliplatin has three optical isomers, namely trans-l (1R, 2R-dach, oxaliplatin), trans-d (1S, 2S-dach) and cis meso- (1R,2S-dach) isomer. Generally speaking, their relative molar potency order is: trans-l>trans-d>cis-isomer, that is, the activity of oxaliplatin is the largest. The chemical structure of oxaliplatin is significantly different from that of cisplatin and carboplatin. This drug not only improves the side effects of cisplatin and carboplatin, but also expands their activity spectrum. or carboplatin tumors were also active. The drug has a good curative effect...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/282A61K31/194A61K47/12A61K47/26A61K47/34A61P35/00A61P35/04
Inventor 安晓霞张静史高尚马素伟
Owner SHANGHAI ACEBRIGHT PHARMA CO LTD
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