Raltitrexed colon specific pellet and preparation method thereof
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A technology of raltitrexed and colon positioning, which is applied in the field of pharmacy, can solve the problems of long time and slow drug onset, and achieve the effect of convenient administration, high safety and effectiveness, and strong pertinence
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Problems solved by technology
The raltitrexed sustained-release preparation made by Chinese patent 200610022370.0 is a unit preparation, and there are certain risks of effectiveness and safety caused by the deviation of the active ingredient content or the thickness of the enteric coating layer (affecting the release control); They are complete and larger flake solids in front of the site, and it takes a long time to reach the drug release site (colon), and it needs to be disintegrated before it can be completely released, and the drug takes effect slowly
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[0034] The drug-containing layer consists of the following components:
[0035]
[0036] The isolation layer consists of the following components:
[0037]
[0038] The colon positioning layer consists of the following components:
[0039]
[0040] (Note: The aqueous dispersion of methacrylic acid, methyl acrylate and methyl methacrylate (1:1:1) copolymer produced by Rohm, Germany, with a solid content of 30%, the same below.)
[0041] The preparation method of raltitrexed colon-localized pellets of the present invention is as follows:
[0042] 1. Weighing and material preparation: Weigh the materials according to the prescription quantity and set aside.
[0043] 2. Preparation of raltitrexed drug-containing layer-based pills:
[0044] A Sprinkle hypromellose into partially purified water to prepare an aqueous hypromellose solution;
[0045] B. Add raltitrexed to the prepared step A aqueous solution to pre...
[0060] The drug-containing layer consists of the following components:
[0061]
[0062] The preparation method is the same as in Example 1.
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Abstract
The invention belongs to the field of pharmacy, relates to a medicine preparation using raltitrexed as an active ingredient, and particularly relates to a raltitrexed colon specific pellet and a preparation method thereof. The pellet sequentially comprises the following structural layers from inside to outside: a drug-loading body, a drug-containing layer, an isolating layer and a colon specific layer. The pellet has the characteristics of orally enteric coating and colon specific targeting, and is mainly dissolved and absorbed in the colon position after being taken orally. Compared with the prior art, the pellet has the advantages that the finally prepared multi-unit preparation has excellent gastrointestinal tract distribution and consistent passing time so as to achieve a consistent plasma drug level and reduce the risk of burst release of drugs. The pellet can be used for improving the bioavailability and has good safety performance.
Description
technical field [0001] The invention belongs to the field of pharmacy, and relates to a pharmaceutical preparation with raltitrexed as an active ingredient, in particular to a raltitrexed colon-targeted pellet and a preparation method thereof. Background technique [0002] Colorectal cancer is one of the most common malignant tumors of the gastrointestinal system and ranks second in cancer deaths in the West. With economic development, changes in people's lifestyles and dietary structure, the incidence rate is increasing year by year, especially in recent years, with a rate of 4%. [0003] Surgery is the mainstay of colorectal cancer treatment, and its success rate depends on the extent of the disease; surgery is often followed by chemotherapy. For patients with locally advanced colorectal cancer, preoperative or postoperative adjuvant radiotherapy can significantly reduce the local recurrence rate compared with surgery alone. In the past forty years, fluorouracil has be...
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Application Information
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