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Calcium gluconate injection and preparation method thereof

A technology of calcium gluconate and calcium gluconate, applied in the field of calcium gluconate injection and its preparation, can solve the problems of easy crystallization and precipitation of calcium gluconate, unstable product quality, etc., and achieve improved dissolution aiding effect and stable product quality Reliable, excellent quality stability effect

Inactive Publication Date: 2017-09-01
SHANGHAI XINYI JINZHU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The technical problem to be solved by the present invention is to overcome the defects that calcium gluconate is easy to crystallize and separate out in the existing calcium gluconate injection, and the product quality is not stable, and a kind of calcium gluconate injection and preparation method thereof are provided

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] A preparation method for calcium gluconate injection, comprising the steps of:

[0031] (1) Add about 40% fresh water for injection into the concentrated preparation tank, heat it to a slight boil, slowly add calcium gluconate, replenish the water for injection to 70% of the total amount, continue heating, and keep stirring until it is completely dissolved. Next, keep stirring for 60 minutes; when boiling in this step, the steam pressure should be strictly controlled so that the liquid medicine does not overflow the tank, and the evaporated water should be continuously replenished;

[0032] (2) Add co-solvent, boil for 30 minutes, then add medicinal charcoal, and boil for 30 minutes; wherein, co-solvent is calcium lactate, prepared in the following way: calcium hydroxide is put into boiling water for injection, and then boiled for 5 After a few minutes, slowly add lactic acid and boil until completely dissolved, add an appropriate amount of medicinal charcoal, and boil ...

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PUM

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Abstract

The invention discloses a calcium gluconate injection and a preparation method thereof. The method comprises (1) adding 40% water for injection into a concentrated preparation tank, heating to slightly boiling, adding calcium gluconate, and replenishing the water for injection to the full amount 70% and stir to dissolve; (2) add calcium lactate, boil for 30 minutes, then add medicinal charcoal, boil for 30 minutes; (3) decarbonize with Suzhou sand filter stick until clear; (4) add water for injection to the full amount and stir; (5) filter back to clarity with Suzhou sand filter rods, 0.45 μm and 0.22 μm polyethersulfone filter elements; (6) test the intermediate content and pH value, filter the liquid medicine after passing the test, and fill it with nitrogen; (7) After filtering through a 0.22 μm polyethersulfone filter element, check for visible foreign matter, and pass it into a liquid storage container; (8) potting; (9) sterilize at a temperature of 121° C. for 30 minutes. The injection of the invention avoids the crystallization of calcium gluconate, and the product quality is stable and reliable.

Description

technical field [0001] The invention discloses a calcium gluconate injection and a preparation method thereof. Background technique [0002] Calcium gluconate is a calcium supplement. Calcium can maintain the normal excitability of neuromuscular and promote the secretion of acetylcholine from nerve endings. When serum calcium decreases, neuromuscular excitability increases and convulsions occur, and if blood calcium is too high, excitability decreases and weakness occurs. Calcium ions can improve the permeability of the cell membrane, increase the compactness of the capillary, reduce the exudation, and play an anti-allergic effect. Calcium ions can promote the calcification of bones and teeth, and there is a competitive antagonism between high-concentration calcium ions and magnesium ions, which can be used for the rescue of magnesium poisoning; calcium ions can form insoluble calcium fluoride with fluoride, which can be used for the treatment of fluorosis. rescue. [00...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/191A61K47/12A61P3/14A61P37/08A61P39/02A61P9/04
CPCA61K9/0019A61K9/08A61K31/191A61K33/06A61K47/12
Inventor 徐欣
Owner SHANGHAI XINYI JINZHU PHARMA
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