Topiroxostat controlled-release granule and preparation method thereof
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A technology of topicastat and granules, applied in the field of topicastat controlled-release granules and their preparation, can solve problems such as obvious side effects, and achieve the effects of stable blood drug concentration, reduced irritation, and reduced peak-to-valley phenomenon
Inactive Publication Date: 2016-03-30
CP PHARMA QINGDAO CO LTD
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[0004] At present, the number of gout patients in my country is still increasing, and there is a trend of spreading to a younger age. Therefore, anti-gout drugs have great potential in the Chinese market. However, most of the anti-gout drugs on the market are old drugs. Although they are cheap, they have obvious side effects. , if there are new drugs launched in time, the market prospect will be very impressive
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Embodiment 1
[0040] Topicastat 27.5g
[0041] β-cyclodextrin 106g
[0042] Ethyl cellulose 6.62g
[0043] Sodium carboxymethylcellulose 0.66g
[0044] Su Lisi E-7-1904021.33g
[0045] Hypromellose E50.26g
[0046] Appropriate amount of purified water
[0047] The specific preparation method is as follows:
[0048] (1) Take an appropriate amount of purified water and heat it to 80°C, add β-cyclodextrin and stir to dissolve, then add topinostat, and stir for 30 minutes to form a topinostat solution;
[0049] (2) Regulating spray drier air inlet temperature 160 ℃, air outlet temperature 80 ℃, pressure 0.3MPa, above-mentioned topinostat solution is spray-dried, obtains topinostat soluble powder;
[0050] (3) get 66.25g above-mentioned topinastat soluble powder, ethyl cellulose, sodium carboxymethyl cellulose and mix, add 26.47g water, mix and make soft material;
[0051] (4) Centrifuge-fluidized granulation and coating method to granulate, bake at 60°C for 2 hours, and screen 40-60 mesh...
Embodiment 2
[0054] Topicastat 27.5g
[0055] β-cyclodextrin 106g
[0056] Ethyl cellulose 6.62g
[0057] Sodium carboxymethylcellulose 0.662g
[0058] Su Lisi E-7-1904017.07g
[0059] Hypromellose E50.21g
[0060] Appropriate amount of purified water
[0061] The specific preparation method is as in Example 1.
Embodiment 3
[0063] Topicastat 27.5g
[0064] β-cyclodextrin 96g
[0065] Ethyl cellulose 8.31g
[0066] Sodium carboxymethyl cellulose 0.332g
[0067] Su Lisi E-7-1904024.81g
[0068] Hypromellose E50.49g
[0069] Appropriate amount of purified water
[0070] The specific preparation method is as in Example 1.
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Abstract
The invention discloses a topiroxostat controlled-release granule. An inner core is prepared from topiroxostat through an inclusion technology, then controlled-release coating is conducted, and the topiroxostat controlled-release granule is obtained. The invention further discloses a preparation method of the topiroxostat controlled-release granule. Compared with the prior art, the topiroxostat controlled-release granule can slowly release a drug at a constant speed in a specified release medium, the release rate and bioavailability of topiroxostat are effectively increased, rapid release can be achieved at the preliminary stage of taking to produce drug efficacy, slow release at a constant speed can be achieved at the later stage of taking, normal plasma concentration can be maintained, the drug efficacy can be maintained for a long time, toxic and side effects do not occur, drug accumulation poisoning is not caused, the curative effect is improved, and safety and rapidness are achieved. Meanwhile, the preparation method of the topiroxostat controlled-release granule is suitable for expanded production.
Description
technical field [0001] The invention belongs to the field of medicine, and in particular relates to a controlled-release topicastat granule and a preparation method thereof. Background technique [0002] Uric acid is a normal product of purine nucleotide metabolism. When uric acid is produced excessively and uric acid excretion decreases, hyperuricemia is formed when the uric acid in the blood rises beyond the normal range; excessive uric acid in the blood is mainly deposited in the joints, cartilage, Subcutaneous soft tissue and kidneys cause comprehensive clinical manifestations such as arthritis and kidney disease, which is called gout. Therefore, hyperuricemia and uric acid deposition in organ tissues are the basic pathogenesis of gout. The etiology leading to elevated uric acid is more complex and can be divided into two categories: primary and secondary. [0003] With the improvement of people's living standards, improvement of nutritional conditions, increase in inta...
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