Calcium zinc gluconate oral solution and preparation method thereof

A technology of calcium zinc gluconate and calcium gluconate, applied in the field of pharmaceutical preparations

Inactive Publication Date: 2021-06-04
海南涛生医药科技研究院有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In order to solve the defects of the prior art, the invention provides a calcium zinc gluconate oral solution, under the premise of ensuring the dosage of calcium gluconate, the problem of crystal precipitation will not occur at a lower ambient temperature, and the prepared product can be used even in Freezing phenomenon occurs at extremely low temperature, as long as the precipitated calcium gluconate can be redissolved after the temperature recovers, the oral liquid is still in a transparent and clear state

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] prescription:

[0034] calcium gluconate 60g Zinc gluconate 3g Lysine hydrochloride 10g lactic acid 6g aspartame 2g sodium benzoate 0.5g sodium hydroxide 0.11g Purified water to a volume of 1000mL

[0035] Preparation Process:

[0036] Take 800mL of purified water, add solubilizer and stir to dissolve, heat to a slight boil for 30 minutes, add 60g of calcium gluconate and stir to dissolve, keep a slight boil and reflux for 30 minutes, continue to stir after cooling to room temperature, add 3g of zinc gluconate, 10g of lysine hydrochloride, aspirin Dissolve 2g of Patan and 0.5g of sodium benzoate; use an appropriate amount of sodium hydroxide to adjust the pH of the solution to 4.5, add the remaining purified water to make the volume to 1000mL; filter the prepared solution through a plate frame first, then pass through 0.8μm and Filtrate with 0.22μm microporous membrane; fill the sterilized solution into PVC / PE c...

Embodiment 2

[0038] prescription:

[0039] calcium gluconate 60g Zinc gluconate 3g Lysine hydrochloride 10g lactic acid 10g aspartame 2g sodium benzoate 0.5g sodium hydroxide 0.18g Purified water to a volume of 1000mL

Embodiment 3

[0041] prescription:

[0042] calcium gluconate 60g Zinc gluconate 3g Lysine hydrochloride 10g lactic acid 12g aspartame 2g sodium benzoate 0.5g sodium hydroxide 0.21g Purified water to a volume of 1000mL

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Abstract

The invention discloses a calcium zinc gluconate oral solution. Every 1000mL of the oral solution contains 60g of calcium gluconate, 3g of zinc gluconate, 10g of lysine hydrochloride, 6-15g of a solubilizer, 0.5-2g of a flavoring agent and a proper amount of sodium hydroxide for adjusting the pH value of the solution to 3.8-4.5, wherein the solubilizer is one or a combination of more than two of lactic acid, citric acid and gluconic acid. Furthermore, the calcium zinc gluconate oral solution also contains a calcium gluconate solubility regulator poloxamer 407, and the proportion of the poloxamer 407 in every 1000mL of the oral solution is less than or equal to 12% (g/v). The calcium zinc gluconate oral solution provided by the invention does not have the problem of crystal precipitation at a relatively low environment temperature on the premise of ensuring the dosage of calcium gluconate. In addition, even if an icing phenomenon occurs at an extremely low temperature, the calcium gluconate in the oral solution is still in a dissolved state as long as the precipitated calcium gluconate can be redissolved after the temperature is recovered.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a calcium zinc gluconate oral solution and a preparation method of the oral solution. Background technique [0002] Calcium zinc gluconate oral solution is a marketed drug used to treat various diseases caused by calcium deficiency and zinc deficiency. Its main indications include osteoporosis, tetany, bone dysplasia, rickets, pregnant women, Calcium supplementation for breastfeeding women and postmenopausal women, children with growth retardation, anorexia, anorexia, recurrent oral ulcers and acne, etc. At present, the main manufacturers of calcium zinc gluconate oral solution include Aonuo (China) Pharmaceutical Co., Ltd., Hubei Furen Jinshen Pharmaceutical Co., Ltd., and Hubei Wushi Pharmaceutical Co., Ltd. The formula of ordinary calcium zinc gluconate oral solution on the market is: 60g calcium gluconate, 3g zinc gluconate, 10g lysine hydroch...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/315A61K31/191A61K31/198A61K9/08A61K47/12A61K47/10A61P3/02
CPCA61K9/0095A61K31/191A61K31/198A61K33/30A61K47/10A61K47/12A61P3/02A61K2300/00
Inventor 汪淮胜陈太博王辉
Owner 海南涛生医药科技研究院有限公司
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