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Calcium gluconate oral solution with specification of 5% and preparation method thereof

A technology for calcium gluconate and oral solution, which is applied in the field of 5% calcium gluconate oral solution and its preparation, can solve problems such as easy crystallization of calcium gluconate supersaturated solution, and achieve excellent performance, excellent quality, The effect of the change in validity

Pending Publication Date: 2021-03-26
广西方略药业集团有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The purpose of the present invention is to aim at the unstable problem of the quality of the present domestic 10% specification calcium gluconate oral solution, and a kind of calcium gluconate oral solution of 5% specification and preparation method thereof provided, both can better solve calcium gluconate excessive The problem of easy crystallization of saturated solution will not cause changes in the material basis of medicines, will not have a significant impact on the absorption and utilization of drugs, and will not cause significant changes in safety and effectiveness

Method used

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  • Calcium gluconate oral solution with specification of 5% and preparation method thereof

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Effect test

Embodiment 1

[0029] A 5% (10ml: 0.5g) calcium gluconate oral solution, its prescription composition is: calcium gluconate 50g; lactic acid 2g; calcium hydroxide 0.5g; sucrose 80g; essence 0.2ml; purified water to 1000ml.

[0030] Its preparation method steps are as follows:

[0031] (1) According to the prescription amount, take calcium hydroxide, lactic acid and an appropriate amount of purified water, stir and dissolve, and make calcium lactate liquid for later use;

[0032] (2) Take purified water with 70% of the total amount of the preparation solution, heat to boil, add the prescribed amount of calcium gluconate, stir to dissolve completely, and obtain calcium gluconate liquid;

[0033] (3) Mix the above calcium lactate liquid and calcium gluconate liquid evenly, add sucrose to dissolve, then add essence, adjust the total amount to 1000ml with freshly boiled purified water, and stir evenly;

[0034] (4) Filtration, filling, and sterilization;

[0035] (5) Light inspection, packaging...

Embodiment 2

[0037] A 5% (10ml: 0.5g) calcium gluconate oral solution, its prescription composition is: calcium gluconate 50g; lactic acid 3g; calcium hydroxide 0.3g; sucrose 120g; essence 0.1ml; purified water to 1000ml.

[0038] Its preparation method steps are as follows:

[0039] (1) According to the prescription amount, take calcium hydroxide, lactic acid and an appropriate amount of purified water, stir and dissolve, and make calcium lactate liquid for later use;

[0040] (2) Take purified water with 70% of the total amount of the preparation solution, heat to boil, add the prescribed amount of calcium gluconate, stir to dissolve completely, and obtain calcium gluconate solution liquid;

[0041] (3) Mix the above calcium lactate liquid and calcium gluconate liquid evenly, add sucrose to dissolve, then add essence, adjust the total amount to 1000ml with freshly boiled purified water, and stir evenly;

[0042] (4) Filtration, filling, and sterilization;

[0043] (5) Light inspection, p...

Embodiment 3

[0045] A 5% (10ml: 0.5g) calcium gluconate oral solution, its prescription composition is: calcium gluconate 50g; lactic acid 5g; calcium hydroxide 0.2g; sucrose 200g; essence 0.05ml; purified water to 1000ml.

[0046] Its preparation method steps are as follows:

[0047] (1) According to the prescription amount, take calcium hydroxide, lactic acid and an appropriate amount of purified water, stir and dissolve, and make calcium lactate liquid for later use;

[0048] (2) Take purified water with 70% of the total amount (volume) of the preparation solution, heat to boil, add the prescribed amount of calcium gluconate, stir to dissolve completely, and obtain calcium gluconate liquid;

[0049] (3) Mix the above calcium lactate liquid and calcium gluconate liquid evenly, add sucrose to dissolve, then add essence, adjust the total amount to 1000ml with freshly boiled purified water, and stir evenly;

[0050] (4) Filtration, filling, and sterilization;

[0051] (5) Light inspection...

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Abstract

The invention relates to the technical field of pharmaceutical preparations, in particular to a calcium gluconate oral solution with the specification of 5% and a preparation method thereof. The formula of the calcium gluconate oral solution consists of 50g of calcium gluconate; 2g-5g of lactic acid; 0.2g-0.5g of calcium hydroxide; 80g-200g of sucrose; 0.05ml-0.2ml of essence; and 1000ml of purified water. The calcium gluconate oral solution with the specification of 5% prepared by the invention not only can well solve the problems that the quality of a calcium gluconate oral solution with thespecification of 10% in China at present is unstable and a supersaturated solution is prone to crystallize, but also cannot cause the change of a medicinal substance basis, cannot generate obvious influence on the absorption and utilization of medicines, and has the advantages of simple preparation process, excellent quality, high stability and safety performance and the like.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a 5% calcium gluconate oral solution and a preparation method thereof. Background technique [0002] Calcium gluconate is one of the commonly used organic calcium supplements, and its raw materials and related preparations are recorded in the pharmacopoeias of various countries. "Chinese Pharmacopoeia" 2015 Edition, Volume 2, and 2020 Edition, Volume 2, both contain calcium gluconate oral solution, calcium gluconate tablets, calcium gluconate buccal tablets, calcium gluconate injection, calcium gluconate granules, and compound calcium gluconate oral 6 kinds of preparations such as solution. Calcium gluconate oral solution is a unique preparation in my country, and foreign pharmacopoeias such as "US Pharmacopoeia", "European Pharmacopoeia", "Japanese Pharmacopoeia" and so on have not been recorded. [0003] Calcium gluconate oral solution is a pha...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/12A61K47/26A61K47/02A61K31/191A61P3/02A61P3/14A61P19/10
CPCA61K9/0095A61K47/12A61K47/26A61K47/02A61K31/191A61P3/02A61P3/14A61P19/10
Inventor 杨进明王德武黄燕
Owner 广西方略药业集团有限公司
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