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Injection preparation containing Entecavir serving as active ingredient
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A technology of entecavir and active ingredients, which is applied in the field of preparations administered by injection and its preparation, and can solve problems such as delayed onset time
Inactive Publication Date: 2011-05-18
TIANJIN TIANCHENG PHARMA
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Embodiment 1
[0034] Take 3g of Entecavir, put it in a container, add 1g of solubilizer polyvinylpyrrolidone, 80ml of water for injection, add 0.2g of sodiumhydroxide, stir to dissolve, add 1mol / L citric acid to adjust the pH to 7-9.0, add mannitol 28g, lactose 22g, stir to dissolve, add water to 100ml. Add 0.5g of activated carbon, stir at 30°C for 20 minutes, decarburize, filter and sterilize with a microporous membrane, divide the filtrate into 1ml tubes, pre-freeze for 2 hours, and dry under reduced pressure for 12 hours until After the temperature of the sample reached room temperature, it was dried for another 5 hours to obtain a white loose block, which was sealed to obtain the entecavir freeze-dried powder injection.
Embodiment 2
[0036] Take 5g of Entecavir, put it in a container, add PEG60002g, 180ml of water for injection, stir to dissolve, adjust the pH to 5.0-9.0 with 1mol / L hydrochloric acid or sodiumhydroxide, add 80g of mannitol and 20g of sorbitol, stir to dissolve, Add water to 200ml. Add 0.5g of activated carbon, stir at 30°C for 20 minutes, decarburize, filter and sterilize with a microporous membrane, divide the filtrate into 2ml tubes, pre-freeze for 2 hours, and dry under reduced pressure for 18 hours until After the temperature of the sample reached room temperature, it was dried for another 5 hours to obtain a white loose block, which was sealed to obtain the entecavir freeze-dried powder injection.
Embodiment 3
[0038] Take 2g of Entecavir, put it in a container, add 1g of poloxamer, add 180ml of water for injection, stir to dissolve, adjust the pH to 5.0-9.0 with 1mol / L hydrochloric acid or sodiumhydroxide, add 70g of mannitol, 30g of lactose, Stir to dissolve, add water to 200ml, add 0.5g of activated carbon, stir at 20°C for 40 minutes, decarburize, filter and sterilize with a microporous membrane, divide the filtrate into 2ml per tube, pre-freeze for 2 hours, Freeze and dry under reduced pressure for 15 hours. After the temperature of the sample reaches room temperature, dry for another 5 hours to obtain a white loose block, which is then sealed to obtain the entecavir freeze-dried powder.
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Abstract
The invention relates to an injection preparation containing Entecavir serving as an active ingredient and a preparation method thereof. The injection preparation is characterized by consisting of Entecavir serving as the active ingredient, a water soluble filler, a pH regulator, a solubilizer, an antioxygen, water for injection and an osmotic pressureregulator, wherein Entecavir serving as the active ingredient accounts for 0.002 to 50 percent of the weight of the injection preparation, and medicinal auxiliary materials and water account for the balance. The invention also discloses preparation methods of freeze-dried preparation, small-needle injection and small infusion solution. The injection preparation containing Entecavir serving as the active ingredient is suitable for treating acute exacerbation of hepatitis.
Description
technical field [0001] The invention belongs to the field of pharmaceutical preparations, and more specifically relates to an injection-administered preparation containing an active ingredient entecavir and a preparation method thereof. Background technique [0002] Hepatitis B virus (HBV) is exclusively hepatotropic Virus , in recent years due to nucleic acid Advances in Molecular Hybridization in Extrahepatic Organs cell HBV-DNA can also be detected. Evidence of replication in extrahepatic cells was provided by experimental studies of HBV in Peking ducks. Human HBV may also replicate in extrahepatic cells, which needs to be further studied. There are three types of virus particles in the serum of HBV-infected patients by electronmicroscopy: ① Dane particles (HBV particles), the coat proteinHBsAg, the core contains HBV-DNA and HBV DNAp (DNA-polymerase), HBcAg, HBeAg; ② small spherical particles; ③ tubular particles . The latter two are excess extraviral (HBsAg) du...
Claims
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Application Information
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