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Pantoprazole sodium freeze-dried powder injection pharmaceutical composition and preparation method thereof

A technology of 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

Inactive Publication Date: 2015-06-03
山东北大高科华泰制药有限公司
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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 pharmaceutical composition and preparation method thereof
  • Pantoprazole sodium freeze-dried powder injection pharmaceutical composition and preparation method thereof
  • Pantoprazole sodium freeze-dried powder injection pharmaceutical composition and preparation method thereof

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

12 mg,

Maltose

8mg,

pH regulator

to pH10.2,

Water for Injection

Appropriate amount, add to 2ml.

[0130] Preparation:

[0131] (1) Weigh the main drug and adjuvant (except the pH regulator) 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 pH value of the freeze-dried gained dry powder diluted wi...

preparation example 2

[0137] Supplementary Preparation Example 2: Referring to the method of Preparation Example 1 above, the difference is that the amount of mannitol in it is adjusted to 0mg, 2mg, 5mg, 10mg, 15mg, 25mg, 50mg, and 75mg, and the numbers of the obtained powder injections are respectively Ex201, Ex202, Ex203, Ex204, Ex205, Ex206, Ex207, Ex208.

preparation example 3

[0138] Supplementary preparation example 3: prepare according to the prescription and the method of preparation of CN101810588A (Chinese Patent Application No. 200910223918.1, Luo Cheng) specification sheet [0086] to [0100] paragraph embodiment 1 (the active ingredient of every bottle subpackage is calculated by pantoprazole 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 samples prepared in the above part of Example 1 according to the chemical stability investigation method in this paper, after placing them for 5 months at 42°C, especially measure their residual content (%), total special impurities (%) and total miscellaneous increment (%), the results are shown in Table 1 below.

[0142] Table 1

[0143] sample

Residual content (%)

Total miscellaneous increment (%)

Total Miscellaneous Increment (%)

Ex1...

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Abstract

The invention relates to a pantoprazole sodium freeze-dried powder injection pharmaceutical composition and a preparation method thereof, and particularly relates to a freeze-dried powder injection. The freeze-dried powder injection comprises pantoprazole sodium and medicinal auxiliary materials such as mannitol. The freeze-dried powder injection is the third generation of proton pump inhibitor; and the pantoprazole sodium is a parietal cell proton pump inhibitor, and has relatively good selectivity on H+ and K+- ATP enzymes. The invention relates to a method for preparing the pantoprazole sodium freeze-dried powder injection. The pantoprazole sodium freeze-dried powder injection can be used for treating a gastric disease, and has excellent pharmaceutical properties shown in the description.

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 pharmaceutical composition containing pantoprazole sodium. The invention also relates to a preparation method of the freeze-dried powder injection pharmaceutical composition 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 sy...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4439A61K47/26A61P1/04
Inventor 徐愈富卢家振吴彦丽姜长通赵文涛
Owner 山东北大高科华泰制药有限公司
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