Famciclovir sustained-release pellet, preparation method and application thereof

A technology of sustained-release pellets and famciclovir, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, and the digestive system. Effects of compliance, reduction of side effects, and reduction of times of taking medication

Active Publication Date: 2015-02-11
LIVZON PHARM GRP INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the large number of daily medications and the long course of treatment, the patient's medication compliance will be poor, and it is prone to poor curative effect due to missed doses

Method used

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  • Famciclovir sustained-release pellet, preparation method and application thereof
  • Famciclovir sustained-release pellet, preparation method and application thereof
  • Famciclovir sustained-release pellet, preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] The present embodiment provides in the famciclovir sustained-release pellets, the medicinal solution prescription and preparation method of the main drug layer, specifically as follows:

[0045] Liquid prescription 1:

[0046]

[0047] Use the solution application method to wrap the main drug layer drug solution of the above prescription outside the blank ball core, and the specific operation is as follows:

[0048] Turn on the fluidized bed, send 250g of sucrose pellets (0.4-0.6mm) into the fluidized bed, after adjusting the parameters, put 2700g of the liquid medicine prepared according to the prescription into the fluidized bed by the peristaltic pump, and spray it on medicine, and make medicine pellets. The yield is not less than 90%.

[0049] Liquid prescription 2:

[0050]

[0051] Use the solution application method to wrap the main drug layer drug solution of the above prescription outside the blank ball core, and the specific operation is as follows: ...

Embodiment 2

[0067] The present embodiment provides in the famciclovir sustained-release pellets, the coating liquid prescription of sustained-release layer and preparation method thereof, specifically as follows:

[0068] Coating Solution Prescription 1:

[0069]

[0070] Wrap the coating solutions of the above different prescriptions on the outside of the drug pellets, the specific operation is as follows:

[0071] Turn on the fluidized bed, send 400 g of the famciclovir drug pellets (0.8-0.9 mm) prepared according to the prescription 1 of the traditional Chinese medicine solution in Example 1 into the fluidized bed, spray and coat the coating solution, and carry out in a 40° C. oven after coating Aged for 12h.

[0072] Coating Solution Prescription 2:

[0073]

[0074] Wrap the coating solutions of the above different prescriptions on the outside of the drug pellets, the specific operation is as follows:

[0075] Turn on the fluidized bed, send 400 g of the famciclovir drug pel...

Embodiment 3

[0091] In this example, samples were taken at different coating amounts of polymers during the preparation of sustained-release pellets, and their release rates were measured. The specific results are as follows.

[0092] The release rate is measured with reference to the first method of Appendix XD of the Chinese Pharmacopoeia 2005 edition, the details are as follows. Adopt the device of the first method of dissolution measurement method, with 0.1mol / L hydrochloric acid 750ml as solvent, rotating speed is 100 revolutions per minute, operate according to law, through 1.5 hours, get solution 10ml, filter, as need testing solution 1, in time Add 10ml of 0.1mol / L hydrochloric acid to the operating container, and at the same time add 250ml of 0.2mol / L sodium phosphate solution at 37°C to the 0.1mol / L hydrochloric acid (use 2mol / L hydrochloric acid solution or 2mol / L sodium hydroxide solution if necessary) Adjust the pH value to 6.8 ± 0.05); take 10ml of the solution at 3 hours and...

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Abstract

The invention provides a famciclovir sustained-release pellet, a preparation method and an application thereof. The famciclovir sustained-release pellet provided by the invention is composed of a blank pellet core used as a core, a main drug layer containing famciclovir and coating the pellet core, and a sustained-release coating layer coating the main drug layer; the weight of polymer contained in the sustained-release coating layer is 8-15% of the total weight of the blank pellet core and the main drug layer. The famciclovir sustained-release pellet is prepared by a spraying method. According to the famciclovir sustained-release pellet provided by the invention, not only the high drug release rate of the famciclovir sustained-release pellet in an acidic medium is significantly inhibited, but also the final complete release is not influenced; and the following release degree scopes can be realized: 10-30% (1.5 hours), 30-70% (3 hours), and not less than 90% (8 hours).

Description

technical field [0001] The invention belongs to the field of pharmacy, and relates to famciclovir sustained-release pellets, a preparation method and application thereof. Background technique [0002] Famciclovir (famciclovir) is the prodrug of penciclovir (penciclovir, PVC), and its molecular formula is C 14 h 19 N 5 o 4 , has inhibitory effect on herpes simplex virus type I (HSV-I), type II (HSV-II), herpes zoster virus (VZV) and hepatitis B virus (HBV), and is clinically used to treat herpes zoster and facial herpes and genital herpes, its curative effect is better than that of acyclovir, which is commonly used in clinical practice. The role of famciclovir in treating hepatitis B has also been paid more and more attention by people. At present, famciclovir, as a new drug for treating chronic hepatitis B, is undergoing clinical research. [0003] Famciclovir is rapidly absorbed after oral administration, removes two acetyl groups through relevant enzymes in the intest...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K9/22A61K9/52A61K31/52A61K47/32A61K47/34A61K47/38A61P1/16A61P31/20A61P31/22
Inventor 王亚娜马小玲金鑫侯雪梅
Owner LIVZON PHARM GRP INC
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