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Pantoprazole sodium freeze-dried powder injection

A technology for freeze-dried powder injection and pantoprazole sodium, which is applied in the field of medicine and can solve the problems of poor water solubility and difficulty in long-term stable storage of preparations.

Active Publication Date: 2013-07-17
CHENGDU TIANTAISHAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Studies have shown that pantoprazole has poor water solubility, but it is easily soluble in water when it forms a salt under alkaline conditions.
Therefore, when pantoprazole sodium is made into injection preparations, the control of alkalinity must be strengthened, and other adjuvants usually need to be added in order to improve the stability of the preparation, but the stability of the obtained preparation is still difficult to reach the requirements of long-term stable storage

Method used

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  • Pantoprazole sodium freeze-dried powder injection
  • Pantoprazole sodium freeze-dried powder injection
  • Pantoprazole sodium freeze-dried powder injection

Examples

Experimental program
Comparison scheme
Effect test

preparation example 1

[0127] Preparation example 1, prepare the powder injection comprising pantoprazole sodium

[0128] formula:

[0129] Pantoprazole Sodium

40mg,

Mannitol

120mg,

citric acid

4 mg,

Methionine

5 mg,

EDTA-2Na

1.5 mg,

pH regulator

to pH10.5,

Water for Injection

Appropriate amount, add to 4ml.

[0130] Preparation:

[0131] (1) Weigh the main drug and excipients (except pH adjuster) of the prescribed amount, place them in a stainless steel bucket, add about 80% of the prescribed amount of water for injection, dissolve each component, and then add 0.1% (w / v) of activated carbon, stirred for 30 minutes, filtered and decarbonized, and added water for injection to close to the full amount of the prescription.

[0132] (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...

preparation example 2

[0137] Supplementary Preparation Example 2: Referring to the method of Preparation Example 1 above, the difference is that the citric acid is replaced with an equivalent amount of sodium citrate or the citric acid is deleted, and the numbers of the obtained powder injections are respectively Ex131 and Ex132.

[0138] Prior art product 1: prepare according to the prescription and method of preparation of CN101810588A (Chinese Patent Application No. 200910223918.1, Luo Cheng) instruction manual [0086] to [0100] paragraph embodiment 1 (the active ingredient of every bottle subpackage is pressed pantoprazole Calculated as 40mg), the powder injection number obtained is CN588A, and its preparation prescription ratio is:

[0139]

[0140] Stability study example:

[0141] 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 ...

preparation example 3

[0159] Preparation example 3, powder injection of the present invention

[0160] formula:

[0161] Pantoprazole Sodium

40mg,

Mannitol

120mg,

citric acid

4 mg,

Methionine

5 mg,

trometamol

6mg,

EDTA-2Na

1.5 mg,

pH regulator

to pH10.5,

Water for Injection

Appropriate amount, add to 1ml.

[0162] Preparation method: refer to the method of Preparation Example 1, and the number of the obtained powder injection is marked as Ex3.

[0163] Referring to the prescription and preparation method of the above sample Ex3, the difference is that the amount of tromethamine is changed to 4mg or 8mg, and two batches of powder injections are obtained, and the numbers are respectively recorded as Ex31 and Ex32.

[0164] Referring to the prescription and preparation method of the above sample Ex3, the difference is that the amount of methionine is changed to 3mg or 7mg, and two batches of powder inj...

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Abstract

The invention relates to pantoprazole sodium freeze-dried powder injection, in particular to freeze-dried powder injection which contains pantoprazole sodium, mannitol, citric acid and optional pH regulator. The invention further relates to a method for preparing the pantoprazole sodium freeze-dried powder injection disclosed by the invention. The pantoprazole sodium freeze-dried powder injection disclosed by the invention can be used for treating stomach diseases and has anticipated 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 pantoprazole 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 st...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4439A61K47/20A61P1/04
Inventor 赵东明贾红军潘旭张守君董国明
Owner CHENGDU TIANTAISHAN PHARMA
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