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A kind of valganciclovir hydrochloride oral solution and preparation method thereof

A technology of valganciclovir hydrochloride and oral solution, applied in the field of valganciclovir hydrochloride oral solution and preparation, can solve the problems of valganciclovir hydrochloride being difficult to be made into a liquid preparation, short storage time, etc. The effect of good safety, reducing the degree of degradation and stabilizing the quality

Active Publication Date: 2022-03-01
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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  • A kind of valganciclovir hydrochloride oral solution and preparation method thereof
  • A kind of valganciclovir hydrochloride oral solution and preparation method thereof
  • A kind of 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 mainly consists of valganciclovir hydrochloride, a solubilizing system, a stabilizing system, a sweetener, and an acidity regulator. The valganciclovir hydrochloride, the complexing agent, the antioxidant, the thickening agent , the content of the sweetener, the acidity regulator, and the preservative in the solubilization system are respectively 7-12% (W / V), 0.08-0.12% (W / V), 0.12-0.12% 0.18% (W / V), 0.15‑0.25% (W / V), 0.06‑0.12% (W / V), 18‑22% (W / V), 0.20‑0.35% (W / V). Each crude drug in the valganciclovir hydrochloride oral solution of the present invention can be uniformly dispersed in the liquid solvent without being hydrolyzed, so that it has uniform and stable quality, and the addition of xanthan gum in the acid solubilizing system can effectively reduce the For the degree of degradation of valganciclovir hydrochloride, the degradation of valganciclovir hydrochloride was less than 1.0% and the RSD of content uniformity was less than 2% as measured by long-term retention of samples for 24 months.

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 Patents(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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