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Preparation method of myocardial viscera preservative fluid

A technology for viscera and myocardium, which is applied in the field of myocardial organ preservation solution HTK solution and its preparation, which can solve the problems of inconvenient use, loss of organ protection effect of the product, high transportation cost, etc., and achieve high repeatability, easy control, and simple process Effect

Active Publication Date: 2014-03-26
北京亿灵医药科技发展有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, most of the organ protection solutions on the market in my country are imported products, and domestic research on this topic is increasing day by day, but so far there is still no domestic organ preservation solution that has been approved by the state to be circulated in the medical market, and imported products need to be stored at low temperature, and the transportation cost is high. Inconvenient to use, one of the main ingredients, potassium hydrogen 2-ketoglutarate, will degrade within 1 hour when the storage temperature reaches above 20°C, causing the product to lose its organ protection effect

Method used

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  • Preparation method of myocardial viscera preservative fluid
  • Preparation method of myocardial viscera preservative fluid
  • Preparation method of myocardial viscera preservative fluid

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Example 1 Preparation of HTK cardiac organ protection solution

[0038] components Prescription amount (g) Molar mass Dosage (mmol) Histidine monohydrochloride 37.733 209.63 18 Histidine 279.289 155.16 180 Mannitol 54.651 182.17 30 Sodium chloride 8.766 58.44 15 potassium chloride 6.710 74.55 9 Magnesium Oxide Hexahydrate 8.132 203.3 4 Calcium Chloride Dihydrate 0.022 147.02 0.015 Tryptophan 4.085 204.23 2 Potassium hydrogen 2-ketoglutarate 1.842 184.19 1 Water for Injection Appropriate amount production 10000ml

[0039] Preparation method: make liquid under nitrogen-filled conditions, measure 75% volume of water for injection in the liquid mixing tank; weigh each component of the prescription amount, add histidine hydrochloride, histidine, mannitol, sodium chloride, Potassium chloride and magnesium chloride are stirred to dissolve; the liquid temperature i...

Embodiment 2

[0046] According to the prescription and method of Example 1, several batches of samples were prepared, and the physical and chemical indicators were investigated, and the commercially available imported HTK liquid was used for comparison. Imported product registration standard YZB / GEM 1746-2006 "HTK Solution" stipulates: The solution should be clear and transparent, without visible particles; the color of the solution should not be darker than the color of the standard colorimetric tube G6. The pH value of the solution should be 7.02~7.20 (25°C ± 1°C). The osmotic pressure should be 310±20 (mOsm / kgH 2 o). The dry residue should be 0.3812~0.4212g / 10ml. Take a sample of 2g, test according to 6 in GB / T 14233.1, the total content of heavy metals in the test solution should not exceed 1μg / ml; test according to 7 in GB / T 14233.1, the content of cadmium should not exceed 0.1μg / ml. The solution should be free of visible foreign matter. Insoluble particles should meet the requirem...

Embodiment 3

[0050] Example 3 Comparative investigation on the stability of 2-ketoglutaric acid content

[0051] In the formula of imported products, potassium hydrogen 2-ketoglutarate will degrade within a few hours when the storage temperature reaches above 20°C and cause the product to lose its protective effect on organs. Therefore, it needs to be stored in a cold chain throughout the whole process. Made improvements. The content stability of the self-made organ preservation solution and the imported product were investigated at 20°C and 40°C respectively.

[0052] According to the method of Example 1, a batch of self-made samples and commercially available imported products were placed at a temperature of 20°C and 40°C, and samples were taken at 0h, 5d, 10d, and 20d to determine the content of potassium hydrogen 2-ketoglutarate (mg / L). And compare with 0d content, test result is as follows:

[0053] Table 7 Comparison results of content stability of 2-ketoglutaric acid at 20°C and 4...

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Abstract

The invention provides a preparation technique of a myocardial viscera preservative fluid (HTK fluid). On the basis of the commercially available standard formula, the addition sequence of the raw materials is adjusted, nitrogen charging is added, and sterilizing parameters are optimized. The technique is simple, and convenient to operate; the content of potassium hydrogen 2-ketoglutarate is stably higher than 95%; and thus, the invention is suitable for industrial production.

Description

technical field [0001] The invention relates to the field of medical devices, in particular to a myocardial organ preservation solution HTK solution and a preparation process thereof. Background technique [0002] HTK solution was developed by Bretschneider in 1975. It is currently the most widely used organ preservation solution. It can be used for the preservation of heart, kidney, liver, pancreas and other organs, and it has greatly improved the success rate of organ transplantation in clinical practice. [0003] A successful organ preservation solution should meet the following requirements: reduce cell edema caused by cryopreservation; prevent cell acidification; prevent cell space expansion during cell perfusion preservation; prevent oxygen free radical damage, especially during reperfusion Medium; provide substrates for regeneration of high-energy phosphate compounds; maintain a stable intracellular environment. [0004] HTK solution has the following characteristics...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C12N5/07C12N5/071
Inventor 关屹闫冬高晓峰
Owner 北京亿灵医药科技发展有限公司
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