CN115624533B - Nifedipine controlled release tablet, preparation method and application thereof - Google Patents
Nifedipine controlled release tablet, preparation method and application thereof Download PDFInfo
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- CN115624533B CN115624533B CN202211652847.9A CN202211652847A CN115624533B CN 115624533 B CN115624533 B CN 115624533B CN 202211652847 A CN202211652847 A CN 202211652847A CN 115624533 B CN115624533 B CN 115624533B
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- 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
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4422—1,4-Dihydropyridines, e.g. nifedipine, nicardipine
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- A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/69—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
- A61K47/6949—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
- A61K47/6951—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using cyclodextrin
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Abstract
The invention belongs to the field of pharmaceutical preparations, and particularly relates to a nifedipine controlled release tablet, a preparation method and application thereof. The raw materials of the controlled release tablet comprise the following components: nifedipine clathrate particles, a hydrophilic gel framework material, a filler and a lubricant; the raw materials of the nifedipine inclusion particles comprise nifedipine, tremella polysaccharide, sodium carboxymethylcellulose and beta-cyclodextrin. The preparation method comprises mixing nifedipine inclusion particles, hydrophilic gel skeleton material and filler, adding ethanol water solution to obtain soft material, drying, adding lubricant, mixing, and tabletting. The invention adopts single-layer tabletting, has higher process realization degree, is easy for industrialized popularization, and has better tablet quality and better stability.
Description
Technical Field
The invention belongs to the field of pharmaceutical preparations, and particularly relates to a nifedipine controlled release tablet, a preparation method and application thereof.
Background
Nifedipine is a dihydropyridine calcium channel antagonist, has strong effects of dilating coronary arteries and peripheral arteries, has obvious effect of inhibiting vasospasm, is a first choice drug for treating variant angina pectoris, and is widely applied to treatment of hypertension and prevention and treatment of angina pectoris in clinic. The action mechanism of the compound mainly comprises the steps of selectively inhibiting calcium inflow of a myocardial cell membrane, blocking excitation contraction coupling of myocardial cells, weakening myocardial contractility, reducing myocardial energy and oxygen consumption, and directly protecting the myocardial cells by preventing calcium overload.
Since nifedipine is a short acting antagonist and has a short half-life, frequent administration is required to maintain an effective blood level. The sustained-release preparation as a third-generation medicinal preparation can obviously reduce the adverse reaction of the medicament, maintain the effective concentration of the medicament in vivo for a long time, overcome the defect of frequent administration, reduce the total dosage of the medicament, thereby greatly improving the compliance of patients in taking the medicament.
The Chinese patent application CN112076173A discloses a nifedipine sustained-release tablet, which is prepared by mixing water-soluble matrix components with moderate glass transition temperature together, carrying out hot melt extrusion, and then mixing the prepared solid dispersion with one or more adhesives; mixing the osmotic pressure promoter, one or more binders, and optionally, a lubricant and a flow aid in the boosting layer; and respectively pouring the total mixed particles of the medicine-containing layer and the boosting layer into a hopper of a double-layer tablet press, firstly pressing the medicine-containing layer, then pressing the boosting layer, then coating the medicine-containing layer and the boosting layer for controlled release, and then carrying out laser drilling. So that the release rate of the nifedipine can be maintained or even improved to provide the required blood concentration, and the bioavailability is improved.
Another chinese patent application CN103565769A discloses a nifedipine controlled release composition, which comprises a double-layer tablet core and a semipermeable membrane controlled release coating, wherein the double-layer tablet core comprises a drug-containing layer and a boosting layer, the drug-containing layer of the composition is granulated by using an aqueous suspension, and the boosting layer is granulated by using an aqueous solution. The double-layer tablet core of the composition does not use a coloring agent, and the coating film is prepared in a coating liquid spraying mode. The nifedipine controlled release composition prepared by the method has the advantages of uniform particle distribution, good tabletting effect and uniform content.
Another chinese patent application CN108338976A discloses a nifedipine double-layer osmotic pump tablet, which comprises a drug-containing layer tablet core, a boosting layer tablet core, a semipermeable membrane and a single drug release pore on the surface of the semipermeable membrane at one side of the drug-containing layer. Has stable medicine release rate, basically realizes zero-order release within 4-16h, and has basically complete medicine release.
The original nifedipine controlled release tablet adopts a push-pull type osmotic pump controlled release tablet, the nifedipine push-pull type osmotic pump controlled release tablet consists of a double-layer tablet core consisting of a drug-containing layer and a boosting layer and a semipermeable membrane controlled release coating, and holes are formed on a coating film of the drug-containing layer by adopting laser so as to form certain drug release holes.
The nifedipine controlled release tablets prepared by the technology all adopt double-layer tablet cores, the preparation process is relatively more complex, the requirements of laser hole making and double-layer tabletting on the technology are higher, the problems of two-layer mixing, flower tablets, split tablets and the like are easily caused when the double-layer tablet cores are respectively tableted and then tableted in an overlapping mode, and the controlled release effect is further improved.
How to improve the above problems and further improve the sustained and controlled release effect of nifedipine is a problem to be solved in the field.
Disclosure of Invention
Aiming at the defects in the prior art, the invention provides the nifedipine controlled release tablet, the preparation method and the application thereof.
In order to realize the purpose of the invention, the technical scheme is as follows:
the invention provides a nifedipine controlled release tablet, which comprises the following raw materials: nifedipine inclusion particles, a hydrophilic gel framework material, a filler and a lubricant; the raw materials of the nifedipine inclusion particles comprise nifedipine, tremella polysaccharide, sodium carboxymethylcellulose and beta-cyclodextrin.
Preferably, the raw materials of the controlled release tablet comprise the following components in parts by weight: 69-85 parts of nifedipine inclusion particles, 10-15 parts of hydrophilic gel framework material, 5-15 parts of filler and 0.2-2 parts of lubricant.
Preferably, the mass ratio of nifedipine to tremella polysaccharide to sodium carboxymethylcellulose is (30-5).
Preferably, the hydrophilic gel matrix material is selected from at least one of sodium carboxymethyl cellulose and polyvinylpyrrolidone.
Preferably, the hydrophilic gel matrix material is selected from polyvinylpyrrolidone.
Preferably, the filler is selected from at least one of starch, dextrin, lactose, compressible starch, microcrystalline cellulose, mannitol, calcium sulfate, calcium hydrogen phosphate and calcium carbonate for pharmaceutical use.
Preferably, the filler is selected from microcrystalline cellulose.
Preferably, the lubricant is selected from at least one of stearic acid, magnesium stearate, calcium stearate, talc, colloidal silicon dioxide.
Preferably, the lubricant is selected from magnesium stearate.
Preferably, the preparation method of the nifedipine inclusion particles comprises the following steps:
(1) Adding nifedipine and beta-cyclodextrin to carry out inclusion to obtain an inclusion compound;
(2) Mixing Tremella polysaccharide and sodium carboxymethylcellulose, adding into water, and dispersing to obtain binder;
(3) And (3) sucking the inclusion compound into a one-step granulator, spraying liquid by using an adhesive, and granulating to obtain nifedipine inclusion particles.
Preferably, the mass ratio of the nifedipine to the beta-cyclodextrin in the step (1) is 1.
Preferably, the inclusion time is 1-3h.
Preferably, the temperature of the inclusion is 45-55 ℃.
Preferably, the preparation of step (1) comprises: and adding water into the beta-cyclodextrin, mixing to obtain a beta-cyclodextrin solution with the concentration of 0.5-1g/mL, mixing nifedipine and the beta-cyclodextrin solution, magnetically stirring for 1h at the constant temperature of 50 ℃ at 200r/min, cooling, carrying out suction filtration, and drying to obtain the inclusion compound.
Preferably, in the step (3), the spraying speed of the spraying liquid is 70-80%, and the pressure of the spray gun is 1.0-2.0bar.
Preferably, the temperature of granulation after inhalation of the inclusion compound is 50-55 ℃.
Preferably, the granulation is followed by a 60-80 mesh sieve, preferably a 60 mesh sieve.
The invention also aims to provide a preparation method of the nifedipine controlled release tablet, which comprises the following steps:
(1) Mixing nifedipine inclusion particles, hydrophilic gel framework materials and fillers, adding ethanol water solution, and mixing to prepare a soft material;
(2) Drying the soft material, adding lubricant, mixing, and tabletting.
The invention also aims to provide the application of the nifedipine controlled release tablet in preparing medicaments for treating hypertension and angina.
Compared with the prior art, the invention has the following beneficial effects:
(1) Compared with the original tablet which adopts a push-pull type double-layer osmotic pump controlled release tablet, the tablet adopts single-layer tabletting, has higher process realization degree, is easy for industrialized popularization, and has better quality and better stability.
(2) The invention firstly carries out proper inclusion on the nifedipine, so that the dissolution of the nifedipine can be more controllable, and the inclusion compound, the tremella polysaccharide and the like are mixed and granulated, and finally mixed with the hydrophilic framework material and the auxiliary material for tabletting, so that the final release rate of the nifedipine is improved, and the chemical stability of the active ingredient in long-term storage is higher.
(3) The nifedipine is granulated firstly, and then mixed with the hydrophilic framework material for tabletting, after the prepared controlled release tablet absorbs water in a machine body, the drug is more stably released and the drug release speed is more controllable through two times of buffering by the first sustained release barrier of the tremella polysaccharide and the sodium carboxymethyl cellulose and the second sustained release barrier of the hydrophilic framework material.
(4) The tremella polysaccharide and the sodium carboxymethyl cellulose are compounded, so that after solution is infiltrated, the aim of thickening and delaying the diffusion of nifedipine can be fulfilled, and the tremella polysaccharide has certain functions of regulating blood pressure and blood fat and preventing thrombus, so that the controlled release tablet disclosed by the invention has better controlled release effect and better stability, and can also assist in regulating blood pressure and blood fat.
Drawings
Fig. 1 is an in vitro release profile of nifedipine controlled release tablets prepared in examples 1 to 4.
Fig. 2 is an in vitro release profile of nifedipine controlled release tablets prepared in example 1 and comparative examples 1 to 4.
Detailed Description
The present invention will be further described with reference to the following specific embodiments.
Example 1
The formulation of this example is shown in table 1 below:
TABLE 1
The preparation method comprises the following steps:
(1) Mixing nifedipine inclusion particles, a hydrophilic gel framework material and a filling agent, and adding 70% ethanol water solution to prepare a soft material;
(2) Oven drying at 60 deg.C, adding lubricant, mixing, and tabletting.
The nifedipine inclusion particles are prepared as follows:
(1) Mixing beta-cyclodextrin with water to obtain 0.8g/mL beta-cyclodextrin solution, mixing nifedipine with the beta-cyclodextrin solution, magnetically stirring at a constant temperature of 50 ℃ for 1h at a speed of 200r/min, cooling, performing suction filtration, and drying to obtain an inclusion compound;
(2) Mixing Tremella polysaccharide and sodium carboxymethylcellulose, adding into water, and dispersing to obtain 3% binder spray;
(3) And (2) sucking the inclusion compound into a cavity of a one-step granulator, adjusting the temperature of the cavity to be 50 ℃, spraying liquid by using an adhesive, wherein the spraying speed of the spraying liquid is 70%, the pressure of a spray gun is 1.0bar, ventilating to ensure that the material is in a boiling state, obtaining granules after granulation, and sieving by using a 60-mesh sieve to obtain nifedipine inclusion granules.
Example 2
The formulation of this example is shown in table 2 below:
TABLE 2
The preparation was carried out as in example 1.
Example 3
The formulation of this example is shown in table 3 below:
TABLE 3
The preparation was carried out as in example 1.
Example 4
The formulation of this example is shown in table 4 below:
TABLE 4
The preparation was carried out according to the method of example 1.
Comparative examples 1 to 4
The formulation is as follows in table 5:
TABLE 5
Comparative example 1 the preparation method was as follows:
(1) Mixing nifedipine inclusion particles, a hydrophilic gel framework material PVK30 and filler microcrystalline cellulose, and adding 70% ethanol water solution to prepare a soft material;
(2) Oven drying at 60 deg.C, adding lubricant, mixing, and tabletting.
The nifedipine inclusion particles are prepared as follows:
(1) Mixing beta-cyclodextrin with water to obtain 0.8g/mL beta-cyclodextrin solution, mixing nifedipine with the beta-cyclodextrin solution, magnetically stirring at a constant temperature of 50 ℃ for 1h at a speed of 200r/min, cooling, performing suction filtration, and drying to obtain an inclusion compound;
(2) Adding sodium carboxymethylcellulose into water, and uniformly dispersing to obtain 3% adhesive spray;
(3) And (3) sucking the inclusion compound into a cavity of a one-step granulator, adjusting the temperature of the cavity to be 50 ℃, spraying liquid by using an adhesive, wherein the spraying speed of the sprayed liquid is 70%, the pressure of a spray gun is 1.0bar, ventilating to ensure that the material is in a boiling state, obtaining particles after the spraying is finished, and sieving by using a 60-mesh sieve to obtain nifedipine inclusion particles.
Comparative example 2 the preparation method was as follows:
(1) Mixing nifedipine inclusion particles, a hydrophilic gel framework material hydroxypropyl methylcellulose and a filler microcrystalline cellulose, and adding 70% ethanol water solution to prepare a soft material;
(2) Oven drying at 60 deg.C, adding lubricant, mixing, and tabletting.
The nifedipine inclusion particles are prepared as follows:
(1) Mixing beta-cyclodextrin with water to obtain 0.8g/mL beta-cyclodextrin solution, mixing nifedipine with the beta-cyclodextrin solution, magnetically stirring for 1h at the constant temperature of 50 ℃ at 200r/min, cooling, performing suction filtration, and drying to obtain an inclusion compound;
(2) Mixing Tremella polysaccharide and sodium carboxymethylcellulose, adding into water, and dispersing to obtain 3% binder spray;
(3) Sucking the clathrate into a cavity of a one-step granulator, adjusting the temperature of the cavity to be 50 ℃, spraying liquid by using an adhesive, wherein the spraying speed of the spraying liquid is 70%, the pressure of a spray gun is 1.0bar, ventilating to ensure that the material is in a boiling state, obtaining granules after granulation, and sieving by using a 60-mesh sieve to obtain nifedipine clathrate granules.
Comparative example 3 the preparation method was as follows:
(1) Mixing nifedipine clathrate particles, a hydrophilic gel framework material PVK30 and filler microcrystalline cellulose, and adding 70% ethanol water solution to prepare a soft material;
(2) Oven drying, adding lubricant, mixing, and tabletting.
The preparation method of the nifedipine inclusion particles comprises the following steps:
(1) And adding water into the beta-cyclodextrin, mixing to obtain a 0.8g/mL beta-cyclodextrin solution, then mixing nifedipine and the beta-cyclodextrin solution, magnetically stirring for 1h at a constant temperature of 50 ℃ at 200r/min, cooling, carrying out suction filtration, and drying to obtain the inclusion compound.
(2) Adding tremella polysaccharide into water, and uniformly dispersing to prepare 3% adhesive spray liquid;
(3) And (3) sucking the inclusion compound into a cavity of a one-step granulator, adjusting the temperature of the cavity to be 50 ℃, spraying liquid by using an adhesive, wherein the spraying speed of the sprayed liquid is 70%, the pressure of a spray gun is 1.0bar, ventilating to ensure that the material is in a boiling state, obtaining particles after the spraying is finished, and sieving by using a 60-mesh sieve to obtain nifedipine inclusion particles.
Comparative example 4 the preparation method was as follows:
(1) Mixing beta-cyclodextrin with water to obtain 0.8g/mL beta-cyclodextrin solution, mixing nifedipine with the beta-cyclodextrin solution, magnetically stirring for 1h at the constant temperature of 50 ℃ at 200r/min, cooling, performing suction filtration, and drying to obtain an inclusion compound;
(2) Mixing nifedipine clathrate, tremella polysaccharide, sodium carboxymethylcellulose, hydrophilic gel skeleton material PVK30 and filler microcrystalline cellulose, and adding 70% ethanol water solution to obtain soft material;
(3) Oven drying at 60 deg.C, adding lubricant, mixing, and tabletting.
In vitro release test
The experimental method refers to a slurry method in 0931 of general rules of the four departments in Chinese pharmacopoeia, specifically, water is used as a medium, the rotating speed is 100rpm, samples are respectively taken at 2h, 4h, 8h, 12h, 16h and 24h, and the measurement is carried out according to a high performance liquid chromatography (the method in the item of nifedipine tablets in Chinese pharmacopoeia); the in vitro release (%) was calculated and the results are shown in tables 6-7 and FIGS. 1-2.
Table 6 in vitro release (%) -of controlled release tablets of examples
| Sampling point | Example 1 | Example 2 | Example 3 | Example 4 |
| 2h | 10.6 | 12.2 | 9.4 | 11.5 |
| 4h | 21.7 | 23.1 | 17.5 | 20.2 |
| 8h | 40.4 | 43.9 | 38.1 | 39.7 |
| 12h | 61.1 | 57.7 | 58.5 | 60.8 |
| 16h | 80.3 | 84.2 | 77.3 | 89.1 |
| 24h | 100.8 | 99.4 | 100.7 | 100.6 |
Table 7 comparative example in vitro release rate (%)
| Sampling point | Comparative example 1 | Comparative example 2 | Comparative example 3 | Comparative example 4 |
| 2h | 14 | 11.2 | 7.5 | 18.7 |
| 4h | 24.6 | 21.3 | 15.9 | 39.4 |
| 8h | 46.3 | 42.7 | 45.7 | 62.1 |
| 12h | 70.7 | 63.9 | 86.3 | 97.9 |
| 16h | 92.1 | 79.3 | 101.0 | 100.2 |
| 24h | 99.5 | 98.8 | 101.3 | 100.8 |
And (4) analyzing results: as can be seen from table 6 and fig. 1, the nifedipine controlled release tablets prepared in examples 1 to 4 of the present invention release smoothly within 24 hours without any significant burst release, i.e., the drug of the present invention can be maintained for 24 hours, and patients only need to take the drug once a day. Comparative examples 1 to 3 of the invention adopt other auxiliary materials to prepare nifedipine controlled release tablets, and comparative example 4 adopts a conventional preparation method, which can be obtained from table 7 and fig. 2, wherein the controlled release tablets either release too slowly and cannot achieve the drug effect in a short time or release too early and cannot achieve the effect of 24h long-acting release.
Accelerated stability test
The controlled release tablet samples were packaged in conventional polyvinyl chloride plastic bottles, placed in a high temperature and high humidity (40 + -2 deg.C, 75 + -5% RH%) incubator, subjected to accelerated stability test investigation, sampled at 0 month, 1 month, and 3 months, respectively, and examined for the content, total impurities, and release degree of the nifedipine controlled release tablets, the results of which are shown in tables 8-10. Wherein the content of nifedipine (%) = the measured content of nifedipine/the feeding amount of nifedipine 100%.
TABLE 8 nifedipine content (%) stability of controlled release tablets
| Detecting items | 0 month | 1 month | 3 month |
| Example 1 | 100.8 | 99.5 | 100.7 |
| Example 2 | 100.3 | 99.7 | 100.8 |
| Example 3 | 100.4 | 99.8 | 99.5 |
| Example 4 | 100.8 | 99.9 | 100.9 |
| Comparative example 1 | 99.5 | 96.4 | 88.2 |
| Comparative example 2 | 100.2 | 97.2 | 95.4 |
| Comparative example 3 | 100.6 | 99.8 | 99.1 |
| Comparative example 4 | 100.3 | 93.0 | 87.8 |
TABLE 9 Total impurity content (%) stability of controlled release tablets
| Detecting items | 0 month | 1 month | Month 3 |
| Example 1 | 0.06 | 0.05 | 0.06 |
| Example 2 | 0.06 | 0.04 | 0.05 |
| Example 3 | 0.06 | 0.06 | 0.07 |
| Example 4 | 0.06 | 0.05 | 0.06 |
| Comparative example 1 | 0.06 | 0.08 | 0.14 |
| Comparative example 2 | 0.05 | 0.07 | 0.11 |
| Comparative example 3 | 0.06 | 0.05 | 0.05 |
| Comparative example 4 | 0.05 | 0.08 | 0.17 |
TABLE 10 Total Release (%) stability of controlled Release tablets
| Detecting items | 0 month | 1 month | Month 3 |
| Example 1 | 100.8 | 100.2 | 100.7 |
| Example 2 | 99.4 | 100.3 | 99.6 |
| Example 3 | 100.7 | 100.8 | 101.5 |
| Example 4 | 100.6 | 100.4 | 99.7 |
| Comparative example 1 | 99.5 | 91.6 | 86.8 |
| Comparative example 2 | 98.8 | 95.4 | 92.7 |
| Comparative example 3 | 101.3 | 99.3 | 96.1 |
| Comparative example 4 | 100.8 | 92.5 | 80.9 |
Conclusion analysis: the experiment results show that 8-10 show that the controlled release tablets prepared in the embodiments 1-4 have good stability and no obvious decrease in the content of nifedipine serving as a main drug component within 3 months, have no obvious increase in the content of total impurities, have good total release degree within 3 months and are completely released. Comparative examples 1-4 adopt different auxiliary materials or preparation methods, the stability of the content of the main drug of the prepared controlled release tablet is poorer, wherein comparative example 3 is superior to other comparative examples; the total release degree of each proportion is reduced in different degrees, and the effect is inferior to that of the invention.
The above detailed description is specific to one possible embodiment of the present invention, and the embodiment is not intended to limit the scope of the present invention, and all equivalent implementations or modifications without departing from the scope of the present invention should be included in the technical scope of the present invention.
Claims (6)
1. The nifedipine controlled release tablet is characterized by comprising the following raw materials in parts by weight: 69-85 parts of nifedipine inclusion particles, 10-15 parts of hydrophilic gel framework material, 5-15 parts of filler and 0.2-2 parts of lubricant; the nifedipine inclusion particles comprise nifedipine, tremella polysaccharide, sodium carboxymethylcellulose and beta-cyclodextrin, wherein the mass ratio of the nifedipine to the tremella polysaccharide to the sodium carboxymethylcellulose is (30-5); the hydrophilic gel framework material is selected from at least one of sodium carboxymethylcellulose and polyvinylpyrrolidone;
the preparation method of the nifedipine inclusion particles comprises the following steps:
(1) Adding nifedipine and beta-cyclodextrin to carry out inclusion to obtain an inclusion compound;
(2) Mixing Tremella polysaccharide and sodium carboxymethylcellulose, adding into water, and dispersing to obtain binder;
(3) And (3) sucking the inclusion compound into a one-step granulator, spraying liquid by using an adhesive, and granulating to obtain nifedipine inclusion particles.
2. The controlled release tablet of claim 1, wherein the hydrophilic gel matrix material is selected from polyvinylpyrrolidone.
3. The controlled release tablet of claim 1, wherein the mass ratio of nifedipine to β -cyclodextrin in step (1) is 1; the inclusion time is 1-3h, and the inclusion temperature is 45-55 ℃.
4. The controlled release tablet of claim 1, wherein in step (3), the granulation process comprises: spraying liquid at a spraying speed of 70-80%, spraying gun pressure of 1.0-2.0bar, granulating at 50-55 deg.C, and sieving with 60 mesh sieve.
5. A method for preparing nifedipine controlled release tablets according to any one of claims 1 to 4, characterized by comprising the steps of:
(1) Mixing nifedipine inclusion particles, a hydrophilic gel framework material and a filling agent, and adding an ethanol aqueous solution to prepare a soft material;
(2) Drying the soft material, adding lubricant, mixing, and tabletting.
6. Use of the nifedipine controlled release tablet according to any one of claims 1 to 4 for the preparation of a medicament for the treatment of hypertension and angina pectoris.
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| US20040219210A1 (en) * | 2003-05-01 | 2004-11-04 | Jian-Hwa Guo | Controlled release solid dosage nifedipine formulations |
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