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Omeprazole sodium freeze-dried powder injection, as well as preparation method and quality control method thereof

A technology of omeprazole sodium and freeze-dried powder injection, which is applied in the field of medicine and can solve the problems of reduced drug efficacy, increased side effects, and difficult release

Active Publication Date: 2010-06-23
BEIJING SIHUAN KEBAO PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This patent application uses β-cyclodextrin as an excipient, which ensures the stability of the preparation by inclusion of the active ingredient omeprazole sodium of the drug, but at the same time, the active ingredient of the drug is not easy to be released after entering the human body, resulting in drug loss Decreased curative effect and increased side effects
[0007] The insoluble particles and related substances of the currently marketed omeprazole sodium freeze-dried powder injection have been plagued by the use of this product. Excipients are important factors that affect the insoluble particles, such as mannitol, β-cyclodextrin, etc., but if It is difficult to guarantee the formability and stability of the drug without excipients

Method used

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  • Omeprazole sodium freeze-dried powder injection, as well as preparation method and quality control method thereof
  • Omeprazole sodium freeze-dried powder injection, as well as preparation method and quality control method thereof
  • Omeprazole sodium freeze-dried powder injection, as well as preparation method and quality control method thereof

Examples

Experimental program
Comparison scheme
Effect test

experiment example 12

[0163] Experimental Example 12 Stability Test

[0164] 1. Sources of samples and reagents: Omeprazole sodium for injection, 3 batches were self-made according to the prescription and process described in Example 1, and the batch numbers were: AZ1, AZ2, AZ3; the reference substance of omeprazole sodium was purchased from China Pharmaceuticals Institute of Biological Products.

[0165] 2. Test method:

[0166] (1) Accelerated stability test: Take 3 batches of samples respectively, according to the commercially available packaging, place them for 6 months at a temperature of 40°C ± 2°C, and a relative humidity of 75% ± 5%. Samples were taken at 6 months to investigate the properties, pH value, related substances and content. The results are shown in the table below

[0167] Accelerated Stability Test Results

[0168]

[0169]

[0170] From the test results, it can be seen that the medicine of the present invention is through the accelerated test for 6 months, and the de...

Embodiment 1

[0207] Omeprazole Sodium 42.6g

[0208] Edetate Disodium 0.75g

[0209] Anhydrous sodium sulfite 1.0g

[0210] Add water for injection to: 1000ml

[0211] A total of 1000 pieces

[0212] For preparation, take about 90% of the prescription amount of water for injection at normal temperature, add disodium edetate and anhydrous sodium sulfite, and stir until completely dissolved. Add the ingredients and stir until completely dissolved. Detect the pH value of the solution, and adjust it to the range of 10.7 with NaOH solution; add 0.1% (W / V) activated carbon for needles, stir and adsorb for 20 minutes, decarbonize, sterilize and filter; add water for injection to the prescribed amount; intermediate inspection, filling;

[0213] Turn on the front box refrigeration to lower the temperature of the product to below -25°C for about 2 to 3 hours; turn on the back box refrigeration to lower the temperature of the condenser to below -35°C; pump the vacuum of the freeze-drying box to ...

Embodiment 2

[0228] Omeprazole Sodium 42.6g

[0229] Edetate Disodium 1.8g

[0230] Anhydrous sodium sulfite 0.6g

[0231] Add water for injection to: 1000ml

[0232] A total of 1000 pieces

[0233] The preparation process is the same as in Example 1, wherein the pH value of the intermediate solution is adjusted to 10.9, and the pre-freezing temperature is at -50°C.

[0234] Take the intermediate solution and finished product of the above method, and investigate the content, related substances, properties and other indicators of the sample.

[0235]

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PUM

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Abstract

The invention relates to omeprazole sodium freeze-dried powder injection, as well as a preparation method and a quality control method thereof, belonging to the technical field of medicines. In the invention, the stability of the medicament is improved by utilizing the combined application of an antioxidant and a chelator, adjusting the pH value of an intermediate solution in the preparation process to be in a certain range and controlling the temperature in each phase of the freeze-drying process. In addition, the quality control method of the omeprazole sodium freeze-dried powder injection is researched, and a quality control method with high sensitivity and strong specificity is established so that the quality of the omeprazole sodium freeze-dried powder injection can be well controlled.

Description

technical field [0001] The invention relates to a proton pump inhibitory drug, a preparation method and a quality control method, in particular to omeprazole sodium freeze-dried powder injection, a preparation method and a quality control method, belonging to the technical field of medicine. Background technique [0002] Omeprazole sodium is a proton pump inhibitor of gastric parietal cells, which can specifically inhibit the secretion of microtubules formed by the apical membrane of parietal cells and the H on the tubular vesicles in the cytoplasm. + 、K + -ATPase, thus effectively inhibiting the secretion of gastric acid. due to H + 、K + -ATPase is the last process of parietal cell acid secretion, so this product has a strong ability to suppress acid. It can not only non-competitively inhibit gastric acid secretion caused by gastrin, histamine, choline and food, stimulate vagus nerve, etc., but also inhibit 2 Part of the basal gastric acid secretion affected by recepto...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4439A61K47/16A61K47/02A61P1/04G01N30/36
Inventor 张建立曹相林解玉红谢亚高锋
Owner BEIJING SIHUAN KEBAO PHARM CO LTD
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