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A premix auxiliary material and a preparation technology thereof

A technology of premixed excipients and preparation technology, which is applied in the direction of medical preparations, pharmaceutical formulas, and capsule delivery of non-active ingredients. The effect of heavy weight, uniform particle size distribution, and good physical strength

Inactive Publication Date: 2014-03-19
SHANDONG UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in the fast or high-speed tableting process, due to the large amount of heat generated during the tableting process, and the unevenness of physical mixing, the tablet will be sticky and punched, which will affect its use.

Method used

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  • A premix auxiliary material and a preparation technology thereof
  • A premix auxiliary material and a preparation technology thereof
  • A premix auxiliary material and a preparation technology thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] Example 1 Preparation of premixed auxiliary materials

[0057] Add 900kg of purified water into the reaction tank, heat and boil for 30 minutes, keep warm at 70-85°C, and set aside. Take 95kg of microcrystalline cellulose, 9.6kg of low-substituted hydroxypropyl cellulose, 1kg of povidone and 0.7kg of glyceryl behenate, mix the latter three for 10 minutes with a square cone mixer, and then add microcrystalline cellulose Mix for 10 minutes, take it out and put it into the reaction tank while stirring. After throwing in, stir at a high speed (400rpm) for 30 minutes. While stirring, keep the temperature at 80°C to make a slurry. Use a spray dryer at a temperature of 120°C Spray-drying under low pressure, the atomization pressure is 1-1.5 MPa, the slurry flow rate is 1.5-3 kg / min, and 97 kg of finished product is obtained with a yield of 91.3%.

Embodiment 2

[0058] Example 2 Preparation of premixed auxiliary materials

[0059] Add 580kg of purified water into the reaction tank, heat and boil for 30 minutes, and keep warm at 70-85°C for later use. Take 95kg of microcrystalline cellulose, 2kg of croscarmellose sodium, 1kg of povidone and 0.5kg of glyceryl behenate, mix the latter three for 5 minutes with a square cone mixer, and then add the microcrystalline fiber Mix the ingredients for 20 minutes, take it out and put it into the reaction tank while stirring. After the throwing is finished, stir at a high speed (300rpm) for 40 minutes. While stirring, keep the temperature at 80°C to make a slurry. Use a spray dryer at a temperature of 115°C Spray-drying under the condition of spraying pressure of 1-1.5MPa, slurry flow rate of 1-2kg / min, 91kg of finished product is obtained, and the yield is 92.3%.

Embodiment 3

[0060] Example 3 Preparation of premixed auxiliary materials

[0061]Add 1100kg of purified water into the reaction tank, heat and boil for 30 minutes, and keep warm at 70-85°C for later use. Take 102kg of microcrystalline cellulose, 8kg of sodium carboxymethyl starch, 2kg of povidone and 1kg of glyceryl behenate respectively, and mix the latter three with a square cone mixer for 10 minutes, then add microcrystalline cellulose and mix for 10 minutes , take it out and put it into the reaction tank while stirring. After throwing in, stir at high speed for 60 minutes, keep the temperature at 75°C while stirring, make a slurry, use a spray dryer, spray dry at a temperature of 110°C, and atomize The pressure is 1-1.5 MPa, the slurry flow rate is 1-3 kg / min, and 105 kg of finished product is obtained with a yield of 92.9%.

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Abstract

The invention discloses a premix auxiliary material. The premix auxiliary material comprises polyvinylpyrrolidone, glyceryl behenate, and a pharmaceutical adjuvant filler and a pharmaceutical adjuvant disintegrant, wherein the weight ratio of the filler, the disintegrant, the polyvinylpyrrolidone and the glyceryl behenate is (80-98.5):(10-0.5):(5-0.5):(5-0.5). The premix auxiliary material comprising the polyvinylpyrrolidone and the glyceryl behenate is good in fluidity, strong in compressibility and good in lubricating effect. The mixing uniformity, the medicine content, the tablet hardness, and the like would not change with prolongation of the total mixing time. The premix auxiliary material is prone to enlargement. Indexes comprising fluidity, the Carr's index, compressibility, friability, etc. of the premix auxiliary material provided by the invention are superior to corresponding indexes of auxiliary materials mixed physically. Uncontrollable factors of the technology are reduced, thus facilitating large-scale production. The premix auxiliary material can be used for direct compression of tablets or encapsulation of capsules.

Description

technical field [0001] The invention relates to a premixed auxiliary material which can be used for direct tablet compression or capsule filling and a preparation process thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] The preparation process of tablets is usually divided into wet granulation, dry granulation and powder direct compression technology. A survey by Shangraw et al. showed that powder direct compression technology has become the preferred production process for most manufacturers. The research on powder direct compression technology began in the late 1950s. Compared with wet granulation, the powder direct compression process can improve the stability of heat-sensitive drugs; compared with dry granulation, it simplifies the process steps and avoids cumbersome process parameters. The advantages. However, the powder direct compression process has relatively high requirements on the materials used for tableting. All ex...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/48A61K47/32A61K47/14
Inventor 翟光喜汪洋
Owner SHANDONG UNIV
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