CN112587499A - Berberine hydrochloride pellet and preparation method thereof - Google Patents

Berberine hydrochloride pellet and preparation method thereof Download PDF

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CN112587499A
CN112587499A CN202011596678.2A CN202011596678A CN112587499A CN 112587499 A CN112587499 A CN 112587499A CN 202011596678 A CN202011596678 A CN 202011596678A CN 112587499 A CN112587499 A CN 112587499A
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berberine hydrochloride
pellets
aqueous solution
slurry
water
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江敏
唐金容
张波
练心结
罗洪
罗丹
胡晶
杨鑫嵎
严冬
郭敏
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Chengdu Jinhua Pharmaceutical Co ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
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    • A61K9/4825—Proteins, e.g. gelatin
    • A—HUMAN NECESSITIES
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    • A61K31/00—Medicinal preparations containing organic active ingredients
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    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4375—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having nitrogen as a ring heteroatom, e.g. quinolizines, naphthyridines, berberine, vincamine
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    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents

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Abstract

The invention provides a berberine hydrochloride pellet and a preparation method thereof, comprising the following steps: s1, placing the raw materials in a formula amount into a granulating pot, stirring at a rotating speed of 120rpm, shearing at a rotating speed of 600rpm, and premixing for 5 minutes; s2, weighing purified water into a slurry adding tank, setting slurry adding atomization pressure to be 0.2-0.25 Mpa, and adding slurry, wherein the slurry adding time is controlled to be 30-60 seconds; s3, after the slurry is added, setting the stirring rotation speed to be 120rpm and the shearing rotation speed to be 1200rpm, and granulating for 1 min; discharging after granulating; s4, extruding the prepared intermediate by adopting a screw, wherein a screen is 40 meshes; s5, placing the extruded soft material in a spheronization pot, setting the rotation speed to be 500-1000 rpm, and carrying out spheronization to obtain pellets with the diameter of 1.5-2.7 mm; s6, paving the pellets on a baking pan, and drying at the temperature of 55-65 ℃ until the moisture is 13-16%; and S7, filling the gelatin hollow capsule by adopting a capsule filling machine. The invention solves the problems that the prior sugar-coated tablets and film-coated tablets have longer disintegration time, can not be dissolved and released quickly and can not take the effect of quick effect.

Description

Berberine hydrochloride pellet and preparation method thereof
Technical Field
The invention relates to the technical field of traditional Chinese medicine pellets, and in particular relates to a berberine hydrochloride pellet and a preparation method thereof.
Background
Berberine hydrochloride is also called berberine, and is an alkaloid extracted from plants such as cortex Phellodendri, Coptidis rhizoma, radix Berberidis, etc., or artificially synthesized, and its molecular formula is C20H18CLNO4 & 2H 2O.
The berberine hydrochloride has wide antibacterial spectrum, and has antibacterial effect on multiple gram positive and negative bacteria in vitro, such as hemolytic streptococcus, Staphylococcus aureus, and Vibrio cholerae. Meningococcus, shigella dysenteriae, typhoid bacillus, diphtheria bacillus and the like have strong inhibiting effect, and can inhibit bacteria at low concentration and kill bacteria at high concentration. It also has certain inhibitory effect on influenza virus, amoeba protozoa, leptospira and certain dermatophytes. In vitro experiments prove that the berberine can enhance the phagocytic capacity of leucocytes and a liver reticuloendothelial system. Dysentery bacillus, hemolytic streptococcus, staphylococcus aureus, etc. are easy to generate drug resistance to the product. It has no cross-resistance with penicillin and streptomycin. Has less adverse reaction after oral administration and wide clinical application.
Because berberine hydrochloride is extremely bitter in taste, the current products sold in the market mainly comprise common sugar-coated tablets or film-coated tablets. However, both sugar-coated tablets and film-coated tablets have long disintegration time, cannot be dissolved and released quickly, and cannot play a role in quick response. Therefore, there is a need to provide berberine hydrochloride pellets and a preparation method thereof to overcome the above problems.
Disclosure of Invention
The invention provides a berberine hydrochloride pellet and a preparation method thereof, which are used for solving the problems that the existing sugar-coated tablets and film-coated tablets have longer disintegration time, can not be dissolved and released quickly and can not take the effect of taking effect quickly.
In order to solve the technical problems, the technical scheme adopted by the invention is as follows:
a berberine hydrochloride pellet is prepared by preparing berberine hydrochloride into quick-release pellet according to prescription, and filling into gelatin hollow capsule; the prescription comprises the following components:
54.47% of berberine hydrochloride, 10.89% of corn starch or microcrystalline cellulose, 8.50% of pregelatinized starch, 3.81% of carboxymethyl starch sodium or carboxymethyl cellulose calcium and the balance of water or aqueous solution.
Preferably, the prescribed amounts are: 100g of berberine hydrochloride, 20g of corn starch, 15.6g of pregelatinized starch, 7g of carboxymethyl starch sodium and 41g of water or aqueous solution.
Preferably, the prescribed amounts are: 100g of berberine hydrochloride, 20g of microcrystalline cellulose, 15.6g of pregelatinized starch, 7g of carboxymethyl starch sodium and 41g of water or aqueous solution.
Preferably, the prescribed amounts are: 100g of berberine hydrochloride, 20g of microcrystalline cellulose, 15.6g of pregelatinized starch, 7g of calcium carboxymethylcellulose and 41g of water or aqueous solution.
Preferably, the prescribed amounts are: 100g of berberine hydrochloride, 20g of corn starch, 15.6g of pregelatinized starch, 7g of calcium carboxymethylcellulose and 41g of water or aqueous solution.
A preparation method of berberine hydrochloride pellets is used for preparing the berberine hydrochloride pellets and comprises the following steps:
s1, placing berberine hydrochloride, corn starch or microcrystalline cellulose, pregelatinized starch, sodium carboxymethyl starch or calcium carboxymethyl cellulose in a prescription amount into a granulating pan, setting a stirring rotating speed of 120rpm and a shearing rotating speed of 600rpm, and premixing for 5 minutes;
s2, keeping the parameters unchanged, weighing water or aqueous solution with the formula amount into a slurry adding tank, setting the slurry adding atomization pressure to be 0.2-0.25 Mpa, and adding slurry, wherein the slurry adding time is controlled to be 30-60 seconds;
s3, after the slurry is added, setting the stirring rotation speed to be 120rpm and the shearing rotation speed to be 1200rpm, and granulating for 1 min; discharging after granulating;
s4, extruding the prepared intermediate by adopting a screw, wherein a screen is 40 meshes;
s5, placing the extruded soft material in a spheronization pot, setting the rotation speed to be 500-1000 rpm, and carrying out spheronization to obtain pellets with the diameter of 1.5-2.7 mm;
s6, paving the pellets on a baking pan, and drying at the temperature of 55-65 ℃ until the moisture content is 13-16%;
and S7, filling the pellets into 2# gelatin hollow capsules by using a capsule filling machine to obtain the soft capsule.
Preferably, the prescription amount in step S1 is: 100g of berberine hydrochloride, 20g of corn starch, 15.6g of pregelatinized starch, 7g of carboxymethyl starch sodium and 41g of water or aqueous solution.
Preferably, the prescription amount in step S1 is: 100g of berberine hydrochloride, 20g of microcrystalline cellulose, 15.6g of pregelatinized starch, 7g of carboxymethyl starch sodium and 41g of water or aqueous solution.
Preferably, the prescription amount in step S1 is: 100g of berberine hydrochloride, 20g of microcrystalline cellulose, 15.6g of pregelatinized starch, 7g of calcium carboxymethylcellulose and 41g of water or aqueous solution.
Preferably, the prescription amount in step S1 is: 100g of berberine hydrochloride, 20g of corn starch, 15.6g of pregelatinized starch, 7g of calcium carboxymethylcellulose and 41g of water or aqueous solution.
Compared with the prior art, the invention has the following beneficial effects: the invention is composed of the following components by the prescription: 54.47% of berberine hydrochloride, 10.89% of corn starch or microcrystalline cellulose, 8.50% of pregelatinized starch, 3.81% of carboxymethyl starch sodium or carboxymethyl cellulose calcium and the balance of water or aqueous solution, and the berberine hydrochloride pellet prepared by the preparation method of the berberine hydrochloride pellet can be rapidly disintegrated and released, so that the contact area is increased, the release speed of the berberine hydrochloride is improved, the berberine hydrochloride can rapidly reach the antibacterial concentration in the gastrointestinal tract, and the onset time is effectively shortened; compared with the conventional sugar-coated tablet and film-coated tablet, the berberine hydrochloride micro-pill has the advantages of quick release speed under various medium conditions, obvious advantages and quick response.
Drawings
FIG. 1 is a schematic diagram of the steps of a berberine hydrochloride pellet preparation method of the present invention.
FIG. 2 is a graphical representation of the dissolution profile at pH1.2 in one example of the invention.
FIG. 3 is a graphical representation of the dissolution profile at pH4.0 in one example of the invention.
FIG. 4 is a graphical representation of the dissolution profile at pH6.8 in a first example of the invention.
Detailed Description
The technical solutions of the present invention are further described in detail below with reference to the accompanying drawings, but the scope of the present invention is not limited to the following.
In order to make the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the technical solutions of the embodiments of the present invention will be described clearly and completely with reference to the accompanying drawings of the embodiments of the present invention, and it is obvious that the described embodiments are some, but not all embodiments of the present invention. All other embodiments, which can be obtained by a person skilled in the art without any inventive step based on the embodiments of the present invention, are within the scope of the present invention. Thus, the following detailed description of the embodiments of the present invention, presented in the figures, is not intended to limit the scope of the invention, as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, which can be obtained by a person skilled in the art without any inventive step based on the embodiments of the present invention, are within the scope of the present invention.
The present invention will be further described with reference to the following examples, which are intended to illustrate only some, but not all, of the embodiments of the present invention. Based on the embodiments of the present invention, other embodiments used by those skilled in the art without any creative effort belong to the protection scope of the present invention.
Referring to fig. 1 to 4, an embodiment of the present invention is shown, which is for illustration purposes only and is not limited to this structure.
Example one
A berberine hydrochloride pellet is prepared by preparing berberine hydrochloride into quick-release pellet according to prescription, and filling into gelatin hollow capsule; the prescription comprises the following components:
54.47% of berberine hydrochloride, 10.89% of corn starch or microcrystalline cellulose, 8.50% of pregelatinized starch, 3.81% of carboxymethyl starch sodium or carboxymethyl cellulose calcium and the balance of water or aqueous solution. The water is purified water.
A preparation method of berberine hydrochloride pellet is used for preparing berberine hydrochloride pellet, as shown in figure 1, and comprises the following steps:
s1, placing berberine hydrochloride, corn starch or microcrystalline cellulose, pregelatinized starch, sodium carboxymethyl starch or calcium carboxymethyl cellulose in a prescription amount into a granulating pan, setting a stirring rotating speed of 120rpm and a shearing rotating speed of 600rpm, and premixing for 5 minutes;
s2, keeping the parameters unchanged, weighing purified water with the prescription amount into a slurry adding tank, setting the slurry adding atomization pressure to be 0.2-0.25 Mpa, and adding slurry, wherein the slurry adding time is controlled to be 30-60 seconds;
s3, after the slurry is added, setting the stirring rotation speed to be 120rpm and the shearing rotation speed to be 1200rpm, and granulating for 1 min; discharging after granulating;
s4, extruding the prepared intermediate by adopting a screw, wherein a screen is 40 meshes;
s5, placing the extruded soft material in a spheronization pot, setting the rotation speed to be 500-1000 rpm, and carrying out spheronization to obtain pellets with the diameter of 1.5-2.7 mm;
s6, paving the pellets on a baking pan, and drying at the temperature of 55-65 ℃ until the moisture content is 13-16%;
and S7, filling the pellets into 2# gelatin hollow capsules by using a capsule filling machine to obtain the soft capsule.
In order to further understand the dissolution situation of the berberine hydrochloride pellets prepared by the invention in vitro and further analyze the release situation of the berberine hydrochloride pellets in vivo, the experiments are designed to measure the dissolution curve of the berberine hydrochloride pellets of the invention and compare the dissolution curve with samples produced by other manufacturers under the conditions that the pH value is 1.2 (simulating the release environment of artificial gastric juice) and the pH values are 4.0 and 6.8 (simulating the release environment in the small intestine) at 37.5 ℃. The measurement data are as follows:
the dissolution profile at ph1.2 is shown in fig. 2, with the dissolution profile at ph1.2 (n-12).
Figure BDA0002868108380000051
Figure BDA0002868108380000061
The dissolution profile at ph4.0 is shown in fig. 3, with the dissolution profile at ph4.0 (n-12).
Figure BDA0002868108380000062
The dissolution profile at ph6.8 is shown in fig. 4, with the dissolution profile at ph6.8 (n-12).
Figure BDA0002868108380000063
The results show that: the berberine hydrochloride quick-release pellet capsule in simulated gastric acid solution has broken capsule shell, and pellets in the capsule are dispersed out and can be rapidly disintegrated and released.
Example two
Embodiment two is a further application of embodiment one.
1) Placing 100g of berberine hydrochloride, 20g of corn starch, 15.6g of pregelatinized starch and 7g of carboxymethyl starch sodium in a granulating pan, setting the stirring speed to be 120rpm, the shearing speed to be 600rpm, and premixing for 5 minutes; 2) keeping the parameters unchanged, weighing 41g of purified water into a slurry adding tank, setting the slurry adding atomization pressure to be 0.2-0.25 Mpa, and adding slurry, wherein the slurry adding time is controlled to be 30-60 seconds; 3) after the slurry is added, the stirring speed is set to be 120rpm, the shearing speed is set to be 1200rpm, and the granulation is carried out for 1 min. Discharging after granulating; 4) extruding the prepared intermediate by adopting a screw, and adopting a 40-mesh screen; 5) placing the extruded soft material in a spheronizing pot, setting the rotating speed to be 500-1000 rpm for spheronization, and obtaining pellets with the diameter of 1.5-2.7 mm; 6) spreading the pellets on a baking pan, and drying at 55-65 ℃ until the water content is 13-16%; 7) filling the above pellets into gelatin hollow capsule by capsule filling machine.
EXAMPLE III
The third embodiment is a further application of the first embodiment.
1) Placing 100g of berberine hydrochloride, 20g of microcrystalline cellulose, 15.6g of pregelatinized starch and 7g of carboxymethyl starch sodium in a granulating pan, setting the stirring speed to be 120rpm, the shearing speed to be 600rpm, and premixing for 5 minutes; 2) keeping the parameters unchanged, weighing 41g of purified water into a slurry adding tank, setting the slurry adding atomization pressure to be 0.2-0.25 Mpa, and adding slurry, wherein the slurry adding time is controlled to be 30-60 seconds; 3) after the slurry is added, the stirring speed is set to be 120rpm, the shearing speed is set to be 1200rpm, and the granulation is carried out for 1 min. Discharging after granulating; 4) extruding the prepared intermediate by adopting a screw, and adopting a 40-mesh screen; 5) placing the extruded soft material in a spheronizing pot, setting the rotating speed to be 500-1000 rpm for spheronization, and obtaining pellets with the diameter of 1.5-2.7 mm; 6) spreading the pellets on a baking pan, and drying at 55-65 ℃ until the water content is 13-16%; 7) filling the above pellets into gelatin hollow capsule by capsule filling machine.
Example four
Example four is a further application of example one.
1) Placing 100g of berberine hydrochloride, 20g of microcrystalline cellulose, 15.6g of pregelatinized starch and 7g of carboxymethylcellulose calcium in a granulating pan, setting the stirring speed to be 120rpm and the shearing speed to be 600rpm, and premixing for 5 minutes; 2) keeping the parameters unchanged, weighing 41g of purified water into a slurry adding tank, setting the slurry adding atomization pressure to be 0.2-0.25 Mpa, and adding slurry, wherein the slurry adding time is controlled to be 30-60 seconds; 3) after the slurry is added, the stirring speed is set to be 120rpm, the shearing speed is set to be 1200rpm, and the granulation is carried out for 1 min. Discharging after granulating; 4) extruding the prepared intermediate by adopting a screw, and adopting a 40-mesh screen; 5) placing the extruded soft material in a spheronizing pot, setting the rotating speed to be 500-1000 rpm for spheronization, and obtaining pellets with the diameter of 1.5-2.7 mm; 6) spreading the pellets on a baking pan, and drying at 55-65 ℃ until the water content is 13-16%; 7) filling the above pellets into gelatin hollow capsule by capsule filling machine.
EXAMPLE five
Example five is a further application of example one.
1) Placing 100g of berberine hydrochloride, 20g of corn starch, 15.6g of pregelatinized starch and 7g of carboxymethylcellulose calcium in a granulating pan, setting the stirring speed to be 120rpm and the shearing speed to be 600rpm, and premixing for 5 minutes; 2) keeping the parameters unchanged, weighing 41g of purified water into a slurry adding tank, setting the slurry adding atomization pressure to be 0.2-0.25 Mpa, and adding slurry, wherein the slurry adding time is controlled to be 30-60 seconds; 3) after the slurry is added, the stirring speed is set to be 120rpm, the shearing speed is set to be 1200rpm, and the granulation is carried out for 1 min. Discharging after granulating; 4) extruding the prepared intermediate by adopting a screw, and adopting a 40-mesh screen; 5) placing the extruded soft material in a spheronizing pot, setting the rotating speed to be 500-1000 rpm for spheronization, and obtaining pellets with the diameter of 1.5-2.7 mm; 6) spreading the pellets on a baking pan, and drying at 55-65 ℃ until the water content is 13-16%; 7) filling the above pellets into gelatin hollow capsule by capsule filling machine.
The dissolution curves of the berberine hydrochloride pellets prepared in the second to fifth examples are measured under the conditions of pH value of 1.2 (simulating the release environment of the artificial gastric juice) and pH values of 4.0 and 6.8 (simulating the release environment in the small intestine).
Dissolution in medium (n ═ 12) at pH1.2
Figure BDA0002868108380000081
Dissolution in medium (n ═ 12) at pH4.0
Figure BDA0002868108380000082
Figure BDA0002868108380000091
Dissolution in medium (pH 6.8) (n ═ 12)
Figure BDA0002868108380000092
The results show that: the capsule shell of the berberine hydrochloride micro-pill is broken in simulated gastric acid solution, the micro-pill in the capsule is dispersed out and can be rapidly disintegrated and released, the berberine hydrochloride micro-pill is released rapidly under various medium conditions, the advantages are obvious, and the effect is rapid.
EXAMPLE six
The sixth embodiment is a further optimization of the fifth embodiment.
The water solution is potato amylose water solution, and can effectively improve the bitter taste of berberine hydrochloride.
Step S1, taking 100g of berberine hydrochloride, 20g of corn starch, 15.6g of pregelatinized starch and 7g of carboxymethyl starch sodium, placing the materials in a granulating pan, setting the stirring rotation speed to be 120rpm, the shearing rotation speed to be 600rpm, and premixing for 5 minutes;
s2, keeping the parameters unchanged, adding distilled water into potato amylose, uniformly stirring to obtain a potato amylose aqueous solution, wherein the concentration of the potato amylose aqueous solution is 30-34%, weighing 41g of the potato amylose aqueous solution into a slurry adding tank, setting the slurry adding atomization pressure to be 0.2-0.25 Mpa, and adding slurry for 30-60 seconds;
s3, after the slurry is added, setting the stirring rotation speed to be 120rpm and the shearing rotation speed to be 1200rpm, and granulating for 1 min; discharging after granulating;
s4, extruding the prepared intermediate by adopting a screw, wherein a screen is 40 meshes;
s5, placing the extruded soft material in a spheronization pot, setting the rotation speed to be 500-1000 rpm, and carrying out spheronization to obtain pellets with the diameter of 1.5-2.7 mm;
s6, paving the pellets on a baking pan, and drying at the temperature of 55-65 ℃ until the moisture content is 13-16%;
and S7, filling the pellets into 2# gelatin hollow capsules by using a capsule filling machine to obtain the soft capsule.
The above-described embodiments are intended to be illustrative, not limiting, of the invention, and therefore, variations of the example values or substitutions of equivalent elements are intended to be within the scope of the invention.
From the above detailed description, it will be apparent to those skilled in the art that the foregoing objects and advantages of the invention are achieved and are in accordance with the provisions of the patent statutes.
While preferred embodiments of the present invention have been described, additional variations and modifications in those embodiments may occur to those skilled in the art once they learn of the basic inventive concepts. Therefore, it is intended that the appended claims be interpreted as including preferred embodiments and all such alterations and modifications as fall within the scope of the invention. The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, it should be noted that any modifications, equivalents and improvements made within the spirit and principle of the present invention should be included in the scope of the present invention.

Claims (10)

1. A berberine hydrochloride pellet is characterized in that berberine hydrochloride is prepared into a quick-release pellet according to a prescription, and then a gelatin hollow capsule is adopted for filling to obtain the berberine hydrochloride pellet; the prescription comprises the following components:
54.47% of berberine hydrochloride, 10.89% of corn starch or microcrystalline cellulose, 8.50% of pregelatinized starch, 3.81% of carboxymethyl starch sodium or carboxymethyl cellulose calcium and the balance of water or aqueous solution.
2. The berberine hydrochloride pellet of claim 1, wherein the amount of the prescription is as follows: 100g of berberine hydrochloride, 20g of corn starch, 15.6g of pregelatinized starch, 7g of carboxymethyl starch sodium and 41g of water or aqueous solution.
3. The berberine hydrochloride pellet of claim 1, wherein the amount of the prescription is as follows: 100g of berberine hydrochloride, 20g of microcrystalline cellulose, 15.6g of pregelatinized starch, 7g of carboxymethyl starch sodium and 41g of water or aqueous solution.
4. The berberine hydrochloride pellet of claim 1, wherein the amount of the prescription is as follows: 100g of berberine hydrochloride, 20g of microcrystalline cellulose, 15.6g of pregelatinized starch, 7g of calcium carboxymethylcellulose and 41g of water or aqueous solution.
5. The berberine hydrochloride pellet of claim 1, wherein the amount of the prescription is as follows: 100g of berberine hydrochloride, 20g of corn starch, 15.6g of pregelatinized starch, 7g of calcium carboxymethylcellulose and 41g of water or aqueous solution.
6. A preparation method of berberine hydrochloride pellets, which is characterized in that the method is used for preparing the berberine hydrochloride pellets of any one of claims 1 to 5, and comprises the following steps:
s1, placing berberine hydrochloride, corn starch or microcrystalline cellulose, pregelatinized starch, sodium carboxymethyl starch or calcium carboxymethyl cellulose in a prescription amount into a granulating pan, setting a stirring rotating speed of 120rpm and a shearing rotating speed of 600rpm, and premixing for 5 minutes;
s2, keeping the parameters unchanged, weighing water or aqueous solution with the formula amount into a slurry adding tank, setting the slurry adding atomization pressure to be 0.2-0.25 Mpa, and adding slurry, wherein the slurry adding time is controlled to be 30-60 seconds;
s3, after the slurry is added, setting the stirring rotation speed to be 120rpm and the shearing rotation speed to be 1200rpm, and granulating for 1 min; discharging after granulating;
s4, extruding the prepared intermediate by adopting a screw, wherein a screen is 40 meshes;
s5, placing the extruded soft material in a spheronization pot, setting the rotation speed to be 500-1000 rpm, and carrying out spheronization to obtain pellets with the diameter of 1.5-2.7 mm;
s6, paving the pellets on a baking pan, and drying at the temperature of 55-65 ℃ until the moisture content is 13-16%;
and S7, filling the pellets into 2# gelatin hollow capsules by using a capsule filling machine to obtain the soft capsule.
7. The method for preparing berberine hydrochloride micro-pellets of claim 6, wherein the prescribed amount in step S1 is: 100g of berberine hydrochloride, 20g of corn starch, 15.6g of pregelatinized starch, 7g of carboxymethyl starch sodium and 41g of water or aqueous solution.
8. The method for preparing berberine hydrochloride micro-pellets of claim 6, wherein the prescribed amount in step S1 is: 100g of berberine hydrochloride, 20g of microcrystalline cellulose, 15.6g of pregelatinized starch, 7g of carboxymethyl starch sodium and 41g of water or aqueous solution.
9. The method for preparing berberine hydrochloride micro-pellets of claim 6, wherein the prescribed amount in step S1 is: 100g of berberine hydrochloride, 20g of microcrystalline cellulose, 15.6g of pregelatinized starch, 7g of calcium carboxymethylcellulose and 41g of water or aqueous solution.
10. The method for preparing berberine hydrochloride micro-pellets of claim 6, wherein the prescribed amount in step S1 is: 100g of berberine hydrochloride, 20g of corn starch, 15.6g of pregelatinized starch, 7g of calcium carboxymethylcellulose and 41g of water or aqueous solution.
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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1931137A (en) * 2006-09-19 2007-03-21 韩志强 Masked berberine hydrochloride micro pill and its prepn
CN102512377A (en) * 2011-12-22 2012-06-27 杭州高成生物营养技术有限公司 Tasteless quick-releasing berberine hydrochloride pellet
CN103393602A (en) * 2013-07-19 2013-11-20 东北制药（沈阳）科技发展有限公司 Berberine ultrafine-particle intestinal adhesion-type sustained-release pellet and preparation method thereof
CN103432082A (en) * 2013-08-29 2013-12-11 江苏正大清江制药有限公司 Glucosamine composition and preparation method thereof
CN105326837A (en) * 2015-10-09 2016-02-17 北京万全德众医药生物技术有限公司 Memantine hydrochloride sustained release-donepezil quick release compound capsule

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1931137A (en) * 2006-09-19 2007-03-21 韩志强 Masked berberine hydrochloride micro pill and its prepn
CN102512377A (en) * 2011-12-22 2012-06-27 杭州高成生物营养技术有限公司 Tasteless quick-releasing berberine hydrochloride pellet
CN103393602A (en) * 2013-07-19 2013-11-20 东北制药（沈阳）科技发展有限公司 Berberine ultrafine-particle intestinal adhesion-type sustained-release pellet and preparation method thereof
CN103432082A (en) * 2013-08-29 2013-12-11 江苏正大清江制药有限公司 Glucosamine composition and preparation method thereof
CN105326837A (en) * 2015-10-09 2016-02-17 北京万全德众医药生物技术有限公司 Memantine hydrochloride sustained release-donepezil quick release compound capsule

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