A kind of compound gargle of chlorhexidine gluconate and preparation method thereof

A technology of chlorhexidine gluconate and gargle, which is applied in the field of medicine, can solve problems such as unstable product quality and precipitation during storage, and achieve the effects of reducing the production of harmful substances p-chloroaniline, strengthening curative effect, and prolonging the therapeutic effect

Active Publication Date: 2017-09-05
SHENZHEN SOUTH CHINA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In order to solve the technical problems that the existing chlorhexidine gluconate compound gargle produces the harmful substance p-chloroaniline during the preparation process, the product quality is unstable during the preparation process, and precipitation occurs during the storage process, a glucose Chlorhexidine acid compound gargle and preparation method thereof

Method used

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  • A kind of compound gargle of chlorhexidine gluconate and preparation method thereof
  • A kind of compound gargle of chlorhexidine gluconate and preparation method thereof
  • A kind of compound gargle of chlorhexidine gluconate and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0021] Experimental example 1: the selection of polysorbate 80, polyethylene glycol 400 dosage

[0022] 1. Purpose of the experiment

[0023] To investigate the effect of the dosage of polysorbate 80 and polyethylene glycol 400 on the quality of chlorhexidine gluconate compound gargle of the present invention.

[0024] 2. Equipment: dissolving tank (barrel), stirrer, several 1000ml beakers, several 1000ml volumetric flasks, several weighing instruments, several pipettes, one 1000ml measuring cylinder, several 200ml compound gargle bottles.

[0025] 3. Materials: configure the corresponding required raw and auxiliary materials for the chlorhexidine gluconate compound gargle of the present invention. As in Table 1.

[0026] Table 1: configure the corresponding raw and auxiliary materials required for the chlorhexidine gluconate compound gargle of the present invention

[0027]

[0028] 4. Operation steps:

[0029] 4.1 Dosage of polysorbate 80:

[0030] 4.1.1 Prepare the ...

experiment example 2

[0055] Experimental Example 2: The way of adding lemon yellow pigment

[0056] 1. Purpose of the experiment

[0057] To explore the effect of the way of adding tartrazine on the product quality of chlorhexidine gluconate compound gargle of the present invention.

[0058] 2. Equipment: Same as Experiment 1.

[0059] 3. Materials: Same as experimental example 1.

[0060] 4. Operation steps:

[0061]4.1 Prepare 4 parts of 5000ml intermediate solution according to the process prescription in Table 2 without adding lemon yellow pigment as follows:

[0062] 4.1.1 Take 5.5g of polysorbate 80 and 1g of metronidazole raw powder and add them to container A and stir at a stirring speed of 60 rpm. After stirring for 20 minutes, continue stirring and take 223g of ethanol and add in five times , 45g each time for the first four times, 43g for the fifth time, then add 1.85g banana essence, 50g mint water and stir for 20 minutes at a stirring speed of 60 rpm to obtain feed liquid A;

[0...

experiment example 3

[0079] Experimental example 3: sodium saccharin, peppermint water concentration affect the mouthfeel of chlorhexidine gluconate compound gargle of the present invention

[0080] 1. Purpose of the experiment

[0081] 1) Discuss the effect of sodium saccharin and peppermint water concentration on the mouthfeel of the chlorhexidine gluconate compound gargle of the present invention, and seek the best mouthfeel sodium saccharin and peppermint water formula.

[0082] 2) Discuss the influence of saccharin sodium and peppermint water concentration on the quality of chlorhexidine gluconate compound gargle of the present invention.

[0083] 2. Equipment: Same as Experiment 1.

[0084] 3. Materials: Same as experimental example 1.

[0085] 4. Operation steps:

[0086] 4.1 Experiment with only changing the dosage of sodium saccharin:

[0087] 4.1.1 Prepare the intermediate solution for the experiment: According to the process prescription in Table 2, prepare 5000ml of the intermediat...

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Abstract

The invention discloses a chlorhexidine gluconate compound gargle and a preparation method thereof. The chlorhexidine gluconate compound gargle is made of the following raw materials in parts by weight: polysorbate 80 is 5.5-6 parts, formazan 0.8-1.2 parts of nidazole powder, 220-225 parts of ethanol, 310-315 parts of glycerin, 275-300 parts of polyethylene glycol 400, 115-125 parts of chlorhexidine gluconate, 42.225-72.728 parts of excipients, Appropriate amount of purified water. The raw materials of the invention complement each other and play a synergistic role, which can assist in the prevention and treatment of oral diseases and improve the effect of oral care. In the preparation process of the chlorhexidine gluconate compound gargle of the present invention, the stability of the product is improved by adjusting the amount of auxiliary materials, the feeding method and even the order of feeding, which not only greatly reduces the generation of the harmful substance p-chloroaniline in the preparation process , and effectively solve the existing chlorhexidine gluconate compound gargle in the preparation process, which is easy to produce turbidity, crystallization and other quality problems.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a compound gargle of chlorhexidine gluconate and a preparation method thereof. Background technique [0002] Oral disease in our country is one of the most extensive and universal health problems, and the incidence rate is high, which is very harmful to human health, but it is often not taken seriously by people. In order to assist the prevention and treatment of oral diseases and improve the effect of oral care, gargles are commonly used for oral care. The use of medicated gargle can effectively inhibit the formation of plaque and improve the inflammation of the gums. [0003] The active ingredients of the chlorhexidine gluconate compound gargle are chlorhexidine and metronidazole. In the preparation process of the existing chlorhexidine gluconate compound gargle, the impurities produced are mainly the harmful substance p-chloroaniline, which can be absorbed throu...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4164A61K8/60A61K8/49A61K9/08A61P1/02A61P31/02A61P31/04A61P31/10A61Q11/00A61K31/155
Inventor 苏宏瑞卢锦华冯永兵刘庆萃
Owner SHENZHEN SOUTH CHINA PHARMA
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