Trospium chloride double-release capsules and preparation method thereof

A technology of trospium chloride and double release is applied in the field of sustained-release capsules and preparation thereof, which can solve the problems of increasing drug cost, low bioavailability, increasing the risk of drug compatibility and the like, and achieves improvement of drug safety and blood drug concentration. Smooth and easy long-term treatment effect

Active Publication Date: 2015-07-01
STAIDSON (BEIJING) BIOPHARMACEUTICALS CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

And because the material used for the delayed-release pellets in the trospium chloride sustained-release capsules of ALLERGAN INC company is the colon release type, because the main absorption site of trospium chloride is in the small intestine, the absorption in the colon and cecum is less, although the selection of the prescription After taking the sustained-release capsule, a stable blood drug concentration can be maintained, but the absolute bioavailability of the capsule is too low, which can only reach about 1.8, so that after the patient takes the drug, the drug that enters the blood and plays a major role decreases, greatly Some drugs are excreted from the kidneys, which will put a lot of pressure on the kidneys, increase the risk of compatibility with drugs excreted by the kidneys, and increase drug costs

Method used

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  • Trospium chloride double-release capsules and preparation method thereof
  • Trospium chloride double-release capsules and preparation method thereof
  • Trospium chloride double-release capsules and preparation method thereof

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Embodiment 1

[0048] Embodiment 1: trospium chloride double-release capsules and preparation method thereof

[0049] The preparation method of trospium chloride double-release capsules comprises the following steps:

[0050] (1) Pellet drug loading: adopt the fluidized bed (Chongqing Jinggong Pharmaceutical Machinery Co., Ltd., DPL 1 / 3) cutting spray process, the air inlet temperature is 40°C, the air inlet frequency is 25HZ, and the atomization pressure is 0.1MPa. (2)-(4) Same as this, according to the proportioning shown in table 1, take trospium chloride crude drug, adhesive and anti-tack agent, with 80% ethanol aqueous solution as solvent, the preparation weight volume percentage content is 20% drug-loaded coating solution, drug-loaded on 30-35 mesh sucrose cores;

[0051] (2) Isolation layer coating: according to the proportion shown in Table 1, the isolation layer material (EG-05 series) was weighed, and 80% ethanol aqueous solution was used as a solvent to prepare an isolation layer...

Embodiment 2

[0056] Embodiment 2: trospium chloride double-release capsules and preparation method thereof

[0057] The preparation method of trospium chloride double-release capsules comprises the following steps:

[0058] (1) Pellet drug loading: adopt the fluidized bed (Chongqing Jinggong Pharmaceutical Machinery Co., Ltd., DPL 1 / 3) cutting spray process, the air inlet temperature is 60°C, the air inlet frequency is 30HZ, and the atomization pressure is 0.3MPa. (2)-(4) Same as above, according to the proportioning shown in table 1, take trospium chloride bulk drug, adhesive and anti-tack agent, take pure water as solvent, the preparation weight volume percentage content is 30% The drug-loaded coating solution is loaded on the 30-35 mesh sucrose core;

[0059] (2) Isolation layer coating: adopt fluidized bed (Chongqing Jinggong Pharmaceutical Machinery Co., Ltd., DPL 1 / 3) bottom spray process, according to the proportion shown in Table 1, take the isolation layer material (PVA103), with...

Embodiment 3

[0064] Embodiment 3, trospium chloride double release capsule and preparation method thereof

[0065] The preparation method of trospium chloride double-release capsules comprises the following steps:

[0066] (1) Pellet drug loading: adopt the fluidized bed (Chongqing Jinggong Pharmaceutical Machinery Co., Ltd., DPL 1 / 3) cutting spray process, the air inlet temperature is 80°C, the air inlet frequency is 40HZ, and the atomization pressure is 0.2MPa. (2)-(4) with this, according to the proportioning shown in table 1, take trospium chloride crude drug, adhesive and anti-tack agent, be the ethanol aqueous solution of 50% with volume percentage concentration as solvent, Prepare a drug-loaded coating solution with a weight-volume percentage of 40%, and load the drug on 30-35 mesh sucrose cores;

[0067] (2) Isolation layer coating: adopt fluidized bed (Chongqing Jinggong Pharmaceutical Machinery Co., Ltd., DPL 1 / 3) bottom spraying process, according to the proportion shown in Tab...

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Abstract

The invention discloses trospium chloride double-release capsules and a preparation method thereof. The trospium chloride double-release capsules are composed of trospium chloride sustained-release pellets with a weight percentage content of 20-90% and trospium chloride delayed-release pellets with a weight percentage content of 10-80%, wherein the trospium chloride sustained-release pellets and the trospium chloride delayed-release pellets are both obtained by coating by taking trospium chloride quick-release pellets as materials. According to the trospium chloride double-release capsules and the preparation method thereof disclosed by the invention, the sustained-release pellets and the delayed-release pellets are mixed in a specific ratio, on one hand, the medicine is slowly released to maintain a stable blood concentration and improve the medication safety; on the other hand, the release speed of the medicine in small intestines is reasonably controlled to improve the bioavailability, improve the treatment effect and save the cost.

Description

technical field [0001] The invention relates to a sustained-release capsule and a preparation method thereof, in particular to a trospium chloride double-release capsule 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 inc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K31/46A61K47/32A61P13/10
Inventor 尹秀菊谭剑平徐江平
Owner STAIDSON (BEIJING) BIOPHARMACEUTICALS CO LTD
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