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Omeprazole sodium freeze-dried powder injection for injection

A technology of freeze-dried powder injection and omeprazole sodium, applied in the field of medicine, can solve the problems of increasing the moisture content of freeze-dried powder injection, instability of freeze-dried powder and the like

Active Publication Date: 2015-05-13
CHENGDU TIANTAISHAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Mannitol itself has a certain degree of water absorption, adding it to the prescription increases the moisture of the freeze-dried powder, making the freeze-dried powder unstable

Method used

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  • Omeprazole sodium freeze-dried powder injection for injection
  • Omeprazole sodium freeze-dried powder injection for injection
  • Omeprazole sodium freeze-dried powder injection for injection

Examples

Experimental program
Comparison scheme
Effect test

preparation example 1

[0092] Preparation example 1, prepare the powder injection comprising omeprazole sodium

[0093] formula:

[0094] Omeprazole Sodium

40mg,

Methionine

5 mg,

EDTA-2Na

1.5 mg,

pH regulator

to pH10.5,

Water for Injection

Appropriate amount, add to 1ml.

[0095] Preparation:

[0096] (1) Take the main drug and auxiliary materials of the prescription amount, place them in a stainless steel bucket, add about 80% of the prescription amount of water for injection to dissolve each component, and then add 0.1% (w / v) of activated carbon according to the volume of the solution, Stir for 30 minutes, filter and decarburize, and add water for injection to nearly the full amount of the prescription.

[0097] (2) The filtrate is sampled, and the pH value is measured, and if necessary, it is adjusted to a specified value with a pH regulator (this specified value is the value of the measured pH value of the freeze-dried gained d...

Embodiment 1

[0108]

[0109] Stability study example: Measure the chemical stability of the sample prepared in the above embodiment 1 part according to the chemical stability investigation method of this paper, after placing 4 months at 45 ° C, especially measure their residual content (%), total special impurity increment (%) ) and total miscellaneous increment (%), the results are shown in Table 1 below.

[0110] Table 1

[0111] sample

Residual content (%)

Total miscellaneous increment (%)

Total Miscellaneous Increment (%)

Ex100

96.6

340

435

Ex101

97.1

270

311

Ex102

98.3

155

244

Ex103

99.1

42

78

Ex104

99.2

33

69

Ex1

99.4

35

73

Ex106

99.2

34

83

[0112] Ex107

99.3

45

78

Ex108

98.4

52

93

Ex109

98.3

58

112

Ex110

98.5

63

144

Ex115

98.0

...

preparation example 2

[0119] Preparation example 2, powder injection of the present invention

[0120] The prescription and production method refer to Preparation Example 1, the only difference is that the dosage of EDTA-2Na is changed to 1mg or 2mg, and two batches of powder injections are obtained, and the numbers are respectively recorded as Ex21 and Ex22.

[0121] The prescription and preparation method refer to Preparation Example 1, the only difference is that the pH value is controlled to 10.0 or 11.0, and the freeze-drying curve B described in this article is used for freeze-drying to obtain two batches of powder injections, and the numbers are respectively recorded as Ex23 , Ex24.

[0122] The prescription and preparation method refer to Preparation Example 1, the only difference is that the amount of water for injection is adjusted so that the solid content of the filtrate obtained in step (3) is 4%, 7%, and 10%, and three batches of powder injections are obtained. They are recorded as...

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Abstract

The invention relates to an omeprazole sodium freeze-dried powder injection for injection. Specifically, the invention relates to the freeze-dried powder injection containing omeprazole sodium, disodium edetate and arbitrarily selected pH regulator. The omeprazole sodium freeze-dried powder injection for injection, disclosed by the invention, can be used for treating stomach diseases and further has exciting good properties.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to a freeze-dried powder injection which can be used for treating stomach diseases, in particular to a freeze-dried powder injection containing omeprazole sodium. The freeze-dried powder injection of the present invention has expected good properties. Background technique [0002] Digestive system disease is a common and frequently-occurring disease, and it is also a chronic disease that is very easy to relapse. So far, there is no effective way to completely cure it. This has become one of the key topics in the field of pharmaceutical research. Statistical analysis shows that the incidence rate of digestive system diseases in the world accounts for 10-12% of human beings, and the incidence rate of digestive system diseases in cities and towns in my country is 11.43%, which is basically similar to many developed countries in Europe and America. Due to the characteristics of diet stru...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/4439A61K47/20A61P1/04
Inventor 赵东明王芳贾红军方专丁多浩董国明
Owner CHENGDU TIANTAISHAN PHARMA
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