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Valganciclovir hydrochloride oral solution and preparation method thereof

A technology of valganciclovir hydrochloride and oral solution, which is applied in the field of valganciclovir hydrochloride oral solution and its preparation, can solve the problems of short storage time and difficulty in making liquid preparations of valganciclovir hydrochloride, and reduce the Degradation degree, good clinical safety, stable quality effect

Active Publication Date: 2020-03-31
HUBEI KANGYUAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In view of this, the present invention aims to propose a kind of valganciclovir hydrochloride oral solution, to solve the problem that existing valganciclovir hydrochloride is difficult to be made into liquid preparation, and the storage time is shorter

Method used

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  • Valganciclovir hydrochloride oral solution and preparation method thereof
  • Valganciclovir hydrochloride oral solution and preparation method thereof
  • Valganciclovir hydrochloride oral solution and preparation method thereof

Examples

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Embodiment 1

[0025] A kind of valganciclovir hydrochloride oral solution, specifically made by the following method:

[0026] 1) Add valganciclovir hydrochloride, disodium edetate, sodium erythorbate, citric acid, and potassium sorbate to the propylene glycol in the solubilization system, heat to 40-50°C, stir, and make the ingredients After fully dissolving, filter with a filter cloth to obtain solution A;

[0027] 2) Add xanthan gum to the polyethylene glycol 200 in the solubilization system, heat to 40-50°C, stir to fully dissolve each component, then add to solution A, stir well to obtain solution B;

[0028] 3) Add the glycerol of the solubilizing system to the solution B, stir well, boil for 5 minutes, and cool to obtain the valganciclovir hydrochloride oral solution, wherein the valganciclovir hydrochloride oral solution can be filled.

[0029] In this example, the content of each component is shown in Table 1.

[0030] Table 1

[0031]

[0032] The valganciclovir hydrochlorid...

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Abstract

The invention provides a valganciclovir hydrochloride oral solution and a preparation method thereof, the valganciclovir hydrochloride oral solution is mainly composed of valganciclovir hydrochloride,a solubilizing system, a stabilizing system, a sweetener, an acidity regulator and a preservative; wherein the stabilizing system consists of a complexing agent, an antioxidant and a thickening agent; the contents of valganciclovir hydrochloride, the complexing agent, the antioxidant, the thickener, the sweetener, the acidity regulator and the preservative in the solubilizing system are respectively 7 to 12 percent (W / V), 0.08 to 0.12 percent (W / V), 0.12 to 0.18 percent (W / V), 0.15 to 0.25 percent (W / V), 0.06 to 0.12 percent (W / V), 18 to 22 percent (W / V) and 0.20 to 0.35 percent (W / V). According to the valganciclovir hydrochloride oral solution disclosed by the invention, the raw material medicines can be uniformly dispersed in the liquid solvent; according to the present invention, and are not hydrolyzed, such that the uniform and stable quality is provided, the xanthan gum is added to the acid solubilizing system so as to effectively reduce the degradation degree of valganciclovir hydrochloride, the valganciclovir hydrochloride degradation is less than 1.0% after the long-term sample reserving for 24 months, and the content uniformity RSD is less than 2%.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a valganciclovir hydrochloride oral solution and a preparation method thereof. Background technique [0002] Valganciclovir hydrochloride is the valine ester hydrochloride of ganciclovir, which is rapidly converted into ganciclovir in the body, and its antiviral activity spectrum and mechanism of action are completely similar to ganciclovir. The absolute oral bioavailability is 59.4±6.1%, which is 7 to 10 times higher than that of oral ganciclovir capsules. Oral valganciclovir hydrochloride tablets once a day can achieve the same therapeutic effect as ganciclovir intravenous administration for patients with CMV infection, while side effects such as bone marrow suppression are greatly reduced, the safety is better, and it is more convenient to use , patients do not need to be hospitalized or observed, which is helpful for doctors to determine the treatment pla...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/522A61K47/10A61K47/36A61P31/12
CPCA61K31/522A61K9/0095A61K47/10A61K47/36A61P31/12
Inventor 江强祝智熊友纯
Owner HUBEI KANGYUAN PHARMA
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