Trospium chloride composition and preparation method thereof

The technology of trospium chloride and composition is applied in the field of pharmaceutical composition and preparation thereof, which can solve the problems of increasing the risk of excretion of drug compatibility, increasing drug cost, low bioavailability and the like, so as to improve drug safety and bioavailability. The effect of improving the blood drug concentration and stabilizing the blood concentration

Inactive Publication Date: 2015-09-09
STAIDSON (BEIJING) BIOPHARMACEUTICALS CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, since the main absorption site of trospium chloride is in the small intestine, the drug is released rapidly in the stomach, the residence time in the small intestine is short, and the bioavailability is low, only about 10%, which will bring a great burden to the kidneys. At the same time, it will increase the risk of compatibility with renal excretion drugs, and increase the cost of medication
In terms of preparation process, Shunmuli adopts traditional wet granulation, including soft material production, granulation and drying, etc. The process is complex

Method used

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  • Trospium chloride composition and preparation method thereof
  • Trospium chloride composition and preparation method thereof
  • Trospium chloride composition and preparation method thereof

Examples

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Effect test

Embodiment 1

[0045] A preparation method of trospium chloride composition, comprising the following steps:

[0046] (1) Drug-loading solution preparation: take trospium chloride and binder according to the proportioning shown in Table 1, disperse in water, and be mixed with the drug-loading solution that the weight volume percentage content is 30%;

[0047](2) Granulation: Weigh the diluent according to the ratio shown in Table 1 and place it in a fluidized bed (Chongqing Jinggong Pharmaceutical Machinery Co., Ltd., DPL1 / 3). The temperature of the material is 60°C, and the frequency of the induced draft fan is 30HZ. The atomization pressure is 0.2MPa, and the drug-loaded solution is sprayed into the fluidized bed for granulation;

[0048] (3) Grain granulation: swing granulator, 80 mesh granulation;

[0049] (4) Total blending: Weigh the anti-sticking agent according to the proportion shown in Table 1, and mix it with the granules obtained after sizing in the step (3), and the mixing time...

Embodiment 2

[0052] A preparation method of trospium chloride composition, comprising the following steps:

[0053] (1) drug-loading solution preparation: take trospium chloride and binder according to the proportioning shown in Table 1, disperse in 50% ethanol aqueous solution, be mixed with the drug-loading solution that weight volume percent content is 10%;

[0054] (2) Granulation: Weigh the diluent according to the ratio shown in Table 1 and place it in a fluidized bed (Chongqing Jinggong Pharmaceutical Machinery Co., Ltd., DPL1 / 3). The temperature of the material is 40°C, and the frequency of the induced draft fan is 35HZ. The atomization pressure is 0.2MPa, and the drug-loaded solution is sprayed into the fluidized bed for granulation;

[0055] (3) Grain granulation: swing granulator, 60 mesh granulation;

[0056] (4) Total blending: Weigh the anti-sticking agent according to the proportion shown in Table 1, and mix it with the granules obtained after sizing in the step (3), and th...

Embodiment 3

[0059] A preparation method of trospium chloride composition, comprising the following steps:

[0060] (1) drug-loaded solution preparation: take trospium chloride and binder according to the proportioning shown in Table 1, disperse in 80% ethanol aqueous solution, be mixed with the drug-loaded solution that weight volume percent content is 20%;

[0061] (2) Granulation: Weigh the diluent according to the ratio shown in Table 1 and place it in a fluidized bed (Chongqing Jinggong Pharmaceutical Machinery Co., Ltd., DPL1 / 3). The temperature of the material is 80°C, and the frequency of the induced draft fan is 30HZ. The atomization pressure is 0.2MPa, and the drug-loaded solution is sprayed into the fluidized bed for granulation;

[0062] (3) Grain granulation: swing granulator, 80 mesh granulation;

[0063] (4) Total blending: Weigh the anti-sticking agent according to the proportion shown in Table 1, and mix it with the granules obtained after sizing in the step (3), and the ...

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Abstract

The invention discloses a trospium chloride composition and a preparation method thereof. The trospium chloride composition comprises, by weight, 2-10 parts of trospium chloride serving as an active ingredient, 80-200 parts of diluent, 1-20 parts of adhesion agent and 1-5 parts of antisticking agent. The trospium chloride composition has the advantages that by means of reasonable proportioning of the diluent and the adhesion agent, the composition can disperse in the stomach rapidly after being taken orally and floats partially to release medicine slowly, so that on one hand, stable blood concentration can be kept, adverse reaction incidence is decreased, and medication safety is improved; on the other hand, stopping time of the medicine in a gastrointestinal tract is prolonged, bioavailability is increased, therapeutic effects are improved and cost is saved. The preparation method of the trospium chloride composition has the advantages that a fluid-bed granulation technology is adopted to enable granulation to be completed at a step, so that time is saved, efficiency is improved and production cost is reduced greatly.

Description

technical field [0001] The invention relates to a pharmaceutical composition and a preparation method thereof, in particular to a trospium chloride composition 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 characterized by urgency, often accompanied by frequent urination and nocturia, with or without with urge urinary incontinence"...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K9/20A61K31/46A61K47/38A61K47/34A61K47/26A61P13/10
Inventor 谭剑平尹秀菊
Owner STAIDSON (BEIJING) BIOPHARMACEUTICALS CO LTD
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