Artemisinin or its derivative sustained release preparation, and preparation method thereof
A technology of sustained-release preparations and derivatives, which is applied in the direction of non-active ingredient medical preparations, medical preparations containing active ingredients, drug combinations, etc., which can solve the difficulties of production process control, incomplete release, and complicated process And other issues
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Embodiment 1
[0050] Element
[0051] Preparation steps: 60g of dihydroartemisinin, 70g of aluminosilicate and BHT are stirred and mixed uniformly with a high-speed stirring granulator. 7 g of hydroxypropylmethylcellulose E6 was dissolved in 50 g of water, and the above mixture was granulated with an aqueous solution of hydroxypropylmethylcellulose E6. If necessary, increase the amount of water appropriately until a satisfactory granulation effect is obtained. The prepared wet granules are transferred to a fluidized bed, and dried to obtain drug-containing granules (loss on drying is less than 3%). Put the dried drug-containing granules, 210g hydroxypropyl methylcellulose 90SH-100SR, 246.94g lactose and 3g silicon dioxide into a V-shaped mixer and mix evenly, then add 3g magnesium stearate and mix for 3 minutes to prepare to obtain the final mixture. The mixture was compressed into tablets using a Fette tablet machine to obtain 1000 dihydroartemisinin sustained-release tablets,...
Embodiment 2
[0054] Preparation steps: Dissolve 9.5g of polyacrylic acid resin L100 and 1.0g of triethyl citrate in 230g of isopropanol, and disperse 9.5g of talcum powder into the above-mentioned isopropanol solution to form a coating solution. 400g of the sustained-release tablet of Example 1 was packed into a coating pan, coated with the above-mentioned coating solution, and the weight of the coating was increased by 5%. According to the Chinese Pharmacopoeia dissolution test method, the dissolution rate was detected in 900 milliliters of pH 4.5 phosphate buffer at 37 degrees with the 50 rpm paddle method, and the dissolution release results were as follows:
[0055] 2 hours release 0%
[0056] 4 hours release 9.7%
[0057] 12 hours release 57.2%
[0058] 92.4% release in 20 hours.
Embodiment 3
[0060] Element
[0061] Preparation steps: take 210g of micronized artesunate: sodium lauryl sulfate (6:1), D90 below 10um. Mix the microcrystalline cellulose and the micronized product evenly, dissolve 20g of hydroxypropyl methylcellulose E6 in 80g of water and mix with the above mixture evenly, if necessary, add an appropriate amount of water to make a suitable wet material. The wet material is prepared into drug-containing pellets using an extrusion spheronizer, and the wet pellets are dried in a fluidized bed. After drying, they are coated with an aqueous dispersion prepared from polyacrylic acid resin NE30D and talcum powder to prepare sustained-release pellets. pill. The pellets after coating were aged for 24 hours under the condition of 40 degrees, and the pellets after aging were filled into 1000 sustained-release capsules, and the specification was 180 mg (artesunate: sodium lauryl sulfate (6: 1 )) / grain.
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