Preparation method of calcium zinc gluconate oral solution

A technology of calcium zinc gluconate and calcium gluconate, which is applied in the field of medicine, can solve problems such as low production efficiency, easy crystallization, and high viscosity of the solution, so as to reduce the impact of human blood sugar concentration, reduce safety risks, and fast filtration speed Effect

Inactive Publication Date: 2019-07-02
HUNAN QIANJIN XIELI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The above-mentioned improved calcium zinc gluconate oral solution still has the following disadvantages: (1) the sucrose content is high, which may cause tooth decay in children, hyperglycemia during pregnancy, and diabetes in the elderly. Large, slow filtration of microporous membrane, low production efficiency; in addition, the high sugar content of sucrose leads to supersaturated state of calcium gluconate in oral solution, easy to crystallize and precipitate, and poor stability
(2) Substances such as aspartame, benzoic acid, or sodium benzoate were used. Although the prescription addition amounts of these substances met the national standards, some experimental studies have proved that aspartame and sodium benzoate have certain physiological toxicity

Method used

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  • Preparation method of calcium zinc gluconate oral solution
  • Preparation method of calcium zinc gluconate oral solution
  • Preparation method of calcium zinc gluconate oral solution

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Embodiment 1. in a kind of calcium zinc gluconate oral solution, comprise the component of following parts by weight:

[0019] Calcium gluconate 600 parts;

[0020] Zinc gluconate 30 parts;

[0021] 100 parts of lysine hydrochloride;

[0022] 120 parts of lactic acid;

[0023] Stevia 10 parts;

[0024] 10 parts of cool alcohol;

[0025] 5 parts of ethylparaben;

[0026] 10 parts of essence;

[0027] Appropriate amount of sodium hydroxide (the amount required to adjust the pH to 4.0-5.0);

[0028] Purified water 10000 parts.

[0029] The preparation method of above-mentioned calcium zinc gluconate oral solution comprises the following steps:

[0030] (1) Boil 8L of purified water for 20 minutes, add calcium gluconate, and keep boiling for 10 minutes to obtain reagent 1;

[0031] (2) Reagent 2 obtained by adding zinc gluconate, lysine hydrochloride, stevioside and cool alcohol to reagent 1 obtained in step (1), and keeping boiling for 40 minutes;

[0032] (3) Ad...

Embodiment 2-4

[0036] The formulation components and preparation method of Examples 2-4 are the same as those of Example 1, except that the amounts of stevioside, ethylparaben and essence are different, see Table 1 for the specific amounts.

[0037] The calcium zinc gluconate oral solution obtained by using the formula in Examples 1-4 was tested for mouthfeel and fragrance, and the results are shown in Table 1 below.

[0038] Table 1: Experimental results of different amounts of stevioside, ethylparaben and essence (parts by weight)

[0039]

[0040] In the above table, flavors include but not limited to apple flavor and sweet orange juice flavor. From the experimental results in the above table, it can be seen that the weight ratio of stevioside, essence and relieving alcohol is 12:12:14 and the experimental effect is the best.

Embodiment 5-8

[0042] The formula components and preparation methods of Examples 5-8 are the same as those in Example 1, except that the amount of ethylparaben is different, see Table 2 for the specific amount.

[0043] The calcium zinc gluconate oral solution obtained by utilizing the formula in Examples 5-8 was subjected to a bacteriostatic efficacy test, and the results are shown in Table 2 below.

[0044] Table 2: The bacteriostatic effect test bacterial count of the ethylparaben of different consumptions drops lg value (weight part)

[0045]

[0046] In the bacteriostatic efficacy test, take 10ml of the test product for bacteriostatic test, add pH 7.0 sterile sodium chloride-peptone buffer to 100ml, and make a 1:10 test solution. Prepare 5 parts of test product, blank oral liquid solution and diluent. Each solution to be tested is inoculated with a test bacterium, and an appropriate amount of the test product is taken, and transferred to 5 suitable sterile containers, each container...

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Abstract

The present invention discloses a preparation method of a calcium zinc gluconate oral solution and mainly solves technical problems that existing sucrose has high sugar content and substances of aspartame, benzoic acid or sodium benzoate, etc. are used. Technical proposal main points are as follows: the calcium zinc gluconate oral solution comprises main medicines and accessory medicines, the mainmedicines comprise calcium gluconate, zinc gluconate and lysine hydrochloride, and the accessory medicines are characterized by containing steviosin, sorbitol and ethylparaben. The calcium zinc gluconate oral solution is mainly applied in the technical field of medicines.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to an oral solution for calcium and zinc supplementation and a preparation method thereof. Background technique [0002] Calcium Zinc Gluconate Oral Solution is a marketed drug, and its indications are diseases caused by calcium deficiency and zinc, including osteoporosis, tetany, rickets, calcium supplementation for pregnant women, lactating women and menopausal women, And children's growth retardation, anorexia, anorexia, recurrent oral ulcers and acne. The traditional prescription is: calcium gluconate 60g, zinc gluconate 3g, lysine hydrochloride 10g, sucrose 100g, sodium chloride 0.1g, essence 1.2g, sodium hydroxide amount, purified water to 1000ml. In recent years, some studies have improved the prescription, changing the flavoring agent in the prescription to aspartame and acesulfame-K alone or in combination with aspartame and acesulfame-K, and adding benzoic acid or sodiu...

Claims

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Application Information

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IPC IPC(8): A61K31/198A61K31/191A61K31/19A61K9/08A61K47/26A61K47/14A61P3/02
CPCA61K9/0095A61K31/19A61K31/191A61K31/198A61K33/30A61K47/14A61K47/26A61K2300/00
Inventor叶胜利
OwnerHUNAN QIANJIN XIELI PHARMA CO LTD