Lamivudine solid dispersion, and preparation method, pharmaceutical composition and use of the dispersion
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A solid dispersion, lamivudine technology, applied in the field of medicine, can solve the problems of high production cost, many influencing factors, operator injury and so on
Inactive Publication Date: 2013-11-20
ANHUI PIOM PHARMA
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Problems solved by technology
However, the preparation process of microspheres is cumbersome, and there are many influencing factors. Microspheres with high drug loading (drug loading is often less than 30%) cannot be obtained. The production cost is relatively large, and the participation of organic solvents is often required, which is harmful to operators. Great damage, also has a certain damage to the environment
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Embodiment 1
[0059] Feeding amount:
[0060] Lamivudine 6.0g
[0061] mPEG-PLA (Mw=750 / 10000) 6.0g
[0062] Triethyl citrate 1.8g
[0063] Cholesterol 0.12g
[0064] Povidone K30 0.08g
[0065] Preparation method: Take mPEG-PLA, lamivudine, triethyl citrate, cholesterol, povidone K30, mix well, heat to melt, shear until evenly mixed, cool, pulverize, collect solid dispersion, namely have to.
[0066] Lamivudine content: 39.7%.
[0067] In this example, the molecular structural formula of mPEG-PLA is
[0068]
[0069] Among them: m≈17, n≈138.
Embodiment 2
[0071] Feeding amount:
[0072] Lamivudine 8.4g
[0073] mPEG-PLA (Mw=2000 / 5000) 5.6g
[0074] Preparation method: Take mPEG-PLA and lamivudine, mix them evenly, heat until melted, shear until mixed evenly, cool, pulverize, and collect the solid dispersion to obtain the product.
[0075] Lamivudine content: 60.2%.
[0076] In this example, the molecular structural formula of mPEG-PLA is
[0077]
[0078] Among them: m≈45, n≈69.
Embodiment 3
[0080] Feeding amount:
[0081] Lamivudine 0.8g
[0082] mPEG-PLA (Mw=2000 / 80000) 8.0g
[0083] Preparation method: Take mPEG-PLA and lamivudine, mix them evenly, heat until melted, shear until mixed evenly, cool, pulverize, and collect the solid dispersion to obtain the product.
[0084] Lamivudine content: 8.5%.
[0085] In this example, the molecular structural formula of mPEG-PLA is
[0086]
[0087] Among them: m≈45, n≈1111.
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Abstract
The invention relates to lamivudine solid dispersion and a preparation method and a use of the lamivudine solid dispersion. The lamivudine solid dispersion provided by the invention is prepared by using a methoxy-terminated polyethylene glycol-polylactic acid block copolymer and derivatives of the block copolymer, polylactic acid, polylactic acid-glycolic acid copolymer or polycaprolactone as carrier materials by a hot melting method. The preparation method of the lamivudine solid dispersion provided by the invention avoids use of an organic solvent. The lamivudine solid dispersion provided by the invention can be applied in subcutaneous injection or intramuscular injection for treating chronic hepatitis B.
Description
technical field [0001] The invention relates to the technical field of medicine. Specifically, the present invention relates to a lamivudine solid dispersion, as well as the preparation method and application of the solid dispersion. Background technique [0002] Lamivudine, English name Lamivudine, chemical name: (2R-cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-1H-pyrimidine -2-ketone is mainly used clinically to treat chronic hepatitis B. [0003] Lamivudine is a nucleoside analog, and nucleotides are the raw materials for the synthesis of human genetic material DNA and RNA (DNA and RNA are actually composed of many nucleotides arranged in a long string hand in hand). Nucleoside analogs mimic the structure of nucleotides in structure, but do not have the function of nucleotides. Therefore, in the process of DNA synthesis, nucleoside analogs can be incorporated, but they cannot synthesize nucleic acid chains with normal functions, so that the replication of the v...
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Application Information
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