Method for granulating medicament for treating osteoporosis

An osteoporosis and drug technology, which is applied in the field of granulation of drugs for the treatment of osteoporosis, can solve the problems of poor granule fluidity, difficulty in filling, and low bulk density.

Inactive Publication Date: 2010-05-19
SICHUAN MEDCO PHARML
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The original capsule adopts the conventional granulation method, the prepared granules are irregular, the particle size distribution is uneven, the thickness ratio is uncontrollable, the granule fluidity is not good, the granule gap is large, and the bulk density is small. The maximum bulk density can only reach about 0.80g / ml, and the weight of the particles filled into the No. 1 capsule shell is less than 0.40g
Therefore, it is very difficult to change No. 0 empty capsules into No. 1 fillings for the osteoporosis drug Zhuangguzhitong capsules

Method used

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  • Method for granulating medicament for treating osteoporosis

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Mix the drug material and auxiliary materials in a wet mixing granulator for 3 minutes to obtain a mixed drug material; take 1 part by weight of hydroxypropyl methylcellulose, 1.5 parts by weight of sodium carboxymethyl cellulose, and 2.5 parts by weight of polyvinylpyrrolidone, add water 25 parts by weight and 70 parts by weight of ethanol are prepared into a polymer mixed material containing 75% alcohol, and 1 part by weight of the polymer mixed material is added according to the ratio of 6 to 8 parts by weight of the mixed drug material, and stirred for 1 minute to obtain a soft Use the rocking granulation machine to wet the granules, pour the prepared wet granules into the boiling dryer, set the main air temperature to 80-90°C when the medicinal material is drying, and set the temperature of the auxiliary air duct to about 70°C, and control the temperature of the medicinal material to 60°C. ~70 DEG C, the time is about 25 minutes, the granules are dried and discharge...

Embodiment 2

[0035] The drug material and the auxiliary material are mixed in a wet mixing granulator for 3 minutes to obtain a mixed drug material; take 6 parts by weight of hydroxypropyl methylcellulose, add 20 parts by weight of water, and 74 parts by weight of ethanol, and prepare a drug containing about 68% alcohol. For the polymer mixed material, add 1 part by weight of the polymer mixed material in a ratio of 6 to 8 parts by weight of the mixed drug material, stir for 1 minute to obtain a soft material, use a swinging granulator to wet the granules, and prepare the wet granules Pour it into the boiling dryer, set the main air temperature to 80-90°C when the drug material is drying, and the auxiliary air duct temperature to about 70°C, control the temperature of the drug material to 65-75°C for about 25 minutes, and discharge the granules after drying. Then use a 24-mesh sieve to granulate, mix, and pack into No. 1 capsules at 0.45 g / grain to obtain capsule medicine.

Embodiment 3

[0037] The drug material and the auxiliary material are mixed in a wet mixing granulator for 3 minutes to obtain a mixed drug material; take 1.5 parts by weight of hydroxypropyl methylcellulose, 2.5 parts by weight of sodium carboxymethyl cellulose, add 35 parts by weight of water, and 61 parts by weight of ethanol 1 part, be mixed with the macromolecule mixed material containing about 65% of alcohol, add 1 weight part of described polymer mixed material in the ratio of 7 weight parts of mixed medicine material, stir 1 minute and make soft material, wet with rocking type granulator Granules, pour the prepared wet granules into the boiling dryer, set the temperature of the main air to 80-90°C and the temperature of the auxiliary air duct to about 70°C when drying the medicinal material, and control the temperature of the medicinal material to 62-72°C for about 25 minutes , discharging after the granules are dried, the granules are sized with a 24-mesh sieve, mixed, packed into N...

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Abstract

The invention relates to a method for granulating a medicament for treating osteoporosis, which comprises the following steps of: firstly uniformly mixing the medicament and auxiliary materials; adding a polymer blend, and stirring the mixture to obtain a soft material; preparing wet granules from obtained soft material with a granulator; placing the prepared wet granules into a boiling drier to dry; discharging the granules after drying the granules; passing the granules through a 25-mesh screen; mixing the granules; and encapsulating 0.45g of granules into each number 1 capsule to obtain a capsule preparation. The polymer blend has the functions of adhesion and coating, and ensure that the medicament fine powder is tightly prepared into balls and each ball is coated with a layer of film coating, so that powder granule gaps are reduced, the requirements of encapsulating materials into the number 1 empty capsule is met, the medicament only encapsulated by a large number 0 empty capsule can be successfully encapsulated by the small number 1 empty capsule, the volume of the finished capsule is decreased which is convenient for administration, the compliance of medication is increased, sale and use of the medicament are promoted, and good benefits for society and enterprises can be created.

Description

technical field [0001] The invention relates to capsule medicine, in particular to a granulation method of medicine for treating osteoporosis. Background technique [0002] Capsules are preparations that are filled with drugs in a hollow capsule shell that is tightly fitted by the capsule body and capsule cap. According to the capsule drug standard, hollow capsules have 8 sizes and specifications code-named No. 000, No. 00, No. 0, and No. 1 to No. 5, all of which are cylindrical. Among them, the specifications of No. 00 to No. 2 and the value of the capsule body volume are: No. 00, the volume is 0.95ml; No. 0, the volume is 0.68ml; No. 1, the volume is 0.50ml; No. 2, the volume is 0.37ml. That is, the larger the number of specifications, the smaller the volume of the bag body, that is, the less weight of the contents. [0003] The appropriate filling volume of No. 0 capsule is generally between 0.4 and 0.6 g, and the filling volume of No. 1 capsule is between 0.3 and 0.4 g...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/815A61K9/48A61K47/38A61K47/32A61P19/10
Inventor 卿光明余定祥钟瑛
Owner SICHUAN MEDCO PHARML
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