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External preparation of ganciclovir and application thereof

An external preparation, the technology of ganciclovir, applied in the field of medicine, can solve the problems of irregular recurrence, inability to be completely cured, HSV-2 can not be cured, etc., and achieve the effect of excellent antiviral effect

Pending Publication Date: 2022-02-15
北京鼎实医药科技有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

More than 400 million people around the world are infected with this virus, and HSV-2 infection is currently incurable, which has caused huge medical and public health problems
[0003] In the clinical treatment of herpes virus, nucleoside analogues (accyclovir or valacyclovir) are mainly used, which stop the ongoing DNA chain extension by inhibiting viral DNA polymerase, and can effectively resist HSV- 2 Infection, reducing the severity and duration of symptoms, but cannot be completely cured, the latent virus will still be reactivated when the immune state is disturbed, causing irregular recurrence of the disease

Method used

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  • External preparation of ganciclovir and application thereof
  • External preparation of ganciclovir and application thereof
  • External preparation of ganciclovir and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 11

[0032] The selection of embodiment 1.1 auxiliary material kind

[0033] In the research and development process, the inventor has carried out the compatibility test of raw materials and auxiliary materials, wherein Table 1 is the ratio of raw materials and auxiliary materials, and Table 2 is the stability test.

[0034] Table 1 Proportion of raw and auxiliary materials

[0035]

[0036]

[0037] Prepare according to the ratio of raw materials and auxiliary materials in Table 1 respectively, mix each raw material and auxiliary materials evenly, melt the solid oil phase matrix and mix it with API (i.e. ganciclovir), directly mix the liquid matrix, and mix the water phase solid auxiliary material preparation with API mix. The mixed materials were placed under light and high temperature conditions of 40°C, and samples were taken for testing after 10 days. The results are shown in Table 2.

[0038] Table 2 Stability test results

[0039]

[0040]

[0041] The result...

Embodiment 12

[0042] Example 1.2 The selection of the amount of auxiliary materials—the screening of the amount of polymer matrix (carbomer)

[0043] In this example, taking carbomer as an example, the influence of dosage on the gel preparation was studied, and the prescriptions in Table 3 were screened.

[0044] table 3

[0045]

[0046] Preparation method: (1) Add the prescribed amount of carbomer into purified water accounting for 40% of the total weight, stir to fully swell, and form a uniform dispersion;

[0047] (2) After dissolving sodium hydroxide, ganciclovir, benzalkonium chloride and glycerin with purified water accounting for 50% of the total weight, add the filtrate to the dispersion in step (1), and stir while adding;

[0048] (3) Use triethanolamine to adjust the pH value to about 7, add purified water to a sufficient amount (100%), and stir to form a uniform gel.

[0049] Observe or measure the character, pH value, and viscosity of the product prepared above. The resul...

Embodiment 1

[0053] The determination of the pH value range of embodiment 1.3 gel

[0054] The external preparation of the present invention belongs to a semi-solid preparation, and the pH value is a key quality attribute. Therefore, the pH value range of the external preparation of the present invention is screened to determine a suitable pH range that can make the preparation stable. The pH value of human skin is about It is 5.5~7.0, and ganciclovir is unstable under acidic conditions, so the proposed investigation range of the present invention is 5.5~7.5. The recipes used are shown in Table 5.

[0055] table 5

[0056]

[0057] Preparation method: (1) Add the prescribed amount of carbomer into purified water accounting for 40% of the total weight, stir to fully swell, and form a uniform dispersion;

[0058] (2) After dissolving sodium hydroxide, ganciclovir, benzalkonium chloride and glycerin with purified water accounting for 50% of the total weight, add the filtrate to the dispe...

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Abstract

The invention relates to an external preparation of ganciclovir and application thereof. The external preparation is prepared from the following raw materials: ganciclovir, a polymer matrix and a pH regulator. Compared with acyclovir gel, the external preparation of ganciclovir disclosed by the invention has a better antiviral effect.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an external preparation of ganciclovir and its application. Background technique [0002] Herpes simplex virus type II (HSV-2), a typical member of the alphaherpesvirus subfamily, infects the epithelium causing genital herpes, remains latent in the peripheral nervous system and spreads to the central nervous system, resulting in lifelong latent infection. More than 400 million people around the world are infected with this virus, and the infection of HSV-2 is currently incurable, which has caused huge medical and public health problems. [0003] In the clinical treatment of herpes virus, nucleoside analogues (accyclovir or valacyclovir) are mainly used, which stop the ongoing DNA chain extension by inhibiting viral DNA polymerase, and can effectively resist HSV- 2. Infection reduces the severity and duration of symptoms, but it cannot be completely cured. The latent...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/06A61K31/522A61K47/06A61K47/10A61K47/14A61K47/32A61K47/36A61K47/44A61P31/22
CPCA61K31/522A61K9/06A61K47/32A61K47/36A61K47/14A61K47/44A61K47/06A61K47/10A61P31/22
Inventor 刘实杨芬芬崔琳邓姿萍
Owner 北京鼎实医药科技有限责任公司
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