Calcium-zinc gluconate oral solution and preparation method thereof

A technology of calcium zinc gluconate and calcium gluconate, which is used in pharmaceutical formulations, dispersion liquid delivery, aluminum/calcium/magnesium active ingredients, etc. , unbalanced and unstable solution systems, etc., to reduce the impact of human blood sugar concentration, fast filtration, and improve safety.

Inactive Publication Date: 2019-03-29
重庆健能医药开发有限公司
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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 high, which may cause tooth decay in children, hyperglycemia during pregnancy and senile diabetes, and sucrose is unstable at high temperatures above 40°C, which will cause the solution to change color; ( 2) The viscosity of the solution is relatively high, the filtration speed of the microporous membrane is slow, and the production efficiency is low; (3) Calcium gluconate is in a supersaturated state in the oral solution, and it is easy to crystallize and has poor stability
[0007] After research, the present invention provides a calcium-zinc gluconate oral solution without sucrose. Since calcium-zinc gluconate is a supersaturated solution, it is an unbalanced unstable solution system, which is easy to form crystal nuclei and precipitate crystallization. When using the calcium zinc gluconate oral solution containing sucrose, many unexpected difficulties were found, especially the clarity and stability of the solution were difficult to maintain. Therefore, the inventor carried out research on various formula ratios and preparation methods, and finally succeeded. Obtaining a kind of excellent oral solution formula and preparation method

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] 1. Prescription:

[0029] calcium gluconate

60g

Zinc gluconate

3g

Lysine hydrochloride

10g

lactic acid

2g

macrogol glyceride laurate

0.5g

Sucralose

0.2g

pineapple flavor

0.1g

sodium hydroxide

Appropriate amount (the required amount to adjust the pH value to 4.0-4.5)

Add purified water to

1000ml

[0030] 2. Process steps:

[0031] (1) Take 90% of the total amount of pure water, heat it to boiling for 10 minutes, and set aside;

[0032] (2) take the calcium gluconate of recipe quantity, stir 20 minutes, make it dissolve completely;

[0033] (3) Add zinc gluconate, lysine hydrochloride and other adjuvants in the prescribed amount successively, stir for 10 minutes, make it dissolve completely, and cool the solution to room temperature;

[0034] (4) Dilute to volume with freshly boiled purified water cooled to room temperature, and filter the medicinal solution through a 0.20 ...

Embodiment 2

[0039] 1. Prescription:

[0040] calcium gluconate

60g

Zinc gluconate

3g

Lysine hydrochloride

10g

lactic acid

1g

macrogol glyceride laurate

1g

Sucralose

0.3g

pineapple flavor

0.1g

sodium hydroxide

Appropriate amount (the required amount to adjust the pH value to 4.0-4.5)

Add purified water to

1000ml

[0041] 2. Process steps:

[0042] (1) Take 90% of the total amount of pure water, heat it to boiling for 15 minutes, and set aside;

[0043] (2) take the calcium gluconate of recipe quantity, stir 30 minutes, make it dissolve completely;

[0044] (3) Add zinc gluconate, lysine hydrochloride and other adjuvants in the prescribed amount successively, stir for 15 minutes, make it dissolve completely, and cool the solution to room temperature;

[0045] (4) Dilute to volume with freshly boiled purified water cooled to room temperature, and filter the medicinal solution through a 0.20 μm...

Embodiment 3

[0050] 1. Prescription:

[0051]

[0052]

[0053] 2. Process steps:

[0054] (1) Take 90% of the total amount of pure water, heat it to boiling for 20 minutes, and set aside;

[0055] (2) take the calcium gluconate of recipe quantity, stir 15 minutes, make it dissolve completely;

[0056] (3) Add zinc gluconate, lysine hydrochloride and other adjuvants in the prescribed amount successively, stir for 15 minutes, make it dissolve completely, and cool the solution to room temperature;

[0057] (4) Dilute to volume with freshly boiled purified water cooled to room temperature, and filter the medicinal solution through a 0.20 μm microporous membrane;

[0058] (5) Pack in a 10ml glass bottle and seal;

[0059] (6) Sterilize the sealed canned samples at 121° C. for 15 minutes.

[0060] (7) The sterilized sample is subjected to light inspection and packaged.

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Abstract

The invention relates to a pharmaceutical preparation composition and a preparation method of the pharmaceutical preparation composition, in particular to a calcium-zinc gluconate oral solution preparation composition. The composition comprises the following ingredients: 50-70g of calcium gluconate, 2-4g of zinc gluconate, 8-12g of lysine hydrochloride, 4-6g of lactic acid, 0.2-1g of gelucire 44-14, 0.1-0.5g sucralose, 0.05-0.2g of sodium hydroxide and 0.05-0.2g of essence per 1000ml calcium-zinc gluconate oral solution. The invention further provides a preparation method of the calcium-zinc gluconate oral solution. The ingredients in the calcium-zinc gluconate oral solution have a synergistic effect, and the calcium-zinc gluconate oral solution prepared finally is higher in stability andsafety.

Description

technical field [0001] The invention relates to a pharmaceutical preparation composition, in particular to a calcium zinc gluconate oral solution preparation composition and a preparation method thereof. Background technique [0002] Calcium zinc gluconate oral solution is a marketed drug for the treatment of diseases caused by calcium and zinc deficiency, including osteoporosis, tetany, osteodysplasia, rickets, pregnant women and lactating women, menopause Calcium supplementation for women, growth retardation in children, loss of appetite, anorexia, recurrent oral ulcers and acne, etc., the traditional prescription is: calcium gluconate 60g, zinc gluconate 3g, lysine hydrochloride 10g, sucrose 100g, chloride Add 0.1g of sodium, 1.2g of essence, appropriate amount of sodium hydroxide, and 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 combinati...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/26A61K47/12A61K47/14A61K33/06A61K33/30A61P3/14A61P3/12
CPCA61K9/0095A61K33/06A61K33/30A61K47/12A61K47/14A61K47/26A61P3/12A61P3/14A61K2300/00
Inventor 李于林刘萍王祖焕
Owner 重庆健能医药开发有限公司
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