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Preparation method for venlafaxine hydrochloride sustained-release pellet

A technology of venlafaxine hydrochloride and sustained-release pellets, which is applied in the field of medicine and can solve problems such as small dosage, frequent medication, and large fluctuations in blood drug concentration

Inactive Publication Date: 2014-09-17
天津新济复兴药业科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, venlafaxine hydrochloride has become the world's No. 1 antidepressant in sales, but the main market is monopolized by imported and joint-venture drugs, and the share of domestic drugs is relatively small, and they are immediate-release preparations or sustained-release capsules that are taken more than twice at the same time , has defects such as low technical content, large fluctuations in blood drug concentration, and frequent medication

Method used

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  • Preparation method for venlafaxine hydrochloride sustained-release pellet
  • Preparation method for venlafaxine hydrochloride sustained-release pellet
  • Preparation method for venlafaxine hydrochloride sustained-release pellet

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Embodiment Construction

[0030] One, the preparation of venlafaxine hydrochloride pellets

[0031] Get MCC blank pellet core 2009 (30-40 mesh), put it in a centrifugal granulator, use distilled water as a wetting agent,

[0032] The experiment was carried out by powder lamination method. After centrifugal granulation, the prepared pellets were dried in an oven at 40°C for 24 hours, and then sieved. The particle size of the target pellet is about 16-24 mesh, and the yield is about 80%.

[0033] 1. The influence of the amount of diluent

[0034] Dilute with MCC as an auxiliary material, and investigate the influence of the mass fraction of the main drug adding 50%, 60%, and 70% of the mixed powder (the mixture of venlafaxine hydrochloride and MCC) on the particle size distribution of the pellets, as shown in Figure-1 The larger the proportion of MCC, the higher the yield of the pellets, but the drug loading decreased. Considering the drug loading of the pellets and the yield of the pellets, the ratio...

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Abstract

The invention discloses a preparation method for a venlafaxine hydrochloride sustained-release pellet. The method comprises the steps of: subjecting MCC to centrifugal granulation, adjusting the guniting speed and powder feeding speed till the material flows in a flocculent state and maintains the flocculent flow state, feeding powder and controlling the powder-slurry ratio to prepare a microcrystalline cellulose blank pellet core; crushing bulk drug powder, mixing the powder with MCC and HPMC (3cp) evenly in proportion, employing a powder lamination technique, taking the MCC blank pellet core as a mother nucleus and adopting water as a wetting agent, adjusting the guniting speed and powder feeding speed, the rotational speed of a main engine, air jetting flow, air jetting pressure and air blast, at the end of powder feeding, polishing the pellet in a pot for 5min, and conducting drying for 24h in a 40DEG C drying oven after removal from the pot so as to obtain a venlafaxine hydrochloride pellet; conducting coating on the venlafaxine hydrochloride pellet, making Surelease, HPMC and TEC into a Surelease coating solution in proportion, and making Sureleae NG and TEC into a Surelease NG coating solution according to a proportion.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a preparation method of venlafaxine hydrochloride sustained-release pellets Background technique [0002] Depression is a common affective disorder mental illness, characterized by symptoms such as extremely low mood, slow thinking, and decreased movement. Physical symptoms include anorexia, weight loss, and sleep disturbance. % of patients have suicidal behavior. According to the statistics of the World Health Organization (WHO) in 2005, the prevalence of depression accounts for about 11% of the total population in the world. Among adults aged 20 and over, depression is increasing at an annual rate of 11.3%. It is predicted that by 2020, depression will become the second largest disease affecting life expectancy and increasing mental burden. About 70% of people in China are in a sub-health state, and physical and mental diseases and psychological disorders have become high i...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/137A61K47/38A61P25/24
Inventor 崔景柏吴传斌梁华辉张乃军
Owner 天津新济复兴药业科技有限公司
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