Double timephase neo-insulin zinc injection (30%) and its prepn process

An insulin injection and protamine technology, which is applied in the field of biphasic protamine zinc insulin injection and its preparation field, can solve the problems such as the preparation method of biphasic protamine zinc insulin injection, etc., which is easy to operate and reduce The number of injections and the effect of simple preparation process

Active Publication Date: 2007-03-21
JIANGSU WANBANG BIOPHARMLS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there is no report on the preparation method of

Method used

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  • Double timephase neo-insulin zinc injection (30%) and its prepn process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] (1) Accurately weigh the insulin powder, isotonic agent, preservative, pH regulator, and protamine sulfate according to Table 1.

[0025] product name

Liquid A

Liquid B

total

insulin

Glycerin

phenol

Disodium phosphate

protamine sulfate

add water to

30000u

10.5g

1.65g

3.6g

750ml

70000u

24.5g

3.85g

8.4g

0.21g

1750ml

100000u

35g

5.5g

12g

0.21g

2500ml

[0026] (2), dosing

[0027] Liquid A: According to the prescription amount of Liquid A, add glycerin, phenol, and disodium hydrogen phosphate to a small amount of water for injection to dissolve, and then add it to the liquid preparation tank A in turn, and then slowly add insulin powder into an appropriate amount of water for injection whose pH value is adjusted to 2.0 , Stir to dissolve and add to the liquid mixing tank A, adjust the pH to 6.9 with 1mol / L hydrochloric acid, add w...

Embodiment 2

[0034] (1) Accurately weigh insulin fine powder, isotonic agent, preservative, pH regulator, protamine sulfate according to Table 2 respectively.

[0035] product name

A

B

total

insulin

Glycerin

phenol

Disodium phosphate

protamine sulfate

add water to

30000u

13.5g

2.1g

3.75g

750ml

70000u

31.5g

4.9g

8.75g

0.42g

1750ml

100000u

45g

7g

12.5g

0.42g

2500ml

[0036] (2), dosing

[0037]Liquid A: According to the prescription amount of Liquid A, add glycerin, phenol, and disodium hydrogen phosphate to a small amount of water for injection to dissolve, and then add it to the liquid preparation tank A in turn, and then slowly add insulin powder into an appropriate amount of water for injection whose pH value is adjusted to 2.0 , stir and dissolve, add to liquid mixing tank A, adjust pH to 7.5 with 1mol / L hydrochloric acid, add water for in...

Embodiment 3

[0046] Example 3:

[0047] (1) Accurately weigh insulin fine powder, isotonic agent, preservative, pH regulator and protamine sulfate according to Table 3.

[0048] product name

A

B

total

Insulin

Glycerin

phenol

Disodium phosphate

protamine sulfate

add water to

30000u

12g

1.87g

3.67g

750ml

70000u

28g

4.37g

8.57g

0.31g

1750ml

100000u

40g

6.2g

12.2g

0.31g

2500ml

[0049] (2), dosing

[0050] Liquid A: According to the prescription amount of Liquid A, add glycerin, phenol, and disodium hydrogen phosphate to a small amount of water for injection to dissolve, and then add it to the liquid preparation tank A in turn, and then slowly add insulin powder into an appropriate amount of water for injection whose pH value is adjusted to 2.0 , Stir to dissolve and add to the liquid mixing tank A, adjust the pH to 7.2 with 1mol / L hydrochloric ...

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PUM

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Abstract

The present invention is double time phase protamine zinc insulin injection (30 %) and its preparation process, and belongs to the field of medicine preparation technology. The double time phase protamine zinc insulin injection (30 %) consists of insulin 100000 IU, isosmotic agent 35-45 g, preservative 5.5-7 g, pH regulator 12-12.5 g and fish protamine sulfate 0.21-0.42 g, and has pH value of 6.9-7.8. Its preparation process includes the steps of preparing neutral insulin injection, preparing low protamine zinc insulin injection, and mixing these two kinds of injection. The double time phase protamine zinc insulin injection (30 %) has two forms of insulin, including one in solution for quick acting and the other in precipitate with combined fish protamine sulfate as the middle acting phase. It has less required injection times.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to biphasic protamine zinc insulin injection (30%) and a preparation method thereof. Background technique [0002] With the economic development of China in the past 20 years, people's lifestyle has undergone tremendous changes, and the incidence of diabetes, the so-called "rich man's disease", has greatly increased. Statistics show that in China, the number of diabetic patients has increased by nearly 5 times in the past 15 years. A survey conducted among more than 40,000 urban and rural residents in 11 provinces and cities in China found that the prevalence of diabetes has increased from 0.6-0.7% in 1980 to 3.21% at present. At present, it is estimated that the total number of diabetic patients reaches nearly 40-50 million, of which the number of patients aged 20 to 79 reaches nearly 30 million, ranking second only to India in the world. Diabetes is harmful, mainly bec...

Claims

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Application Information

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IPC IPC(8): A61K38/28A61K9/08A61P3/10
Inventor 乔德水李显林田海英沈洲
Owner JIANGSU WANBANG BIOPHARMLS
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