CN114452264B - Pioglitazone hydrochloride capsule and preparation method thereof - Google Patents

Pioglitazone hydrochloride capsule and preparation method thereof Download PDF

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CN114452264B
CN114452264B CN202111533447.1A CN202111533447A CN114452264B CN 114452264 B CN114452264 B CN 114452264B CN 202111533447 A CN202111533447 A CN 202111533447A CN 114452264 B CN114452264 B CN 114452264B
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pioglitazone hydrochloride
sodium dodecyl
dodecyl sulfate
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crospovidone
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CN114452264A (en
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何峣
蒋贵东
高健勋
赵凯
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Northeast Pharmaceutical Group Shenyang Shide Pharmaceutical Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4858Organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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Abstract

The application belongs to the technical field of pioglitazone hydrochloride preparations, and relates to a pioglitazone hydrochloride capsule and a preparation method thereof, wherein the pioglitazone hydrochloride capsule comprises the following components in parts by weight: 14.5-15.5 parts of pioglitazone hydrochloride; 128-136 parts of lactose; 2.00-2.12 parts of crosslinked povidone; 7.70-8.18 parts of hydroxypropyl cellulose; 1.54-1.64 parts of magnesium stearate; 0.155-0.165 parts of sodium dodecyl sulfate; the preparation method adopts a wet granulation method, and sodium dodecyl sulfate adopts a mode of adding one part of sodium dodecyl sulfate and adding the other part of sodium dodecyl sulfate. The prescription and the preparation method thereof have the characteristics of consistent dissolution effect of capsule products and original grinding tablets, good stability, good fluidity of mixed powder, suitability for industrial production and the like.

Description

Pioglitazone hydrochloride capsule and preparation method thereof
Technical Field
The application relates to the technical field of pioglitazone hydrochloride preparations, in particular to a pioglitazone hydrochloride capsule and a preparation method thereof.
Background
Pioglitazone hydrochloride tablet (Pioglitazone hydrochloride, ACTOS) is a raw preparation of the japan wuta pharmacy company. In 1999, the drug is marketed in the united states for the treatment of type 2 diabetes, the first line drug for type 2 diabetes. Pioglitazone is thiazolidinedione antidiabetic drug, it is insulin sensitizer, its action mechanism is selective activation peroxisome growth factor activated receptor, regulate insulin control gene strengthen the action of peripheral muscle, adipose tissue and liver insulin, promote consumption of glucose and 2-deoxyglucose, thus improve metabolism of glucose lipid, have apparent antihyperglycemic effect, reduce the level of insulin in the blood plasma, the clinical study shows that pioglitazone can improve insulin sensitivity of insulin resistant patient, raise the reactivity of insulin to cells, and improve glucose balance disorder in vivo.
From the point of view of pharmaceutical preparation, the in vitro dissolution curve of the capsule and the tablet is consistent, and the technical difficulty is conceivable. The existing prescription and process of pioglitazone hydrochloride capsules cannot be consistent with the dissolution behavior of the original grinding tablets, so that the development of a capsule prescription which is suitable for industrial mass production and has the dissolution behavior consistent with that of the original grinding tablets and a preparation method thereof are new problems to be solved urgently.
Disclosure of Invention
The application aims to provide a capsule prescription which is suitable for industrial mass production and has dissolution behavior consistent with that of an original grinding tablet and a preparation method thereof, and the prescription and the preparation method thereof have the characteristics of simple prescription, good fluidity of the prepared mixed powder, good stability of the capsule and the like.
In order to achieve the above purpose, the application adopts the following technical scheme: pioglitazone hydrochloride capsules comprise the following components in parts by weight:
the capsule is prepared by adopting a wet granulation method.
The capsule comprises the following components in parts by weight:
the capsule comprises the following components in parts by weight:
the sodium dodecyl sulfate is added by adding a part of sodium dodecyl sulfate in the form of particles and adding the other part of sodium dodecyl sulfate outside particles. The weight ratio of the sodium dodecyl sulfate added in the particles to the sodium dodecyl sulfate added outside the particles is 1:0.8-1.2. The weight ratio of the sodium dodecyl sulfate added in the particles to the sodium dodecyl sulfate added outside the particles is 1:1.
The preparation method of the pioglitazone hydrochloride capsule comprises the following components in parts by weight:
the preparation method comprises the following steps:
(1) Sieving lactose, crospovidone, hydroxypropyl cellulose, magnesium stearate and sodium dodecyl sulfate with 80 mesh sieve respectively;
(2) Weighing the pioglitazone hydrochloride with the prescription amount and lactose, crospovidone, hydroxypropyl cellulose, magnesium stearate and sodium dodecyl sulfate after sieving;
(3) Adding the prescribed amount of the crospovidone into purified water to prepare a water solution of the crospovidone;
(4) Dissolving pioglitazone hydrochloride with a prescription amount in an ethanol solution, and then adding the pioglitazone hydrochloride into a crosslinked povidone water solution to obtain pioglitazone hydrochloride preparation liquid;
(5) Adding lactose, hydroxypropyl cellulose and sodium dodecyl sulfate with the prescription amount into a mixer, and adding pioglitazone hydrochloride preparation solution to prepare a soft material;
(6) Preparing the soft material into wet particles by using a screen;
(7) Drying the wet particles to obtain dry particles;
(8) Finishing the dry granules by using a screen;
(9) Adding added part of sodium dodecyl sulfate and prescribed amount of magnesium stearate into the granulated dry particles, mixing uniformly to obtain mixed powder, and filling the mixed powder into capsules according to the theoretical weight to obtain the pioglitazone hydrochloride capsules.
In the step (3), the weight content of the crospovidone aqueous solution is 4-6%; in the step (4), the concentration of the ethanol solution is 90% -99%; the weight ratio of the pioglitazone hydrochloride to the ethanol solution is 15:18-22; the weight ratio of the sodium dodecyl sulfate in the added part to the sodium dodecyl sulfate in the added part is 1:0.8-1.2; the screen mesh in the step (6) is selected from 20 meshes; in the step (7), the drying temperature is selected from 40-60 ℃; in the step (7), the drying time is selected from 1.5-2.5 hours; the screen in step (8) is selected from 20 mesh; the particle size range of the dry particles after finishing is 100-800um; the capsule is selected from gelatin hollow capsules.
In the step (3), the weight content of the crospovidone aqueous solution is 5%; in the step (4), the concentration of the ethanol solution is 95%; the weight ratio of the pioglitazone hydrochloride to the ethanol solution is 15:20; the weight ratio of the sodium dodecyl sulfate in the added part to the sodium dodecyl sulfate in the added part is 1:1; in the step (7), the drying temperature is selected from 50 ℃; in the step (7), the drying time is selected from 2 hours.
The capsule comprises the following components in parts by weight:
the key point of the application is a pioglitazone hydrochloride capsule and a preparation method thereof. The principle is that the raw material of pioglitazone hydrochloride and the crosslinked povidone are dissolved and mixed with lactose, the added part of sodium dodecyl sulfate and other materials, and then the mixture is put into a soft material of a mixing machine, dried and sieved to prepare dry particles with the particle size range of 100-800um, and the magnesium stearate and the added part of sodium dodecyl sulfate are added and then filled into capsules, wherein the produced capsules are consistent with the dissolution of the original ground tablets in vitro.
Compared with the prior art, the pioglitazone hydrochloride capsule and the preparation method thereof have the advantages of consistent dissolution behavior of the capsule and the original grinding tablet, simple prescription, good fluidity of the prepared mixed powder, good stability of the capsule, simple preparation process, contribution to industrialization and the like, and can be widely applied to the technical field of pioglitazone hydrochloride preparations.
Drawings
The present application will be described in detail with reference to the accompanying drawings and examples.
FIG. 1 is a graph showing the particle size distribution of dry particles of pioglitazone hydrochloride after sieving according to the present application
FIG. 2 is a graph showing the dissolution of pioglitazone hydrochloride capsules and the original developing agent in a medium of pH3.0 using a wet granulation process according to the present application;
FIG. 3 is a graph showing the dissolution of pioglitazone hydrochloride capsules and the original developer of the present application in a medium having a pH of 1.2 using a wet granulation process;
FIG. 4 is a graph showing the dissolution of pioglitazone hydrochloride capsules and the original development agent in a medium of pH3.0 using a dry granulation process according to the present application;
FIG. 5 is a graph showing the dissolution of pioglitazone hydrochloride capsules and the original formulation of the present application in a medium having a pH of 1.2 using a dry granulation process;
Detailed Description
The present application will be further illustrated with reference to the following examples, which are not intended to limit the scope of the application.
Example 1
The pioglitazone hydrochloride capsule consists of the following components in percentage by weight:
composition of the components Dosage (KG) Weight percent (%)
Pioglitazone hydrochloride 1.5 9.46%
Lactose and lactose 13.175 83.12%
Crosslinked povidone 0.206 1.30%
Hydroxypropyl cellulose 0.794 5.01%
Magnesium stearate 0.159 1.00%
Sodium dodecyl sulfate 0.016 0.10%
Totalizing 15.85 100%
The preparation method comprises the following steps,
(1) Sieving lactose, crospovidone, hydroxypropyl cellulose, magnesium stearate and sodium dodecyl sulfate with 80 mesh sieve respectively;
(2) Weighing pioglitazone hydrochloride, screened lactose, crosslinked povidone, hydroxypropyl cellulose, magnesium stearate and sodium dodecyl sulfate according to the prescription amount of the table;
(3) Adding 0.206kg of crospovidone into purified water to prepare a 5% by weight aqueous solution of crospovidone;
(4) 1.5kg of pioglitazone hydrochloride is dissolved in 2kg of 95% ethanol solution, and then added into 5% by weight of cross-linked povidone aqueous solution to obtain pioglitazone hydrochloride preparation liquid;
(5) 13.175kg lactose, 0.794kg hydroxypropyl cellulose and 0.008kg sodium dodecyl sulfate (added part) are put into a mixer, and pioglitazone hydrochloride preparation liquid is added to prepare a soft material;
(6) Preparing the soft material into wet particles by using a 20-mesh screen;
(7) Drying the wet granules in an environment of 50 ℃ for 2 hours to obtain dry granules (wet granulation method);
(8) Finishing the dry granules by using a 20-mesh screen;
(9) And adding 0.008kg of sodium dodecyl sulfate (an additional part) and 0.159kg of magnesium stearate into the finished dry granules, uniformly mixing to obtain mixed powder, and filling the mixed powder into gelatin hollow capsules according to the theoretical granule weight to obtain the pioglitazone hydrochloride capsules.
The acceleration test is carried out on three batches of 9 ten thousand products prepared according to the prescription amount and the preparation process according to the method specified in the XIX C part of the second appendix of 2015 edition of Chinese pharmacopoeia, and the self-made pioglitazone hydrochloride capsules are packaged by adopting aluminum plastic, and are shown in tables 1-3.
TABLE 1 stability of pioglitazone hydrochloride capsules bglt-1 batch test acceleration data sheet
TABLE 2 stability of pioglitazone hydrochloride capsules bglt-2 test batch accelerated test data sheet
TABLE 3 stability of pioglitazone hydrochloride capsules bglt-3 test batch accelerated test data sheet
From the stability test data of pioglitazone hydrochloride in tables 1-3, it can be known that the accelerated batches bglt1-bglt3 of pioglitazone hydrochloride capsules all meet the requirements of Chinese pharmacopoeia from key quality parameters such as (dissolution rate, content and related substances).
The capsule prepared according to the prescription process of the embodiment according to the guidelines of the study on the quality consistency of imitated medicines for evaluating the bioequivalence of human bodies is subjected to an in vitro dissolution test with the original developing agent (pioglitazone hydrochloride tablet, trade name of Aikappy, specification of 15mg, subpackage enterprises: tianjin Wuta medicine Co., ltd., batch number of 11810797), and the f2 factor is larger than 50, so that the dissolution behavior of the two preparations is judged to be consistent.
Example two
Prescription screening
1. Screening of filler in prescriptions
TABLE 4 filler screening
The mixed powder was prepared according to the formulation weight ratio (specific selection and amount of filler are shown in table 4) and the preparation method of the first embodiment of the present application. As can be seen from the results of the property measurements in Table 4, lactose was used as the filler to give a mixed powder having a repose angle of 34℃and a good flowability.
2. Screening of Lubricants in prescriptions
TABLE 5 screening of lubricants
The mixed powder was prepared according to the formulation weight ratio (wherein the specific selection and amount of the lubricant are shown in Table 5) and the preparation method of the first embodiment of the present application. As can be seen from table 5, the powder flowability of the formulation using magnesium stearate was good, so magnesium stearate was selected as the lubricant of the formulation of the present application.
3. Screening of adhesives in prescriptions
TABLE 6 screening of adhesives
The mixed powder was prepared according to the formulation weight ratio (wherein the specific selection and amount of binder are shown in Table 6) and the preparation method of the first embodiment of the present application. As can be seen from Table 6, the use of hydroxypropyl cellulose resulted in better flowability after drying and granulating. Hydroxypropyl cellulose was chosen as the binder for the formulation of the present application.
4. Screening of disintegrants in prescriptions
TABLE 7 screening of disintegrants
The mixed powder was prepared according to the formulation weight ratio (wherein the specific selection and amount of the disintegrating agent are shown in Table 7) and the preparation method of the first embodiment of the present application. As can be seen from Table 7, the disintegration time after dry granulation of crospovidone was shorter. Crospovidone was chosen as the disintegrant for the formulation of the present application.
5. Screening of filler usage
According to the prescription weight proportion (wherein the dosage of pioglitazone hydrochloride is 15g, the specific selection of lactose dosage is shown in table 8) and the preparation method of the first embodiment of the application, mixed powder is prepared, filled into capsules, the dissolution rate is used as an investigation index by referring to the standard of pioglitazone hydrochloride capsules in the 2015 edition pharmacopoeia, and the dosage of the filling agent is screened, and the test result is shown in table 8.
TABLE 8 screening test results of filler lactose usage
As is clear from the results in Table 8, the dissolution behavior of prescription 2 was closer to that of the original developer, so the amount of prescription 2 was selected as the filler amount of the product.
6. Screening of the adhesive usage
In order to examine the influence of the adhesive amount on the capsules, the hydroxypropyl cellulose with different weight percentages was screened, the prescription weight ratio according to the first embodiment of the application (wherein the amount of pioglitazone hydrochloride is 15g, the specific selection of the adhesive hydroxypropyl cellulose amount is shown in table 9) and the preparation method were prepared to obtain mixed powder, the mixed powder was filled into capsules, and the dissolution rate of the capsules was used as an index for examination, and the test results are shown in table 9.
TABLE 9 Experimental results on the amounts of adhesive used
As is clear from the results in Table 9, the amount of the hydroxypropylcellulose used in the formulation was 7.94g (5.01% of the total amount of the formulation), taking into consideration the combination of the amount of the binder and the elution effect.
7. Screening of surfactant usage
According to the prescription weight proportion (wherein the dosage of pioglitazone hydrochloride is 15g, the specific selection of the dosage of the surfactant sodium dodecyl sulfate is shown in table 9, the proportion of internal addition and external addition is 1:1) and the preparation method of the first embodiment of the application, mixed powder is prepared, the mixed powder is filled into capsules, the dissolution rate is used as an investigation index, and the test result is shown in table 10.
TABLE 10 results of experiments on surfactant levels
As is clear from the results in table 11, the dissolution rate did not increase significantly with increasing amount of surfactant. Since sodium lauryl sulfate is an anionic surfactant, the dissolution-promoting effect can be achieved by selecting an amount of 0.16g (0.1% of the total amount of the formulation).
8. Screening of Lubricant usage
The mixed powder is prepared according to the prescription weight proportion of the first embodiment of the application (wherein the dosage of pioglitazone hydrochloride is 15g, the specific selection of the dosage of magnesium stearate serving as a lubricant is shown in table 11) and the preparation method, the mixed powder is filled into capsules, and the fluidity of the mixed powder and the dissolution of the capsules are taken as investigation indexes, and the test results are shown in table 11.
TABLE 11 results of experiments on lubricant amounts
As is clear from the results in Table 11, the amount of magnesium stearate to be used was 1.59g (1% of the total amount of the formulation) by considering the dissolution rate and the angle of repose.
9. Screening of disintegrant usage
The mixed powder is prepared according to the prescription weight proportion of the first embodiment of the application (wherein the dosage of pioglitazone hydrochloride is 15g, the specific selection of the dosage of the disintegrating agent crosslinked povidone is shown in table 12) and the preparation method, the mixed powder is filled into capsules, and the dissolution rate of the capsules is taken as an investigation index, and the test result is shown in table 12.
Table 12 experimental results of disintegrant dosage
As is clear from the experimental results in Table 12, the amount of the disintegrant crospovidone was 2.06g (1.3% of the total amount of the formulation) by comprehensively considering the relation between the amount of the disintegrant and the dissolution effect.
10. Particle size screening of dry particles
TABLE 13 particle size screening of dry particles
Screen mesh 10 meshes of 20 meshes of 30 mesh
Difference in loading (%) 4.2 1.3 1.2
Angle of repose (°) 32 34 36
According to the prescription weight proportion (wherein the dosage of pioglitazone hydrochloride is 15 g) and the preparation method (wherein the screen mesh number of the dry granules is selected as shown in table 13), mixed powder is prepared, capsules are filled, the repose angle of the mixed powder and the filling quantity difference of the capsules are taken as investigation indexes, and the test results are shown in table 13.
The mesh number of the screen is determined to be 20 mesh by comprehensively considering the loading difference and the repose angle. The particle size of the particles passing through a 20-mesh sieve is measured by a laser particle sizer (Dendonco Baite), the particle size range is 100-800um, and the particle size distribution diagram of the dry particles after finishing is shown in figure 1.
Example III
Surfactant internal and external screening
According to the prescription weight proportion (wherein the dosage of pioglitazone hydrochloride is 15 g) and the preparation method (wherein the specific conditions of the internal addition and the external addition of the surfactant are shown in table 14) of the first embodiment of the application, mixed powder is prepared, capsules are filled, the dissolution rate of the capsules is taken as an investigation index, and the test results are shown in table 14.
Table 14 comparison of the effect of the manner of addition of the surfactants
As can be seen from the comparison of the addition modes of the surfactant, the dissolution rate effect is optimal in the mode of adding sodium dodecyl sulfate internally and externally.
Example IV
Wet granulation and dry granulation process comparison
Wet granulation (wet granulation): according to the prescription weight proportion (the dosage of pioglitazone hydrochloride is 15 g) and the preparation method of the pioglitazone hydrochloride, mixed powder is prepared, and capsules are filled, and the dissolution rate of the capsules is taken as an investigation index.
Dry granulating: according to the first prescription weight proportion (the dosage of pioglitazone hydrochloride is 15 g), the preparation method comprises the steps of mixing, pressing into large tablets, crushing, sieving with a 20-mesh sieve, and finally filling capsules, wherein the dissolution rate of the capsules is used as an investigation index.
The dissolution effect of two granulation modes in media at pH3.0 and pH1.2, respectively, was compared with the dissolution effect of the dissolution medium according to Japanese pharmacopoeia (JP 16/226), and compared with the original formulation, wherein the original formulation was derived from: pioglitazone hydrochloride tablet, trade name Aiketuo, specification 15mg, split charging enterprise: tianjin Wuta medicine Co., ltd., batch number: 11810797. the results are shown in Table 15 and FIGS. 2 to 5:
TABLE 15 Effect of wet granulation and Dry granulation
Test item Wet granulation Dry granulation
Dissolution profile F2 factor greater than 50 F2 factor is less than 50
Fluidity (repose angle degree) 34 36
In fig. 2 to 3, "represents pioglitazone hydrochloride capsules using the wet granulation process of this example," "diamond-solid" represents the original formulation. In fig. 4 to 5, "represents pioglitazone hydrochloride capsules using the dry granulation process of this example," "diamond-solid" represents the original formulation.
It can be seen that the wet granulation has better fluidity and higher similarity with the dissolution curve of the original preparation, thus the wet granulation process is one of the key conditions that the dissolution behavior of the capsule is consistent with that of the original preparation.
The foregoing description of the preferred embodiments of the application is not intended to be limiting, but rather is intended to cover all modifications, equivalents, and alternatives falling within the spirit and principles of the application.
It will be understood that modifications and variations will be apparent to those skilled in the art from the foregoing description, and it is intended that all such modifications and variations be included within the scope of the following claims.

Claims (4)

1. The pioglitazone hydrochloride capsule is characterized by comprising the following components in parts by weight:
pioglitazone hydrochloride 15.0 parts;
131.75 parts of lactose;
2.06 parts of crospovidone;
7.94 parts of hydroxypropyl cellulose;
1.59 parts of magnesium stearate;
0.16 parts of sodium dodecyl sulfate;
the capsules are prepared by adopting a wet granulation method;
the sodium dodecyl sulfate is added in a mode of adding one part of sodium dodecyl sulfate in particles and adding the other part of sodium dodecyl sulfate outside particles;
the preparation method of the pioglitazone hydrochloride capsule comprises the following steps:
(1) Sieving lactose, crospovidone, hydroxypropyl cellulose, magnesium stearate and sodium dodecyl sulfate with 80 mesh sieve respectively;
(2) Weighing the pioglitazone hydrochloride with the prescription amount and lactose, crospovidone, hydroxypropyl cellulose, magnesium stearate and sodium dodecyl sulfate after sieving;
(3) Adding the prescribed amount of the crospovidone into purified water to prepare a water solution of the crospovidone;
(4) Dissolving pioglitazone hydrochloride with a prescription amount in an ethanol solution, and then adding the pioglitazone hydrochloride into a crosslinked povidone water solution to obtain pioglitazone hydrochloride preparation liquid;
(5) Adding lactose, hydroxypropyl cellulose and sodium dodecyl sulfate with the prescription amount into a mixer, and adding pioglitazone hydrochloride preparation solution to prepare a soft material;
(6) Preparing the soft material into wet particles by using a screen;
(7) Drying the wet particles to obtain dry particles;
(8) Finishing the dry granules by using a screen; the particle size range of the dry particles after finishing is 100-800um;
(9) Adding an added part of sodium dodecyl sulfate and a prescribed amount of magnesium stearate into the granulated dry particles, uniformly mixing to obtain mixed powder, and filling the mixed powder into capsules according to the theoretical weight to obtain pioglitazone hydrochloride capsules;
the weight ratio of the sodium dodecyl sulfate in the added part to the sodium dodecyl sulfate in the added part is 1:1.
2. The preparation method of the pioglitazone hydrochloride capsule is characterized in that the capsule consists of the following components in parts by weight:
pioglitazone hydrochloride 15.0 parts;
131.75 parts of lactose;
2.06 parts of crospovidone;
7.94 parts of hydroxypropyl cellulose;
1.59 parts of magnesium stearate;
0.16 parts of sodium dodecyl sulfate;
the preparation method comprises the following steps:
(1) Sieving lactose, crospovidone, hydroxypropyl cellulose, magnesium stearate and sodium dodecyl sulfate with 80 mesh sieve respectively;
(2) Weighing the pioglitazone hydrochloride with the prescription amount and lactose, crospovidone, hydroxypropyl cellulose, magnesium stearate and sodium dodecyl sulfate after sieving;
(3) Adding the prescribed amount of the crospovidone into purified water to prepare a water solution of the crospovidone;
(4) Dissolving pioglitazone hydrochloride with a prescription amount in an ethanol solution, and then adding the pioglitazone hydrochloride into a crosslinked povidone water solution to obtain pioglitazone hydrochloride preparation liquid;
(5) Adding lactose, hydroxypropyl cellulose and sodium dodecyl sulfate with the prescription amount into a mixer, and adding pioglitazone hydrochloride preparation solution to prepare a soft material;
(6) Preparing the soft material into wet particles by using a screen;
(7) Drying the wet particles to obtain dry particles;
(8) Finishing the dry granules by using a screen; the particle size range of the dry particles after finishing is 100-800um;
(9) Adding an added part of sodium dodecyl sulfate and a prescribed amount of magnesium stearate into the granulated dry particles, uniformly mixing to obtain mixed powder, and filling the mixed powder into capsules according to the theoretical weight to obtain pioglitazone hydrochloride capsules;
the weight ratio of the sodium dodecyl sulfate in the added part to the sodium dodecyl sulfate in the added part is 1:1.
3. A process for preparing pioglitazone hydrochloride capsules as claimed in claim 2, wherein,
in the step (3), the weight content of the crospovidone aqueous solution is 4-6%;
in the step (4), the concentration of the ethanol solution is 90% -99%; the weight ratio of the pioglitazone hydrochloride to the ethanol solution is 15:18-22;
the screen mesh in the step (6) is selected from 20 meshes; in the step (7), the drying temperature is selected from 40-60 ℃; in the step (7), the drying time is selected from 1.5-2.5 hours;
the screen in step (8) is selected from 20 mesh;
the capsule is selected from gelatin hollow capsules.
4. A process for preparing pioglitazone hydrochloride capsules as claimed in claim 3, wherein,
in the step (3), the weight content of the crospovidone aqueous solution is 5%;
in the step (4), the concentration of the ethanol solution is 95%; the weight ratio of the pioglitazone hydrochloride to the ethanol solution is 15:20;
in the step (7), the drying temperature is selected from 50 ℃; in the step (7), the drying time is selected from 2 hours.
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