A kind of tamsulosin hydrochloride sustained-release pellets and preparation method thereof
A technology of tamsulosin hydrochloride and sustained-release pellets, which is applied in the direction of block delivery, urinary system diseases, active ingredients of amides, etc., can solve the problems of immature industrialization and less application of semi-permeable membrane materials, and achieve batch-to-batch variation Small size, stable drug release, and good content uniformity
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[0055] The preparation method of the tamsulosin hydrochloride sustained-release pellets of the present invention includes but not limited to the above preparation method.
[0056] Those skilled in the art can subpackage the tamsulosin hydrochloride sustained-release pellets of the present invention and then compress them into tablets or pack them into capsules to make capsules, so that patients can take them conveniently. Wherein, the capsule is preferably a gelatin capsule. The capsule is composed of two precisely processed capsule shells. The sizes of the capsules are various, including No. 000, No. 00, and No. 0 to No. 5 capsules. In some embodiments the capsule is a size 3 capsule.
[0057] Taking the capsules of tamsulosin hydrochloride sustained-release pellets prepared in the embodiment of the present invention as the research object, the content uniformity test was carried out. The results show that A+1.80S=0.6 of the prepared tamsulosin hydrochloride sustained-rele...
Embodiment 1
[0061] Embodiment 1: tamsulosin hydrochloride sustained-release pellets of the present invention
[0062] formula:
[0063]
[0064]
[0065] Preparation method: Weigh the Eudragit L100 of the prescription amount of drug-loaded sustained-release pellets, add it to the ethanol-water system of the prescription amount, stir to dissolve; then add tamsulosin hydrochloride to the solution, stir to dissolve, and obtain Drug solution. Weigh the prescribed amount of ethyl cellulose, starch, and microcrystalline cellulose, mix them evenly, use the drug solution as a binder to wet the mixture to prepare a soft material, and pass the prepared soft material through a Mini250 extrusion-spheronizer to prepare pellets. Drug-loaded sustained-release pellets with diameters ranging from 350 to 700 μm.
[0066]Weigh the raw and auxiliary materials of the prescription amount of enteric-coated pellets, disperse HP-55 in 80% ethanol, stir to dissolve; add triethyl citrate, stir to mix evenly...
Embodiment 2
[0068] Example 2: Detection of content uniformity of tamsulosin hydrochloride sustained-release pellets of the present invention
[0069] The tamsulosin hydrochloride is prepared into sustained-release pellets and loaded into capsules, and the tamsulosin hydrochloride content in each capsule is 0.2 mg. Due to the small dosage specification, it is easy to have the problem of unqualified content uniformity. It is necessary to check the content uniformity of tamsulosin hydrochloride sustained-release capsules. The specific operation and experimental results are as follows.
[0070] Get 1 capsule prepared in specific example 1, pour the contents into a 50mL hard stoppered glass tube, add about 100 glass beads with a diameter of about 5mm, add 20mL of sodium hydroxide solution (1→600) precisely, and place Heat in a water bath at 50°C for 10 minutes, take it out, shake vigorously until the particles are completely broken, add 10 mL of acetonitrile accurately, add 5 mL of 0.2 mol / L h...
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Abstract
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