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Compound olanzapine subcutaneous implantable sustained-release preparation

A compound olanzapine and olanzapine technology, applied in the field of antipsychotic medical drugs, can solve the problems of insurmountable olanzapine hygrosensitivity, poor compliance with maintenance treatment, low bioavailability and the like, and achieve stable maintenance treatment effect, Mild toxic and side effects in humans and reliable drug release

Inactive Publication Date: 2014-06-25
陈德香 +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Aiming at this problem, various new orally disintegrating tablet preparation schemes have appeared in this field in an attempt to overcome this problem. However, considering the formulation characteristics of the orally disintegrating tablet itself and the physicochemical properties of olanzapine, it is difficult to overcome the problem no matter how the preparation method is improved. Unstable defects caused by olanzapine's moisture sensitivity, easy oxidation, metastable properties, etc.
[0005] At the same time, orally disintegrating tablets also face a defect in application: due to the characteristics of psychiatric diseases that have a long treatment period, the bioavailability of olanzapine after oral administration is low, and the patient’s clinical treatment and subsequent continuous treatment There will be problems of poor compliance with maintenance treatment. Patients often voluntarily discontinue medication in a short period of time, resulting in recurrent disease and even a persistent state that is difficult to relieve.

Method used

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  • Compound olanzapine subcutaneous implantable sustained-release preparation
  • Compound olanzapine subcutaneous implantable sustained-release preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Take 150mg olanzapine granules plus 1.5ul propionic acid as a controlled release agent, prepare it as a preparation, the steps are as follows:

[0028] 1) Preparation of raw materials: take the required medical silicone tube, olanzapine plain drug, controlled release agent, and medical adhesive for quality confirmation and disinfection;

[0029] 2) Compound drug preparation: put olanzapine and propionic acid into a container, add 60% ethanol, stir fully under normal temperature and pressure to make a uniform suspension, and make ethanol under normal temperature and pressure conditions Completely volatilize to obtain the agglomerate of compound olanzapine, and crush the agglomerate of compound olanzapine into 400 mesh powder under aseptic and normal temperature conditions for subsequent use;

[0030] 3) Compound drug filling: according to the measurement requirements, the powder is filled into medical silicone tubes at room temperature and pressure under the condition of...

Embodiment 2

[0035] Take 150mg olanzapine granules and add 0.5ul propionic acid as a controlled release agent, prepare it as a preparation, the preparation steps are the same as in Example 1; wherein the medical adhesive used is medical silica gel, the organic solvent used is 70% ethanol, and the filling specification 160mg per tube.

Embodiment 3

[0037] Take 150mg olanzapine granules and add 0.25ul propionic acid as a controlled release agent, prepare it as a preparation, the preparation steps are the same as in Example 1. The medical adhesive used is medical silica gel, the organic solvent used is 90% ethanol, and the filling specification 150mg per tube.

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Abstract

The invention discloses a compound olanzapine subcutaneous implantable sustained-release preparation which comprises olanzapine and a medicinal carrier. The medicinal carrier is a controlled release agent. The invention further discloses a medicinal preparation of the compound olanzapine subcutaneous implantable sustained-release preparation, a preparation method and an application method. The compound olanzapine subcutaneous implantable sustained-release preparation disclosed by the invention has the advantages of high blood concentration stability after medicament, long time of effective effect of medicines, economical and practical benefits, convenience in delivery and the like.

Description

technical field [0001] The invention relates to a compound olanzapine subcutaneous implant slow-release agent, which belongs to the technical field of antipsychotic medical drugs. Background technique [0002] Schizophrenia is the most common severe mental illness in psychiatry. Its clinical feature is that it is prone to relapse. For this reason, in order to effectively prevent recurrence, it is necessary to maintain drug treatment for a long time, otherwise it will become a lifelong disease and cause serious harm. Patients, families, and society have caused multiple burdens. The incidence rate of this disease is close to 1%, which is mainly typical. Among them, olanzapine is the most commonly used new drug with definite curative effect and mild side effects. According to the common diseases and frequently-occurring diseases diagnosed and treated, the current medical treatment routine for such diseases is: after the acute treatment period with various psychotropic drugs, in...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K31/5513A61K47/04A61P25/18
Inventor 郑士全
Owner 陈德香
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