CN111249242A - Preparation method of glimepiride tablet - Google Patents
Preparation method of glimepiride tablet Download PDFInfo
- Publication number
- CN111249242A CN111249242A CN202010064124.1A CN202010064124A CN111249242A CN 111249242 A CN111249242 A CN 111249242A CN 202010064124 A CN202010064124 A CN 202010064124A CN 111249242 A CN111249242 A CN 111249242A
- Authority
- CN
- China
- Prior art keywords
- glimepiride
- lactose
- povidone
- tablet according
- producing
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/64—Sulfonylureas, e.g. glibenclamide, tolbutamide, chlorpropamide
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Diabetes (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Hematology (AREA)
- Medicinal Preparation (AREA)
- Molecular Biology (AREA)
- Emergency Medicine (AREA)
- Endocrinology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Obesity (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Biophysics (AREA)
Abstract
The invention relates to a preparation method of a glimepiride tablet, which optimizes the prescription process of the glimepiride tablet, simplifies the granulating and drying processes, adds a glimepiride raw material and lactose as a base material, and adjusts and controls the particle size of the glimepiride raw material and the lactose, so that the dissolution performance of the raw materials is unexpectedly changed in the process of fluidizing and granulating by adopting proper spray pressure, thus ensuring the dissolution rate, improving the similarity of a plurality of dissolution curves of a self-prepared product and a reference preparation, and improving the possibility of in vivo equivalence with the reference preparation.
Description
Technical Field
The invention belongs to the technical field of medicines, and relates to a preparation method of a glimepiride tablet.
Background
Glimepiride, chemical name 1- [4- [2- (3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl ] benzenesulfonyl ] -3- (trans-4-methylcyclohexyl) urea, is a novel sulfonylurea hypoglycemic agent developed by Hoechst Marion Roussel (HMR) in germany, first marketed in sweden under the trade name Amaryl in 9 months 1995, approved by the FDA for entry into the us market in 1996 for the treatment of type ii diabetes mellitus that cannot be controlled by diet and exercise, which is the first sulfonylurea agent approved by the FDA to be used simultaneously with insulin. The action time of the medicine and a receptor is short, so that the islet cord secretion time is shortened, the medicine has a strong insulin-saving effect, and the secondary failure of islet cells can be overcome to a certain extent. The glimepiride has the advantages of high efficiency, long acting, small dosage (1-4 mg/d), small side effect and the like, and is the sulfonylurea hypoglycemic agent which is the best in clinical evaluation at present.
Glimepiride is a poorly soluble drug, and its solubilities (37 ℃) in water, hydrochloric acid at pH1.2, an acetate buffer solution at pH4.0, a phosphate buffer solution at pH6.8 and a phosphate buffer solution at pH7.8 (see, e.g., Japan medical product, Collection ) are reported to be 2.7 × l0-4、7.0×10-6、9.4×10-6、1.0×10-3And 7.1X 10-3mg/ml, is a hydrophobic and poorly soluble substance. The conventional oral preparation has low blood concentration, low bioavailability and poor repeatability of treatment effect after administration due to low solubility of the medicine.
A new standard is made for the dissolution rate of the glimepiride tablet in the Chinese pharmacopoeia of 2015 edition, the dissolution rate is required to reach 80% at 15min, and a surfactant with a solubilizing effect is not added into the adopted medium.
The national food and drug administration of 03, 17 and 2017 publishes a content of imitation-drug reference preparations (the first batch), determines that the glimepiride tablet reference preparation is AMARYL, and requires evaluation of imitation-drug quality and curative effect consistency. No further registration was performed without passing the quality consistency evaluation. For solid preparations, the most central evaluation index is BE.
At present, in the prior art, the invention patent of the patent of my applied patent with the granted publication number of CN102488667B discloses a glimepiride tablet and a preparation method thereof, the product prepared according to the prescription process has poor similarity with the dissolution curve of a reference preparation, and meanwhile, the medicine particle size of the patent is controlled below 2 μm, the conditions are harsh, the performance of a high-performance jet mill is required, and a large amount of energy and manpower are consumed.
The invention patent with the patent number of CN105769787A provides a preparation method of glimepiride tablets, and the prepared sample has good data, but the similarity of the dissolution curve of the glimepiride tablet and a reference preparation is still poor.
The invention patent with the patent number of CN109481408A provides a glimepiride tablet, which utilizes the hydrogen bond effect between crospovidone and the glimepiride, adopts the direct powder tabletting technology, has higher requirement on auxiliary material control, and has poorer similarity of the dissolution curve of the prepared sample and a reference preparation.
The invention patent with the patent number of CN109432031A provides a glimepiride tablet, which comprises a quick release layer and a slow release layer, wherein the quick release layer and the slow release layer have different compositions, and the slow release layer needs to be freeze-dried to prepare an inclusion compound, so that the preparation process is complex.
Disclosure of Invention
In order to overcome the defects of the prior art, the invention provides a preparation method of a glimepiride tablet, which optimizes the prescription process of the glimepiride tablet, simplifies the granulating and drying procedures, and can ensure the dissolution rate, improve the similarity of a plurality of dissolution curves of a self-prepared product and a reference preparation and improve the possibility of in vivo equivalence with the reference preparation by adjusting and controlling the particle size of a glimepiride raw material and lactose and adopting proper spray pressure (the spray pressure is 0.2-0.3 Mpa) to carry out fluidization and granulation together to change the dissolution performance of the raw material unexpectedly.
The invention provides the following technical scheme:
a preparation method of glimepiride tablets comprises the following steps:
step (1), respectively weighing glimepiride raw material medicines, lactose, carboxymethyl starch sodium, povidone, microcrystalline cellulose and magnesium stearate;
step (2), adding the glimepiride bulk drug with proper particle size and at least the lactose weighed in the step (1) into a fluidized bed;
step (3), preparing a povidone aqueous solution or an ethanol aqueous solution, adding the obtained solution into the fluidized bed for spray granulation, and drying;
and (4) adding the dried granules into the residual components weighed in the step (1), mixing and tabletting.
Preferably, in the step (1), 0.5-6% of glimepiride raw material medicine, 60-90% of lactose, 0.5-2% of povidone, 5-20% of carboxymethyl starch sodium, 0.1-1% of microcrystalline cellulose and 0.5-3% of magnesium stearate are adopted.
In any of the above schemes, the composition is preferably prepared from the following raw materials in parts by weight: 2-5% of glimepiride raw material medicine, 65-85% of lactose, 1-1.5% of povidone, 8-15% of carboxymethyl starch sodium, 0.3-0.8% of microcrystalline cellulose and 0.8-1.8% of magnesium stearate.
In any of the above schemes, the composition is preferably prepared from the following raw materials in parts by weight: 1% of glimepiride raw material medicine, 90% of lactose, 0.5% of povidone, 5.5% of carboxymethyl starch sodium, 1% of microcrystalline cellulose and 2% of magnesium stearate.
In any of the above schemes, the composition is preferably prepared from the following raw materials in parts by weight: 3% of glimepiride raw material medicine, 80% of lactose, 1.2% of povidone, 13% of carboxymethyl starch sodium, 1% of microcrystalline cellulose and 1.8% of magnesium stearate.
In any of the above schemes, the composition is preferably prepared from the following raw materials in parts by weight: 2% of glimepiride raw material medicine, 85% of lactose, 1.5% of povidone, 8.7% of carboxymethyl starch sodium, 0.8% of microcrystalline cellulose and 2% of magnesium stearate.
In any of the above embodiments, preferably, in the step (1), the particle size D90 of the glimepiride bulk drug is 2 to 250 μm.
In any of the above embodiments, preferably, in the step (1), the particle size D90 of the glimepiride bulk drug is 50 to 150 μm.
In any of the above embodiments, preferably, the particle size D90 of the glimepiride drug substance in step (1) is 2 μm.
In any of the above embodiments, preferably, the particle size D90 of the glimepiride drug substance in step (1) is 50 μm.
In any of the above embodiments, preferably, the particle size D90 of the glimepiride drug substance in step (1) is 10 μm.
In any of the above embodiments, preferably, the particle size D90 of the glimepiride drug substance in step (1) is 50 μm.
In any of the above embodiments, preferably, the particle size D90 of the glimepiride drug substance in step (1) is 80 μm.
In any of the above embodiments, preferably, the particle size D90 of the glimepiride drug substance in step (1) is 100 μm.
In any of the above embodiments, preferably, the particle size D90 of the glimepiride drug substance in step (1) is 150 μm.
In any of the above schemes, preferably, the particle size D90 of the glimepiride bulk drug in step (1) is 180 μm.
In any of the above embodiments, preferably, the particle size D90 of the glimepiride drug substance in step (1) is 200 μm.
In any of the above embodiments, preferably, the particle size D90 of the glimepiride drug substance in step (1) is 220 μm.
In any of the above embodiments, preferably, the particle size D90 of the glimepiride drug substance in step (1) is 250 μm.
In any of the above schemes, the lactose in the step (1) is preferably 100-300 meshes.
In any of the above schemes, the lactose in the step (1) is 150-250 meshes.
In any of the above embodiments, it is preferred that the lactose in step (1) is 100 mesh.
In any of the above embodiments, it is preferred that the lactose in step (1) is 120 mesh.
In any of the above embodiments, it is preferred that the lactose in step (1) is 150 mesh.
In any of the above embodiments, it is preferred that the lactose in step (1) is 180 mesh.
In any of the above embodiments, it is preferred that the lactose in step (1) is 200 mesh.
In any of the above embodiments, it is preferred that the lactose in step (1) is 250 mesh.
In any of the above embodiments, preferably, the lactose in step (1) is 300 mesh.
In any of the above schemes, preferably, the air inlet amount in the step (2) is 20Hz, the air inlet temperature is 50-70 ℃, the spraying pressure is 0.15-0.3MPa, and the liquid spraying rotation speed is 100-.
In any of the above schemes, preferably, the air inlet temperature in the step (2) is 50 ℃, the spraying pressure is 0.15Mpa, and the spray liquid rotating speed is 100 r/min.
In any of the above schemes, the air inlet temperature in the step (2) is preferably 50 ℃, the spraying pressure is preferably 0.2Mpa, and the spray liquid rotating speed is preferably 200 r/min.
In any of the above schemes, the air inlet temperature in the step (2) is preferably 70 ℃, the spraying pressure is preferably 0.3Mpa, and the spraying speed is preferably 300 r/min.
In any of the above embodiments, it is preferable that the fluidized bed in the step (2) is a WBF-2G fluidized bed.
In any of the above schemes, preferably, the povidone in step (3) is formulated to have a concentration of 4% to 20%
The povidone aqueous solution of (a).
In any of the above schemes, preferably, the povidone in step (3) is configured into povidone aqueous solution with a concentration of 6% -15%.
In any of the above schemes, preferably, the povidone in step (3) is configured into a povidone aqueous solution with a concentration of 4%.
In any of the above schemes, preferably, the povidone in step (3) is configured into an 8% concentration povidone aqueous solution.
In any of the above schemes, preferably, the povidone in step (3) is configured into 15% concentration povidone aqueous solution.
In any of the above schemes, preferably, the povidone in step (3) is configured into a 20% aqueous solution of povidone.
In any of the above embodiments, preferably, the ratio of ethanol to water in the ethanol aqueous solution in the step (3) is 1/4-2/3.
In any of the above schemes, the drying temperature in the step (3) is preferably 50-70 ℃, and the drying time is preferably 15-30 min.
In any of the above embodiments, it is preferable that the drying temperature in the step (3) is 50 ℃ and the drying time is 30 min.
In any of the above embodiments, it is preferable that the drying temperature in the step (3) is 60 ℃ and the drying time is 20 min.
In any of the above embodiments, it is preferable that the drying temperature in the step (3) is 70 ℃, and the drying time is 15 min.
In any of the above embodiments, preferably, the remaining components in step (4) include at least one of sodium starch glycolate, microcrystalline cellulose and magnesium stearate.
The invention also discloses a glimepiride tablet which is prepared by adopting the method.
The invention has the beneficial effects that: the invention provides a preparation method of glimepiride tablets, which optimizes the prescription process of the glimepiride tablets, adopts WBF-2G fluidized bed granulation, simplifies the granulation and drying processes, adds the raw material of glimepiride and lactose as base materials, and adjusts and controls the particle size of the raw material of glimepiride and lactose, and unexpectedly changes the solubility property of the raw materials in the fluidized granulation process, thereby ensuring the dissolution rate, improving the similarity of a plurality of dissolution curves of a self-prepared product and a reference preparation, and improving the possibility of in vivo equivalence with the reference preparation.
Detailed Description
In order to further understand the technical features of the present invention, the present invention is described in detail with reference to the specific embodiments below. The embodiments are given by way of illustration only and not by way of limitation, and any insubstantial modifications, based on the present disclosure, may be made by those skilled in the art without departing from the scope of the present disclosure.
Example 1:
a preparation method of a glimepiride tablet comprises the following steps:
(1)30g of glimepiride raw material is ground by a universal grinder to obtain common powder with the grain diameter D90 of about 150 mu m;
(2) preparing 15g of povidone into a 15% concentration aqueous solution;
(3) 30g of glimepiride raw material, 1.8kg of lactose and 300g of sodium carboxymethyl starch are sieved by a 100-mesh sieve and then added into a fluidized bed;
(4) setting the air inlet temperature, the fan frequency, the spraying pressure and the spraying speed of the fluidized bed, spraying the povidone aqueous solution into the fluidized bed for granulation and drying;
the specific setting parameters are as follows: the air inlet amount is 20HZ, the air inlet temperature is 60 ℃, the spraying pressure is 0.2Mpa, the spraying rotating speed is 250r/min,
(5) After the dried granules are granulated by a grinding and granulating machine with 20 meshes, adding 3g of microcrystalline cellulose and 15g of magnesium stearate and mixing; tabletting, wherein the hardness of the plain tablets is controlled to be 2-8 kgf.
Example 2
A preparation method of a glimepiride tablet comprises the following steps: (1)25g of glimepiride raw material is ground by a universal grinder to obtain micro powder with the particle size D90 less than 10 mu m;
(2) preparing 40g of povidone into a 20% ethanol aqueous solution (2: 3);
(3) sieving 25g of glimepiride, 1.8kg of lactose and 400g of sodium carboxymethyl starch together with a 100-mesh sieve, and adding the sieved mixture into a fluidized bed;
(4) setting proper air inlet temperature of the fluidized bed, fan frequency, spraying pressure and spraying speed, spraying povidone aqueous solution into the fluidized bed for granulation, and drying;
the specific setting parameters are as follows: the air inlet amount is 20HZ, the air inlet temperature is 50 ℃, the spraying pressure is 0.3Mpa, and the spraying rotating speed is 300 r/min.
(5) After the dried granules are granulated by a grinding and granulating machine with 20 meshes, 20g of microcrystalline cellulose and 40g of magnesium stearate are added and mixed; the hardness of the tablet is controlled to be 2-8 kgf during tabletting.
Example 3
Preparation method of glimepiride tablet in prior art (I si patent number CN105769787A)
The glimepiride raw material powder is ground to be below 10 mu m, 2kg of glimepiride raw material powder, 55kg of lactose, 5.2kg of sodium carboxymethyl starch I (added internally), 0.4kg of povidone, 0.25kg of microcrystalline cellulose, 1.9kg of sodium carboxymethyl starch II (added externally) and 0.325kg of magnesium stearate are weighed, and the glimepiride raw material powder, the lactose and the sodium carboxymethyl starch I (added internally) are added into a wet granulator to be mixed for 20-30 min to obtain a glimepiride mixture;
(2) dissolving polyvidone in 9.6kg water to obtain 4% polyvidone water solution (W/W);
(3) adding 4% polyvidone water solution into wet granulator to obtain soft material, granulating with swing granulator and 14 mesh sieve, and drying the obtained granule with fluidized bed;
(4) granulating the dried granules with 20 mesh sieve, adding microcrystalline cellulose, carboxymethyl starch sodium II (added), and magnesium stearate, mixing, and tabletting. The tablet hardness is controlled to 3 kgf-5 kgf, and the prepared amount is 100 ten thousand tablets. Example 4
Example 4
Preparation method i of glimepiride tablet in prior art (control group 1):
dissolving glimepiride, hydroxypropyl betadex and deoxycholic acid in absolute ethyl alcohol, then granulating the solution on lactose and crospovidone, drying at 40 ℃, granulating by using a 20-mesh sieve, adding magnesium stearate into the dried granules, uniformly mixing and tabletting to obtain the tablet.
Example 5
Preparation method II of Glimepiride tablets in the prior art (control group 2)
(1) Omnipotently crushing the glimepiride raw material medicine, weighing the glimepiride raw material medicine and various auxiliary materials according to a prescription, wherein the particle size D90 is 22 mu m;
(2) stirring and chopping glimepiride and lactose in a wet mixing granulator, and gradually mixing by adopting an equivalent progressive method to obtain a mixture A;
(3) adding the mixture A and the rest lactose, microcrystalline cellulose, crospovidone and copovidone into a wet granulator, stirring, chopping, and mixing for 120s to obtain a mixture B;
(3) adding mixture B and magnesium stearate into a mixer, and mixing for 8min to obtain mixture C;
(4) the mixture C was compressed in a tablet press to prepare a tablet sample.
Example 6
The dissolution test of the glimepiride tablet prepared in the above example shows the specific results in table 1:
TABLE 1 examples and reference formulations (reference formulations in particular
) Dissolution rate comparison of
Example 7
The dissolution curve test of the glimepiride tablet prepared in the above example shows the specific results as shown in the following table 2:
table 2 f2 similarity factor comparing multiple dissolution curves of the examples to the reference formulation
Example 8
Glimepiride tablet pre-BE test:
referring to guiding principles of chemical drug pharmaceutical-simulated human body bioequivalence research technology with pharmacokinetic parameters as end-point evaluation indexes and Chinese pharmacopoeia, the test adopts single-center, random, open, postprandial, single-dose, two-cycle and double-cross test design.
12 healthy subjects (male or female) who meet the requirements of the test and are 18-55 years old; the weight of the male is more than or equal to 50kg, and the weight of the female is more than or equal to 45 kg; body Mass Index (BMI) in the range of 19.0-26.0kg/m 2; good health condition, no history of serious diseases such as heart, liver, kidney, digestive tract, respiratory system, nervous system, mental disorder and metabolic disorder, physical examination, vital sign examination, and electrocardioThe important indexes of the chart inspection and the laboratory inspection are normal or abnormal and have no clinical significance, and the researchers are judged as qualified. Subjects were randomly divided into two groups, and the glimepiride tablets prepared in example 2 and the reference preparation were administered separately
Venous blood was collected from all subjects at each cycle at 0.5h, 1h, 1.5h, 2h, 2.33h, 2.67h, 3h, 3.33h, 3.67h, 4h, 4.5h, 5h, 6h, 8h, 10h, 12h, 24h and 48h post-dose for a total of 19 time points, and the results of bioequivalence analysis of the test and reference formulations are shown in table 3.
The biological sample processing method comprises the following steps: 4mL of blood is taken to K2-EDTA anticoagulant vacuum blood collection tube each time, and after centrifugal separation, the blood is placed into a low-temperature refrigerator with the temperature not higher than-60 ℃ for storage after 60min for pharmacokinetic analysis.
TABLE 3 results of bioequivalence analysis of test and reference formulations
From the results of the dissolution test and the dissolution curve test of example 6 and example 7, it can be seen that the dissolution rate (ph7.8 condition) of the samples prepared by the prior art (example 4 and example 5) and the dissolution curve of the samples prepared by the prior wet granulation technique (example 3) is higher, but the similarity factor of the dissolution curves under other ph conditions and the reference preparation is less than 50 (dissimilar).
The preparation method adopts fluidized bed granulation, the raw material of glimepiride and lactose are required to be added into the fluidized bed as a base material during operation, and the dissolution rate can be ensured by adjusting and controlling the particle size and adjusting granulation parameters (such as atomization pressure) so as to improve the similarity of a plurality of dissolution curves of a self-prepared product and a reference preparation and improve the possibility of in vivo equivalence of the self-prepared product and the reference preparation.
Claims (10)
1. A preparation method of glimepiride tablets comprises the following steps:
step (1), respectively weighing glimepiride raw material medicines, lactose, carboxymethyl starch sodium, povidone, microcrystalline cellulose and magnesium stearate;
step (2), adding the glimepiride bulk drug with proper particle size and at least the lactose weighed in the step (1) into a fluidized bed;
step (3), preparing a povidone aqueous solution or an ethanol aqueous solution, spraying the obtained solution into the fluidized bed for spray granulation, and drying;
and (4) granulating the dried granules, adding the rest components weighed in the step (1), mixing and tabletting.
2. The method for producing a glimepiride tablet according to claim 1, characterized in that: in the step (1), 0.5-6% of glimepiride raw material medicine, 60-90% of lactose, 0.5-2% of povidone, 5-20% of carboxymethyl starch sodium, 0.1-1% of microcrystalline cellulose and 0.5-3% of magnesium stearate.
3. The method for producing a glimepiride tablet according to claim 1, characterized in that: the particle size D90 of the glimepiride bulk drug in the step (1) is 2-250 microns.
4. The method for producing a glimepiride tablet according to claim 3, characterized in that: the particle size D90 of the glimepiride bulk drug in the step (1) is 50-150 mu m.
5. The method for producing a glimepiride tablet according to claim 1, characterized in that: the lactose in the step (1) is 100-300 meshes.
6. The method for preparing a glimepiride tablet according to claim 5, characterized in that: the lactose in the step (1) is 150-250 meshes.
7. The method for producing a glimepiride tablet according to claim 1, characterized in that: in the step (2), the air inlet amount is 20HZ, the air inlet temperature is 50-70 ℃, the spraying pressure is 0.15-0.3Mpa, and the liquid spraying rotating speed is 100-.
8. The method for producing a glimepiride tablet according to claim 1, characterized in that: and (4) preparing povidone into povidone aqueous solution with the concentration of 4% -20% in the step (3).
9. The method for producing a glimepiride tablet according to claim 1, characterized in that: in the step (3), the drying temperature is 50-70 ℃, and the drying time is 15-30 min.
10. A glimepiride tablet prepared by the method of any one of claims 1-9.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010064124.1A CN111249242A (en) | 2020-01-20 | 2020-01-20 | Preparation method of glimepiride tablet |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010064124.1A CN111249242A (en) | 2020-01-20 | 2020-01-20 | Preparation method of glimepiride tablet |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN111249242A true CN111249242A (en) | 2020-06-09 |
Family
ID=70923719
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202010064124.1A Pending CN111249242A (en) | 2020-01-20 | 2020-01-20 | Preparation method of glimepiride tablet |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN111249242A (en) |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103505466A (en) * | 2012-06-20 | 2014-01-15 | 天津药物研究院 | Solid compound preparation containing metformin hydrochloride and glimepiride, preparation method and application thereof |
| CN106361712A (en) * | 2016-10-19 | 2017-02-01 | 石家庄市华新药业有限责任公司 | Glimepiride tablet and preparation method thereof |
-
2020
- 2020-01-20 CN CN202010064124.1A patent/CN111249242A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103505466A (en) * | 2012-06-20 | 2014-01-15 | 天津药物研究院 | Solid compound preparation containing metformin hydrochloride and glimepiride, preparation method and application thereof |
| CN106361712A (en) * | 2016-10-19 | 2017-02-01 | 石家庄市华新药业有限责任公司 | Glimepiride tablet and preparation method thereof |
Non-Patent Citations (2)
| Title |
|---|
| 杨明: "《药剂学》", 31 August 2001, 中国医药科技出版社 * |
| 罗小英等: "格列美脲片制备工艺改进", 《中国药业》 * |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN103070864B (en) | Repaglinide and metformin hydrochloride medicinal composition and its preparation method | |
| CN112190559B (en) | Controlled-release folic acid tablet and preparation method thereof | |
| CN111265488B (en) | Telmisartan tablets and preparation method thereof | |
| WO2021238978A1 (en) | Pharmaceutical composition containing nitroxoline prodrug, and preparation method and application therefor | |
| CN112641742B (en) | Sacubitril valsartan sodium sustained-release tablet and preparation method thereof | |
| CN110037994A (en) | A kind of brufen quick-release and slow-release double-layer tablets and preparation method thereof | |
| CN111329841A (en) | Gliclazide sustained release tablet and preparation method thereof | |
| CN111603453A (en) | Preparation method of glimepiride tablet | |
| CN111135150A (en) | Preparation method of glimepiride tablet | |
| CN109646417B (en) | Trimetazidine sustained release tablet and preparation method thereof | |
| WO2013189305A1 (en) | Valsartan-amlodipine compound solid preparation and preparation method therefor | |
| CN111249242A (en) | Preparation method of glimepiride tablet | |
| CN112156096B (en) | Folic acid sustained-release composition, sustained-release preparation and application thereof | |
| CN107080741A (en) | Pirfenidone sustained release preparation and preparation method | |
| CN114796136A (en) | Voglibose tablet with high dissolution rate and preparation method thereof | |
| CN114392249A (en) | Enteric-coated pellet of polysaccharide-iron compound and powder direct-compression tablet | |
| CN107744509B (en) | Mosapride citrate tablet and preparation method thereof | |
| CN112618526A (en) | Compound preparation for treating diabetes complicated with hypertension and preparation method thereof | |
| CN116725985B (en) | Micropill combined urapidil sustained-release capsule and preparation method thereof | |
| CN110917162A (en) | Ambrisentan oral pharmaceutical composition and preparation method thereof | |
| CN110115715A (en) | A kind of composite tablet and preparation method thereof containing Irbesartan | |
| CN112022827B (en) | Cyproheptadine hydrochloride quick-release pharmaceutical preparation and preparation method thereof | |
| CN103494816B (en) | A kind of pharmaceutical composition for treating diabetes | |
| CN115671070B (en) | Desloratadine citrate osmotic pump controlled release tablet and preparation method thereof | |
| CN102512388B (en) | Glimepiride orally disintegrating medicine composition |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| CB02 | Change of applicant information |
Address after: 401122 Chongqing city Yubei District North New District No. 101 garden Jinyu Road Applicant after: Chongqing kangkere Pharmaceutical Co.,Ltd. Address before: 401122 Chongqing city Yubei District North New District No. 101 garden Jinyu Road Applicant before: CHONGQING CONQUER PHARMACEUTICAL Co.,Ltd. |
|
| CB02 | Change of applicant information | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20200609 |
|
| RJ01 | Rejection of invention patent application after publication |