Ganciclovir tablet composition and its preparation method

A technology of ganciclovir hydrate and lovir tablet, which is applied in the field of ganciclovir tablet composition, can solve the problems of difficult quality standard control, high packaging and storage costs, increased mixing difficulty, etc. Improve bioavailability, accurate dosage and stable effect

Active Publication Date: 2012-01-11
SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, dispersible tablets also have their own limitations. In the production process, it is generally required to micronize the raw material drug, which increases the production process; and the micronized drug is prone to static electricity during the mixing process, which increases the difficulty of mixing; The cost of choosing a good disintegrant is relatively high; the quality requirements are relatively high, and it is difficult to control quality standards, etc.
At the same time, the storage conditions are also more demanding than ordinary tablets. Due to the large disintegration dose and strong hygroscopicity used in dispersible tablets, the requirements for the moisture resistance effect of packaging materials are higher, so the packaging and storage costs are higher.

Method used

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  • Ganciclovir tablet composition and its preparation method
  • Ganciclovir tablet composition and its preparation method
  • Ganciclovir tablet composition and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Preparation of ganciclovir hydrate crystals:

[0029] At a temperature of 65°C, 10g of ganciclovir was dissolved in 90ml of acetic acid-water mixed solvent (the volume ratio of acetic acid to water was 3 / 2), and the ganciclovir solution was slowly cooled to -5°C to precipitate crystals, and then Stand at 5°C for 6 hours, filter, and wash the filter cake with acetone three times to obtain ganciclovir hydrate crystals. Thermogravimetric analysis showed that ( figure 1 Shown), the content of the water of crystallization that contains in the ganciclovir crystal that obtains is 9.60% (theory is 9.57%), promptly contains 1.5 water of crystallization, the X-ray powder diffraction of gained ganciclovir hydrate crystal ( figure 2 Shown) the characteristic peaks are displayed at 5.46°, 7.25°, 11.45°, 15.62°, 16.21°, 17.64°, 18.15°, 19.54°, 22.55° and 23.71° diffraction angles.

Embodiment 2

[0031] Preparation of ganciclovir hydrate crystals:

[0032] Under the condition that the temperature is 70°C, 10g of ganciclovir is dissolved in 85ml of acetic acid-water mixed solvent (the volume ratio of acetic acid to water is 2 / 1), and the temperature of the ganciclovir solution is slowly cooled to -5°C to precipitate The crystals were left to stand at 5° C. for 7 hours, filtered, and the filter cake was washed with acetone for 3 times to obtain ganciclovir hydrate crystals. Show through powder XRD detector and thermogravimetric analysis, accord with the result shown in the accompanying drawing of embodiment 1 product.

Embodiment 3

[0034] Preparation of ganciclovir hydrate crystals:

[0035] Under the condition that the temperature is 60°C, 10g of ganciclovir is dissolved in 90ml of acetic acid-water mixed solvent (the volume ratio of acetic acid to water is 5 / 3), the temperature of the ganciclovir solution is slowly cooled to 0°C, and crystals are precipitated , and then stood at 0° C. for 7 hours, filtered, and the filter cake was washed twice with acetone to obtain ganciclovir hydrate crystals. Show through powder XRD detector and thermogravimetric analysis, accord with the result shown in the accompanying drawing of embodiment 1 product.

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PUM

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Abstract

A ganciclovir tablet composition. The ganciclovir tablet composition comprises the following components of: by weight, 1part of ganciclovir hydrate crystals, 0.1-0.5 part of lactose, 0.05-0.08 part of hydroxypropylcellulose, 0.008-0.014 part of carboxyl methyl starch sodium, a proper amount of polyvinylpyrrolidone K30 and 0.01-0.05 part of magnesium stearate, wherein the brief molecular formula of the ganciclovir hydrate crystals is C9H13N504.1.5H2O; the weight of the ganciclovir hydrate crystals is calculated according to the weight of ganciclovir; and major peaks in powder XRD of the crystals are shown at diffraction angles of 5.45+ / -0.1 degrees, 7.28+ / -0.1 degrees, 11.45+ / -0.1 degrees, 15.67+ / -0.1 degrees and the like. The preparation technology of the prepared ganciclovir tablets is simple; tablets have good stability; dosage is accurate; active components are easy to dissolve; and the bioavailability of the active components is raised.

Description

technical field [0001] The invention relates to a ganciclovir tablet composition and a preparation method of the tablet. Background technique [0002] Ganciclovir (ganciclovir) has broad-spectrum antiherpes virus activity and is the first effective antiviral drug for the treatment of human cytomegalovirus (CMV) infection. The inhibitory effect on cytomegalovirus is one of the most active antiviral drugs approved for use so far, and the incidence of adverse reactions is low. It is currently recognized as the first choice drug for the treatment of cytomegalovirus, and it is also an indispensable prevention of organ transplantation. and therapeutic drugs. Ganciclovir is widely distributed in various tissues in the body, and can pass through the placenta. The concentration in the cerebrospinal fluid is 7%-67% of the blood concentration in the same period; it can also enter the intraocular tissue, and the distribution volume (Vd) is 0.74L / kg, the protein binding rate is low, 1...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/522A61K47/38A61P31/22
Inventor 陈雨高菲菲朱绪辉
Owner SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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