CN111053747A - Acarbose medicinal preparation - Google Patents

Acarbose medicinal preparation Download PDF

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Publication number
CN111053747A
CN111053747A CN201811207730.3A CN201811207730A CN111053747A CN 111053747 A CN111053747 A CN 111053747A CN 201811207730 A CN201811207730 A CN 201811207730A CN 111053747 A CN111053747 A CN 111053747A
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Prior art keywords
acarbose
preparation
pharmaceutical formulation
diluent
lubricant
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CN201811207730.3A
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Inventor
陈海建
刘宇海
贾俊
耿玉先
产运霞
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Beijing Fuyuan Pharmaceutical Co Ltd
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Beijing Fuyuan Pharmaceutical Co Ltd
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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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • 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
    • 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
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Diabetes (AREA)
  • Biophysics (AREA)
  • Hematology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Obesity (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Endocrinology (AREA)
  • Emergency Medicine (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention provides an acarbose medicinal preparation, which comprises acarbose, a diluent and a lubricant, wherein the diluent comprises calcium glycerophosphate, pregelatinized starch and a water-soluble diluent. The diluent in the acarbose preparation is the combination of calcium glycerophosphate, pregelatinized starch and water-soluble diluent, so that the characteristic of easy moisture absorption of acarbose can be overcome, and the problems of disintegration and slow dissolution of the prepared acarbose preparation are avoided.

Description

Acarbose medicinal preparation
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to an acarbose medicinal preparation and a preparation method thereof.
Background
Acarbose is an oral hypoglycemic different from sulfonylureas and biguanides, prepared by a biosynthetic method, is an α -glucosidase inhibitor, and has strong affinity for amylase at the upper edge of intestinal cells and α -glucosidase.
Acarbose (Acarbose) is a drug developed in 70 th middle of the Bayer' S in Germany for the treatment of type II diabetes, and is first marketed in Germany in 1990, was approved by the FDA in 1996 and marketed in the United states, and is introduced into China in 1998, wherein the chemical name is O-4, 6-dideoxy-4- [ (1S,4R,5S,6S) -4,5, 6-trihydroxy-3- (hydroxymethyl) -2-cyclohexenyl-1-amino ] - α -D-glucopyranosyl- (1 → 4) -O- α -D-glucopyranosyl- (1 → 4) -D-glucopyranosyl.
Figure 202190DEST_PATH_IMAGE001
。
Acarbose is extremely easy to absorb moisture and deliquesce, and becomes hard after moisture absorption, and because the acarbose tablet has the physical and chemical characteristics of moisture absorption, the phenomena of disintegration and slow dissolution can occur due to the increase of the hardness of the tablet in the storage process; meanwhile, the stability of acarbose preparations is closely related to the water content thereof, and Japanese patent publication (Kokai No. 39340/1995) states that acarbose degradation occurs when the water content of acarbose exceeds 6% after storage at 60 ℃ for 6 weeks, the substances involved increase significantly, and the therapeutic effect of acarbose is seriously affected with discoloration.
Patent CN104013590A discloses a pharmaceutical composition containing acarbose and a preparation method thereof, which protects an orally disintegrating tablet of acarbose, and the acarbose is mixed with microcrystalline cellulose, then mixed with a water-insoluble excipient and a disintegrant, subjected to wet granulation by ethanol, and prepared into granules, the disintegrant and a lubricant which are mixed and tabletted. The orally disintegrating tablet can be rapidly disintegrated in oral cavity, is easy to take, and avoids the defect of inconvenient taking of common tablets and capsules.
Patent CN101019874A discloses acarbose pharmaceutical composition and its preparation method, which comprises mixing acarbose and lubricant with flow-assisting effect, adding filler, adding lubricant, mixing, and tabletting. The method has the following disadvantages: acarbose is easy to absorb moisture and poor in flowability, the flowability of acarbose cannot be well improved even though a lubricant is added, the acarbose raw material is light, and after the acarbose raw material is directly mixed with auxiliary materials, tablets are pressed, so that the tablet weight difference is large, even unqualified phenomenon occurs, the powder spraying phenomenon occurs in the tabletting process, and the qualification of the tablet weight cannot be guaranteed.
Patent CN101336904B discloses an acarbose chewable tablet, which comprises the following specific components: acarbose: 5-30%, filler: 60-90% of lubricant: 0.1-10%, wetting agent: 0-10%, taste-modifying agent: 0 to 10 percent; wherein the filler is mannitol, sorbitol, mannitol and microcrystalline cellulose, sorbitol and microcrystalline cellulose, mannitol and sorbitol and microcrystalline cellulose; wherein the lubricant is one or more of the following: stearic acid, magnesium stearate, calcium stearate, zinc stearate, sodium dodecyl sulfate, magnesium dodecyl sulfate, polyethylene glycol, talcum powder or superfine silica powder. The invention emphasizes that the obstacle that acarbose is not easy to prepare into chewable tablets is overcome through the optimization of specific auxiliary materials, the defects that ordinary acarbose tablets are easy to absorb moisture and have sandy sense when being taken are overcome, the drug effect is ensured, and the compliance of patients in taking the tablets is greatly improved.
Therefore, the research and development of the invention focuses on selecting proper excipients to overcome the property defects of hard absorption and poor stability of the acarbose.
Disclosure of Invention
The technical problems to be solved by the invention are to overcome the defect that acarbose is easy to absorb moisture and harden, thereby solving the technical problems of slow disintegration and dissolution, obvious increase of related substances and poor stability of acarbose pharmaceutical preparations.
The invention provides an acarbose pharmaceutical preparation, which comprises acarbose, a diluent and a lubricant, wherein the diluent comprises calcium glycerophosphate, pregelatinized starch and a water-soluble diluent.
Through a plurality of experimental researches, the inventor finds that the diluent in the acarbose preparation is the combination of calcium glycerophosphate, pregelatinized starch and water-soluble diluent, can overcome the characteristic that acarbose is easy to absorb moisture, enables the process of acarbose in the preparation process of the preparation to be smooth, does not cause the hardening and caking phenomena of acarbose due to moisture absorption, and avoids the problems of disintegration and slow dissolution of the prepared acarbose preparation; meanwhile, the addition of the calcium glycerophosphate, the pregelatinized starch and the water-soluble diluent also ensures the stability of the quality of the preparation in the storage process, particularly has better stability in the long-term storage process, does not cause the phenomenon of obvious increase of related substances, ensures the stable quality of the acarbose medicinal preparation, and ensures that the acarbose medicinal preparation can exert better curative effect.
The water-soluble diluent is one or more of mannitol, lactose, sorbitol and sucrose.
The preferred diluent is a combination of calcium glycerophosphate, pregelatinized starch, and mannitol.
The above diluent also comprises one or more of microcrystalline cellulose, starch, calcium hydrogen phosphate, dextrin, and calcium phosphate.
The lubricant is one or more of magnesium stearate, stearic acid, calcium stearate, talcum powder and sodium stearyl fumarate.
The pharmaceutical preparation comprises the following components in percentage by mass:
Figure 188731DEST_PATH_IMAGE002
。
preferably, the dosage of the pharmaceutical preparation calculated by mass percent of each component is as follows:
Figure 792888DEST_PATH_IMAGE003
。
further preferably, the pharmaceutical preparation comprises the following components in percentage by mass:
Figure 78288DEST_PATH_IMAGE004
。
the invention also provides a preparation method of the acarbose medicinal preparation, which comprises the following steps:
a. uniformly mixing acarbose and a diluent to prepare mixed powder;
b. mixing the above mixed powder with lubricant, and dry granulating to obtain medicinal granule;
c. tabletting the obtained medicinal granule.
Preferably, the invention provides a preparation method of the acarbose medicinal preparation, which specifically comprises the following steps:
a. uniformly mixing acarbose and calcium glycerophosphate to prepare mixed powder;
b. mixing the obtained mixed powder with pregelatinized starch, water-soluble diluent and lubricant, and dry granulating to obtain medicinal granule;
c. tabletting the obtained medicinal granule.
Further preferably, the preparation method of the acarbose pharmaceutical preparation provided by the invention specifically comprises the following steps:
a. uniformly mixing acarbose and calcium glycerophosphate to prepare mixed powder;
b. mixing the above mixed powder with pregelatinized starch (added), water soluble diluent and lubricant (added), and dry granulating to obtain medicinal granule;
c. mixing the above obtained medicinal granules with pregelatinized starch (and lubricant (and) uniformly, and tabletting.
The acarbose medicinal preparation also contains one or more of adhesive, disintegrant and correctant.
The binder includes but is not limited to one or more of hydroxypropyl cellulose, hydroxypropyl methylcellulose, polyvinylpyrrolidone, polyvidone, and starch slurry. The disintegrant includes but is not limited to one or more of low-substituted hydroxypropyl cellulose, carboxymethyl cellulose, crospovidone, sodium carboxymethyl starch and croscarmellose sodium. Flavoring agents include, but are not limited to, sugars, sodium saccharin, calcium saccharin, cyclamate, stevioside, glycyrrhizin, cyclamate, sodium cyclamate, asparagine, dihydrochalcones, alcoholic sugars, aspartame, sucralose, acesulfame potassium, aspartame, and other sweeteners; one or more of aromatic agents such as orange essence and strawberry essence.
The acarbose medicinal preparation provided by the invention is added with the calcium glycerophosphate, the pregelatinized starch and the water-soluble diluent, so that the physicochemical property of acarbose that the acarbose absorbs moisture and becomes hard can be overcome, and the prepared preparation has good disintegration and dissolution and good smoothness of the preparation process. The calcium glycerophosphate, the pregelatinized starch and the water-soluble diluent are matched for use, so that the acarbose preparation still has good stability under the long-term storage condition; the invention can be prepared by adopting the conventional preparation process such as dry granulation, wet granulation and the like, and is more suitable for industrial production.
Detailed Description
Example 1
Figure 705578DEST_PATH_IMAGE005
The preparation method comprises the following steps:
a. uniformly mixing acarbose, calcium glycerophosphate, pregelatinized starch and mannitol to obtain mixed powder;
b. mixing the prepared mixed powder with magnesium stearate, and performing dry granulation to obtain medicine granules;
c. tabletting the obtained medicinal granule.
Example 2
Figure 213920DEST_PATH_IMAGE006
The preparation method comprises the following steps:
a. uniformly mixing acarbose and calcium glycerophosphate to prepare mixed powder;
b. mixing the obtained mixed powder with pregelatinized starch, sorbitol, calcium stearate and pulvis Talci, and dry granulating to obtain medicinal granule;
c. tabletting the obtained medicinal granule.
Example 3
Figure 360999DEST_PATH_IMAGE007
The preparation method comprises the following steps:
a. uniformly mixing acarbose and calcium glycerophosphate to prepare mixed powder;
b. mixing the above mixed powder with pregelatinized starch (added), lactose and sodium stearyl fumarate (added), and dry granulating to obtain medicinal granule;
c. mixing the above obtained medicinal granules with pregelatinized starch (additionally added) and pulvis Talci (additionally added), and tabletting.
Example 4
Figure 562173DEST_PATH_IMAGE008
The preparation method is the same as example 3.
Example 5
Figure 457185DEST_PATH_IMAGE009
The preparation method is the same as example 3.
Example 6
Figure 379005DEST_PATH_IMAGE010
The preparation method is the same as example 1.
Example 7
Figure 941442DEST_PATH_IMAGE011
The preparation method is the same as example 1.
Example 8
Figure 313518DEST_PATH_IMAGE012
The preparation method comprises the following steps:
a. uniformly mixing acarbose, calcium glycerophosphate, pregelatinized starch, mannitol and povidone to obtain mixed powder;
b. wet granulating the above mixed powder with ethanol to obtain medicinal granule;
c. mixing the above obtained medicinal granules with sodium carboxymethyl starch, stearic acid, and sodium stearyl fumarate, and tabletting.
Determination of disintegration time and dissolution
900ml of phosphate buffer solution with pH of 6.8 was used as a dissolution medium, and according to a dissolution and release determination method (0931 second method of the four general guidelines of the 2015 edition of Chinese pharmacopoeia), the rotation speed was 75 revolutions per minute, a chromatographic column using aminosilane-bonded silica gel as a filler, acetonitrile-phosphate buffer solution (600 mg of potassium dihydrogen phosphate, 700mg of disodium hydrogen phosphate, and 1000ml of water were added to dissolve) (65: 35) was used as a mobile phase, the detection wavelength was 210nm, the column temperature was 35 ℃, and the flow rate was 2.0ml per minute, and disintegration time limit (min) and dissolution (%) were determined for the prescription samples of examples 1-8 and the originally-ground commercial preparation of baitang apple. The results are shown in Table 1.
TABLE 1
Figure 197291DEST_PATH_IMAGE013
As can be seen from the above data, the disintegration time of the acarbose preparation prepared by the method of the present invention is 7-8 minutes; in dissolution data, the initial dissolution rate in 5 minutes reaches more than 40%, the accumulated dissolution rate in 15 minutes reaches more than 96%, the dissolution is completed in 60 minutes, and the disintegration time and the dissolution property are consistent with those of the original preparation, namely the benangsie.
Stability detection
Accelerated test
The tablets of examples 1 to 8 were continuously left for 6 months at 40. + -. 2 ℃ and RH 75. + -. 5% and the total content (%) of acarbose impurities was measured for 6 months over 0 day by HPLC, and the results are shown in Table 2.
TABLE 2
Figure 313015DEST_PATH_IMAGE014
As can be seen from the data in Table 2, the acarbose preparation prepared by the method of the present invention has good stability, and the total impurity content in the preparation is basically unchanged after 6 months of accelerated test. Has more excellent stability than the commercial byalurone.
Comparative examples
Figure 464379DEST_PATH_IMAGE015
Comparative examples 1 to 4 were prepared in the same manner as in example 1.
Determination of disintegration time and dissolution
900ml of phosphate buffer solution with pH6.8 is used as a dissolution medium, according to a dissolution and release determination method (0931 second method of the four general rules of the national pharmacopoeia 2015 edition), the rotation speed is 75 revolutions per minute, a chromatographic column using aminosilane bonded silica gel as a filler is adopted, acetonitrile-phosphate buffer solution (taking 600mg of potassium dihydrogen phosphate and 700mg of disodium hydrogen phosphate, adding 1000ml of water for dissolution) (65: 35) is used as a mobile phase, the detection wavelength is 210nm, the column temperature is 35 ℃, the flow rate is 2.0ml per minute, and the disintegration time limit (min) and the dissolution (%) of the formula of the comparative proportions 1-4 are determined. The results are shown in Table 3.
TABLE 3
Figure 7356DEST_PATH_IMAGE016
As is apparent from table 3, in comparative examples 1 to 4, calcium glycerophosphate, pregelatinized starch, and a water-soluble diluent were not added simultaneously as diluents, and the obtained acarbose preparation had a disintegration time of 11 minutes or more, an integrated dissolution data of less than 35% in 5 minutes, and an integrated dissolution data of less than 90% in 15 minutes, which had problems of disintegration and dissolution delay. Example 1 the formulation contained calcium glycerophosphate, pregelatinized starch and mannitol, and the prepared acarbose pharmaceutical formulation did not show delayed disintegration and dissolution, consistent with the original formulation of bgrasp.
Stability detection
Accelerated test
The tablets of comparative examples 1 to 4 were continuously left for 6 months at 40. + -. 2 ℃ and RH 75. + -. 5% and the total acarbose impurity content (%) was measured for 6 months over 0 day by HPLC, and the results are shown in Table 4.
TABLE 4
Figure 112846DEST_PATH_IMAGE017
As can be seen from Table 4, in comparative examples 1, 2 and 4, calcium glycerophosphate and pregelatinized starch were not added as diluents, and the related substances of the acarbose pharmaceutical preparations prepared by the accelerated test for 6 months were significantly increased. In comparative example 3, mannitol is not added, and although the stability is not greatly different from that of example 1, the data in table 3 shows that the dissolution rate and disintegration time are not consistent with those of the original formulation of benangtang, and the quality requirement is not met. Therefore, only when the diluent simultaneously adopts calcium glycerophosphate, pregelatinized starch and mannitol, the prepared acarbose medicinal preparation can meet the dissolution rate of the medicinal preparation and improve the stability of the medicinal preparation.

Claims (10)

1. An acarbose pharmaceutical formulation comprising acarbose, a diluent, and a lubricant, wherein the diluent comprises calcium glycerophosphate, pregelatinized starch, and a water-soluble diluent.
2. The acarbose pharmaceutical formulation according to claim 1, wherein the water soluble diluent is one or more of mannitol, lactose, sorbitol, sucrose.
3. The acarbose pharmaceutical formulation according to claim 1, wherein the lubricant is one or more of magnesium stearate, stearic acid, calcium stearate, talc, and sodium stearyl fumarate.
4. The acarbose pharmaceutical formulation according to claim 1, wherein the acarbose is present in the form of a solution or suspension,
Figure DEST_PATH_IMAGE001
。
5. the acarbose pharmaceutical formulation according to claim 1, wherein the acarbose is present in the form of a solution or suspension,
Figure 93106DEST_PATH_IMAGE002
。
6. the acarbose pharmaceutical formulation according to claim 1, wherein the acarbose is present in the form of a solution or suspension,
Figure DEST_PATH_IMAGE003
。
7. the acarbose pharmaceutical formulation according to claim 1, further comprising one or more of a binder, a disintegrant, and a flavoring agent.
8. A process for the preparation of the acarbose pharmaceutical formulation according to claim 1, comprising the steps of:
a. uniformly mixing acarbose and a diluent to prepare mixed powder;
b. mixing the above mixed powder with lubricant, and dry granulating to obtain medicinal granule;
c. tabletting the obtained medicinal granule.
9. A process for preparing the acarbose pharmaceutical formulation of claim 5, comprising the steps of:
a. uniformly mixing acarbose and calcium glycerophosphate to prepare mixed powder;
b. mixing the obtained mixed powder with pregelatinized starch, water-soluble diluent and lubricant, and dry granulating to obtain medicinal granule;
c. tabletting the obtained medicinal granule.
10. A process for the preparation of the acarbose pharmaceutical formulation according to claim 6, comprising the steps of:
a. uniformly mixing acarbose and calcium glycerophosphate to prepare mixed powder;
b. mixing the above mixed powder with pregelatinized starch (added), water soluble diluent and lubricant (added), and dry granulating to obtain medicinal granule;
c. mixing the above obtained medicinal granules with pregelatinized starch (and lubricant (and) uniformly, and tabletting.
CN201811207730.3A 2018-10-17 2018-10-17 Acarbose medicinal preparation Pending CN111053747A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116763752A (en) * 2023-08-24 2023-09-19 北京福元医药股份有限公司 Acarbose tablet and preparation method thereof

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102688252A (en) * 2012-06-12 2012-09-26 北京韩美药品有限公司 Acarbose oral solid preparation composition and preparation method thereof
CN105213341A (en) * 2015-10-29 2016-01-06 无锡福祈制药有限公司 A kind of acarbose tablet and preparation method thereof
CN106265702A (en) * 2016-08-16 2017-01-04 浙江得恩德制药有限公司 Acarbose medicine composition and preparation method thereof

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102688252A (en) * 2012-06-12 2012-09-26 北京韩美药品有限公司 Acarbose oral solid preparation composition and preparation method thereof
CN105213341A (en) * 2015-10-29 2016-01-06 无锡福祈制药有限公司 A kind of acarbose tablet and preparation method thereof
CN106265702A (en) * 2016-08-16 2017-01-04 浙江得恩德制药有限公司 Acarbose medicine composition and preparation method thereof

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116763752A (en) * 2023-08-24 2023-09-19 北京福元医药股份有限公司 Acarbose tablet and preparation method thereof
CN116763752B (en) * 2023-08-24 2023-11-17 北京福元医药股份有限公司 Acarbose tablet and preparation method thereof

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