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Lactose-polyvidone-crospolyvidone premixed agent and preparation method thereof

A technology of cross-linked povidone and povidone, which is applied in the direction of pharmaceutical formulations and medical preparations of non-active ingredients, etc., can solve the problems of complex production technology of premixed auxiliary materials, production and promotion restrictions, etc., to improve production conditions, Eliminate cumbersome procedures and improve the effect of disintegration and dissolution

Active Publication Date: 2011-08-10
SHANDONG LIAOCHENG E HUA PHARM CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the complex production technology of premixed excipients, each excipient used must undergo strict screening. Its stability and safety, and whether the excipients are chemically inert need to be strictly inspected, carefully selected, and the amount of each raw material. The ratio also needs to be strictly calculated
Therefore, the production and popularization of lactose-povidone-crospovidone premix are limited

Method used

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  • Lactose-polyvidone-crospolyvidone premixed agent and preparation method thereof
  • Lactose-polyvidone-crospolyvidone premixed agent and preparation method thereof
  • Lactose-polyvidone-crospolyvidone premixed agent and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Embodiment 1: prepare lactose-povidone-crospovidone premix, the steps are as follows:

[0048] 1) Add 1200kg of process water to the reactor, heat it with steam to 100°C for 15 minutes, cool to 50°C for later use;

[0049] 2) Put 560.4kg of lactose, 19.2kg of povidone, and 20.4kg of crospovidone into the reaction tank, stir for 2 hours, release 30-50kg of slurry from the outlet and return to the reaction tank, continue stirring for 30 minutes, and take samples to check the slurry It is a milky white, uniform colloid, and it is transferred to the next process;

[0050] 3) Debug the spray drying equipment in a normal state, control the drying temperature within the range of 100-120°C, carry out drying, pick up the materials every 30 minutes, and transfer to the screening and packaging process;

[0051]4) After the product passes through a 100-mesh sieve, each package is 20kg, which is the finished product of lactose-povidone-crospovidone.

Embodiment 2

[0052] Embodiment 2: prepare lactose-povidone-crospovidone premix, the steps are as follows:

[0053] 1) Add 1188kg of process water to the reactor, heat it with steam to 100°C for 20 minutes, and cool it to 45°C for later use;

[0054] 2) Drop into 562.6kg of lactose, 18kg of povidone, 21.6kg of crospovidone in the reaction tank, stir for 3 hours, release 30-50kg of slurry from the outlet and return to the reaction tank, continue to stir for 50 minutes, and take a sample to check that the slurry is Milky white, uniform colloid, transferred to the next process;

[0055] 3) Debug the spray drying equipment in a normal state, control the drying temperature within the range of 100-120°C, carry out drying, pick up the materials every 30 minutes, and transfer to the screening and packaging process;

[0056] 4) After the product passes through a 100-mesh sieve, each package is 20kg, which is the finished product of lactose-povidone-crospovidone.

Embodiment 3

[0057] Embodiment 3: prepare lactose-povidone-crospovidone premix, the steps are as follows:

[0058] 1) Add 1212kg of process water to the reactor, heat it with steam to 100°C for 18 minutes, cool to 40°C for later use;

[0059] 2) Drop into 558kg of lactose, 20.4kg of povidone, 19.2kg of crospovidone in the reaction tank, stir for 2.5 hours, release 30-50kg of slurry from the outlet and return to the reaction tank, continue to stir for 40 minutes, and take a sample to check that the slurry is Milky white, uniform colloid, transferred to the next process;

[0060] 3) Debug the spray drying equipment in a normal state, control the drying temperature at 110°C for drying, pick up the materials every 30 minutes, and transfer to the screening and packaging process;

[0061] 4) After the product passes through a 100-mesh sieve, it becomes the finished product of lactose-povidone-crospovidone.

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Abstract

The invention discloses a lactose-polyvidone-crospolyvidone premixed agent which is prepared form the following components in proportion by weight: 93-93.8 parts of lactose, 3.0-3.4 parts of polyvidone, 3.2-3.6 parts of crospolyvidone and 198-203 parts of water. A preparation method comprises the following steps: mixing the water, the lactose, the polyvidone and the crospolyvidone, stirring for 2-3 hours to prepare an emulsified serous fluid; discharging the serous fluid accounting for 1.5-3 percent of the gross weight from an outlet of a reaction pot, then re-adding the serous fluid into thereaction pot, continuing to stir for 30-50 minutes until the sampling inspection serous fluid is milky and uniform colloid, and then spraying and drying and packaging to obtain the lactose-polyvidone-crospolyvidone premixed agent. The lactose-polyvidone-crospolyvidone premixed agent product not only has the functions of figuration, binding, filling, disintegration and adsorption, but also can be used as an adhesive, a filling agent and a disintegrant for direct tablet compression in medicine manufacture.

Description

technical field [0001] The invention relates to a lactose-polyvidone-crospovidone premix and a preparation method thereof, belonging to the technical field of pharmacy. Background technique [0002] Pharmaceutical excipients refer to the substances added to maintain the stability, safety or homogeneity of pharmaceutical preparations when they are formed, or to adapt to the characteristics of the preparations for the purpose of promoting dissolution and sustained release. They are the necessary basis for the development of pharmaceuticals. The 2005 edition of "Chinese Pharmacopoeia" is divided into 15 categories according to the use of pharmaceutical excipients, namely: acidifiers, antifoaming agents, adsorbents, antimicrobial preservatives, antioxidants, coloring agents, ointment bases, sweeteners, flavorings Agents, solvents, alkalizing agents, skin penetration enhancers, excipients, surfactants, pharmaceutical excipients. According to incomplete statistics, nearly a thous...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/32
Inventor 尹健朱风光王凤英
Owner SHANDONG LIAOCHENG E HUA PHARM CO LTD
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