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Enema liquid and preparation method thereof

A technology of enema solution and purified water, which is applied in the field of medicine, can solve the problem that tablets and granules cannot accurately divide the dosage, cannot meet the precise dosage of children under 6 years old, and affect the effectiveness of the drug , safety and compliance issues, to avoid liver first-pass effect, improve drug bioavailability, and avoid oral swallowing inconvenience

Inactive Publication Date: 2017-06-13
SOUTHWEST HOSPITAL OF CHONGQING
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The object of the present invention is to provide an enema and its preparation method, aiming at solving the problem that the current commercially available montelukast sodium dosage form for children cannot meet the requirement of accurately dividing the dosage due to the small dosage of tablets and granules. Precise dosage administration of children under 6 years old and especially infants and young children will affect the clinical requirements for medication for allergic diseases such as asthma, thus affecting the effectiveness, safety and compliance of the drug

Method used

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  • Enema liquid and preparation method thereof

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preparation example Construction

[0020] Such as figure 1 As shown, the preparation method of the enema solution provided by the embodiment of the present invention includes the following steps: take 6.0g-8.0g hydroxypropyl-β-cyclodextrin and dissolve it in 100g-200g of purified water above 60°C; add paraben Stir 0.3g~0.5g of ethyl ester until cold to make liquid A;

[0021] Take 200-600g of purified water, add 5g-10g of hydroxypropyl methylcellulose or 200g-400g of polyethylene glycol 6000, stir and dissolve to form B liquid;

[0022] After mixing liquids A and B, add 10 g of montelukast sodium and 10.0 g to 100.0 g of Tween 80, stir and dissolve until a clear solution, add purified water to 1000 g, and stir evenly to obtain an enema; after passing the test, quantify Subpackage.

[0023] The rectal administration of the micro-enema solution provided by the invention can avoid the trauma of injection administration, avoid difficulties such as inconvenient oral swallowing by infants, and because the administr...

Embodiment 1

[0026] The preparation method of the enema solution provided by the embodiment of the present invention comprises the following steps: taking 6.0 g of hydroxypropyl-β-cyclodextrin and dissolving it in 100 g of purified water above 60°C; adding 0.3 g of ethylparaben and stirring until cold into A liquid;

[0027] Take 200g of purified water, add 5g of hydroxypropyl methylcellulose or 200g of polyethylene glycol 6000 and stir to dissolve to form liquid B;

[0028] After mixing liquids A and B, add 10 g of montelukast sodium and 10.0 g of Tween 80 and stir to dissolve until the solution is clear, add purified water to 1000 g, and stir evenly to obtain an enema solution; after passing the test, carry out quantitative packaging.

Embodiment 2

[0030] The preparation method of the enema provided by the embodiment of the present invention comprises the following steps: take 8.0 g of hydroxypropyl-β-cyclodextrin and dissolve it in 200 g of purified water above 60°C; add 0.5 g of ethylparaben and stir until cold into A liquid;

[0031] Take 600g of purified water, add 10g of hydroxypropyl methylcellulose or 400g of polyethylene glycol 6000 and stir to dissolve to form liquid B;

[0032] After mixing liquids A and B, add 10 g of montelukast sodium and 100.0 g of Tween 80 and stir to dissolve until the solution is clear, add purified water to 1000 g, and stir evenly to obtain an enema solution; after passing the test, carry out quantitative packaging.

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Abstract

The invention discloses enema liquid and a preparation method thereof. The enema liquid comprises, by mass, 5.0-20.0g of montelukast, 10.0-100.0g of tween 80, 5-10g of hydroxypropyl methylcellulose, 0.3-0.5g of ethylparaben, 6.0-8.0g of hydroxypropyl-beta-cyclodextrin and the balance of purified water, wherein the total mass of the enema liquid is 1000g. The enema liquid has the advantages that precise dose adjustment is achieved through dose fractionation so as to prepare miniature montelukast enema gel, the problems that the dose of current montelukast tablets and granules cannot be accurate fractionated, inaccurate medicine taking dose caused by the swallowing difficulty of infants during oral medicine taking, and accordingly an uncertain curative effect and unpredictable adverse effects are caused can be avoided, medicine bioavailability is increased, and liver damage caused by medicine is reduced.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an enema liquid and a preparation method thereof. Background technique [0002] Asthma in infants and young children is a common clinical disease that seriously threatens the lives of children. Anti-inflammation and anti-allergy are important methods for the treatment of asthma. Montelukast sodium is a selective leukotriene receptor antagonist that specifically inhibits cysteinyl leukotriene receptors and has effects on the etiology of inflammation, allergic reactions, and asthma and is used in adults and children Prevention and long-term treatment of asthma, including prevention of daytime and nighttime asthma symptoms, treatment of asthma allergic to aspirin, prevention of exercise-induced bronchoconstriction, etc. [0003] Due to the differences between children's physiology and psychology and the process of drugs in the body and adults, the injection and oral ad...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/47A61K47/26A61K47/38A61K47/40A61K47/10A61K47/14A61P11/06A61P37/08
CPCA61K9/0031A61K9/08A61K31/47A61K47/10A61K47/14A61K47/26A61K47/38A61K47/40
Inventor 王章阳曹娅琪代青桂勤刘耀贾运涛
Owner SOUTHWEST HOSPITAL OF CHONGQING
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