Calcium and zinc gluconate oral solution composition and preparation method thereof

A technology of calcium zinc gluconate and calcium gluconate, which is applied in the field of pharmaceutical preparations, can solve the problems of complex preparation process, easy precipitation of crystallization, poor stability, etc., and achieves the effects of simple preparation process, wide applicability to people, and enhanced stability.

Active Publication Date: 2015-07-29
HEBEI RENHE YIKANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The above-mentioned calcium zinc gluconate oral solution that has been on the market has the following disadvantages: (1) the sucrose content is relatively high, which may cause tooth decay in children, hyperglycemia during pregnancy and senile diabetes; , low production efficiency; (3) Calcium gluconate is supersaturated in oral solution, easy to precipitate crystallization, poor stability
[0004] Although the prior art has made certain improvements to the above-mentioned shortcomings, such as CN103690521A, CN102526009A, CN102038670A, and CN103070852A disclose prescriptions and / or preparation techniques of various calcium-zinc gluconate oral solutions, but all do not completely solve the above-mentioned problems, and even bring about Defects such as increased cost, complex preparation process, and difficulty in improving stability

Method used

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  • Calcium and zinc gluconate oral solution composition and preparation method thereof
  • Calcium and zinc gluconate oral solution composition and preparation method thereof
  • Calcium and zinc gluconate oral solution composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] The preparation of embodiment 1 calcium zinc gluconate oral solution of the present invention

[0025] prescription:

[0026]

[0027] Preparation Process:

[0028] (1) Take 80% purified water, add lactic acid and stir to dissolve;

[0029] (2) Heat the material obtained in step (1) to 50-80°C, add calcium gluconate, stir for 20-30 minutes to completely dissolve, and stop heating;

[0030] (3) adding zinc gluconate and other auxiliary materials to the material obtained in step (2), stirring and dissolving;

[0031] (4) Add water to the material obtained in step (3) to the full amount, sterilize at 121° C. for 8 minutes, and potting, the specification is 10 mL / bottle.

Embodiment 2

[0032] The preparation of embodiment 2 calcium zinc gluconate oral solution of the present invention

[0033] prescription:

[0034]

[0035] Preparation Process:

[0036] (1) Take 80% purified water, add lactic acid and stir to dissolve;

[0037] (2) Heat the material obtained in step (1) to 50-80°C, add calcium gluconate, stir for 20-30 minutes to completely dissolve, and stop heating;

[0038] (3) adding zinc gluconate and other auxiliary materials to the material obtained in step (2), stirring and dissolving;

[0039] (4) Add water to the full amount of the material obtained in step (3), filter through a 0.22-1.0 μm microporous membrane, potting, and the specification is 10 mL / cartridge.

experiment example

[0066] Experimental example The stability research of calcium zinc gluconate oral solution of the present invention

[0067] The calcium zinc gluconate oral solution prepared by embodiment 1-2 and comparative example 1-2 is carried out stability test (high temperature 60 ℃, low temperature 4 ℃, place respectively 10 days), the results are as follows:

[0068] Table 1 High Temperature 60°C Stability Test Results

[0069]

[0070] Table 2 Low Temperature 4°C Stability Test Results

[0071]

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PUM

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Abstract

The invention provides stable calcium and zinc gluconate oral solution composition and a preparation method thereof. The calcium and zinc gluconate oral solution composition comprises calcium gluconate, zinc gluconate, L-lysine monohydrochloride and lactic acid, and a corrective agent, a preservative, a flavoring agent and the like can also be added. The calcium and zinc gluconate oral solution composition has the advantages of high quality, good stability, simple preparation technology and the like.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a calcium zinc gluconate oral solution composition and a preparation method thereof. Background technique [0002] Calcium Zinc Gluconate Oral Solution is a marketed drug, indicated for diseases caused by calcium deficiency and zinc, including osteoporosis, tetany, bone dysplasia, rickets, pregnant women, lactating women and menopausal women Calcium supplementation, as well as growth retardation in children, anorexia, recurrent oral ulcers and acne, etc., the prescription is: calcium gluconate 60g, zinc gluconate 3g, lysine hydrochloride 10g, lactic acid 6g, sucrose 100g, Add 0.1g of sodium chloride, 1.2g of essence, appropriate amount of sodium hydroxide and purified water to 1000mL. [0003] The above-mentioned calcium zinc gluconate oral solution that has been on the market has the following disadvantages: (1) the sucrose content is relatively high, which ...

Claims

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Application Information

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IPC IPC(8): A61K31/198A61K31/191A61K9/08A61P3/02
Inventor 牛菁菁
Owner HEBEI RENHE YIKANG PHARMA
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