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

A technology of insulin injection and protamine, which is applied in the field of dual-phase protamine zinc insulin injection and its preparation, can solve the problems such as the preparation method of dual-phase protamine zinc insulin injection, and achieve easy operation and preparation The process is simple and the effect of reducing the number of injections

Active Publication Date: 2013-02-13
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 biphasic protamine zinc insulin injection in the prior art

Method used

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

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] Table 1 The formula of dual-phase low protamine zinc insulin injection

[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 water for injection to the total volume of liquid A, stir well, and filter through a 0.22μm filter to sterilize.

[0028] Liquid B: Liquid B is made by mixing equal volumes of liquid C and liquid D, and the volumes of liquid C and liquid D are half of the total volume of liqui...

Embodiment 2

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

[0035] Table 2 The formula of dual-phase low protamine zinc insulin injection

[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 injection to the total volume of liquid A, stir well, filter through 0.22μm filter membrane

[0038] Filter out bacteria.

[0039] Liquid B: Liquid B is made by mixing equal volumes of liquid C and liquid D. The volumes of liquid C and liquid D are respectively

[0040] Hal...

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] Table 3 The formulation of dual-phase low protamine zinc insulin injection

[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 acid, add water for injection to the total volume of liquid A, stir well, and filter through a 0.22μm filter to sterilize.

[0051] Liquid B: Liquid B is made by mixing equal volumes of liquid C and liquid D, and the volumes of liquid C and liquid D are half of the tota...

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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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Patent Type & Authority Patents(China)
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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