CN110101674A - A kind of preparation method of betamethasone piece - Google Patents

A kind of preparation method of betamethasone piece Download PDF

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Publication number
CN110101674A
CN110101674A CN201910374000.0A CN201910374000A CN110101674A CN 110101674 A CN110101674 A CN 110101674A CN 201910374000 A CN201910374000 A CN 201910374000A CN 110101674 A CN110101674 A CN 110101674A
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CN
China
Prior art keywords
betamethasone
piece
parts
preparation
added
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201910374000.0A
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Chinese (zh)
Inventor
徐三能
强泽明
陈永恒
陈宝乾
张强
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Anhui Jintaiyang Biochemical Medicine Co Ltd
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Anhui Jintaiyang Biochemical Medicine Co Ltd
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Publication date
Application filed by Anhui Jintaiyang Biochemical Medicine Co Ltd filed Critical Anhui Jintaiyang Biochemical Medicine Co Ltd
Priority to CN201910374000.0A priority Critical patent/CN110101674A/en
Publication of CN110101674A publication Critical patent/CN110101674A/en
Pending legal-status Critical Current

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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
    • A61K31/56—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
    • 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
    • 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
    • A61K9/2027—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
    • A61K9/205—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
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • 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
    • 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

Abstract

The present invention provides a kind of preparation method of betamethasone piece, its contained component of the betamethasone piece includes betamethasone, cornstarch, sucrose, carboxyrnethyl starch sodium, lauryl sodium sulfate, magnesium stearate, the PVP K30 of dose therapeutically effective.Using slurrying, mixing, granulation, drying, tablet forming technique.The unilateral glossiness of betamethasone piece tabletting provided by the invention is good, and hardness is high, meets process goal；Lauryl sodium sulfate is added, under the premise of not changing its chemical structure and pharmacological action, hence it is evident that the water solubility of the betamethasone piece improved solves that dissolution rate is slow, the low problem of bioavilability.

Description

A kind of preparation method of betamethasone piece
Technical field
The invention belongs to field of medicaments, and in particular to the preparation method of betamethasone piece.
Background technique
Betamethasone piece is a kind of corticoid drug, has anti-inflammatory, antiallergy, antiendotoxin and inhibits immune etc. more Kind pharmacological action, clinical application is extensive, and effect is identical as dexamethasone, but anti-inflammatory effect is equal compared with dexamethasone, triamcinolone etc. By force, fever, rubescent and swelling caused by local non-infectious inflammation are eliminated in the reaction that can mitigate and prevent tissue to inflammation, To mitigate the performance of inflammation.Now it is chiefly used in activity rheumatism, rheumatoid arthritis, lupus erythematosus, serious bronchus to roar Asthma, serious dermatitis, acute leukemia etc., are also used for the complex treatment of certain infection.Existing betamethasone piece there are cost compared with The problems such as height, loose pieces is unilateral rough, and hardness is not high.
Summary of the invention
The object of the invention is to remedy the disadvantages of known techniques, provides a kind of preparation method of betamethasone piece.
The present invention is achieved by the following technical solutions:
The preparation method of betamethasone piece, it is characterised in that be prepared by the raw material of following parts by weight: betamethasone 0.4 ~0.6 part, 65~75 parts of cornstarch, 28~33 parts of sucrose, 7~10 parts of carboxyrnethyl starch sodium, 1~4 part of lauryl sodium sulfate, 0.5~1.5 part of magnesium stearate, 0.3~0.7 part of PVP K30；
Such as the preparation method of above-mentioned betamethasone piece, comprising the following steps:
(1) it crushes, be pre-mixed: two-dimensional mixing machine mixing 10- is added in betamethasone, carboxyrnethyl starch sodium by prescription ratio 20min adds cornstarch, sucrose mixing 15-30min, finally crushes to obtain 100 mesh powder；
(2) slurrying: PVP K30 is added in purified water, and slurry is made in stirring；
(3) step (1) material after premixing is added in trough type mixing machine, it is 5-10 minutes dry-mixed, step (2) are added and match The slurry of system stirs 5-10 minutes, then with 16 mesh stainless steel mesh wet granulations；
(4) the wet granular fluidized drying that will first make, control drying temperature are 75~85 DEG C, are then sieved with 20 mesh stainless steels Net whole grain；
(5) particle made from lauryl sodium sulfate and magnesium stearate and step (4) is added in two-dimensional motion mixer Mixing 30-60 minutes, obtains betamethasone piece single-size；Tabletting；Packaging.
The preparation method of the betamethasone piece, it is characterised in that be prepared by the raw material of following parts by weight: times he Rice loose 0.5 part, 71 parts of cornstarch, 31.5 parts of sucrose, 8.5 parts of carboxyrnethyl starch sodium, 2 parts of lauryl sodium sulfate, magnesium stearate 1 Part, 0.5 part of PVP K30.
The weight of PVP K30 slurry is the 10-25% of weight of material after premixing.
The wet granular fluidized drying time is 30-90 minutes.
The invention has the advantages that
Betamethasone piece provided by the invention, joined larger amount of cornstarch since bulk pharmaceutical chemicals are less, in formula is Filler, but cornstarch is without viscosity, it is scattered, after additive amount increase, it is difficult to tabletting, the problems such as there are discrete piece loose pieces.But It is that cornstarch safety is good, price is low.After the application mixes bulk pharmaceutical chemicals and sucrose, cornstarch etc., crushed, a side Face improves the distributing homogeneity of bulk pharmaceutical chemicals, on the other hand changes the property of cornstarch, increases cornstarch surface Bonding force takes PVP K30 for after adhesive slurrying, granulation, the unilateral glossiness of tabletting is good, and hardness is high, meets technique mesh Mark；Lauryl sodium sulfate is added, under the premise of not changing its chemical structure and pharmacological action, hence it is evident that improve betamethasone The water solubility of piece, solves that dissolution rate is slow, the low problem of bioavilability.
Specific embodiment
A kind of preparation method of betamethasone piece, comprising the following steps:
A kind of betamethasone piece, to prepare in terms of betamethasone piece 100,000, the raw material components of the betamethasone piece are times for he Rice pine 0.05kg, cornstarch 7.1kg, sucrose 3.15kg, carboxyrnethyl starch sodium 0.85kg, lauryl sodium sulfate 0.2kg, tristearin Sour magnesium 0.1kg, PVP K30 0.05kg.
(1) it crushes, be pre-mixed: two dimension mixing is added in betamethasone 0.05kg, carboxyrnethyl starch sodium 0.85kg by prescription ratio Machine mixing 10-20min adds cornstarch 7.1kg, sucrose 3.15kg mixing 15-30min, finally crushes to obtain 100 mesh powder End；
(2) slurrying: 0.05kg PVP K30 is added in 1.65kg purified water, and the slurry of concentration 3% is made in stirring；
(3) step (1) material after premixing is added in trough type mixing machine, it is 5-10 minutes dry-mixed, step (2) are added and match The slurry of system stirs 5-10 minutes, then with 16 mesh stainless steel mesh wet granulations；
(4) will the wet granular that made put into boiling drier in, set blower frequency 35Hz, control drying temperature be 75~ It is 85 DEG C, 20 minutes dry, then with 20 mesh stainless steel mesh whole grains；
(5) two maintenance and operations are added in particle made from 0.2kg lauryl sodium sulfate and 0.1kg magnesium stearate and step (4) It is mixed 60 minutes in dynamic mixing machine, obtains betamethasone piece single-size；φ 6.5mm shallow concave punch tabletting；Packaging.
Dissolution rate, friability, uniformity of dosage units and the content for detecting the betamethasone piece of embodiment, as a result see the table below.
Detection project Dissolution rate (%) Friability (%) Uniformity of dosage units Content (%)
Testing result 95,90,92,88,92,85 0.2 6.3 97.0

Claims (4)

1. the preparation method of betamethasone piece, it is characterised in that be prepared by the raw material of following parts by weight: betamethasone 0.4 ~ 0.6 part, 65 ~ 75 parts of cornstarch, 28 ~ 33 parts of sucrose, 7 ~ 10 parts of carboxyrnethyl starch sodium, 1 ~ 4 part of lauryl sodium sulfate, stearic acid 0.5 ~ 1.5 part of magnesium, 0.3 ~ 0.7 part of PVP K30；
Such as the preparation method of above-mentioned betamethasone piece, comprising the following steps:
(1) it crushes, be pre-mixed: two-dimensional mixing machine mixing 10-20min is added in betamethasone, carboxyrnethyl starch sodium by prescription ratio, then Cornstarch, sucrose mixing 15-30min is added, finally crushes to obtain 100 mesh powder；
(2) slurrying: PVP K30 is added in purified water, and slurry is made in stirring；
(3) step (1) material after premixing is added in trough type mixing machine, it is 5-10 minutes dry-mixed, step (2) preparation is added Slurry stirring 5-10 minutes, then with 16 mesh stainless steel mesh wet granulations；
(4) the wet granular fluidized drying that will first make, control drying temperature is 75 ~ 85 DEG C, then whole with 20 mesh stainless steel mesh Grain；
(5) lauryl sodium sulfate and magnesium stearate are added in two-dimensional motion mixer with particle made from step (4) and are mixed 30-60 minutes, obtain betamethasone piece single-size；Tabletting；Packaging.
2. the preparation method of betamethasone piece as described in claim 1, it is characterised in that prepared by the raw material of following parts by weight Form: 0.5 part of betamethasone, 71 parts of cornstarch, 31.5 parts of sucrose, 8.5 parts of carboxyrnethyl starch sodium, 2 parts of lauryl sodium sulfate, 1 part of magnesium stearate, 0.5 part of PVP K30.
3. the preparation method of betamethasone piece as described in claim 1, it is characterised in that the weight of PVP K30 slurry is premix The 10-25% of weight of material after conjunction.
4. the preparation method of betamethasone piece as described in claim 1, it is characterised in that the wet granular fluidized drying time is 30- 90 minutes.
CN201910374000.0A 2019-05-07 2019-05-07 A kind of preparation method of betamethasone piece Pending CN110101674A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201910374000.0A CN110101674A (en) 2019-05-07 2019-05-07 A kind of preparation method of betamethasone piece

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Application Number Priority Date Filing Date Title
CN201910374000.0A CN110101674A (en) 2019-05-07 2019-05-07 A kind of preparation method of betamethasone piece

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5897878A (en) * 1991-12-06 1999-04-27 Alza Corporation Method for administering steroid
CN1593429A (en) * 2004-07-14 2005-03-16 李�杰 Novel oral guacetisal solid preparation and its preparing method
CN1942193A (en) * 2004-04-22 2007-04-04 杜奥科特公司 Pharmaceutical compositions for acute glucocorticoid therapy
CN101190227A (en) * 2006-11-29 2008-06-04 天津市润拓生物技术有限公司 Betamethasone chewable tablets for dog or cat
CN101332194A (en) * 2007-06-28 2008-12-31 上海华氏制药有限公司 Compound atenolol tablet and preparation method thereof
CN104274475A (en) * 2013-07-11 2015-01-14 青岛康地恩药业股份有限公司 Gentamicin sulfate and betamethasone valerate containing compound tablet for treating skin infection of dogs

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5897878A (en) * 1991-12-06 1999-04-27 Alza Corporation Method for administering steroid
CN1942193A (en) * 2004-04-22 2007-04-04 杜奥科特公司 Pharmaceutical compositions for acute glucocorticoid therapy
CN1593429A (en) * 2004-07-14 2005-03-16 李�杰 Novel oral guacetisal solid preparation and its preparing method
CN101190227A (en) * 2006-11-29 2008-06-04 天津市润拓生物技术有限公司 Betamethasone chewable tablets for dog or cat
CN101332194A (en) * 2007-06-28 2008-12-31 上海华氏制药有限公司 Compound atenolol tablet and preparation method thereof
CN104274475A (en) * 2013-07-11 2015-01-14 青岛康地恩药业股份有限公司 Gentamicin sulfate and betamethasone valerate containing compound tablet for treating skin infection of dogs

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
D. RAVI KUMAR ET AL.: "Estimation of Betamethasone in Pharmaceutical Dosage Forms by Visible Spectrophotometry", 《ASIAN JOURNAL OF CHEMISTRY》 *
杨明等: "《药剂学》", 31 August 2014, 中国医药科技出版社 *
潘卫三: "《工业药剂学》", 31 August 2015, 中国医药科技出版社 *

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Application publication date: 20190809