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Preparation method of polygeline injection

A technology for preparation of injections and polygeline peptides, which is applied in the field of preparation of polygeline peptides injections, can solve problems such as difficulty in ensuring curative effect and safety, poor operability of cross-linking process, and inaccurate process parameters, etc., so as to achieve easy control of product quality , prolong the retention time, and accurately control the distillation conditions

Active Publication Date: 2011-01-05
WUHAN DONGFANGHONG PHARMA TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation method has inaccurate process parameters, poor controllability, unstable product quality, and certain potential safety hazards. The main disadvantages are: 1. Poor degree of thermal degradation
2. The operability of the cross-linking process is poor
Cyclohexane diisocyanate is insoluble in water and must be dissolved in an appropriate solvent before adding, so the above cross-linking process cannot be applied to the cross-linking reaction using cyclohexane diisocyanate as a cross-linking agent
3. Low degree of cross-linking
4. Since the product is mainly chain-like molecules, the effect of clinically supplementing blood volume and maintaining blood pressure is relatively poor, and it is difficult to guarantee the curative effect and safety

Method used

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  • Preparation method of polygeline injection
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  • Preparation method of polygeline injection

Examples

Experimental program
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Effect test

Embodiment 1

[0043] 1. Take 200g of pork bone gelatin, add 1750ml of water for injection at a temperature of 40°C, and stir to dissolve. Use hydrochloric acid or sodium hydroxide solution to adjust the pH value of the gelatin solution to 4.5, raise the temperature to 116°C, and keep the temperature for 3 hours until the relative viscosity of the solution reaches 1.85, so that the weight average molecular weight of the peptide chain obtained by hydrolysis is 16000-18500, stop immediately Heat and rapidly (e.g. using a conventional cooling cycle) cool the solution to 25°C.

[0044] 2. Use NaOH solution to adjust the pH value of the above degradation solution to 8.0, maintain the solution temperature at 25°C, and slowly (at a speed of 28ml / hour) add cyclohexane diisocyanate acetone solution (dissolve 3.4ml cyclohexane diisocyanate in 68ml Cyclohexane diisocyanate acetone solution in acetone), stirring continuously for 2.5 hours, every 20 minutes, measure the pH value of the solution, and adju...

Embodiment 2

[0051] 1. Take 200g of bovine bone gelatin, add 1900ml of water for injection at a temperature of 65°C, and stir to dissolve. Use hydrochloric acid or sodium hydroxide solution to adjust the pH value of the gelatin solution to 5.5, raise the temperature to 121°C, and keep the temperature for 2.5 hours until the relative viscosity of the solution reaches 1.60, so that the weight average molecular weight of the peptide chain obtained by hydrolysis is 10000-15500, stop immediately Heat and rapidly cool the solution to 35°C.

[0052] 2. Use NaOH solution to adjust the pH value of the above degradation solution to 8.5, maintain the solution temperature at 35°C, slowly add cyclohexane diisocyanate acetone solution (obtained by dissolving 3.4ml cyclohexane diisocyanate in 34ml acetone), and keep stirring for 2 Hourly, every 20 minutes, the pH of the solution was measured and adjusted with NaOH solution to maintain the pH of the solution at 8.5.

[0053] 3. The above solution was dis...

Embodiment 3

[0059] 1. Take 200g of pork bone gelatin, add 2000ml of water for injection at a temperature of 90°C, and stir to dissolve. Use hydrochloric acid or sodium hydroxide solution to adjust the pH value of the gelatin solution to 6.0, raise the temperature to 131°C, and keep the temperature for 2 hours until the relative viscosity of the solution reaches 1.3, so that the weight average molecular weight of the peptide chain obtained by hydrolysis is 5500-9000, stop immediately Heat and rapidly cool the solution to 40°C.

[0060] 2. Use NaOH solution to adjust the pH value of the above degradation solution to 9.0, maintain the solution temperature at 40°C, slowly add cyclohexane diisocyanate acetone solution (obtained by dissolving 3.4ml cyclohexane diisocyanate in 24ml acetone), and keep stirring for 1.5 Hourly, every 20 minutes, the pH of the solution was measured and adjusted with NaOH solution to maintain the pH of the solution at 9.0.

[0061] 3. The above solution was distille...

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Abstract

The invention discloses a prescription of polygeline injection and a preparation method thereof. The preparation method comprises the following steps: a. dissolving gelatin with water for injection, regulating the pH value of the gelatin solution to be 4.5-6.0, heating to 116-131 DEG C, keeping the temperature constant for 2-3 hours, stopping heating, and cooling to 25-40 DEG C; b. regulating thepH value of degradation liquid to be 8.0-9.0, adding cyclohexyl diisocyanate acetone solution, and stirring and crosslinking for 1.5-2.5 hours; c. carrying out reduced pressure distillation to obtainacetone; d. adding water for injection, potassium chloride, sodium chloride and calcium chloride in the remaining solution after distillation, and regulating the pH value to be 6.5-7.5; d. adsorbing and filtering; and e. sterilizing, carrying out visual check and packaging. The degradation condition controllability of the method is good; the weight-average molecular weight of polypeptide obtainedby hydrolysis is 5000-18500, which can satisfy the optimum conditional requirements of the crosslinking reaction; the crosslinking degree is high; the crosslinking product polypeptide is globular molecule; and the prepared polygeline injection conforms to the National Drug Standards. The clinical use result proves that the product is safe and effective.

Description

technical field [0001] The invention relates to a preparation method of polygeline injection, in particular to a prescription and a preparation process for producing polygeline injection with bovine bone or pig bone gelatin. Background technique [0002] Gelatin injection is widely used clinically for hemorrhagic shock and fluid loss shock caused by various reasons. It has the effect of rapidly replenishing blood volume and maintaining blood pressure, and has replaced plasma. At present, there are different preparation methods for this product, such as the invention patent application of "Preparation Process of Gelatin Injection" with publication number CN1387912A, which discloses the following technical methods: 1. Sol: dissolve bovine bone with hot water for injection , pork bone or other gelatin; 2. Thermal degradation: adjust the pH value of beef bone, pork bone or other gelatin aqueous solution between 5.0~6.0, raise the temperature to 110~125°C, maintain this temperatu...

Claims

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Application Information

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IPC IPC(8): A61K38/17A61K9/08A61P7/08
Inventor 魏学惠
Owner WUHAN DONGFANGHONG PHARMA TECH
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