Topiroxostat controlled-release capsule and preparation method thereof
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A technology of topicastat and capsules, which is applied in the field of topicastat controlled-release capsules and their preparation, can solve problems such as obvious side effects, and achieve the effects of improving bioavailability, preventing burst release, and being easy to purchase.
Inactive Publication Date: 2016-09-07
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] Ethylcellulose 6.62g
[0043] Sodium carboxymethylcellulose 0.66g
[0044] Surelease E-7-19040 21.33g
[0045] Hypromellose E5 0.26g
[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) Adjust the air inlet temperature of the spray drier to 160° C., the air outlet temperature to 80° C., and the pressure to 0.3 MPa. The above-mentioned topinostat solution is spray-dried to obtain the topinostat soluble powder;
[0050] (3) Get 66.25g of above-mentioned topinastat soluble powder, ethyl cellulose, sodium carboxymethyl cellulose and mix, add 26.47g of water, mix and make soft material;
[0051] (4) Centrifuge-fluidized granulation coating method to granulate, ...
Embodiment 2
[0055] Topicastat 27.5g
[0056] β-cyclodextrin 106g
[0057] Ethylcellulose 6.62g
[0058] Sodium carboxymethylcellulose 0.662g
[0059] Surelease E-7-19040 17.07g
[0060] Hypromellose E5 0.21g
[0061] Appropriate amount of purified water
[0062] The specific preparation method is as in Example 1.
Embodiment 3
[0064] Topicastat 27.5g
[0065] β-cyclodextrin 96g
[0066] Ethylcellulose 8.31g
[0067] Sodium carboxymethylcellulose 0.332g
[0068] Surelease E-7-19040 24.81g
[0069] Hypromellose E5 0.49g
[0070] Appropriate amount of purified water
[0071] The specific preparation method is as in Example 1.
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Abstract
The invention discloses a topiroxostat controlled-release capsule, which is prepared by preparing a core from topiroxostat through an inclusion technology and conducting controlled-release coating. The invention also discloses a preparation method of the topiroxostat controlled-release capsule. Compared with the prior art, the controlled-release capsule disclosed by the invention can achieve slow constant-speed release of the drug (the topiroxostat) in a specified release medium, so that the release degree and bioavailability of the topiroxostat are effectively improved; the drug can be rapidly released to generate efficacy in the initial period of administration and can be slowly released at a constant speed in the late period of the administration, so that a normal blood concentration is kept, and the efficacy is kept for a long time, without the problems of toxic and side reactions or poisoning due to drug accumulation; therefore, the efficacy is improved, and the drug is safe and rapid to take the efficacy. Meanwhile, the preparation method disclosed by the invention is applicable to expanded production.
Description
technical field [0001] The invention belongs to the field of medicine, and in particular relates to a topicastat controlled-release capsule 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...
Claims
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