CN113304115A - Prednisone acetate micro-tablets and preparation method thereof - Google Patents
Prednisone acetate micro-tablets and preparation method thereof Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
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- A—HUMAN NECESSITIES
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- A61P11/06—Antiasthmatics
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- A61P17/00—Drugs for dermatological disorders
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P21/00—Drugs for disorders of the muscular or neuromuscular system
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/02—Antineoplastic agents specific for leukemia
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/08—Antiallergic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/14—Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
Abstract
The invention discloses a prednisone acetate micro-tablet and a preparation method thereof, wherein the micro-tablet comprises an active ingredient prednisone acetate and pharmaceutic adjuvant; the active ingredient prednisone acetate accounts for 2-20% of the micro tablet by mass. The preparation method of the prednisone acetate micro-tablet comprises the following steps: the prednisone acetate micro-tablets are prepared by the steps of pretreatment, premixing, wet granulation, total mixing and tabletting of raw materials and auxiliary materials. The raw materials and the auxiliary materials are mixed according to a set proportion and then crushed, and the particle size of the crushed mixed powder is controlled, so that the production process is improved, the loss of the raw materials is reduced, and the problem of low dissolution speed of tablets is solved.
Description
Technical Field
The invention relates to the technical field of medicinal preparations, in particular to a prednisone acetate micro-tablet and a preparation method thereof.
Background
Glucocorticoids (GCs) are a class of steroid hormones secreted by the fasciculate band in the adrenal cortex, which not only have the effects of regulating biosynthesis and metabolism of sugars, fats and proteins, but also have the effects of suppressing immune response, resisting inflammation, resisting toxicity and shock. Because of its powerful anti-inflammatory and immunosuppressive effects, glucocorticoids are commonly used drugs for clinical treatment of autoimmune and acute and chronic inflammatory diseases.
Prednisone acetate is an adrenocortical hormone drug, belongs to a national basic drug, has a chemical name of 17 alpha, 21-dihydroxypregna-1, 4-diene-3, 11, 20-trione-21-acetate, has a molecular formula of C23H28O6, has a molecular weight of 400.47, is white or white-like crystalline powder at room temperature, and is mainly used for allergic and autoimmune inflammatory diseases. Is suitable for treating connective tissue diseases, systemic lupus erythematosus, severe bronchial asthma, dermatomyositis, vasculitis and other allergic diseases, acute leukemia, malignant lymphoma, other adrenocortical hormone drugs and the like. Prednisone acetate needs to be converted into prednisolone with pharmacological activity after the II-position ketone group is reduced to the II-position hydroxyl group by the liver. Prednisone acetate is easily soluble in chloroform, slightly soluble in acetone, slightly soluble in ethanol or ethyl acetate, and insoluble in water, and its solubility directly influences the dissolution rate in vivo, and further influences the absorption and metabolism in vivo. Therefore, in the preparation process of the prednisone acetate tablet, the dissolution speed needs to be increased to accelerate the in vivo absorption.
Wu Riming researches that the prednisone acetate tablets and the azithromycin are combined to treat the infantile refractory mycoplasma pneumonia, and the result shows that the two medicines are matched to treat the infantile refractory mycoplasma pneumonia, so that the symptoms of the infant can be relieved, and the curative effect is obvious; the effect of prednisolone acetate on the radioactive oral mucositis of rats and the expression of oral epithelial beta defensins is researched by the Liuli, and the severity of prednisolone acetate for relieving the oral mucositis is obtained; in the patent of a prednisone acetate tablet and a preparation method thereof, the preparation method of the prednisolone acetate tablet is protected, and the preparation method mainly comprises the steps of mixing a drug dispersion and pharmaceutically acceptable auxiliary materials uniformly and then directly tabletting; the patent of a pharmaceutical composition of prednisone acetate tablets protects the prescription composition and the production process thereof. In the existing prednisone acetate production formula and process, the dosage form and process of prednisone acetate are not obviously improved.
The prednisone acetate tablets at the present stage have the following main problems:
firstly, the content of the tablets is fixed, the weight of the tablets is larger, prednisone acetate is suitable for wide diseases for hormone medicines, the dosage difference of prednisone acetate required for different diseases is larger, the sodium acetate prednisone tablets are taken for a long time, the dosage can be gradually reduced or increased according to the disease condition in the medication process, the content of the currently produced tablets is fixed, the weight of the tablets is larger, certain difficulty is brought to patients to take the tablets, for example, 100mg needs to be taken orally every day in order to prevent organ transplantation rejection reaction, 20 tablets need to be taken before an operation according to the specification of 5mg, and great challenge is brought to the medication of the patients if the weight of the tablets is larger.
Prednisone acetate tablets are slow to dissolve, prednisone acetate is a fat-soluble drug, and can be well absorbed in intestines and stomach only by being quickly dissolved in water, and the biggest difficulty in the current research and development is to accelerate the dissolution speed.
Therefore, the prednisone acetate is used as the active ingredient of the medicine, and when the prednisone acetate is prepared into an oral preparation, accurate administration is realized, and the speed of dissolution is particularly important.
Disclosure of Invention
Therefore, the technical problem to be solved by the present invention is to overcome the defects in the prior art, and to provide a prednisone acetate micro tablet and a preparation method thereof, wherein the dissolution rate of the tablet is increased by improving the components of the prednisone acetate micro tablet.
The invention provides a prednisone acetate micro-tablet, which comprises an active ingredient prednisone acetate and pharmaceutic adjuvants; the active ingredient prednisone acetate accounts for 2-20% of the micro tablet by mass.
Preferably, the pharmaceutical excipients comprise a disintegrant, a filler, a lubricant and a wetting agent.
Preferably, the micro-slabs further comprise colloidal silica.
Preferably, the mass percentage of the colloidal silica in the microchip is 0.05% -3%.
Preferably, the mass percentage content of the disintegrating agent in the micro-tablets is 1% -10%; the disintegrant is one or more of croscarmellose sodium, crospovidone or sodium carboxymethyl starch.
Preferably, the mass percentage content of the filler in the micro-tablets is 50% -95%; the filler is one or more of lactose, sucrose, dextrin, microcrystalline cellulose, starch or mannitol.
Preferably, the mass percentage content of the lubricant in the micro-tablets is 0.1% -5%; the lubricant is one or more of magnesium stearate, sodium stearyl fumarate, talcum powder or polyethylene glycol.
Preferably, the micro-slabs are in the shape of a cylinder, an ellipse or a sphere in space.
The invention also provides a preparation method of the prednisone acetate micro-tablet, which comprises the following steps:
(1) pretreatment of raw materials and auxiliary materials: mixing prednisone acetate and a filling agent according to the mass ratio of 1 (1-5), and then crushing to obtain mixed powder; sieving the rest adjuvants, pulverizing the adjuvants which can not be sieved, and sieving;
(2) premixing: putting the mixed powder obtained in the step (1), the sieved disintegrating agent and the rest filling agent into a mixer for mixing for 10-35 min;
(3) and (3) wet granulation: adding ethanol, granulating, sieving, granulating, and drying to obtain prednisone acetate granule;
(4) total mixing: mixing prednisone acetate particles and colloidal silicon dioxide, adding a lubricant, and mixing;
(5) tabletting: and punching and pressing by a tablet press.
Preferably, the particle size D (90) of the crushed prednisone acetate is less than or equal to 15 mu m.
The technical scheme of the invention has the following advantages:
1. the prednisone acetate micro-tablets provided by the invention can be repeatedly administered in a small dose, can be taken in a counting manner for patients needing to gradually increase or decrease the dose, particularly for people with large individual metabolism difference, such as the elderly and children, so that accurate administration is realized, and the compliance of taking medicines can be improved for people who have difficulty in taking conventional preparations;
2. the prednisone acetate micro-tablets provided by the invention are prepared by strictly screening the added auxiliary materials and testing the prescription amount for many times, and particularly, the added silicon dioxide ensures that the obtained mixed powder has good fluidity and is convenient to tablet, the obtained tablets have good friability, and the tablet detection is not influenced;
3. according to the preparation method of the prednisone acetate micro-tablets, the raw and auxiliary materials are mixed according to a set proportion and then crushed, and the particle size of the crushed mixed powder is controlled, so that the production process is improved, the loss of the raw materials is reduced, the problem of slow dissolution speed of the tablets is solved, and a stable and controllable technical guide is provided for the mass production of medicines.
4. The preparation method of the prednisone acetate micro-tablets has the advantages of cheap and easily-obtained raw materials, simple preparation method, strong controllability and suitability for industrial production, and the prednisone acetate micro-tablets are prepared by the pretreatment, premixing, wet granulation, total mixing and tabletting of raw materials and auxiliary materials.
Detailed Description
The following examples are provided to further understand the present invention, not to limit the scope of the present invention, but to provide the best mode, not to limit the content and the protection scope of the present invention, and any product similar or similar to the present invention, which is obtained by combining the present invention with other prior art features, falls within the protection scope of the present invention.
The examples do not show the specific experimental steps or conditions, and can be performed according to the conventional experimental steps described in the literature in the field. The reagents or instruments used are not indicated by manufacturers, and are all conventional reagent products which can be obtained commercially.
Example 1
The prednisone acetate micro-tablets comprise the following components:
the preparation method of the prednisone acetate micro-tablet comprises the following steps:
(1) pretreatment of raw materials and auxiliary materials: prednisone acetate was mixed with starch in a ratio of 1: 2, crushing the mixture, mixing the crushed mixture for three times to obtain the average value of the particle size D (90) ═ 10.081 mu m, sieving the starch and other auxiliary materials by a 40-mesh sieve, and sieving the auxiliary materials which cannot be sieved after crushing;
(2) premixing: mixing the pre-treated mixed powder with the rest starch, crospovidone and mannitol for 20 min;
(3) and (3) granulating: preparing a soft material with proper hardness by adopting a proper amount of 50% ethanol solution, granulating by adopting a 20-mesh screen, drying at the temperature of 60 ℃, and measuring the water content to be 5.1%;
(4) total mixing: mixing the obtained granules with colloidal silicon dioxide for 3min, adding magnesium stearate according to the prescription amount, and mixing for 2 min;
(5) tabletting: and stamping and pressing by using a tablet press to obtain cylindrical prednisone acetate micro-tablets with the height of 4mm and the diameter of 4 mm.
Example 2
The prednisone acetate micro-tablets comprise the following components:
the preparation method of the prednisone acetate micro-tablet comprises the following steps:
(1) pretreatment of raw materials and auxiliary materials: prednisone acetate was mixed with sucrose in a 1: 2, crushing the mixture, mixing the crushed mixture for three times to obtain the average value of the particle size D (90) ═ 13.479 mu m, sieving the starch and other auxiliary materials by a 40-mesh sieve, and sieving the auxiliary materials which cannot be sieved after crushing;
(2) premixing: mixing the pre-treated mixed powder with the prescription amount, the cross-linked sodium carboxymethyl cellulose with the prescription amount and the microcrystalline cellulose in a mixer for 20 min;
(3) and (3) granulating: preparing a soft material with proper hardness by adopting a proper amount of 50% ethanol solution, granulating by adopting a 20-mesh screen, drying at the temperature of 60 ℃, and measuring the water content to be 5.4%;
(4) total mixing: mixing the obtained granules with colloidal silicon dioxide for 3min, adding magnesium stearate according to the prescription amount, and mixing for 2 min;
(5) tabletting: and stamping and pressing by using a tablet press to obtain cylindrical prednisone acetate micro-tablets with the height of 1mm and the diameter of 4 mm.
Example 3
The prednisone acetate micro-tablets comprise the following components:
the preparation process comprises the following steps:
(1) pretreatment of raw materials and auxiliary materials: prednisone acetate was mixed with starch in a ratio of 1: 1, grinding, mixing the powder for three times to obtain an average value D (90) ═ 11.823 mu m, sieving the starch and other auxiliary materials with a 40-mesh sieve, and sieving the auxiliary materials which cannot be sieved after grinding;
(2) premixing: mixing the pre-treated mixed powder with the prescription amount, the residual starch, the cross-linked sodium carboxymethylcellulose with the prescription amount and the dextrin in a mixer for 30 min;
(3) and (3) granulating: preparing a soft material with proper hardness by adopting a proper amount of 50% ethanol solution, granulating by adopting a 20-mesh screen, drying at the temperature of 60 ℃, and measuring the water content to be 4.6%;
(4) total mixing: mixing the obtained granules with colloidal silicon dioxide for 2min, adding magnesium stearate according to the prescription amount, and mixing for 2 min;
(5) tabletting: and stamping and pressing by using a tablet press to obtain cylindrical prednisone acetate micro-tablets with the height of 3mm and the diameter of 3 mm.
Comparative example
The prednisone acetate micro-tablets comprise the following components:
the preparation process comprises the following steps:
(1) pretreatment of raw materials and auxiliary materials: prednisone acetate was mixed with starch in a ratio of 1: 1, grinding, mixing the powder for three times to obtain an average value D (90) ═ 11.823 mu m, sieving the starch and other auxiliary materials with a 40-mesh sieve, and sieving the auxiliary materials which cannot be sieved after grinding;
(2) premixing: mixing the pre-treated mixed powder with the prescription amount, the residual starch, the cross-linked sodium carboxymethylcellulose with the prescription amount and the dextrin in a mixer for 30 min;
(3) and (3) granulating: preparing a soft material with proper hardness by adopting a proper amount of 50% ethanol solution, granulating by adopting a 20-mesh screen, drying at the temperature of 60 ℃, and measuring the water content to be 4.6%;
(4) total mixing: adding the obtained granules into magnesium stearate in a prescribed amount, and mixing for 2 min;
(5) tabletting: and stamping and pressing by using a tablet press to obtain cylindrical prednisone acetate micro-tablets with the height of 3mm and the diameter of 3 mm.
Dissolution and related substances of the prednisolone acetate micro tablets prepared in the above examples and comparative examples were measured, and the measurement results are shown in table 1.
1. The chromatographic conditions are determined by high performance liquid chromatography (the national pharmacopoeia 2015 edition rules 0512). Octadecylsilane chemically bonded silica is used as a filling agent in chromatographic conditions and system applicability tests; acetonitrile-water (33: 67) is used as a mobile phase; the detection wavelength was 240 nm. Injecting 20ul of the control solution under the related substance item into a liquid chromatograph, and recording a chromatogram map, wherein the separation degree between a prednisone acetate peak and a cortisone acetate peak is required to meet the requirement.
2. Related substances. Taking the product, precisely weighing, adding the mobile phase for dissolution and quantitatively diluting to prepare a solution containing 0.5mg in each 1ml as a test solution, taking a proper amount of each of a prednisone reference substance and a cortisone acetate reference substance, precisely weighing, adding the mobile phase for dissolution and quantitatively diluting to prepare a mixed solution containing 0.5mg in each lml, precisely weighing 1ml of the lml and the test solution, placing the lml and the test solution in the same 100ml measuring flask, diluting with the mobile phase to scale, and shaking up to obtain a reference solution. Injecting 20 μ l of the control solution into a liquid chromatograph under the above chromatographic conditions, wherein the peak sequence is prednisone, prednisone acetate, and cortisone acetate, and the separation degree of the prednisone acetate peak and cortisone acetate peak should be greater than 2.5. Precisely measuring 20 μ l of each of the test solution and the control solution, respectively injecting into a liquid chromatograph, and recording the chromatogram until the retention time of the main component peak is 2 times. If an impurity peak with the same retention time as prednisone and cortisone acetate peaks in a control solution exists in a chromatogram of the test solution; calculated by peak area according to an external standard method, respectively not exceeding 0.5 percent and 1.5 percent; the sum of the impurity peak areas must not be greater than 2.2 times (2.0%) of the area of the prednisone acetate peak in the control solution. The chromatographic peak of the chromatogram of the test solution, which is 0.01 times (0.01%) less than the peak area of the prednisone acetate of the control solution, is ignored.
3. And (4) dissolution. Taking the product, according to dissolution and release determination method (0931, second method of the general rules of the Chinese pharmacopoeia 2015), using 600ml of 0.25% sodium dodecyl sulfate solution as dissolution medium, and rotating speed of 100 rpm, operating according to the method. After 45 minutes, 8ml of the solution was filtered, and 1.5ml of the subsequent filtrate was used as the test solution. And accurately weighing 10mg of prednisone acetate reference substance, placing the reference substance in a 100ml volumetric flask, adding 10ml of absolute ethanol for dissolving, diluting with a dissolution medium to scale, shaking up, accurately weighing 2ml, placing the reference substance in a 25ml volumetric flask, diluting with the dissolution medium to scale, and shaking up to obtain the reference substance solution. The test solution and the reference solution are precisely measured by 20ul each, and the measurement is carried out according to the method under the measurement of related substances. The elution amount of each tablet was calculated by peak area according to the external standard method. The limit is 70% of the indicated amount and should be met.
Table 1: results of mass measurement of samples of each example
Note: the accelerated test conditions were 40 ℃. + -. 2 ℃/75% RH. + -. 5% RH.
As can be seen from table 1, the prednisone acetate tablets prepared in the embodiments of the present invention dissolve rapidly and have stable quality; and the samples prepared by the embodiment are detected according to the standard of Chinese pharmacopoeia and all accord with the regulation.
It should be understood that the above examples are only for clarity of illustration and are not intended to limit the embodiments. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. And obvious variations or modifications therefrom are within the scope of the invention.
Claims (10)
1. The prednisone acetate micro-tablet is characterized in that the micro-tablet comprises an active ingredient prednisone acetate and pharmaceutic adjuvants;
the active ingredient prednisone acetate accounts for 2-20% of the micro tablet by mass.
2. The prednisone acetate micro tablet of claim 1, wherein the pharmaceutical excipients comprise a disintegrant, a filler, a lubricant and a wetting agent.
3. The prednisolone acetate micro-tablet of claim 1 or 2, wherein the micro-tablet further comprises colloidal silica.
4. The prednisone acetate micro tablet of claim 3, wherein the colloidal silica is present in an amount of 0.05% to 3% by mass of the micro tablet.
5. The prednisone acetate micro-tablet of claim 2, wherein the disintegrant is present in the micro-tablet in an amount of 1% to 10% by weight;
the disintegrant is one or more of croscarmellose sodium, crospovidone or sodium carboxymethyl starch.
6. The prednisone acetate micro-tablet of claim 2, wherein the filler is present in the micro-tablet in an amount of 50% to 95% by weight;
the filler is one or more of lactose, sucrose, dextrin, microcrystalline cellulose, starch or mannitol.
7. The prednisolone acetate micro tablet of claim 2, wherein the lubricant is present in an amount of 0.1% to 5% by weight of the micro tablet;
the lubricant is one or more of magnesium stearate, sodium stearyl fumarate, talcum powder or polyethylene glycol.
8. The prednisolone acetate micro tablet of any one of claims 1-7, wherein the micro tablet has a cylindrical, ellipsoidal or spherical spatial shape.
9. The method for preparing prednisolone acetate micro tablets of claims 1-8, comprising the steps of:
(1) pretreatment of raw materials and auxiliary materials: mixing prednisone acetate and a filling agent according to the mass ratio of 1 (1-5), and then crushing to obtain mixed powder; sieving the rest adjuvants, pulverizing the adjuvants which can not be sieved, and sieving;
(2) premixing: putting the mixed powder obtained in the step (1), the sieved disintegrating agent and the rest filling agent into a mixer for mixing for 10-35 min;
(3) and (3) wet granulation: adding ethanol, granulating, sieving, granulating, and drying to obtain prednisone acetate granule;
(4) total mixing: mixing prednisone acetate particles and colloidal silicon dioxide, adding a lubricant, and mixing;
(5) tabletting: and punching and pressing by a tablet press.
10. The method for preparing prednisone acetate micro-tablets according to claim 9, wherein the particle size D (90) of the crushed prednisone acetate is less than or equal to 15 μm.
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| CN114129527A (en) * | 2021-11-02 | 2022-03-04 | 北京微智瑞医药科技有限公司 | Miniature tablet and preparation method and preparation thereof |
| WO2023078180A1 (en) * | 2021-11-02 | 2023-05-11 | 北京微智瑞医药科技有限公司 | Mini-tablet, and preparation method therefor and formulation thereof |
| CN114469879A (en) * | 2022-01-20 | 2022-05-13 | 北京微智瑞医药科技有限公司 | Scopolamine butylbromide micro-tablets and preparation method and preparation thereof |
| CN114469879B (en) * | 2022-01-20 | 2022-09-20 | 北京微智瑞医药科技有限公司 | Scopolamine butylbromide micro-tablets and preparation method and preparation thereof |
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