Trospium chloride slow-release composition and preparation method thereof

A slow-release composition, trospium chloride technology, applied in the direction of drug combination, heterocyclic compound active ingredients, drug delivery, etc., can solve the problem of irritating talcum powder, etc., to achieve long-term treatment, stable and effective drug concentration, The effect of reducing the amount of excipients

Active Publication Date: 2015-05-13
STAIDSON (BEIJING) BIOPHARMACEUTICALS CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the two kinds of excipients are non-toxic and non-irritating in a small amount, it has been reported that there are acute and chronic adverse reactions when acrylic resin is used in large quantities, while talcum powder is irritating after inhalation, and long-term large-scale exposure cause pneumoconiosis etc.

Method used

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  • Trospium chloride slow-release composition and preparation method thereof
  • Trospium chloride slow-release composition and preparation method thereof
  • Trospium chloride slow-release composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] The trospium chloride sustained-release composition was prepared by the following preparation method.

[0047] (1) Pill core drug loading: Weigh trospium chloride raw material, adhesive and anti-adhesive agent according to the ratio shown in Table 1, and disperse them in an ethanol aqueous solution with a volume percentage of 80%, and prepare A coating solution with a weight volume percentage content of 20% is coated on the blank ball core shown in Table 1 by a fluidized bed (Chongqing Jinggong Pharmaceutical Machinery Co., Ltd., DPL1 / 3), and the coating solution is Coated on the blank pellet core to prepare drug-loaded pellets.

[0048] (2) Coating of the isolation layer: Weigh Opadry according to the ratio shown in Table 1, disperse it in an aqueous ethanol solution with a volume percentage of 80%, and make a suspension with a weight volume percentage of 5%. liquid, the drug-loaded pellets prepared in step (1) are coated by a fluidized bed process, and the suspension...

Embodiment 2

[0052] The trospium chloride sustained-release composition was prepared by the following preparation method.

[0053] (1) Pill core drug loading: Weigh trospium chloride raw material, adhesive and anti-adhesive agent according to the proportion shown in Table 1, disperse them in 50% ethanol aqueous solution by volume, and prepare the weight The coating solution with a volume percentage content of 40% is coated on the blank ball core shown in Table 1 by using a fluidized bed (Chongqing Jinggong Pharmaceutical Machinery Co., Ltd., DPL1 / 3) process, and the coating solution is coated Cover the blank ball core to prepare drug-loaded micropills.

[0054] (2) Coating of the isolation layer: Weigh Opadry according to the ratio shown in Table 1, disperse it in an aqueous ethanol solution with a volume percentage content of 50%, and make a suspension with a weight volume percentage content of 5%. liquid, the drug-loaded pellets prepared in step (1) are coated by a fluidized bed process...

Embodiment 3

[0058] According to the proportioning shown in Table 1, the trospium chloride sustained-release composition was prepared according to the method of Example 1, but in the step (1), the ethanol aqueous solution with a volume percentage content of 70% was used, and the weight of the coating solution configured was The volume percentage content is 25%. Then, the prepared trospium chloride sustained-release composition is added with conventional auxiliary materials, and compressed into trospium chloride sustained-release tablets with a specification of 50 mg using conventional techniques.

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Abstract

The present invention provides a trospium chloride slow-release composition and a preparation method thereof. According to the trospium chloride slow-release composition, an active drug component trospium chloride, an enteric material and a slow-release material are directly mixed according to a specific ratio so as to be adopted as a slow-release coating layer, such that rapid-release, slow-release and enteric delayed-release can be integrated, the drug release behavior and the blood drug level are stable, the toxic-side effect is reduced, and the treatment effect is good. The trospium chloride slow-release composition comprises, by weight, 40-60 parts of a blank pill core, 20-30 parts of a drug loading layer wrapped on the blank pill core, 1-5 parts of a separation layer wrapped on the drug loading layer, and 20-30 parts of a slow-release coating layer wrapped outside the separation layer, wherein the active drug of the drug loading layer is trospium chloride, and the slow-release coating layer comprises, by weight, 19-26 parts of a slow-release material, 0.8-1.8 parts of an enteric material and 0.2-1.2 parts of trospium chloride.

Description

technical field [0001] The present invention relates to a trospium chloride sustained-release composition and a preparation method thereof, in particular to a trospium chloride sustained-release composition integrating quick release, sustained release and enteric-coated delayed release and a preparation method thereof . Background technique [0002] Overactive bladder (OAB) is one of the common clinical manifestations of voiding dysfunction, which is defined by the International Continence Society (ICS) as involuntary contraction of the detrusor muscle, excluding those caused by acute urinary tract infection or Other forms of symptoms caused by local lesions of the bladder and urethra, manifested as frequent urination, urgency, and nocturia, with or without symptoms such as urge urinary incontinence. In 2007, the "Guidelines for the Diagnosis and Treatment of Overactive Bladder" promulgated by the Urology Branch of the Chinese Medical Association defined OAB as: "a syndrome...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/30A61K9/52A61K31/46A61P13/10
Inventor 谭剑平尹秀菊蒋立新
Owner STAIDSON (BEIJING) BIOPHARMACEUTICALS CO LTD
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