Trospium chloride controlled release capsule and preparation method thereof

Abstract

The present invention provides a trospium chloride controlled release capsule and a preparation method thereof. A capsule shell is filled with pills; the pills are wrapped with film coatings; a pill cladded with the coating is provided with a hole with a diameter of 0.05 mm; the pills in the capsule shell comprise an active ingredient trospium chloride; controlled release carriers in the pills are sodium carboxymethyl cellulose and natural alginate; a weight ratio of trospium chloride and the controlled release carrier is 1:0.6; a weight ratio of sodium carboxymethyl cellulose sodium and natural alginate is 1:0.8; viscosity of the sodium carboxymethyl cellulose is 3000-5000 centipoise; and viscosity of the natural alginate is 300-500 centipoise. According to the invention, the trospium chloride can be released at a constant speed in 9-12 h, so as to reduce frequency of drug usage.

Description

technical field [0001] The invention relates to medicines, and is a trospium chloride controlled-release capsule and a preparation method thereof. Background technique [0002] Trospium chloride capsule is a drug for treating overactive bladder. It is a new powerful M receptor blocker with high affinity and specificity for M receptors, and its lipid Low solubility, not through the blood-brain barrier. [0003] At present, trospium chloride short-acting dosage forms in the domestic and foreign markets are generally trospium chloride tablets 20 mg (such as trade name Sanctura, Germany) and capsules. Because the drug is a symptom-improving drug, it requires long-term concomitant medication for elderly patients. However, these short-acting tablets and capsules on the market at home and abroad are taken 3 times a day, and the number of times of taking is too many to bring loaded down with trivial details to the patient, and it is difficult for the patient to persist in long-ter...

AI Technical Summary

Problems solved by technology

However, these short-acting tablets and capsules currently on the market at home and abroad are taken 3 times a day, and the number of times of taking them is cumbersome to the patient. It is difficult for the patient to persist in the long-term medication and it is easy to forget.

In 2007, Germany launched a new trospium chloride sustained-release tablet 60mg (Sanctura XR produced by Madaus AG, Dr. Ma, Germany). The in vitro release curve of this sustained-release tablet is not stable and cannot achieve the purpose of constant release.

However, the price of the controlled-release matrix used in this method is relatively expensive, and the technology is difficult to be widely promoted.

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