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Stable chloral hydrate syrup as well as preparation method, quality control method and application thereof

A technology of chloral hydrate syrup and chloral hydrate, which is applied in the field of medicine, can solve the problems of poor stability, harsh storage conditions, and short validity period of chloral hydrate, and achieve the effects of accurate dosage, scientific design, and stable properties

Pending Publication Date: 2021-04-16
CHENGDU SHIBEIKANG BIOLOGICAL MEDICINE TECH CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] One of the purposes of the present invention is to provide a stable chloral hydrate syrup that does not need to be refrigerated, is easy to use, does not need to be newly prepared before use, and solves the problems of poor stability, harsh storage conditions, and short validity period of chloral hydrate in the prior art. problem of dilution

Method used

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  • Stable chloral hydrate syrup as well as preparation method, quality control method and application thereof
  • Stable chloral hydrate syrup as well as preparation method, quality control method and application thereof
  • Stable chloral hydrate syrup as well as preparation method, quality control method and application thereof

Examples

Experimental program
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Effect test

preparation example Construction

[0064] Preparation of reference solution: Accurately weigh an appropriate amount of 5-hydroxymethylfurfural reference substance, dissolve it with 10mmol / L potassium dihydrogen phosphate solution (adjust the pH value to 4.0 with phosphoric acid)-acetonitrile (85:15) to make a concentration of 5.0 μg / ml of the reference substance solution;

[0065] Preparation of the test solution: get an appropriate amount of chloral hydrate syrup test sample, accurately weighed, dissolve or dilute and constant volume with mobile phase, to obtain a test solution with a chloral hydrate concentration of about 1 mg / ml;

[0066] Get each 10 μ L of need testing solution, reference substance solution, inject liquid chromatograph respectively, measure according to described chromatographic conditions, record chromatogram, according to the chromatogram of need testing solution and the chromatogram of reference substance solution, determine the The content of 5-hydroxymethylfurfural in the product solu...

Embodiment 1

[0076] The present embodiment discloses the prescription of chloral hydrate syrup of the present invention and preparation method thereof, and prescription is:

[0077]

[0078] The preparation method is as follows: respectively take prescription quantities of sodium benzoate and stevioside, add appropriate amount of purified water respectively, stir until dissolved, and prepare sodium benzoate solution and stevioside solution. Weigh the prescribed amount of chloral hydrate, add an equal amount of 0.1M hydrochloric acid solution, stir until completely dissolved, and prepare a chloral hydrate solution.

[0079] Preparation of syrup: Weigh 50g of sucrose and 12g of purified water in a beaker, heat and boil for 10min, when the temperature drops to about 50°C, add the prescribed amount of glycerin, stevia solution, sodium benzoate solution, stir for 15min, cool down to about 25°C, add Stir and mix the chloral hydrate solution, adjust the pH value to 2.0 with hydrochloric acid s...

Embodiment 2

[0081] This example discloses the investigation of different pHs of chloral hydrate syrup. The preparation method of the chloral hydrate syrup described in this embodiment is the same as that of Example 1, the only difference being that the final adjusted pH value is different. . The prepared samples with different pH values ​​were placed at 60°C for 30 days, and the degradation products chloroform and 5-hydroxymethylfurfural were used as indicators to conduct stability investigations. The results are shown in the table below:

[0082] Table 5. Results of Stability Investigation of Chloral Hydrate Syrup with Different pH Values ​​(pH: 2.0~4.0)

[0083]

[0084] From the test results in Table 5, it can be seen that within the range of pH 2.0 to pH 4.0, as the pH increases, the content of the degradation product chloroform in each numbered sample gradually increases. According to the requirements of the residual solvent limit, The control limit of chloroform in the chloral...

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Abstract

The invention discloses stable chloral hydrate syrup as well as a preparation method, a quality control method and application thereof, belongs to the technical field of medicines, and solves the problems that chloral hydrate is poor in stability, harsh in storage condition and short in validity period and needs to be diluted during use in the prior art. The stable chloral hydrate syrup comprises chloral hydrate, cane sugar and water, the mass volume concentration of chloral hydrate is 10%, and the pH value of the chloral hydrate syrup is 2.3-3.0. The chloral hydrate syrup disclosed by the invention also comprises glycerol. The chloral hydrate syrup disclosed by the invention adopts the specification that the concentration of chloral hydrate used clinically is 10%, does not need to be newly prepared when in use, and is accurate in dosage, safe, controllable and stable in property.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a stable chloral hydrate syrup, its preparation method, quality control method and application. Background technique [0002] At present, there are no sedative-hypnotic preparations approved by the State Food and Drug Administration that can be produced by pharmaceutical companies and suitable for children's examinations. Hospital preparations of chloral hydrate are generally used in clinical pediatric examinations. [0003] Chloral hydrate is also known as chloral hydrate, its chemical name is 2,2,2-trichloro-1,1-ethylene glycol, and its molecular formula is C 2 h 3 Cl 3 o 2 , has a sedative and hypnotic effect. Field surveys in many domestic hospitals show that chloral hydrate oral solution or chloral hydrate syrup is the sedative and hypnotic drug that has been used for the longest time, is the most widely used, is the most mature, and is used in the largest...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K31/11A61K47/10A61K47/26A61J3/00G01N30/02G01N30/06G01N30/34A61P25/20
Inventor 牟霞姚秋鸣易泽琴苏永文张海张蓉曾燕群
Owner CHENGDU SHIBEIKANG BIOLOGICAL MEDICINE TECH CO LTD
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