Calcium zinc gluconate oral solution and preparation method thereof

Abstract

The invention provides a calcium zinc gluconate oral solution and a preparation method thereof, and relates to the field of medicines. The calcium zinc gluconate oral solution is prepared from the following raw materials: calcium gluconate, zinc gluconate, lysine hydrochloride, lactic acid, sucralose, a preservative and water, and the flavoring agent is prepared from sucralose and juicy peach essence in a mass ratio of (0.7-0.8): (0.8-1.2). Each liter of the calcium zinc gluconate oral solution is prepared from the following raw materials by weight: 55.8 to 64.2 g of calcium gluconate, 3.72 to 4.28 g of zinc gluconate, 9.3 to 10.7 g of lysine hydrochloride, 12.6 to 15.4 g of lactic acid, 1.5 to 2.0 g of a flavoring agent, 0.9 to 1.1 g of a preservative and the balance of water. According to the calcium zinc gluconate oral solution, calcium gluconate, zinc gluconate and lysine hydrochloride are used as active ingredients, lactic acid is used as a cosolvent, sucralose and juicy peach essence are used as a flavoring agent, sodium benzoate is used as a preservative, purified water is used as a solvent, and the prepared calcium zinc gluconate oral solution is good in taste and good in stability; the quality of the calcium zinc gluconate oral solution is effectively improved.

Description

Technical Field

[0001] The invention relates to the field of pharmaceutical preparations, and in particular to a calcium zinc gluconate oral solution and a preparation method thereof. Background Art

[0002] The main ingredients of calcium gluconate zinc oral solution include calcium gluconate, zinc gluconate and lysine hydrochloride, which play an important role in promoting children's growth and development and enhancing immune function. Among them, calcium gluconate helps maintain the normal development and health of bones and teeth, and prevents related diseases such as rickets and osteoporosis; zinc gluconate also plays a positive role in children's growth, improving taste and appetite, and enhancing immunity; lysine hydrochloride, as an essential amino acid, can promote growth and development, enhance immunity and enhance the function of the central nervous system. These ingredients work together to enhance the intake of important nutrients such as calcium and zinc. Indications of calcium gluconate zinc oral solution: used to treat diseases caused by calcium and zinc deficiency, including osteoporosis, tetany, bone dysplasia, rickets, calcium supplementation for pregnant and lactating women, menopausal women, growth retardation in children, lack of appetite, anorexia, recurrent oral ulcers and acne.

[0003] The existing preparation methods of calcium gluconate zinc oral solution have many problems, such as poor taste, complicated preparation process, poor product stability, etc. These problems not only reduce the palatability, but also affect the quality of the final product. The present invention further develops and optimizes the prescription and process of calcium gluconate zinc oral solution, aims to improve the quality of calcium gluconate zinc oral solution, and has great significance. Summary of the invention

[0004] In view of this, the present invention provides a calcium zinc gluconate oral solution and a preparation method thereof to solve the above problems.

[0005] The technical solution of the present invention is achieved in this way:

[0006] A calcium gluconate zinc oral solution is prepared from the following raw materials: calcium gluconate, zinc gluconate, lysine hydrochloride, lactic acid, sucralose, a preservative and water, wherein the flavoring agent is sucralose and peach essence in a mass ratio of 0.7-0.8:0.8-1.2.

[0007] A further technical solution is that the sucralose is anhydrous sucralose.

[0008] A further technical solution is that each liter of calcium gluconate zinc oral solution contains the following raw materials by weight: 55.8-64.2 g of calcium gluconate, 3.72-4.28 g of zinc gluconate, 9.3-10.7 g of lysine hydrochloride, 13-15 g of lactic acid, 1.5-2.0 g of flavoring agent, 0.9-1.1 g of preservative, and the balance of water.

[0009] A further technical solution is that the preservative is sodium benzoate.

[0010] A further technical solution is that each liter of calcium gluconate zinc oral solution contains the following raw materials by weight: 55.8-64.2 g of calcium gluconate, 3.72-4.28 g of zinc gluconate, 9.3-10.7 g of lysine hydrochloride, 12.6-15.4 g of lactic acid, 0.7-0.8 g of sucralose, 0.8-1.2 g of peach flavor, 0.9-1.1 g of preservatives, and the balance of water.

[0011] A further technical solution is that each liter of calcium gluconate zinc oral solution contains the following raw materials by weight: 60g of calcium gluconate, 3g of zinc gluconate, 10g of lysine hydrochloride, 14g of lactic acid, 0.75g of sucralose, 1g of peach flavor, 1g of preservative and the remainder of water.

[0012] The preparation method of calcium zinc gluconate oral solution of the present invention comprises the following steps:

[0013] (1) Take 80-90% v / v of the total amount of the prescription water, raise the temperature to 75° C. to 95° C., add lactic acid to the water under stirring, then add calcium gluconate, zinc gluconate and lysine hydrochloride, then add preservatives, and finally add flavoring agents, keep the temperature and stir, cool the solution to room temperature, add the remaining amount of water, and obtain a solution;

[0014] (2) filtering the prepared solution using a filter membrane;

[0015] (3) Fill the filtered sample.

[0016] A further technical solution is that in step (1), the pH value of the prepared solution is 3.0-4.0.

[0017] A further technical solution is: step (2), filter membrane material: polypropylene, filter membrane pore size: 0.75-0.85 μm.

[0018] A further technical solution is that in step (1), lactic acid is first added to water under stirring, and stirred at 40-60 rpm for 1-2 min; calcium gluconate, zinc gluconate and lysine hydrochloride are then added, and stirred at 100-150 rpm for 4-6 min; a preservative is then added, and stirred at 200-300 rpm for 1-2 min; and a flavoring agent is finally added, and stirred at 20-30 rpm for 5-10 min.

[0019] Compared with the prior art, the present invention has the following beneficial effects:

[0020] (1) The calcium gluconate zinc oral solution prepared by the prescription and process of the present invention has calcium gluconate, zinc gluconate and lysine hydrochloride as active ingredients, lactic acid as a cosolvent, sucralose + peach essence as a flavoring agent, sodium benzoate as a preservative, and purified water as a solvent. The prepared calcium gluconate zinc oral solution not only has a good taste but also has good stability, thereby effectively improving the quality of the calcium gluconate zinc oral solution.

[0021] (2) Moreover, the specific liquid preparation process of the present invention is not only conducive to reducing the amount of lactic acid added, but also shortening the liquid preparation time, improving the stability of the preparation, and is conducive to improving the quality of the calcium zinc gluconate oral solution. DETAILED DESCRIPTION

[0022] In order to better understand the technical content of the present invention, specific examples are provided below to further illustrate the present invention. The experimental methods used in the examples of the present invention are all conventional methods unless otherwise specified.

[0023] Unless otherwise specified, the materials, reagents, etc. used in the embodiments of the present invention can be obtained from commercial sources.

[0024] The sucralose used in the embodiment of the present invention is anhydrous sucralose.

[0025] Table 1 Information on raw materials and auxiliary materials

[0026] name factory Calcium Gluconate Jiangxi New Ganjiang Pharmaceutical Co., Ltd. Zinc Gluconate Jiangxi New Ganjiang Pharmaceutical Co., Ltd. Lysine Hydrochloride Hubei Bafeng Pharmaceutical Chemical Co., Ltd. lactic acid Sichuan Jinshan Pharmaceutical Co., Ltd. Sucralose Jiangxi Alpha Hi-Tech Pharmaceutical Co., Ltd. Sodium Benzoate Hubei Gedian Renfu Pharmaceutical Excipients Co., Ltd. Peach flavor Senxin Flavor & Color Technology (China) Co., Ltd. Sodium calcium glass oral liquid bottle Chongqing Zhengchuan Pharmaceutical Packaging Materials Co., Ltd. Aluminum-plastic combination cover for oral liquid bottle Chongqing Zhengchuan Pharmaceutical Packaging Materials Co., Ltd.

[0027] Example 1 - Preparation of calcium zinc gluconate oral solution

[0028]

prescription

[0029] Table 2 Prescription table

[0030] Material Name Dosage(g) Calcium Gluconate 60 Zinc Gluconate 3 Lysine Hydrochloride 10 lactic acid 14 Sucralose 0.75 Sodium Benzoate 1 Peach flavor 1 Purified water Moderate to 1000ml

[0031]

Technology

[0032] (1) Take 80% v / v of the total amount of the prescription in water, raise the temperature to 85°C, add lactic acid to the water under stirring, then add calcium gluconate, zinc gluconate and lysine hydrochloride, then add preservatives (sodium benzoate), and finally add flavoring agents (sucralose + peach flavor), keep warm and stir for 45 minutes (stirring speed is 100 rpm), cool the solution to room temperature, add the remaining amount of water, and make up to volume;

[0033] (2) Filter using a membrane, membrane material: polypropylene, membrane pore size: 0.8 μm;

[0034] (3) The filtered sample is filled in a volume of 10 ml. The packaging material is a soda-lime glass tube oral liquid bottle. The oral liquid bottle uses an aluminum-plastic composite cap to roll-cap the filled sample.

[0035] Table 3 Test results and taste

[0036]

[0037] Stability test

[0038] The calcium gluconate zinc oral solution was placed under accelerated conditions such as high temperature of 60°C and light for 30 days. The results showed that compared with 0 days, the properties, pH value and content of the calcium gluconate zinc oral solution met the requirements after 30 days under accelerated conditions, and there was no significant difference, and the stability was good.

[0039] Example 2

[0040] The difference from Example 1 is that the temperature is raised to 75°C. Specifically, 80% v / v of the total amount of the prescription is taken in water, the temperature is raised to 75°C, lactic acid is first added to the water, followed by calcium gluconate, zinc gluconate and lysine hydrochloride, and then a preservative (sodium benzoate), and finally a flavoring agent (sucralose + peach flavor) is added, the solution is stirred and dissolved, and the remaining amount of water is added after the solution is cooled to room temperature. Other treatments are consistent with Example 1.

[0041] The results showed that the properties, pH value and content of the calcium zinc gluconate oral solution prepared in this example all met the requirements.

[0042] Example 3

[0043] The difference from Example 1 is that the temperature is raised to 95°C. Specifically, 80% v / v of the total amount of the prescription is taken in water, the temperature is raised to 95°C, lactic acid is first added to the water, followed by calcium gluconate, zinc gluconate and lysine hydrochloride, then a preservative (sodium benzoate), and finally a flavoring agent (sucralose + peach flavor), the solution is stirred and dissolved, and the remaining amount of water is added after the solution is cooled to room temperature. Other treatments are consistent with Example 1.

[0044] The results showed that the properties, pH value and content of the calcium zinc gluconate oral solution prepared in this example all met the requirements.

[0045] Example 4

[0046] The difference from Example 1 is that the amount of lactic acid is adjusted to 11.34 g / L, and the stirring speed and stirring time of the feed are adjusted at the same time.

[0047] Specifically (1) Take 80% v / v of the total amount of the prescription in water, raise the temperature to 85°C, add lactic acid to the water under stirring, and stir at 50rpm for 1min; then add calcium gluconate, zinc gluconate and lysine hydrochloride and stir at 120rpm for 5min; then add preservatives and stir at 250rpm for 1min; finally add flavoring agents and stir at 25rpm for 8min, add the remaining water after the solution is cooled to room temperature, and make up to volume. Other treatments are consistent with Example 1. The results show that the properties, pH value and content of the calcium gluconate zinc oral solution prepared in this example meet the requirements.

[0048] The calcium gluconate zinc oral solution was placed under accelerated conditions such as high temperature of 60°C and light for 90 days. The results showed that compared with 0 days, the properties, pH value and content of the calcium gluconate zinc oral solution met the requirements after 90 days under accelerated conditions, and there was no significant difference, and the stability was better.

[0049] In summary, the liquid preparation process of this embodiment is not only conducive to reducing the amount of lactic acid added, but also shortens the liquid preparation time, improves the stability, and improves the quality of the preparation.

[0050] Comparative Example 1

[0051] The difference from Example 1 is that the peach flavor is replaced by snow pear powder flavor, and the other treatments are consistent with Example 1. The test results show that the calcium gluconate zinc oral solution prepared in this example has a sour taste.

[0052] Comparative Example 2

[0053] The difference from Example 1 is that sucralose is replaced by acesulfame potassium, and the other treatments are the same as those in Example 1. The test results show that the calcium gluconate zinc oral solution prepared in this example has a greasy taste.

[0054] Comparative Example 3

[0055] The difference from Example 1 is that the amount of sucralose and peach essence in the flavoring agent is adjusted. Specifically: sucralose 1g / L, peach essence 0.75g / L. Other treatments are consistent with Example 1. The test results show that the calcium gluconate zinc oral solution prepared in this example tastes sweet, and the taste changes significantly after 30 days under high temperature 60°C accelerated conditions, and the taste stability is poor.

[0056] Comparative Example 4

[0057] The difference from Example 1 is that the heat preservation and stirring time is extended to 60 min.

[0058] Specifically: take 80% v / v of the total amount of the prescription in water, raise the temperature to 85°C, add lactic acid to the water under stirring, then add calcium gluconate, zinc gluconate and lysine hydrochloride, then add preservatives (sodium benzoate), and finally add flavoring agents (sucralose + peach flavor), keep warm and stir for 60 minutes (stirring speed is 100rpm), add the remaining water after the solution is cooled to room temperature, and fix the volume. Other treatments are consistent with Example 1. The results show that the calcium gluconate zinc oral solution prepared in this example produces degradation impurity pentahydroxymethylfurfural.

[0059] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the principles of the present invention should be included in the protection scope of the present invention.

Claims

1. A calcium zinc gluconate oral solution, characterized in that: The invention comprises the following raw materials: calcium gluconate, zinc gluconate, lysine hydrochloride, lactic acid, sucralose, a preservative and water; the flavoring agent comprises sucralose and peach essence in a mass ratio of 0.7-0.8:0.8-1.

2.

2. The calcium gluconate zinc oral solution according to claim 1, characterized in that Each liter of calcium zinc gluconate oral solution contains the following raw materials by weight: 55.8-64.2g of calcium gluconate, 3.72-4.28g of zinc gluconate, 9.3-10.7g of lysine hydrochloride, 11.34-15.4g of lactic acid, 1.5-2.0g of flavoring agent, 0.9-1.1g of preservative, and the balance of water.

3. The calcium gluconate zinc oral solution according to claim 1, characterized in that The sucralose is anhydrous sucralose.

4. The calcium gluconate zinc oral solution according to claim 1, characterized in that The preservative is sodium benzoate.

5. The calcium gluconate zinc oral solution according to claim 2, characterized in that: Each liter of calcium zinc gluconate oral solution contains the following raw materials by weight: 55.8-64.2g of calcium gluconate, 3.72-4.28g of zinc gluconate, 9.3-10.7g of lysine hydrochloride, 13-15g of lactic acid, 0.7-0.8g of sucralose, 0.8-1.2g of peach flavor, 0.9-1.1g of preservatives, and the balance water.

6. The calcium gluconate zinc oral solution according to claim 5, characterized in that Each liter of calcium zinc gluconate oral solution contains the following raw materials by weight: 60g of calcium gluconate, 3g of zinc gluconate, 10g of lysine hydrochloride, 14g of lactic acid, 0.75g of sucralose, 1g of peach flavor, 1g of preservative and the balance of water.

7. The method for preparing the calcium gluconate zinc oral solution according to any one of claims 1 to 6, characterized in that: The following steps are involved: (1) Take 80% to 90% v / v of the total amount of the prescription water, raise the temperature to 75° C. to 95° C., add lactic acid to the water under stirring, then add calcium gluconate, zinc gluconate and lysine hydrochloride, then add a preservative, and finally add a flavoring agent, keep the temperature and stir, cool the solution to room temperature, add the remaining amount of water, and obtain a solution; (2) filtering the prepared solution using a filter membrane; (3) Fill the filtered sample.

8. The method for preparing the calcium gluconate zinc oral solution according to claim 7, characterized in that: In step (1), the pH value of the prepared solution is 3.0-4.

0.

9. The method for preparing calcium gluconate zinc oral solution according to claim 7, characterized in that: Step (2), filter membrane material: polypropylene, filter membrane pore size: 0.75-0.85 μm.

10. The method for preparing the calcium zinc gluconate oral solution according to claim 7, characterized in that: Step (1) is to first add lactic acid into water under stirring, and stir at 40-60 rpm for 1-2 min; then add calcium gluconate, zinc gluconate and lysine hydrochloride, and stir at 100-150 rpm for 4-6 min; then add preservative, and stir at 200-300 rpm for 1-2 min; finally add flavoring agent, and stir at 20-30 rpm for 5-10 min.

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