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Method for preparing calcium gluconate injection

A technology for calcium gluconate and injection, which is applied in the field of preparation of calcium gluconate injection, which can solve the problems of reduced solubility, etc., and achieve the effects of enhanced stability, increased dissolution aiding effect, and stable quality

Inactive Publication Date: 2017-05-10
CISEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

In traditional prescriptions, lactic acid and calcium hydroxide produce calcium lactate, which can help dissolve calcium gluconate to a certain extent, but it can only prevent calcium gluconate from crystallizing in a short period of time. , especially under low temperature conditions, the solubility of calcium gluconate gradually decreases, so that saturated calcium gluconate gradually precipitates and crystallizes

Method used

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  • Method for preparing calcium gluconate injection
  • Method for preparing calcium gluconate injection

Examples

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Effect test

Embodiment 1

[0011] ①Take 90L of water for injection, add 200g of sodium acetate, 500ml of glacial acetic acid, and 3560g of calcium acetate, stir to dissolve, heat to boiling, add 11kg of calcium gluconate, stir to dissolve; ②Adjust the pH value to 6.01 with sodium hydroxide, add 200g Activated carbon, add water for injection to 100L, stir and circulate for adsorption for 20 minutes; ③Filtrate to remove carbon, filter with 0.45μm, 0.22μm, 0.22μm filters in sequence until qualified; Bacteria, light inspection, packaging.

Embodiment 2

[0013] ①Take 90L of water for injection, add 100g of sodium acetate, 300ml of glacial acetic acid, and 1560g of calcium acetate, stir to dissolve, heat to boiling, add 9kg of calcium gluconate, stir to dissolve; ②Adjust the pH value to 5.93 with sodium hydroxide, add 200g Activated carbon, add water for injection to 100L, stir and circulate for adsorption for 20 minutes; ③Filtrate to remove carbon, filter with 0.45μm, 0.22μm, 0.22μm filters in sequence until qualified; Bacteria, light inspection, packaging.

Embodiment 3

[0015] ① Take 90L of water for injection, add 150g of sodium acetate, 300ml of glacial acetic acid, and 3560g of calcium acetate, stir to dissolve, heat to boiling, add 10kg of calcium gluconate, stir to dissolve; ②Adjust the pH value to 5.97 with sodium hydroxide, add 200g Activated carbon, add water for injection to 100L, stir and circulate for adsorption for 20 minutes; ③Filtrate to remove carbon, filter with 0.45μm, 0.22μm, 0.22μm filters in sequence until qualified; Bacteria, light inspection, packaging.

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Abstract

The invention belongs to the technical field of medicament preparation, and particularly relates to a method for preparing a calcium gluconate injection. Every liter of the injection contains 90 to 110g of calcium gluconate, 3 to 40g of calcium acetate, 0.5 to 2g of sodium acetate, 0.5 to 6ml of glacial acetic acid, 1 to 10g of sodium hydroxide and the balance of water for injection. Compared with the prior art, the method has the advantages that the sodium acetate and the calcium acetate are added in a prescription process of the calcium gluconate injection, so that the dissolution-promoting effect of the calcium gluconate is enhanced; the sodium acetate and the calcium acetate are taken as a co-solvent and a stabilizer of the calcium gluconate, so that the stability of the calcium gluconate injection is enhanced. As proved by long-time review of stability, crystals are basically not produced in a storage period, particularly under a low-temperature condition, and stable quality is achieved.

Description

technical field [0001] The invention belongs to the technical field of medicine preparation, and in particular relates to a method for preparing calcium gluconate injection. Background technique [0002] In the prior art, calcium gluconate injection is a small-volume injection product, the solubility of calcium gluconate in water is 3.33%, and the product specification is 10% concentration, which is a supersaturated solution. Therefore, crystallization tends to occur during storage. In traditional prescriptions, lactic acid and calcium hydroxide produce calcium lactate, which can help dissolve calcium gluconate to a certain extent, but it can only prevent calcium gluconate from crystallizing in a short period of time. , especially under low temperature conditions, the solubility of calcium gluconate gradually decreases, so that saturated calcium gluconate gradually precipitates and crystallizes. Contents of the invention [0003] In order to solve the above technical pro...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/191A61K47/12A61P3/02
CPCA61K9/08A61K9/0019A61K31/191A61K47/12
Inventor 王绍同卢秀莲刘婷袁洪雨
Owner CISEN PHARMA
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