CN114886866A - Gliclazide tablet (II) pharmaceutical composition and preparation method thereof - Google Patents

Gliclazide tablet (II) pharmaceutical composition and preparation method thereof Download PDF

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CN114886866A
CN114886866A CN202210367136.0A CN202210367136A CN114886866A CN 114886866 A CN114886866 A CN 114886866A CN 202210367136 A CN202210367136 A CN 202210367136A CN 114886866 A CN114886866 A CN 114886866A
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gliclazide
parts
tablet
carbomer
water repellent
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李莎莎
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Suzhou Chunghwa Chemical & Pharmaceutical Industrial 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
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/64—Sulfonylureas, e.g. glibenclamide, tolbutamide, chlorpropamide
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • A61K9/2036—Silicones; Polysiloxanes
    • 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
    • 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
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Health & Medical Sciences (AREA)
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  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
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  • General Chemical & Material Sciences (AREA)
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  • Organic Chemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The invention discloses a gliclazide tablet (II) pharmaceutical composition and a preparation method thereof, wherein the pharmaceutical composition comprises a hydrophobic agent coated gliclazide, lactose, carbomer, povidone and magnesium stearate; the preparation method comprises the following steps: s1, mixing the gliclazide and the water repellent in a high-shear mixer for a period of time, discharging, and sealing and storing at normal temperature for more than 12 hours to obtain the water repellent-coated gliclazide for later use; s2, mixing the gliclazide coated by the water repellent obtained in the step S1 with carbomer, lactose, povidone and magnesium stearate, and uniformly mixing; s3, further tabletting the total mixture obtained in the step S2 according to the standard tablet weight to obtain the tablet. According to the invention, gliclazide and dimethicone are subjected to high-shear mixing, and then the premixed material, carbomer, lactose, povidone and magnesium stearate are mixed and then tabletted, so that the prepared gliclazide tablet has better stability and dissolution.

Description

Gliclazide tablet (II) pharmaceutical composition and preparation method thereof
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to a gliclazide tablet (II) pharmaceutical composition and a preparation method thereof.
Background
Gliclazide belongs to the second generation of sulfonylurea oral hypoglycemic agents, which promotes Ca through direct action on pancreas 2+ Transport to beta cells, thereby stimulating insulin secretion and simultaneously increasing peripheral tissue glucoseGlucose metabolism, and ultimately, blood sugar. The oral preparation is mainly characterized by fast oral absorption, blood sugar reducing activity which is tens to hundreds times higher than that of the first generation, low incidence rate of hypoglycemia, granulocytopenia and cardiovascular adverse reactions, dual functions of reducing blood sugar and improving blood coagulation, and capability of improving metabolism of diabetics and improving or delaying the occurrence of diabetic vascular complications, is widely applied to clinic at home and abroad, and becomes one of the most common medicines for treating type II diabetes at present.
The chemical name of gliclazide is 1- (3-azabicyclo [3,3,0 ]]Octyl) -3-p-toluenesulfonylurea, a second generation antidiabetic drug of sulfonylurea, molecular formula C 15 H 21 N 3 O 3 S, relative molecular mass 323.41, is white crystal or crystalline powder, insoluble in water and slightly soluble in ethanol.
The original preparation of the gliclazide tablet is developed by a Les laboratories server, has a trade name of damekang, and comprises a gliclazide ordinary tablet, a gliclazide tablet (II) and a gliclazide sustained-release tablet. The gliclazide common tablet has the defects of over-quick response, easy occurrence of hypoglycemia, frequent administration for patients, inconvenient administration, easy occurrence of missed administration, large blood concentration fluctuation and the like. Based on the current situation that diabetes needs to be taken for a long time, the sustained-release preparation which is taken once a day is prepared, so that the compliance of patients is greatly improved. However, at present, the sustained-release matrix material is mostly adopted in the gliclazide sustained-release tablets sold in the market, and although the defects of the common tablets are overcome, the matrix type sustained-release tablets still have the problems of nonuniform drug release, easy occurrence of burst release or incomplete drug release. The gliclazide tablet (II) has the function of a controlled release preparation in a certain sense and can release more slowly. However, the gliclazide tablet (II) developed by Les laboratories Server releases extremely smoothly from the view point of the dissolution curve, and in addition, the relevant substances of the preparation grow faster during the influencing period, and the acceleration test is even extremely close to the limit.
Disclosure of Invention
Aiming at the defects in the prior art, the invention provides a gliclazide tablet (II) pharmaceutical composition and a preparation method thereof.
The technical scheme of the invention is as follows:
a gliclazide tablet (II) pharmaceutical composition comprises gliclazide coated by a water repellent, lactose, carbomer, povidone and magnesium stearate.
Preferably, the water repellent is dimethicone.
Preferably, the raw materials are used in the following weight portions: 80 parts of gliclazide, 10-30 parts of a water repellent, 20-60 parts of lactose, 5-25 parts of carbomer, 3-7 parts of povidone and 1-2 parts of magnesium stearate.
Preferably, the raw materials are used in the following weight portions: 80 parts of gliclazide, 20-30 parts of water repellent, 24-39 parts of lactose, 15-20 parts of carbomer, 5 parts of povidone and 1 part of magnesium stearate.
Preferably, the raw materials are used in the following weight portions: 80 parts of gliclazide, 20 parts of water repellent, 39 parts of lactose, 15 parts of carbomer, 5 parts of povidone and 1 part of magnesium stearate.
Preferably, the weight ratio of the water repellent to the carbomer is 4:1 to 5.
Preferably, the weight ratio of the hydrophobe to carbomer is 4: 3.
A preparation method of a gliclazide tablet (II) pharmaceutical composition comprises the following steps:
s1, mixing the gliclazide and the water repellent in a high-shear mixer for a period of time, discharging, and sealing and storing at normal temperature for more than 12 hours to obtain the water repellent-coated gliclazide for later use;
s2, finally mixing the gliclazide coated by the water repellent obtained in the step S1 with carbomer, lactose, povidone and magnesium stearate, and uniformly mixing;
s3, further tabletting the total mixture obtained in the step S2 according to the standard tablet weight to obtain the tablet.
Preferably, the mixing speed in the step S1 is 15000rpm, and the mixing time is 20 min; the mixing speed in the step S2 was 12rpm, and the mixing time was 5 min.
The invention has the beneficial effects that:
in general, the gliclazide tablet (II) is hydrolyzed at high temperature to generate impurities which affect the quality and safety of products, in order to reduce the generation of the impurities, not only the external moisture entry needs to be cut off, but also the influence of moisture carried by other auxiliary materials in the tablet on raw materials needs to be cut off, the invention uses the hydrophobicity of a water repellent such as dimethicone as a stabilizer to wrap the gliclazide raw materials, but the hydrophobic agent can block the dissolution of the tablet, carbomer has certain wetting function, the wetting of the tablet can be promoted, but the carbomer is insoluble in water, and three-position cross-linked microgel is formed in the water to control the release of the medicine; the preparation method is simple and convenient, and the gliclazide raw material is pretreated by the dimeticone, then is mixed with other auxiliary materials and is tabletted, so that the influence on the properties of the gliclazide raw material is small.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail with reference to the following embodiments. It is to be understood that these descriptions are only illustrative and are not intended to limit the scope of the present invention. Moreover, in the following description, descriptions of well-known structures and techniques are omitted so as to not unnecessarily obscure the concepts of the present invention.
Example 1
Each gliclazide tablet (II) comprises the following components: 80mg of gliclazide, 20mg of dimethicone, 39mg of lactose, 15mg of carbomer, 5mg of povidone and 1mg of magnesium stearate.
The preparation method comprises the following steps:
s1, mixing the gliclazide and the dimeticone in a high-shear mixer for 20min, discharging, wherein the mixing speed is 15000rpm, and then sealing and storing at normal temperature for more than 12h to obtain the water repellent coated gliclazide for later use;
s2, mixing the gliclazide coated by the water repellent obtained in the step S1 with carbomer, lactose, povidone and magnesium stearate, and uniformly mixing at the mixing speed of 12rpm for 5 min;
s3, further tabletting the total mixture obtained in the step S2 according to the standard tablet weight, and obtaining the tablet by a tabletting machine with the rotating speed of 20-30 rpm.
Example 2
Each gliclazide tablet (II) comprises the following components: 80mg of gliclazide, 30mg of dimethicone, 24mg of lactose, 15mg of carbomer, 5mg of povidone and 1mg of magnesium stearate.
The preparation method is the same as example 1.
Example 3
Each gliclazide tablet (II) comprises the following components: 80mg of gliclazide, 20mg of dimethicone, 34mg of lactose, 20mg of carbomer, 5mg of povidone and 1mg of magnesium stearate.
The preparation method is the same as example 1.
Comparative example 1
Each gliclazide tablet (II) comprises the following components: 80mg of gliclazide, 59mg of lactose, 15mg of carbomer, 5mg of povidone and 1mg of magnesium stearate.
The preparation method comprises the following steps:
a1, preparing povidone solution as adhesive with 50% ethanol as solvent;
a2, carrying out wet granulation on the gliclazide, the carbomer and the lactose by using the adhesive prepared in the step A1, wherein the stirring speed is 300 +/-20 rpm, the rotating speed of a cutting knife is 1200 +/-200 rpm, the wet granulation time is 3min, and the gliclazide, the carbomer and the lactose are sieved by a 20-mesh sieve;
a3, drying the product prepared in the step A1 below 40 ℃ in a fluidized bed until the drying weight loss is lower than 2.0%, discharging and sieving by a 24-mesh sieve;
a4, adding magnesium stearate, mixing at 12rpm for 5min, and mixing;
a5, further tabletting the total mixture obtained in the step A4 according to the standard tablet weight, and obtaining the tablet by a tabletting machine with the rotating speed of 20-30 rpm.
Comparative example 2
Each gliclazide tablet (II) comprises the following components: 80mg of gliclazide, 58mg of lactose, 15mg of carbomer, 5mg of povidone and 2mg of magnesium stearate.
The preparation method comprises the following steps:
b1, premixing the gliclazide raw material with lactose, carbomer, povidone and 50% of formula amount of magnesium stearate for 3min, and then performing dry granulation, wherein the process parameters are as follows: the oil pressure is 30-50bar, the rotating speed of the crusher is 90-150rpm, the rotating speed of the granulator is 150-200rpm, and the material pushing speed is 40-100rpm, wherein the grain of more than 24 meshes is not less than 25%;
b2, adding the rest magnesium stearate into the dry-process granules obtained in the step 1, mixing and uniformly mixing, wherein the mixing rotating speed is 12rpm, and the mixing time is 5 min;
b3, further tabletting the total mixture obtained in the step B2 according to the standard tablet weight, and obtaining the tablet by a tabletting machine at the rotating speed of 20-30 rpm; comparative example 3
Each gliclazide tablet (II) comprises the following components: 80mg of gliclazide, 20mg of dimethicone, 54mg of lactose, 5mg of povidone and 1mg of magnesium stearate.
The preparation method comprises the following steps:
c1, mixing the gliclazide raw material and the dimeticone in a high-shear mixer for 20min, discharging, wherein the mixing speed is 15000rpm, and sealing and storing at normal temperature for more than 12 h;
c2, adding lactose, povidone and magnesium stearate into the mixture obtained in the step C1, mixing uniformly, wherein the mixing speed is 12rpm, and the mixing time is 5 min;
c3, further tabletting the total mixture obtained in the step C2 according to the standard tablet weight, and obtaining the tablet by a tabletting machine with the rotating speed of 20-30 rpm.
The products prepared in examples 1-3 and comparative examples 1-3 were tested with damimekang, and the dissolution results of the medium (30% ethanol phosphate buffer) at pH8.6 are shown in Table 1:
TABLE 1
Figure BDA0003586331210000041
Accelerated stability tests were conducted on the products obtained in examples 1 to 3 and comparative examples 1 to 3 and on Damicang at 40 ℃ and 75% RH, respectively, to determine the substances, and the results are shown in Table 2:
TABLE 2
Figure BDA0003586331210000042
Figure BDA0003586331210000051
From the experimental results, the gliclazide tablet prepared by the preparation method of the invention has better stability and better dissolution, especially the product prepared by the embodiment 1 has a slow release curve similar to that of damimekang, and related substances do not obviously increase in the period of influencing factors and do not obviously increase under an acceleration condition. According to the invention, the gliclazide raw material is subjected to high-shear mixing by utilizing the dimeticone, so that the gliclazide raw material has good uniformity and effectively wraps the raw material, the stability of the gliclazide raw material is ensured, the growth of related substances is controlled, and the carbomer is added, so that the dissolution of the hydrophobic mixture can be promoted, the release rate can be controlled, and the slow release effect can be achieved.
It is to be understood that the above-described embodiments of the present invention are merely illustrative of or explaining the principles of the invention and are not to be construed as limiting the invention. Therefore, any modification, equivalent replacement, improvement and the like made without departing from the spirit and scope of the present invention should be included in the protection scope of the present invention. Further, it is intended that the appended claims cover all such variations and modifications as fall within the scope and boundaries of the appended claims or the equivalents of such scope and boundaries.

Claims (9)

1. A gliclazide tablet (II) pharmaceutical composition is characterized by comprising gliclazide coated by a water repellent, lactose, carbomer, povidone and magnesium stearate.
2. The gliclazide tablet (II) pharmaceutical composition as claimed in claim 1, wherein the water repellent is simethicone.
3. The gliclazide tablet (II) pharmaceutical composition as claimed in claim 2, wherein the dosage of each raw material is as follows in parts by weight: 80 parts of gliclazide, 10-30 parts of water repellent, 20-60 parts of lactose, 5-25 parts of carbomer, 3-7 parts of povidone and 1-2 parts of magnesium stearate.
4. The gliclazide tablet (II) pharmaceutical composition as claimed in claim 3, wherein the dosage of each raw material is as follows in parts by weight: 80 parts of gliclazide, 20-30 parts of water repellent, 24-39 parts of lactose, 15-20 parts of carbomer, 5 parts of povidone and 1 part of magnesium stearate.
5. The gliclazide tablet (II) pharmaceutical composition as claimed in claim 4, wherein the dosage of each raw material is as follows in parts by weight: 80 parts of gliclazide, 20 parts of water repellent, 39 parts of lactose, 15 parts of carbomer, 5 parts of povidone and 1 part of magnesium stearate.
6. The gliclazide tablet (II) pharmaceutical composition as claimed in claim 3, wherein the weight ratio of the water repellent to the carbomer is 4: 1-5.
7. The gliclazide tablet (II) pharmaceutical composition of claim 6, wherein the weight ratio of the hydrophobic agent to the carbomer is 4: 3.
8. The preparation method of the gliclazide tablet (II) pharmaceutical composition is characterized by comprising the following steps:
s1, mixing the gliclazide and the water repellent in a high-shear mixer for a period of time, discharging, and sealing and storing at normal temperature for more than 12 hours to obtain the water repellent-coated gliclazide for later use;
s2, mixing the gliclazide coated by the water repellent obtained in the step S1 with carbomer, lactose, povidone and magnesium stearate, and uniformly mixing;
s3, further tabletting the total mixture obtained in the step S2 according to the standard tablet weight to obtain the tablet.
9. The preparation method of a gliclazide tablet (ii) pharmaceutical composition as claimed in claim 8, wherein the mixing speed in step S1 is 15000rpm, and the mixing time is 20 min; the mixing speed in the step S2 was 12rpm, and the mixing time was 5 min.
CN202210367136.0A 2022-04-08 2022-04-08 Gliclazide tablet (II) pharmaceutical composition and preparation method thereof Pending CN114886866A (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030113371A1 (en) * 2001-08-21 2003-06-19 Council Of Scientific & Industrial Research Composition and method for maintaining blood glucose level by employing the hydrophilic matrix based oral controlled release antidiabetic composition
WO2007003972A1 (en) * 2005-06-30 2007-01-11 Pharmathen S.A. Improved pharmaceutical composition containing ace inhibitor and method for the preparation thereof
CN102440972A (en) * 2011-09-16 2012-05-09 浙江众益药业有限公司 Gliclazide tablet (II) and preparation method thereof

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030113371A1 (en) * 2001-08-21 2003-06-19 Council Of Scientific & Industrial Research Composition and method for maintaining blood glucose level by employing the hydrophilic matrix based oral controlled release antidiabetic composition
WO2007003972A1 (en) * 2005-06-30 2007-01-11 Pharmathen S.A. Improved pharmaceutical composition containing ace inhibitor and method for the preparation thereof
CN102440972A (en) * 2011-09-16 2012-05-09 浙江众益药业有限公司 Gliclazide tablet (II) and preparation method thereof

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
唐秀秀: "格列齐特缓释片体外释放度及其杂质研究", 《中国优秀硕士学位论文全文数据库 医药卫生科技辑》, pages 079 - 130 *
杨明: "《中药药剂学》", 中国中医药出版社, pages: 373 *
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