CN114762650A

CN114762650A - Method for processing material with poor bulk density into medicament with predetermined specification

Info

Publication number: CN114762650A
Application number: CN202110030122.5A
Authority: CN
Inventors: 韩立彬; 王勇强; 赵德发
Original assignee: Langfang Xinlongli Machinery Manufacturing Co ltd
Current assignee: Langfang Xinlongli Machinery Manufacturing Co ltd
Priority date: 2021-01-11
Filing date: 2021-01-11
Publication date: 2022-07-19

Abstract

A method of processing a material having poor bulk density to a predetermined specification of a pharmaceutical product comprising the steps of: step one, micronizing the raw materials by adopting a jet mill; adding auxiliary materials according to the proportion of the components of the original grinding medicine, and uniformly mixing; step three, preparing the uniformly mixed materials in the step two into particles with the particle size of 0.2mm-2mm by adopting a granulator; step four, granulating or crushing the particles prepared in the step three by using a granulator or a crusher to obtain particle size distribution D90 or D95 which is close to or the same as that of the original ground medicament; and step five, separating the fine powder and the coarse powder into unqualified materials by using an airflow classifier, wherein the bulk density of the rest materials is close to or the same as that of the original ground medicine, and the unqualified materials are used as qualified materials to be filled into capsules or packaged powder. The method can effectively control the bulk density of the final powder, and better solves the problem that the bulk density of the imitation drugs in the existing pharmaceutical enterprises can not be close to that of the original drugs.

Description

Method for processing material with poor bulk density into medicament with preset specification

Technical Field

The invention relates to a medicine processing method, in particular to a method for processing a material with poor bulk density into a medicine with a preset specification, and belongs to the technical field of powder crushing and granule finishing.

Background

At present, the bulk density of the imitation drugs cannot be close to that of the original drugs, for example, the original drugs of a certain capsule are in a capsule form, and the specification is 0.2 g; the enterprise researchers find that no matter which granulating, crushing or granule finishing method is adopted in the enterprise laboratory or pharmaceutical equipment manufacturer for testing, the bulk density of the materials can not reach the level close to that of the original ground medicines at all, and the 1# hollow capsule is filled with the medicines, so that the weight is not enough and the requirements of the same specification can not be met. Meanwhile, the national evaluation work of the consistency of the imitation drugs is further promoted, and a plurality of guidance opinions are provided in succession, wherein the ' determination of dissolution curve of common oral solid preparation and comparison guidance principle ' clearly indicates that the preparation with the same dosage form and the same specification is adopted for the comparison of the similarity of the dissolution curve '. Therefore, this problem is a problem that needs to be solved at present.

Disclosure of Invention

The present invention is directed to solving the above problems of the prior art by providing a method for processing a material with poor bulk density into a predetermined size of a pharmaceutical.

In order to achieve the purpose, the technical solution of the invention is as follows: a method of processing a material having poor bulk density to a predetermined specification of a pharmaceutical product comprising the steps of: step one, micronizing the raw materials by using a jet mill; adding auxiliary materials according to the proportion of the components of the original grinding medicine, and uniformly mixing; step three, preparing the uniformly mixed materials in the step two into particles with the particle size of 0.2mm-2mm by adopting a granulator; step four, granulating or crushing the particles prepared in the step three by using a granulator or a crusher to obtain particle size distribution D90 or D95 which is close to or the same as that of the original ground medicament; and step five, separating the over-fine powder and the over-coarse powder in a certain proportion by using an airflow classifier to obtain unqualified materials, wherein the bulk density of the residual materials is close to or equal to that of the original ground medicines, and the unqualified materials are used as qualified materials to be filled into capsules or packaged powder.

The sixth step further comprises the following steps: and repeating the processes from the third step to the fifth step on the unqualified materials which are separated by the airflow classifier and are too fine powder and too coarse powder.

In the first step, a fluidized bed jet mill is adopted to micronize the initial raw materials.

And in the second step, a mixer is adopted to mix the materials.

And in the third step, a dry-process machine is adopted for granulating.

And the pulverizer in the fourth step is used for pulverizing.

Compared with the prior art, the invention has the beneficial effects that:

the method adopts the scheme of superfine grinding of raw materials → mixing of auxiliary materials → dry granulation → crushing and finishing → air classification → capsule filling, can effectively control the bulk density of the final powder, and better solves the problem that the bulk density of the prior imitation drug in pharmaceutical enterprises can not be close to that of the prior grinding drug.

Drawings

FIG. 1 is a flow chart of the present invention.

Detailed Description

The invention is described in further detail below with reference to the drawing description and the detailed description.

Referring to fig. 1, a method for processing a material with poor bulk density into a medicament with a predetermined specification belongs to the technical field of powder crushing and granule finishing, and is particularly suitable for crushing and granule finishing of a material with a bulk density requirement on a final material in the industries of pharmacy, food, health care products and the like; the method comprises the following steps:

and step one, micronizing the raw materials by using a jet mill, so that the dissolution rate of the materials is improved conveniently.

And step two, adding auxiliary materials according to the proportion of the components of the original grinding medicine, and uniformly mixing.

And step three, preparing the uniformly mixed materials in the step two into particles with the particle size of 0.2mm-2mm by adopting a dry method granulator.

And step four, granulating or crushing the particles prepared in the step three by using a granulator or a crusher to further reduce the particle size until the particle size distribution D90 or D95 is close to or the same as that of the original ground medicament.

Separating fine powder and coarse powder which are separated by using an airflow classifier in a certain proportion to form unqualified materials, wherein the certain proportion is different according to different material bulk density requirements, so the proportion is also different; the bulk density of the residual materials is close to or the same as that of the original ground medicament, and the residual materials are used as qualified materials to be filled into capsules or packaged powder;

referring to fig. 1, specifically, the sixth step further includes the following steps: and repeating the processes from the third step to the fifth step on the unqualified materials which are separated from the airflow classifier and are too fine powder and too coarse powder.

Referring to fig. 1, specifically, in the first step, a TC30 fluidized bed jet mill is used to micronize the starting material, and the air pressure is 0.75MPa, the vertical classification frequency is 47Hz, and the feeding frequency is 10 Hz.

Referring to fig. 1, in the second step, the HTD100 column type lifting hopper mixer is used to mix the materials, and the mixing time is 20 min.

Referring to fig. 1, in the third step, an LGS150 dry-process machine is used for granulation, with a pressure of 210bar, a screw feeding speed of 40rpm, a compression roller speed of 10rpm, a whole granule speed of 120rpm, and a 0.6mm circular hole screen.

Referring to fig. 1, in the fourth step, a FCWS400 multifunctional pulverizer is used for pulverizing, wherein the pulverizing frequency is 22Hz, the feeding speed is 20rpm, and the screen is a 0.6mm round hole screen.

In detail, in the fifth step, a TCF30 airflow classifier is used for separating the fine powder, the separation frequency is 26Hz, and the feeding speed is 200 rpm.

The first embodiment is as follows:

the bulk density of the original raw materials of the original medicine of the simulated medicine of a certain enterprise is 0.53g/ml, and the bulk density of the final medicine of the filled capsule is 0.66ml, which is superior to the bulk density of the original raw materials adopted by the enterprise; the average grain diameter of the material D90186 μm. The enterprise adopts the method, and the specific process is as follows:

step one, micronizing the initial raw materials by adopting a TC30 fluidized bed jet mill, wherein the use air pressure is 0.75MPa, the vertical grading frequency is 47Hz, the feeding frequency is 10 Hz, the particle size of a product is D906.2 mu m, and the bulk density of the material is 0.194 g/ml.

And step two, mixing the materials added with the auxiliary materials by adopting an HTD100 column type lifting hopper mixer for 20 min.

And step three, granulating by adopting an LGS150 dry-process machine, wherein the use pressure is 210bar, the spiral feeding speed is 40rpm, the compression roller rotating speed is 10rpm, the whole grain rotating speed is 120rpm, a round hole screen with a screen of 0.6mm is adopted, the product particle size is D900.4mm, and the bulk density is 0.477 g/ml.

And step four, crushing by adopting an FCWS400 multifunctional crusher, wherein the crushing frequency is 22Hz, the feeding speed is 20rpm, a screen is a circular hole screen with the size of 0.6mm, the particle size of the product is D90171 mu m, and the bulk density is 0.563 g/ml.

And step five, separating the over-fine powder by using a TCF30 airflow classifier, wherein the separation frequency is 26Hz, the feeding rotation speed is 200rpm, the particle size of the product after partial fine powder separation is D90192 microns, and the bulk density is 0.672 g/ml.

And step five, repeating the dry granulation → pulverization → airflow classification process of the step three to the step five on the separated fine powder, wherein the particle size of the product is D90189 mu m, and the bulk density is 0.668 g/ml.

The first embodiment completely solves the problem that the filling amount of the empty capsule of the user is not enough. Meanwhile, if the user wants the bulk density of the final material to be low, the unqualified material separated by the airflow classifier is partial coarse powder, and the requirement is met.

Referring to fig. 1, the bulk density of the material is not equal to the operating pressure of the dry granulator, the particle size distribution after crushing and granulating is not dense, the operating pressure of the dry granulator is adjustable, and the complete particle size distribution after crushing and granulating of the material is not controllable, which results in the fact that the bulk density of the final material is greatly different from that of the original ground drug. The method for processing the material with poor bulk density into the medicament with the preset specification adopts the scheme of superfine grinding of raw materials → mixed auxiliary materials → dry granulation → crushed whole granules → air flow classification → capsule filling, can effectively control the bulk density of the final powder, better solves the problem that the similarity of dissolution curves of common oral solid preparation is compared with the preparation with the same dosage form and the same specification which is definitely pointed out in the guiding principle of dissolution curve measurement and comparison of common oral solid preparation, and provides beneficial help for the consistency evaluation of the simulated medicament of pharmaceutical enterprises.

The foregoing is a more detailed description of the invention in connection with specific preferred embodiments and it is not intended that the invention be limited to these specific details. For those skilled in the art to which the invention relates, numerous changes, substitutions and alterations may be made without departing from the spirit of the invention, and the above described structures are deemed to be within the scope of the invention.

Claims

1. A method of processing a material having poor bulk density to a predetermined specification of a pharmaceutical, comprising the steps of:

step one, micronizing the raw materials by adopting a jet mill;

adding auxiliary materials according to the proportion of the components of the original grinding medicine, and uniformly mixing;

step three, preparing the uniformly mixed materials in the step two into particles with the particle size of 0.2mm-2mm by adopting a granulator;

step four, granulating or crushing the particles prepared in the step three by using a granulator or a crusher to obtain particle size distribution D90 or D95 which is close to or the same as that of the original ground medicament;

and step five, separating the fine powder and the coarse powder which are in a certain proportion by using an airflow classifier to obtain unqualified materials, wherein the bulk density of the rest materials is close to or the same as that of the original ground medicines, and the unqualified materials are used for filling capsules or packaging powder.

2. The method of claim 1, wherein step six further comprises the steps of: and repeating the processes from the third step to the fifth step on the unqualified materials which are separated from the airflow classifier and are too fine powder and too coarse powder.

3. The method of claim 1, wherein the method comprises the steps of: in the first step, a fluidized bed jet mill is adopted to micronize the initial raw materials.

4. The method of processing a poorly dense material into a predetermined size pharmaceutical product of claim 1, comprising: and in the second step, a mixer is adopted to mix the materials.

5. The method of claim 1, wherein the method comprises the steps of: and in the third step, a granulator is adopted for granulation.

6. The method of claim 1, wherein the method comprises the steps of: and in the fourth step, a crusher is adopted for crushing.