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Solid preparation of telbivudine liposome
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A technology of telbivudine and solid preparation, applied in the field of medicine, can solve the problems of low bioavailability, long dissolution time, many times of taking medicine, etc., and achieves high bioavailability, good sustained release effect and excellent dissolution. Effect
Inactive Publication Date: 2013-04-17
海南路易丹尼生物科技有限公司
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[0007] At present, there are telbivudine ordinary tablets in the domestic marketed drugs, but this dosage form has the following problems: due to reasons such as preparation technology, most oral preparations of drugs have long dissolution time, low dissolution rate, and poor absorption after taking. Poor, high frequency of medication, uncontrollable drug release, hepatic and intestinal first-pass effect and low bioavailability, etc., which affect the efficacy of the drug and directly affect the therapeutic effect, so its bioavailability is low
[0013] However, the challenge in preparing liposomes lies in selecting the appropriate liposome composition and formulation
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Embodiment 1
[0075] Example 1 Telbivudine liposome tablet
[0076] The raw and auxiliary materials used are as follows:
[0077]
[0078]
[0079] Adopt following production process to prepare telbivudine liposome tablet:
[0080] (1) Accurately weigh 3000g egg yolklecithin, 1500g dipalmitoylphosphatidylglycerol, 1500g cholesterol acetyl ester, 600g Tween 80, dissolve in 5000ml ethanol and isopropanol mixed solvent with a volume ratio of 2:1, stir to make its dissolution;
[0081] (2) Put the above solution in an eggplant-shaped bottle, remove ethanol and isopropanol under reduced pressure in a water bath at 45°C, and form a uniform transparent film on the wall of the bottle;
[0082] (3) Dissolve 600g of telbivudine in 5000ml of phosphatebuffer solution with a pH value of 7.0, and add the solution into the above-mentioned eggplant-shaped bottle, and continue to rotate in a water bath at 45°C under normal pressure to swell and hydrate the film;
[0083] (4) Filter the above so...
Embodiment 2
[0087] Example 2 Telbivudine liposome tablet
[0088] The raw and auxiliary materials used are as follows:
[0089]
[0090] Adopt following production process to prepare telbivudine liposome tablet:
[0091] (1) Accurately weigh 7000g egg yolklecithin, 3500g dipalmitoylphosphatidylglycerol, 3500g cholesterol acetyl lipid, 100g Tween 80, dissolve in 10000ml of a mixed solvent of ethanol and isopropanol with a volume ratio of 2:1, and stir to make its dissolution;
[0092] (2) Put the above solution in an eggplant-shaped bottle, remove ethanol and isopropanol under reduced pressure in a water bath at 45°C, and form a uniform transparent film on the wall of the bottle;
[0093] (3) Dissolve 600g of telbivudine in 10,000ml of phosphatebuffer solution with a pH value of 7.0, and add the solution to the above-mentioned eggplant-shaped bottle, and continue to rotate in a water bath at 45°C under normal pressure to swell and hydrate the film;
[0094] (4) Filter the above s...
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Abstract
The invention discloses a solid preparation of a telbivudine liposome and a preparation method thereof. An active component telbivudine, specific combined egg yolklecithin, dipalmitoyl phosphatidylglycerol, cholesterol acetyl ester and Tween 80 are prepared into the liposome, so that the stability, the dissolvability and the bioavailability of the solid preparation of the telbivudine liposome are greatly improved and the solid preparation of the telbivudine liposome is steady and lasting in effect and significant in therapeutic effect; and the product quality of the solid preparation of the telbivudine liposome is improved and toxic and side effects of the solid preparation of the telbivudine liposome are reduced.
Description
technical field [0001] The invention relates to a new preparation of telbivudine, in particular to a telbivudine liposome solid preparation and a preparation method, and belongs to the technical field of medicine. Background technique [0002] Hepatitis B is a common infectious disease caused by hepatitis B virus infection. The pathogenesis of hepatitis B is that after hepatitis B virus infects the human body, the virus itself does not directly cause liver cell lesions, but survives and replicates in the liver cells. The antigen it replicates is expressed on the liver cell membrane It stimulates the body's immune system to recognize and thus attack and clearly respond to an infection. Among them, acute hepatitis B is when the immune system of the body has a healthy immune system and is activated to recognize the hepatitis B virus to attack the infected liver cells and eliminate it; chronic hepatitis B is when the immune function of the hepatitis B virus is activated after th...
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