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A kind of calcium gluconate injection and preparation method thereof

A technology of calcium gluconate and injection, which is used in pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc. High pass rate, not easy to crystallize, and the effect of improving production efficiency

Active Publication Date: 2022-07-01
YANGZHOU ZHONGBAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Purpose of the invention: the technical problem to be solved by this invention is to provide a kind of calcium gluconate injection for the problem that the bulk drug of calcium gluconate injection in the prior art is easy to separate out, and the qualified rate of visible foreign matter is low.

Method used

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  • A kind of calcium gluconate injection and preparation method thereof
  • A kind of calcium gluconate injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Add 80% of the batch of water for injection into the liquid preparation tank, the water temperature is 68 ° C, turn on the stirrer and stir, the stirring speed is 120 rpm, add 9.52 kg of calcium gluconate and 360 g of calcium gluconate in the liquid preparation tank. The uniformly stirred liquid is added to the heating part of the heat exchanger, and then the water for injection is added to the liquid preparation tank three times to the full amount and then transferred to the heat exchanger for heating and dissolving. The inlet temperature of the shell side is 110 °C, the outlet temperature is 105 °C, The inlet temperature of the process is 65°C, the outlet temperature is about 90°C, and the heating is performed for 40 minutes; after the end, it is transferred to the cooling part, the inlet temperature of the shell side is -5°C, the outlet temperature is -4°C, and the inlet temperature of the tube side is 90°C , the outlet temperature is 30℃, and the cooling time is 15mi...

Embodiment 2

[0030] Add 80% of the batch of water for injection into the liquid preparation tank, the water temperature is 65 ° C, turn on the stirrer and stir, the stirring speed is 120 rev / min, add 9.68kg calcium gluconate and 376g calcium glucarate in the liquid preparation tank, mix The uniformly stirred liquid is added to the heating part of the heat exchanger, and then the water for injection is added to the liquid preparation tank three times to the full amount and then transferred to the heat exchanger for heating and dissolving. The inlet temperature of the shell side is 110 °C, the outlet temperature is 105 °C, The inlet temperature of the process is 66°C, the outlet temperature is about 90°C, and the heating is performed for 40 minutes; after the end, it is transferred to the cooling part, the inlet temperature of the shell side is -5°C, the outlet temperature is -4°C, and the inlet temperature of the tube side is 90°C , the outlet temperature is 30°C, the cooling time is 15min, ...

Embodiment 3

[0032] Add 80% of the batch of water for injection to the liquid dispensing tank, the water temperature is 69 ° C, turn on the stirrer and stir, the stirring speed is 120 rpm, add 10.0 kg calcium gluconate and 384 g calcium gluconate in the liquid dispensing tank, and mix The uniformly stirred liquid is added to the heating part of the heat exchanger, and then the water for injection is added to the liquid preparation tank three times to the full amount and then transferred to the heat exchanger for heating and dissolving. The inlet temperature of the shell side is 110 °C, the outlet temperature is 105 °C, The inlet temperature of the process is 69°C, the outlet temperature is about 90°C, and the heating is performed for 40 minutes; after the end, it is transferred to the cooling part, the inlet temperature of the shell side is -5°C, the outlet temperature is -4°C, and the inlet temperature of the tube side is 90°C , the outlet temperature is 30°C, the cooling time is 15min, th...

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Abstract

The invention discloses a calcium gluconate injection and a preparation method thereof, comprising calcium gluconate, calcium glucarate and water for injection; each liter of the injection contains 85-115g calcium gluconate and 3.5-5.5g calcium glucarate. The calcium gluconate injection of the present invention adds calcium glucarate in the formulation process, increases the dosage of calcium salt, and significantly improves the stability. In addition, the use of heat exchangers and the control of pH value significantly improve production efficiency and The final prepared product has good stability, and it can be seen that the qualified rate of foreign matter is high, and crystallization is not easy to occur during the storage period.

Description

technical field [0001] The invention belongs to the technical field of drug preparation, in particular to a calcium gluconate injection and a preparation method thereof. Background technique [0002] Calcium gluconate injection is a commonly used calcium supplement. Compared with other calcium supplements, it is less irritating to human tissues and is safer than calcium chloride for injection. [1] . Calcium gluconate can also be used for anti-allergic treatment, as well as magnesium poisoning and fluorosis rescue. However, calcium gluconate injection is a special variety in the production of injections, and calcium gluconate is listed as one of the special varieties in the state's "Clarity Inspection Rules and Judgment Standards", and a small amount of white spots are allowed in the inspection. [2] . [0003] The solubility of calcium gluconate raw material in water is not large, and 1 part of raw material needs 30 parts of cold water or 5 parts of boiling water to be com...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K47/12A61K31/191A61P3/14
CPCA61K9/0019A61K9/08A61K47/26A61K31/191A61P3/14
Inventor 张广明张冠亚李艺敏王利
Owner YANGZHOU ZHONGBAO PHARMA