CN111265489A - Divisible acarbose pellet sustained-release tablet - Google Patents
Divisible acarbose pellet sustained-release tablet Download PDFInfo
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- CN111265489A CN111265489A CN202010160917.3A CN202010160917A CN111265489A CN 111265489 A CN111265489 A CN 111265489A CN 202010160917 A CN202010160917 A CN 202010160917A CN 111265489 A CN111265489 A CN 111265489A
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- 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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
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- 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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
- A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
- A61K31/7036—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin having at least one amino group directly attached to the carbocyclic ring, e.g. streptomycin, gentamycin, amikacin, validamycin, fortimicins
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- 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
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- 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
- A61K9/2095—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
- 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
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Abstract
The invention discloses a divisible acarbose pellet sustained-release tablet, which is prepared by preparing pellets from an active ingredient acarbose, HPMC, a disintegrating agent, an adhesive and the like, uniformly mixing the pellets with other external auxiliary materials and tabletting. The invention adopts the pellet sustained-release technology to control the drug delivery speed so as to prolong the curative effect of the drug, and integrates the advantages of a multi-unit preparation and the capability of accurately breaking off the sustained-release tablets. Each pellet is an independently controlled drug release unit, and the drug release is uniform and stable. The pellet sustained-release tablet can ensure the dissolution of the drug and package the stability of the drug, and the process is simple and is suitable for mass production.
Description
Technical Field
The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a divisible acarbose pellet sustained-release tablet and a preparation method thereof.
Background
Diabetes mellitus is a group of metabolic diseases characterized by hyperglycemia, which is caused by defects in insulin secretion or impairment of its biological actions, or both, and hyperglycemia occurring over a long period of time in diabetes mellitus results in chronic damage to, and dysfunction of, various tissues, particularly the eye, kidney, heart, blood vessels, nerves. Diabetes has become the third largest non-infectious disease following cardiovascular disease and tumors.
Acarbose belongs to α -glycosidase inhibitors, is a hypoglycemic drug, is a common drug for clinically treating type 2 diabetes, is applicable to 1, people who cannot satisfactorily control blood sugar by simple diet treatment, especially type 2 diabetes of postprandial blood sugar, type 2 and impaired glucose tolerance, are approved by the FDA in the United states at present, are used for early-stage diabetes patients, 3 and 2 diabetes patients, are applied with sulfonylurea oral hypoglycemic drugs or biguanide oral hypoglycemic drugs, have unsatisfactory curative effect, especially can be applied when the postprandial blood sugar is not well controlled, 4, and can be used as an auxiliary therapeutic drug of insulin to reduce the dosage of the insulin and stabilize the blood sugar.
Acarbose tablets are developed by Bayer, are sold under the trade name of 'Glucobay', and are used for treating type 2 diabetes mellitus, acarbose is a α -glucosidase inhibitor, the action mechanism of the acarbose is that α -glucosidase, which is a brush border wall cell of small intestinal tracts, can be competitively inhibited, and the hydrolysis and absorption of disaccharide and polysaccharide are delayed, so that the postprandial blood sugar is effectively reduced.
The invention patent CN1268060A discloses a gastrointestinal mucosa-attached sustained-release oral hypoglycemic preparation, which can prolong the retention time of a medicament in a digestive tract and prolong the inhibition effect of acarbose on α -glycosidase.A polyglycerol fatty acid ester or lipoid and a viscosity-causing agent are adopted to form a gastrointestinal tract retention prolonged matrix, the matrix has a complex process, the polyglycerol fatty acid ester or lipoid needs to be heated to be molten, particles need to be prepared by a spray freezing technology, the process is complex and is not suitable for industrial production, and the attached preparation is attached to the digestive tract for a long time and continuously releases the medicament for 3-4 hours, has slow effect and short sustained-release time, can generate a large stimulation effect on the gastrointestinal tract of an attached part and generate adverse reaction.
The invention discloses an oral preparation authorized by patent CN102210866B for delaying absorption of α -glycosidase inhibitor and enhancing hypoglycemic drug effect, wherein the oral preparation is an acarbose sustained-release tablet prepared by using sodium carboxymethylcellulose as a binder.
Disclosure of Invention
The invention aims to overcome the problems of rapid absorption of acarbose in vivo and insufficient action time, the pellet type divisible sustained-release tablet prepared by the invention has long action time, the stable and sustained release of the drug can be kept after the tablet is divided, the treatment effect is ensured, the action time of the drug is improved, the preparation process is simpler, and the preparation method is suitable for large-scale production in a workshop.
The sustained-release tablet is a pellet type divisible sustained-release tablet, and the sustained-release pellets are prepared by adopting an HPMC (hydroxy propyl methyl cellulose) extrusion-spheronization method as a sustained-release framework material, so that the method is a novel pelleting method, and the obtained pellets are uniform in size, narrow in particle size distribution and uniform in drug content. The required devices mainly comprise an extruder and a rounding machine. The extruder can extrude the kneaded wet material into a cylindrical shape, and the spheronizer can roll the extruded cylindrical material into a spherical shape. It has: short granulation time, high yield, no need of screening, adjustable particle diameter, uniform distribution of components in the spherulites and the like. Compared with other pellet preparation processes, the method has simple process, does not need to coat the pellets for multiple times, and can save the production cost. Other pellet sustained-release tablets are prepared by coating sustained-release pellets, so the requirements on pellet particle size, externally added auxiliary material particle size and tabletting are high, otherwise, the problems of uneven mixing, cracking of tabletting coating films and the like are easy to occur, and the problems can be avoided.
Compared with a single-unit skeleton sustained-release tablet, the multi-unit pellet sustained-release tablet has the advantages that the release speed of the sustained-release preparation cannot be influenced after being divided, and compared with a single-unit preparation of the sustained-release tablet, the sustained-release pellets are uniformly distributed in the gastrointestinal tract, so that the utilization degree of the medicine can be improved, the medicine dosage can be reduced, and adverse reactions can be relieved; the defects of the preparation of individual pellets do not influence the overall treatment effect, the influence of gastric emptying is small, and the individual difference caused by food is reduced. In addition, the pellet also has the advantages of good fluidity, uniform size and easy processing.
Specifically, the purpose of the invention is realized by the following technical scheme:
the invention discloses a pellet sustained-release tablet of divisible acarbose, which is prepared by extruding and rolling HPMC (hydroxy propyl methyl cellulose) serving as a sustained-release framework material, mixing with an additional auxiliary material and tabletting.
A pellet sustained release tablet capable of dividing acarbose comprises sustained release pellets and additional adjuvants; the sustained-release tablet comprises the following components by mass:
the slow release pellet comprises the following components:
the auxiliary materials are added:
20-50 parts of filler
1-3 parts of lubricant
The sustained-release tablet is a divisible sustained-release pellet tablet and is provided with one or more breaking grooves perpendicular to the height or length of the tablet.
The hydroxypropyl methyl cellulose (HPMC) is a sustained-release framework material for preparing sustained-release pellets.
Preferably, the filler is selected from one or more of corn starch, lactose monohydrate and microcrystalline cellulose.
Preferably, the binder is selected from one or more of starch, pregelatinized starch and hydroxypropyl cellulose.
Preferably, the lubricant is selected from one or more of magnesium stearate, colloidal silicon dioxide, sodium fumarate stearate, zinc stearate, stearic acid and calcium stearate.
The invention also provides a preparation method of the sustained-release tablet containing the acarbose, which comprises the following steps:
(1) granulating a wet material:
uniformly mixing acarbose, the slow-release framework, the filler and the lubricant in a formula ratio in a mixer, adding an adhesive, and preparing powder into a wet and uniform material with certain plasticity or preparing a wet material into wet granules through a granulator;
(2) extrusion-spheronization into pills:
the plastic wet material or wet granules prepared in the first step are placed in an extruder, and the wet material is extruded into a cylindrical strip-shaped extrudate through a hole or a sieve with a certain diameter in an extrusion mode such as spiral propulsion or rolling. The extrudate is piled up and discharged on a self-rotation friction plate of a rounding machine, the extrudate is dispersed into smaller cylinders with the length equal to the diameter of the extrudate, and due to the action of friction force, the plastic cylindrical materials roll on the plate ceaselessly and roll into a spherical shape gradually.
(3) And (3) drying:
placing the pellet in fluidized bed (evaporation temperature), and drying to obtain sustained-release pellet;
(4) mixing:
adding the prepared sustained-release pellets and external auxiliary materials into a hopper mixer to be uniformly mixed;
(5) tabletting:
and (4) selecting an elliptical middle-scored punching die to perform tabletting on the uniformly mixed intermediate product in the step (4), and finally preparing the divisible sustained-release tablet containing the acarbose.
Compared with the prior art, the invention has the following beneficial effects:
the sustained-release pellet tablet containing the acarbose provided by the invention has stable dissolution, long-acting release, improved drug utilization rate, prolonged drug intestinal tract action time and long-term effective treatment concentration maintenance. The preparation process is simple, the quality and the curative effect of the medicine are ensured, and the toxic and side effects are reduced.
The tablet still has good stability under the environment of 40 ℃ and 75% of relative humidity after 6 months of accelerated test.
Detailed Description
The invention will be further illustrated and described with reference to specific embodiments. The technical features of the embodiments of the present invention can be combined correspondingly without mutual conflict.
Example 1:
the preparation method comprises
(1) Granulating a wet material:
uniformly mixing acarbose, hydroxypropyl methylcellulose, microcrystalline cellulose and colloidal silicon dioxide in a formula ratio in a wet mixer, adding an adhesive prepared from hydroxypropyl cellulose, and preparing powder into plastic wet granules;
(2) extrusion-spheronization into pills:
the plastic wet granules prepared in the first step are placed in an extruder, and the wet granules are extruded into cylindrical strip-shaped extrudates by a screen with the aperture of 0.1mm through the extrusion modes of spiral propulsion, rolling and the like. The extrudate is piled up on a self-rotation friction plate of a rounding machine, the extrudate is dispersed into smaller cylinders with the length equal to the diameter of the extrudate, and due to the action of friction force, the plastic cylindrical materials roll on the plate ceaselessly and roll into a spherical shape gradually.
(3) And (3) drying:
placing the spheres in a fluidized bed, drying at 50 ℃, and controlling the loss on drying LOD to be less than or equal to 2% to obtain sustained-release pellets;
(4) mixing:
adding the prepared sustained-release pellets, the added microcrystalline cellulose and magnesium stearate into a hopper mixer, and uniformly mixing;
(5) tabletting:
selecting a middle-nicked oval die, tabletting the intermediate product uniformly mixed in the step (5), controlling the weight of the tablet to be about 280mg and the hardness range to be 8-12kg, and finally preparing the slow-release tablet containing the acarbose.
It should be noted that, as an alternative implementation manner of this embodiment, the microcrystalline cellulose of the filler may also be replaced by corn starch and lactose monohydrate; the hydroxypropyl cellulose of the adhesive can be replaced by pregelatinized starch and starch; the lubricant colloidal silicon dioxide and magnesium stearate can be replaced by sodium stearate fumarate, zinc stearate, stearic acid and calcium stearate.
The technical effects of the above alternative technical solutions are not obviously different from those of the present embodiment.
Comparative example 1:
the preparation method comprises
(1) Melting:
the behenyl hexa (tetra) glyceride in the formula amount was melted by heating at 84 ℃. Acarbose and acrylic acid polymer were added to the melt in this order and stirred at a constant temperature of 84 ℃ for 15min to disperse uniformly.
(2) And (3) granulating:
the melted mixture was dropped on an aluminum disk having a diameter of 15cm, rotating at 1950rpm, at a speed of 10g/min to provide spherical fine particles.
(3) Sieving:
sieving the above granules with 42 mesh sieve, and retaining the granules above 60 mesh sieve.
(4) Mixing:
adding the prepared granules, hydroxypropyl cellulose and magnesium stearate into a hopper mixer, and uniformly mixing;
(5) tabletting:
selecting a middle-nicked oval die, tabletting the intermediate product uniformly mixed in the step (5), controlling the weight of the tablet to be about 132mg and the hardness range to be 8-12kg, and finally preparing the slow-release tablet containing the acarbose.
Comparative example 2:
the preparation method comprises
(1) Sieving:
sieving the raw materials and the auxiliary materials with a 60-mesh sieve.
(2) And (3) granulating:
mixing the raw materials with sodium carboxymethylcellulose for 5min, adding mannitol, mixing for 5min, and adding 95% ethanol to obtain soft mass.
(3) And (3) drying:
placing the soft material in a fluidized bed, drying at 50 ℃, and controlling the loss on drying LOD to be less than or equal to 2 percent to obtain dried particles;
(4) mixing:
adding the prepared dried granules and magnesium stearate into a hopper mixer, and uniformly mixing;
(5) tabletting:
selecting a middle-nicked oval die, tabletting the intermediate product uniformly mixed in the step (5), controlling the weight of the tablet to be about 103mg and the hardness range to be 6-10kg, and finally preparing the slow release tablet containing the acarbose.
And (3) yield comparison:
| sample source | Yield of intermediate product | Overall yield of |
| Example 1 | 96.4％ | 92.4％ |
| Comparative example 1 | 76.2％ | 73.1％ |
| Comparative example 2 | 95.8％ | 93.1％ |
The yield of the example 1 and the yield of the comparative example 2 are both in the required range, and the yield of the comparative example 1 is only 73.1 percent, so that the method is not suitable for industrial mass production.
And (3) dissolution detection:
the solution preparation method of the test sample comprises the following steps: the results are shown in the following table according to the general rule for determination of dissolution and release (third method of 0931 in general rules of the "Chinese pharmacopoeia"):
from experimental results, the acarbose sustained-release tablet prepared in the embodiment 1 of the invention is uniformly and stably dissolved in a medium with pH of 5.8, can ensure that the medicine is completely released and dissolved, maintains the release time of 12 hours, and keeps the continuous treatment effect; the half tablet has the same dissolving trend as the whole tablet, i.e. the sustained release tablet can be divided without affecting the curative effect of the medicine. The medicine in the comparative example 1 is slowly dissolved out at the early stage, the treatment effect cannot be exerted in time, the attachment time of the digestive tract is 3-4 hours, and the action time of the medicine is shorter than that of the embodiment; in comparative example 2, the drug is almost completely dissolved in 8 hours, the treatment action time is shorter than that of example 12 hours, the half-tablet is dissolved for 4 hours to reach more than 85 percent, the action time is only 4 hours, and no sustained-release effect is basically produced after the drug is taken by dividing.
Example 2: detecting the content and content uniformity of the sample:
and (3) measuring the content and content uniformity: the content uniformity is detected according to the general rule of 0941 content uniformity inspection method in the general rules of Chinese pharmacopoeia. And (3) judging the content uniformity result: a +2.2S is less than or equal to 15
The results are shown in the following table:
from the experimental results in the table above, it can be seen that the uniformity of the content of the acarbose tablets prepared in example 1 of the present invention meets the specification, and compared with comparative example 1, the content is all acceptable and the uniformity is better. The invention can ensure the even dispersion of the medicine and the effectiveness of each medicine.
Example 3: and (3) detecting substances related to the stability of the sample, wherein the experimental results are shown in the following table:
from the above table, it can be seen that all the related substances meet the legal standards under the acceleration conditions in the example 1 of the present invention, and the impurities grow slowly; compared with the substance growth condition related to the comparative example 1, the impurity growth of the example 1 is slower, the change is smaller and obviously better than that of the comparative example 1, the accelerated test is carried out for 6 months, the stability of the example 1 is qualified, and the stability of the comparative example 1 does not meet the standard for 6 months.
Claims (7)
1. A divisible acarbose pellet sustained-release tablet is characterized in that the sustained-release tablet is a divisible sustained-release pellet tablet; the sustained-release pellet is prepared by uniformly mixing and tabletting sustained-release pellets and external auxiliary materials, and the sustained-release pellets consist of the following components in parts by mass:
the auxiliary materials are added:
20-50 parts of filler
1-3 parts of a lubricant.
2. The extended release tablet of claim 1, wherein: the sustained-release tablet is provided with one or more breaking grooves vertical to the height or length direction of the tablet, and the tablet after being divided has the same dissolution characteristic with the complete tablet.
3. The extended release tablet of claim 1, wherein: the filler is selected from one or more of corn starch, lactose monohydrate or microcrystalline cellulose.
4. The extended release tablet of claim 1, wherein: the adhesive is selected from one or more of starch, pregelatinized starch or hydroxypropyl cellulose.
5. The extended release tablet of claim 1, wherein: the lubricant is selected from one or more of magnesium stearate, colloidal silicon dioxide, sodium fumarate stearate, zinc stearate, stearic acid and calcium stearate.
6. The extended release tablet of claim 1, wherein: the sustained-release pellet is prepared by adopting an extrusion-spheronization method.
7. A process for preparing a divisible acarbose pellet extended release tablet according to claim 1, comprising the steps of:
(1) uniformly mixing acarbose, HPMC, filler and lubricant according to the formula amount of the pellets, and adding adhesive to prepare a soft material;
(2) extruding the soft material into a strip column shape through an extruder, cutting the cylindrical material in a rolling machine, rolling into a spherical shape with uniform size and regularity, and finally drying to obtain the sustained-release pellets;
(3) and uniformly mixing the prepared sustained-release pellets with an external auxiliary material, selecting an elliptical middle-scored punch die for tabletting, and finally preparing the divisible sustained-release tablet containing the acarbose.
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| Application Number | Priority Date | Filing Date | Title |
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| CN202010160917.3A CN111265489A (en) | 2020-03-10 | 2020-03-10 | Divisible acarbose pellet sustained-release tablet |
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| CN202010160917.3A CN111265489A (en) | 2020-03-10 | 2020-03-10 | Divisible acarbose pellet sustained-release tablet |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113181127A (en) * | 2021-05-07 | 2021-07-30 | 苏州康恒研新药物技术有限公司 | Preparation method of dapoxetine hydrochloride pellet tablets |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113181127A (en) * | 2021-05-07 | 2021-07-30 | 苏州康恒研新药物技术有限公司 | Preparation method of dapoxetine hydrochloride pellet tablets |
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