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Insulin-protamine zinc injection and method for preparing the same

An insulin injection and insulin technology, which can be applied to peptide/protein components, pharmaceutical formulations, medical preparations containing active ingredients, etc. Effect

Inactive Publication Date: 2008-07-16
JIANGSU WANBANG BIOPHARMLS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In this invention application, insulin exists in two forms, one is in the solution, which exerts a quick-acting effect; the other is combined with protamine sulfate and exists in the precipitate, which has the phase characteristics of intermediate-acting insulin, so there are two kinds of insulin preparations The characteristics of the function greatly facilitate the diabetic patients, reduce the number of injections and the resulting pain and inconvenience, but the stability is not enough

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Table 1

[0047] formula

measurement

low protamine zinc insulin

100000IU

Glycerin

35g

Phenol and m-cresol

5.5g

Zinc chloride

20.9mg

Disodium phosphate

12g

protamine sulfate

0.3g

Water for Injection

2500ml

[0048] The preparation method comprises the following steps:

[0049] A. Add low-protamine zinc insulin powder into an appropriate amount of water for injection with a pH value of 2.0 according to the formula, then add zinc chloride and stir to dissolve, and add glycerin, preservatives, and protamine sulfate prepared according to Table 1. Aqueous solution, made into 1250ml solution, mixed to keep the total concentration of zinc at 0.01g / 100000IU insulin, adjust the pH value to 2.5, and filter through a 0.22μm filter membrane to sterilize.

[0050] B. Disodium hydrogen phosphate was formulated into 1250ml solution according to the amount in Table 1, and the pH value was...

Embodiment 2

[0053] Table 2

[0054] formula

measurement

low protamine zinc insulin

100000IU

Glycerin

35g

Phenol and m-cresol

5.5g

Zinc chloride

62.7mg

Disodium phosphate

12g

protamine sulfate

0.6g

Water for Injection

2500ml

[0055] The preparation method comprises the following steps:

[0056] A. According to the formula in Table 2, add the low-protamine zinc insulin powder into an appropriate amount of water for injection with a pH value of 2.0, then add zinc chloride and stir to dissolve, add the pre-prepared according to Table 2 containing glycerin, preservatives, and fish sulfate. Protamine aqueous solution for injection, made into 1250ml solution, mixed to keep the total zinc concentration at 0.03g / 100000IU insulin, adjust the pH value to 3.0, and filter to sterilize through 0.22μm filter membrane.

[0057] B. Dissolve disodium hydrogen phosphate in water for injection according to the ...

Embodiment 3

[0060] table 3

[0061] formula

measurement

insulin

100000u

Glycerin

35g

Phenol and m-cresol

5.5g

Zinc chloride

83.6mg

Disodium phosphate

12g

protamine sulfate

0.45g

add water to

2500ml

[0062] The preparation method comprises the following steps:

[0063] A. According to Table 3, add low protamine zinc insulin powder into an appropriate amount of water for injection with a pH value of 2.0, then add zinc chloride and stir to dissolve, and add glycerin, preservatives, protamine sulfate prepared in advance according to Table 3 The aqueous protein solution was made into 1250ml solution, mixed to keep the total zinc concentration at 0.04g / 100000IU insulin, adjusted the pH value to 2.7, and sterilized by filtration through a 0.22μm filter membrane.

[0064] B, the disodium hydrogen phosphate of the formulation amount that dissolves with water for injection is made into 1250ml solutio...

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Abstract

The invention pertains to a pharmaceutical preparation field, and in particular relates to a zinc protamine insulin ampoule injection and a preparation method thereof. The zinc protamine insulin ampoule injection comprises insulin, isotonizing agent, antiseptic agent, pH regulator, protamine sulfate and bi-distilled water for injection, wherein, the bi-distilled water for injection contains divalent zinc salt and the concentration of zinc ion is 0.01-0.04g per100000IU of insulin. The injection of the invention has the advantages that minim zinc ion is added into the insulin to form a stable polymer, which stabilizes the insulin and has a prolonged curative effect; the invention has simple, scientific and reasonable preparation and easy manipulation. The insulin can exist in two patterns: firstly, in liquor with quick effect; secondly, combining with protamine sulfate and in precipitation with action characters of both two insulin preparations, which reduces injection time and pain caused by rejection. Animal insulin is used for the injection, thus reducing the cost.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a protamine zinc insulin injection and a preparation method thereof. Background technique [0002] Diabetes is the fourth leading cause of death in the world and the third leading cause of death in China. About 194 million people worldwide currently suffer from diabetes. There are about 25 million diabetics in China, and if the potential population is added, the total number of people threatened by diabetes will reach 40 million. It is estimated that by 2025, diabetes will become one of the diseases with the largest number of patients in the world. By then, 330 million people worldwide will suffer from diabetes, and the number of diabetic patients in China will reach 50 million. [0003] Since the introduction of insulin in the 1920s, the treatment of diabetes has continued to advance by leaps and bounds. [0004] Insulin classification: [0005] According to the so...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/28A61K47/02A61K47/42A61P3/10
Inventor 乔德水高雪芹
Owner JIANGSU WANBANG BIOPHARMLS
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