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CN109512796A - Method for filling paracetamol capsules - Google Patents

Method for filling paracetamol capsules Download PDF

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Publication number
CN109512796A
CN109512796A CN201811597065.3A CN201811597065A CN109512796A CN 109512796 A CN109512796 A CN 109512796A CN 201811597065 A CN201811597065 A CN 201811597065A CN 109512796 A CN109512796 A CN 109512796A
Authority
CN
China
Prior art keywords
parts
weight
oxycodone
oxycodone hydrochloride
paracetamol
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
CN201811597065.3A
Other languages
Chinese (zh)
Inventor
张彩霞
宋月红
宋敏平
陈耀武
刘杰
倪继鹏
张光亮
董福天
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.)
Gansu Pu Pharmaceutical Ltd By Share Ltd
Original Assignee
Gansu Pu Pharmaceutical Ltd By Share Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Gansu Pu Pharmaceutical Ltd By Share Ltd filed Critical Gansu Pu Pharmaceutical Ltd By Share Ltd
Priority to CN201811597065.3A priority Critical patent/CN109512796A/en
Publication of CN109512796A publication Critical patent/CN109512796A/en
Pending legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/485Morphinan derivatives, e.g. morphine, codeine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4833Encapsulating processes; Filling of capsules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4858Organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

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  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Pain & Pain Management (AREA)
  • Emergency Medicine (AREA)
  • Rheumatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention discloses a method for filling an aminophenol oxycodone capsule, which comprises the steps of crushing a raw material acetaminophen medicament and screening the crushed raw material medicament through a screen; weighing 250-750 parts by weight of smashed and sieved acetaminophen, and adding the acetaminophen into a wet mixing granulator; weighing 2.5-7.5 parts of oxycodone hydrochloride, and adding 12.5-75 parts of purified water to completely dissolve the oxycodone hydrochloride; uniformly spraying an oxycodone hydrochloride aqueous solution into acetaminophen, adding 5-20 parts by weight of a flow aid and 25-75 parts by weight of a disintegrating agent into a wet mixing granulator, and fully and uniformly mixing the mixture with the materials and then discharging; drying; adding 5-20 mg of lubricant in parts by weight, and uniformly mixing; putting the obtained material into a full-automatic hard capsule filling machine to fill capsules. The problem of uneven mixing of oxycodone hydrochloride is solved by adding an appropriate amount of water to dissolve the oxycodone hydrochloride and spraying the oxycodone hydrochloride into other materials. The auxiliary materials used in the filling method can be uniformly mixed in the mixing process due to the characteristics of the materials.

Description

A kind of ammonia phenol oxycodone capsules fill method
Technical field:
The invention belongs to technical field of medicine preparation, more particularly, to a kind of ammonia phenol oxycodone capsules fill method.
Background technique:
Ammonia phenol oxycodone capsules, indication be caused by a variety of causes, severe it is anxious, chronic ache.A small amount of systems When standby, generally filled by hand using hard capsule dispenser.When mass production, semi-automatic or fully-automatic capsule filler is commonly used at present and is filled out It fills.The capsule material of the above fill method production is uniform, content and weight aspect are less than normal without consistency, especially loading amount, Loading amount shakiness phenomenon, not only influences production efficiency, also brings hidden danger to the product produced.
Summary of the invention:
The technical problems to be solved by the present invention are: provide it is a kind of can make the material of every capsule is uniform, content is consistent, The consistent ammonia phenol oxycodone capsules fill method of weight.
In order to solve the above-mentioned technical problem, the present invention is achieved by the following technical solutions: a kind of ammonia phenol Oxycodone glue Capsule fill method, includes the following steps,
S1, the sieve that paracetamol bulk pharmaceutical chemicals crushed to 20~80 mesh numbers;
S2, weigh in parts by weight 250~750 parts pulverize and sieve after paracetamol, be added wet-mixing Granulator;
S3, the oxycodone hydrochloride for weighing 2.5~7.5 parts in parts by weight, and 12.5~75 parts are added in parts by weight Purified water makes it completely dissolved;
S4, oxycodone hydrochloride aqueous solution is uniformly sprayed in paracetamol, then in parts by weight by 5~20 parts Wet mixing pelletizer is added in glidant and 25~75 portions of disintegrating agents, discharging after being sufficiently mixed uniformly with above-mentioned material;
S5, it is then dried in micro-wave vacuum equipment;
S6, the sieve that material drying is crossed to 20~80 mesh numbers again, are then added the profit of 5~20mg in parts by weight Lubrication prescription is uniformly mixed;
S7, resulting material is put into automatic hard capsule filler and fills capsule.
Preferably, the drying temperature in step S5 is 30 DEG C~60 DEG C.
Preferably, lubricant described in step S6 is magnesium stearate or talcum powder.
Preferably, the drying time in step S5 is 15~60min.
Compared with prior art, usefulness of the present invention is: since oxycodone hydrochloride dosage is smaller in prescription, tentatively Test discovery directly mixes paracetamol and oxycodone hydrochloride, and since the two ratio differs greatly, oxycodone hydrochloride is difficult To be uniformly mixed, uniformity of dosage units is caused to differ greatly, since oxycodone hydrochloride is soluble easily in water, so determining oxycodone hydrochloride The method in unclassified stores is sprayed on after suitable water dissolution is added to solve the problems, such as that oxycodone hydrochloride mixing is non-uniform.Filling side Auxiliary material used in method can be mixed uniformly in mixed process due to its substance self character.
Specific embodiment:
The present invention will be described in detail With reference to embodiment:
Embodiment one:
A kind of ammonia phenol oxycodone capsules fill method, includes the following steps, paracetamol bulk pharmaceutical chemicals crushed 30 The sieve of mesh number;Weigh in parts by weight 350mg parts pulverize and sieve after paracetamol, be added wet-mixing granulation Machine;The oxycodone hydrochloride of 3.7mg is weighed in parts by weight, and the purified water that 24mg is added in parts by weight makes it completely dissolved;, Oxycodone hydrochloride aqueous solution is uniformly sprayed in paracetamol, then in parts by weight by the glidant of 8mg and 45mg parts Wet mixing pelletizer is added in disintegrating agent, discharging after being sufficiently mixed uniformly with above-mentioned material;Then in micro-wave vacuum equipment In dried, drying time 28min, drying temperature be 42 DEG C;The sieve that material drying is crossed to 30 mesh numbers again, is then pressed The lubricant of 10mg is added in parts by weight, and the lubricant is magnesium stearate, is then uniformly mixed;Resulting material is put into Capsule is filled in automatic hard capsule filler.This method can make that the material of every capsule is uniform, content is consistent, weight one It causes.
Embodiment two:
A kind of ammonia phenol oxycodone capsules fill method, includes the following steps, paracetamol bulk pharmaceutical chemicals crushed 30 The sieve of mesh number;Weigh in parts by weight 420mg parts pulverize and sieve after paracetamol, be added wet-mixing granulation Machine;The oxycodone hydrochloride of 4.4mg is weighed in parts by weight, and the purified water that 28mg is added in parts by weight makes it completely dissolved;, Oxycodone hydrochloride aqueous solution is uniformly sprayed in paracetamol, then in parts by weight by the glidant of 9mg and 54mg parts Wet mixing pelletizer is added in disintegrating agent, discharging after being sufficiently mixed uniformly with above-mentioned material;Then in micro-wave vacuum equipment In dried, drying time 35min, drying temperature be 45 DEG C;The sieve that material drying is crossed to 30 mesh numbers again, is then pressed The lubricant of 15mg is added in parts by weight, and the lubricant is magnesium stearate, is then uniformly mixed;Resulting material is put into Capsule is filled in automatic hard capsule filler.This method can make that the material of every capsule is uniform, content is consistent, weight one It causes.
It is emphasized that: it is obvious to a person skilled in the art that the present invention is not limited to the above exemplary embodiments Details can realize this in other specific forms and without departing from the spirit or essential characteristics of the present invention Invention.Therefore, in all respects, the present embodiments are to be considered as illustrative and not restrictive, the present invention Range be indicated by the appended claims rather than the foregoing description, it is intended that the meaning that the equivalent requirements of the claims will be fallen in It is included within the present invention with all changes in range.

Claims (4)

1. a kind of ammonia phenol oxycodone capsules fill method, it is characterised in that: include the following steps,
S1, the sieve that paracetamol bulk pharmaceutical chemicals crushed to 20~80 mesh numbers;
S2, weigh in parts by weight 250~750 parts pulverize and sieve after paracetamol, be added wet-mixing granulation Machine;
S3, the oxycodone hydrochloride for weighing 2.5~7.5 parts in parts by weight, and 12.5~75 parts of purifying is added in parts by weight Water makes it completely dissolved;
S4, oxycodone hydrochloride aqueous solution is uniformly sprayed in paracetamol, then helps stream for 5~20 parts in parts by weight Wet mixing pelletizer is added in agent and 25~75 portions of disintegrating agents, discharging after being sufficiently mixed uniformly with above-mentioned material;
S5, it is then dried in micro-wave vacuum equipment;
S6, the sieve that material drying is crossed to 20~80 mesh numbers again, are then added the lubrication of 5~20mg in parts by weight Agent is uniformly mixed;
S7, resulting material is put into automatic hard capsule filler and fills capsule.
2. ammonia phenol oxycodone capsules fill method according to claim 1, it is characterised in that: the drying temperature in step S5 It is 30 DEG C~60 DEG C.
3. ammonia phenol oxycodone capsules fill method according to claim 1, it is characterised in that: lubrication described in step S6 Agent is magnesium stearate or talcum powder.
4. ammonia phenol oxycodone capsules fill method according to claim 1, it is characterised in that: the drying time in step S5 For 15~60min.
CN201811597065.3A 2018-12-26 2018-12-26 Method for filling paracetamol capsules Pending CN109512796A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201811597065.3A CN109512796A (en) 2018-12-26 2018-12-26 Method for filling paracetamol capsules

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201811597065.3A CN109512796A (en) 2018-12-26 2018-12-26 Method for filling paracetamol capsules

Publications (1)

Publication Number Publication Date
CN109512796A true CN109512796A (en) 2019-03-26

Family

ID=65796908

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201811597065.3A Pending CN109512796A (en) 2018-12-26 2018-12-26 Method for filling paracetamol capsules

Country Status (1)

Country Link
CN (1) CN109512796A (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115656390A (en) * 2022-12-08 2023-01-31 成都苑东生物制药股份有限公司 Method for measuring content of paracetamol and oxycodone sustained release tablets

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CN1403078A (en) * 2002-09-28 2003-03-19 上海雅虎制药股份有限公司 Slow-releasing prepn containing p-acetamidophenol and opium
CN101534792A (en) * 2006-08-04 2009-09-16 爱的发 Granules and orally disintegrating tablets containing oxycodone
CN101563069A (en) * 2006-08-04 2009-10-21 爱的发 Multilayer orally disintegrating tablet
CN101721706A (en) * 2008-10-13 2010-06-09 青岛启元生物技术有限公司 Medicine composition containing matrine class alkaloid, preparation method and pharmaceutical application
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WO2013030177A1 (en) * 2011-08-29 2013-03-07 Sanofi Abuse resistant tablet comprising oxycodone and paracetamol
CN103402499A (en) * 2010-12-21 2013-11-20 马林克罗特有限公司 Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
US8658631B1 (en) * 2011-05-17 2014-02-25 Mallinckrodt Llc Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia
CN103860502A (en) * 2014-04-15 2014-06-18 白玲强 Tablet containing moxonidine hydrochloride and preparation method thereof
CN104644584A (en) * 2015-01-22 2015-05-27 扬子江药业集团有限公司 Roflumilast tablet and preparation method thereof
CN105209021A (en) * 2013-03-15 2015-12-30 马林克罗特有限公司 Compositions comprising an opioid and an additional active pharmaceutical ingredient for rapid onset and extended duration of analgesia that may be administered without regard to food
CN106176639A (en) * 2015-04-30 2016-12-07 四川科伦药物研究院有限公司 A kind of method preparing Roflumilast tablet
CN106413717A (en) * 2014-04-10 2017-02-15 查尔斯顿实验室公司 Pharmaceutical compositions
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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1403078A (en) * 2002-09-28 2003-03-19 上海雅虎制药股份有限公司 Slow-releasing prepn containing p-acetamidophenol and opium
CN101534792A (en) * 2006-08-04 2009-09-16 爱的发 Granules and orally disintegrating tablets containing oxycodone
CN101563069A (en) * 2006-08-04 2009-10-21 爱的发 Multilayer orally disintegrating tablet
CN101721706A (en) * 2008-10-13 2010-06-09 青岛启元生物技术有限公司 Medicine composition containing matrine class alkaloid, preparation method and pharmaceutical application
CN103402499A (en) * 2010-12-21 2013-11-20 马林克罗特有限公司 Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
US8658631B1 (en) * 2011-05-17 2014-02-25 Mallinckrodt Llc Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia
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CN102319245A (en) * 2011-07-08 2012-01-18 杭州华东医药集团生物工程研究所有限公司 Composition containing repaglinide and metformin hydrochloride and preparation thereof
WO2013030177A1 (en) * 2011-08-29 2013-03-07 Sanofi Abuse resistant tablet comprising oxycodone and paracetamol
CN105209021A (en) * 2013-03-15 2015-12-30 马林克罗特有限公司 Compositions comprising an opioid and an additional active pharmaceutical ingredient for rapid onset and extended duration of analgesia that may be administered without regard to food
CN106413717A (en) * 2014-04-10 2017-02-15 查尔斯顿实验室公司 Pharmaceutical compositions
CN103860502A (en) * 2014-04-15 2014-06-18 白玲强 Tablet containing moxonidine hydrochloride and preparation method thereof
CN104644584A (en) * 2015-01-22 2015-05-27 扬子江药业集团有限公司 Roflumilast tablet and preparation method thereof
CN106176639A (en) * 2015-04-30 2016-12-07 四川科伦药物研究院有限公司 A kind of method preparing Roflumilast tablet
CN107468660A (en) * 2016-06-07 2017-12-15 北京济美堂医药研究有限公司 A kind of new technology for preparing roflumilast tablet

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佚名: ""泰勒宁(氨酚羟考酮胶囊)简要讲义", 《中国药物滥用防止杂志》 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115656390A (en) * 2022-12-08 2023-01-31 成都苑东生物制药股份有限公司 Method for measuring content of paracetamol and oxycodone sustained release tablets

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Application publication date: 20190326

RJ01 Rejection of invention patent application after publication