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CN112603902A - Dexketoprofen trometamol capsule and preparation process thereof - Google Patents

Dexketoprofen trometamol capsule and preparation process thereof Download PDF

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Publication number
CN112603902A
CN112603902A CN202011438831.9A CN202011438831A CN112603902A CN 112603902 A CN112603902 A CN 112603902A CN 202011438831 A CN202011438831 A CN 202011438831A CN 112603902 A CN112603902 A CN 112603902A
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CN
China
Prior art keywords
mixing
dexketoprofen
capsule
magnesium stearate
spraying
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
CN202011438831.9A
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Chinese (zh)
Inventor
付德昭
付建家
付立家
武俊杰
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Beijing Asia East Bio Pharmaceutical Co Ltd
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Beijing Asia East Bio Pharmaceutical Co 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 Beijing Asia East Bio Pharmaceutical Co Ltd filed Critical Beijing Asia East Bio Pharmaceutical Co Ltd
Priority to CN202011438831.9A priority Critical patent/CN112603902A/en
Publication of CN112603902A publication Critical patent/CN112603902A/en
Pending legal-status Critical Current

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    • 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
    • A61K9/4866Organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/192Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/205Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine
    • 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
    • A61K9/485Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • 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)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Immunology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention discloses a dexketoprofen tromethamine capsule which is characterized by consisting of the following components in parts by weight: the preparation method comprises the following steps of mixing, granulating, finishing granules, totally mixing, sampling and inspecting to obtain a finished product. Compared with the prior art, the invention has the advantages that: quick action, better analgesic effect and less side effect.

Description

Dexketoprofen trometamol capsule and preparation process thereof
Technical Field
The invention relates to the technical field of capsule medicines, in particular to a dexketoprofen tromethamine capsule and a preparation process thereof.
Background
Dexketoprofen trometamol is used for all pains and is suitable for eliminating pains caused by wounds, postoperative pains, gall, sharp pains and various reasons in a short time. The tablet or injection can be used for relieving moderate to severe postoperative pain, including abdominal, thoracic, gynecological, oral, orthopedic and urological operations. In addition, the medicine can also relieve acute renal glue pain, biliary colic, toothache, wound pain, trigeminal neuralgia, cancer visceral pain and various pains which can be achieved only by using morphine or pethidine.
Moderate pain is a common clinical symptom, patients have a large amount, such as various postoperative pain, cancer pain and the like, in the case of the moderate pain, the analgesic effect of nonsteroidal anti-inflammatory analgesic drugs is not enough, narcotic analgesics are usually needed, but the narcotic analgesics are easy to generate dependence because of repeated administration. In clinical analgesia, two types of analgesics are usually combined to enhance the analgesic effect and reduce the dosage of narcotic analgesics, especially the dosage of strong dependence drugs such as morphine and the like.
Disclosure of Invention
The invention aims to solve the problems in the prior art, and further provides a dexketoprofen tromethamine capsule which has the advantages of quick response, better analgesic effect and small side effect, and a preparation process thereof.
The purpose of the invention is realized by the following technical scheme:
the dexketoprofen trometamol capsule consists of the following components in percentage by weight: 3.7 parts of dexketoprofen trometamol, 6 parts of pregelatinized starch, 14 parts of microcrystalline cellulose, 1 part of hydroxypropyl methyl cellulose, and a proper amount of magnesium stearate, talcum powder and 30% ethanol.
Further, the weight ratio of the magnesium stearate to the talcum powder is 1:6, and the mixing weight of the magnesium stearate and the talcum powder is equal to the mixing weight of the dexketoprofen tromethamine, the pregelatinized starch, the microcrystalline cellulose and the hydroxypropyl methyl cellulose.
The preparation process of the dexketoprofen tromethamine capsule comprises the following steps:
step one, mixing: starting a multifunctional fluidized granulation coating machine, preheating a pot body, placing dexketoprofen trometamol, pregelatinized starch, microcrystalline cellulose and hydroxypropyl methylcellulose which are weighed according to the weight ratio into the multifunctional fluidized granulation coating machine, setting the temperature to be 75-90 ℃, starting a fan, setting the induced air frequency of the fan to be 20-30 Hz, boiling and mixing the fine powder, and mixing for 10 minutes;
step two, granulation: when the air outlet temperature rises to 40-55 ℃, spraying by using 30% ethanol, controlling the frequency of an induced draft fan at 20-40 Hz, controlling the speed of a peristaltic pump at 30-50 r/min, observing the boiling fluidization state of the material in the spraying process, stopping spraying when the boiling fluidization state of the material is slow, drying, spraying again when the boiling fluidization state of the material is good, alternately performing the process until the granulation is finished, stopping spraying after the granulation is finished, and continuously drying for 20-40 minutes until the moisture content of the particles is less than or equal to 6%;
step three, granule finishing: after drying, finishing the particles by using a ternary rotary vibration sieve, mounting a 24-mesh screen on the ternary rotary vibration sieve, and putting the particles smaller than 24 meshes into a clean container for sealing and storing;
step four, total mixing: taking the sized dexketoprofen tromethamine granules, magnesium stearate and talcum powder, adopting an equivalent incremental method, firstly taking a proper amount of magnesium stearate and talcum powder to mix for five minutes, weighing equivalent dexketoprofen tromethamine granules after mixing, adding into the mixture and mixing for 5 minutes; by analogy, adding the rest particles into the mixture until the weight of the mixture is 10% of that of all the materials, mixing, and filling the total mixed powder into a clean container for sealed storage after the mixture is finished;
step six, sampling inspection; sampling and detecting the content;
step seven, finished product: loading into No. 3 capsule according to the loading requirement, wherein the loading of the capsule is 110mg-130 mg.
Compared with the prior art, the invention has the advantages that:
the traditional Chinese medicine composition has the main effects of diminishing inflammation and easing pain, can be used for treating osteoarthritis, ankylosing spondylitis, gouty arthritis and rheumatoid arthritis, has a certain relieving effect on postoperative pain, cancer pain, toothache and abdominal pain during menstruation, has a certain auxiliary effect on treating general pain caused by cold and fever, and can quickly take effect, achieve a better analgesic effect and reduce side effects.
The function of each auxiliary material in the prescription is as follows:
microcrystalline cellulose: as a disintegrant, filler;
compressible starch: the fluidity is good, and the difference is small after the capsule is filled;
hydroxypropyl methylcellulose: as a binder;
talc powder: the function of fluidity is achieved;
magnesium stearate: and acts as a lubricant.
Detailed Description
The amount of the needed dexketoprofen tromethamine is calculated according to the following formula: the raw material x (1-loss on drying) x content was calculated to be 3.7kg, and then pregelatinized starch was weighed in order: 6.0kg, microcrystalline cellulose: 14.0kg, hypromellose: 1.0kg, then dividing the above components into 8 parts, namely, each part of dexketoprofen trometamol: 462.5g, pregelatinized starch: 0.75kg, microcrystalline cellulose: 1.75kg, hypromellose: 0.125 kg; preparing a proper amount of the components with the weight ratio of 1:6 magnesium stearate and talcum powder, and a proper amount of 30% ethanol.
The preparation process comprises the following steps:
step one, mixing: starting a multifunctional fluidized granulation coating machine, preheating a pot body, putting the separated dexketoprofen trometamol, pregelatinized starch, microcrystalline cellulose and hydroxypropyl methylcellulose into the multifunctional fluidized granulation coating machine, setting the temperature to be 75-90 ℃, starting a fan, setting the induced air frequency of the fan to be 20-30 Hz, boiling and mixing the fine powder, and mixing for 10 minutes;
step two, granulation: when the air outlet temperature rises to 40-55 ℃, spraying by using 30% ethanol, controlling the frequency of an induced draft fan at 20-40 Hz, controlling the speed of a peristaltic pump at 30-50 r/min, observing the boiling fluidization state of the material in the spraying process, stopping spraying when the boiling fluidization state of the material is slow, drying, spraying again when the boiling fluidization state of the material is good, alternately performing the process until the granulation is finished, stopping spraying after the granulation is finished, and continuously drying for 20-40 minutes until the moisture content of the particles is less than or equal to 6%;
step three, granule finishing: after drying, finishing the particles by using a ternary rotary vibration sieve, mounting a 24-mesh screen on the ternary rotary vibration sieve, and putting the particles smaller than 24 meshes into a clean container for sealing and storing;
step four, total mixing: taking the sized dexketoprofen tromethamine granules, 0.1kg of magnesium stearate and 0.6kg of talcum powder, firstly mixing the magnesium stearate and the talcum powder for five minutes by adopting an equivalent incremental method, weighing equivalent dexketoprofen tromethamine granules after mixing, adding the granules into the mixture, and mixing for 5 minutes; by analogy, adding the rest particles into the mixture until the weight of the mixture is 10% of that of all the materials, mixing, and filling the total mixed powder into a clean container for sealed storage after the mixture is finished;
step six, sampling inspection; sampling and detecting the content;
step seven, finished product: loading into No. 3 capsule according to the loading requirement, wherein the loading of the capsule is 110mg-130 mg.

Claims (3)

1. The dexketoprofen trometamol capsule is characterized by consisting of the following components in parts by weight: 3.7 parts of dexketoprofen trometamol, 6 parts of pregelatinized starch, 14 parts of microcrystalline cellulose, 1 part of hydroxypropyl methyl cellulose, and a proper amount of magnesium stearate, talcum powder and 30% ethanol.
2. The dexketoprofen trometamol capsule according to claim 1, wherein the weight ratio of magnesium stearate to talc is 1:6, and the mixing weight of magnesium stearate and talc is equal to the mixing weight of dexketoprofen trometamol, pregelatinized starch, microcrystalline cellulose and hydroxypropyl methyl cellulose.
3. The preparation process of the dexketoprofen tromethamine capsule is characterized by comprising the following steps of:
step one, mixing: starting a multifunctional fluidized granulation coating machine, preheating a pot body, placing dexketoprofen trometamol, pregelatinized starch, microcrystalline cellulose and hydroxypropyl methylcellulose which are weighed according to the weight ratio into the multifunctional fluidized granulation coating machine, setting the temperature to be 75-90 ℃, starting a fan, setting the induced air frequency of the fan to be 20-30 Hz, boiling and mixing the fine powder, and mixing for 10 minutes;
step two, granulation: when the air outlet temperature rises to 40-55 ℃, spraying by using 30% ethanol, controlling the frequency of an induced draft fan at 20-40 Hz, controlling the speed of a peristaltic pump at 30-50 r/min, observing the boiling fluidization state of the material in the spraying process, stopping spraying when the boiling fluidization state of the material is slow, drying, spraying again when the boiling fluidization state of the material is good, alternately performing the process until the granulation is finished, stopping spraying after the granulation is finished, and continuously drying for 20-40 minutes until the moisture content of the particles is less than or equal to 6%;
step three, granule finishing: after drying, finishing the particles by using a ternary rotary vibration sieve, mounting a 24-mesh screen on the ternary rotary vibration sieve, and putting the particles smaller than 24 meshes into a clean container for sealing and storing;
step four, total mixing: taking the sized dexketoprofen tromethamine granules, magnesium stearate and talcum powder, adopting an equivalent incremental method, firstly taking a proper amount of magnesium stearate and talcum powder to mix for five minutes, weighing equivalent dexketoprofen tromethamine granules after mixing, adding into the mixture and mixing for 5 minutes; by analogy, adding the rest particles into the mixture until the weight of the mixture is 10% of that of all the materials, mixing, and filling the total mixed powder into a clean container for sealed storage after the mixture is finished;
step six, sampling inspection; sampling and detecting the content;
step seven, finished product: loading into No. 3 capsule according to the loading requirement, wherein the loading of the capsule is 110mg-130 mg.
CN202011438831.9A 2020-12-07 2020-12-07 Dexketoprofen trometamol capsule and preparation process thereof Pending CN112603902A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202011438831.9A CN112603902A (en) 2020-12-07 2020-12-07 Dexketoprofen trometamol capsule and preparation process thereof

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Application Number Priority Date Filing Date Title
CN202011438831.9A CN112603902A (en) 2020-12-07 2020-12-07 Dexketoprofen trometamol capsule and preparation process thereof

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Publication Number Publication Date
CN112603902A true CN112603902A (en) 2021-04-06

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114864906A (en) * 2022-05-31 2022-08-05 焦作熔创石墨科技有限公司 Carbon cathode material of lithium ion battery and preparation method and system thereof

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013182609A1 (en) * 2012-06-06 2013-12-12 Galenicum Health S.L. Stable pharmaceutical compositions with a fast onset
CN104188947A (en) * 2014-08-26 2014-12-10 安徽省逸欣铭医药科技有限公司 Compound pharmaceutical composition of tapentadol hydrochloride and dexketoprofen trometamol

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013182609A1 (en) * 2012-06-06 2013-12-12 Galenicum Health S.L. Stable pharmaceutical compositions with a fast onset
CN104188947A (en) * 2014-08-26 2014-12-10 安徽省逸欣铭医药科技有限公司 Compound pharmaceutical composition of tapentadol hydrochloride and dexketoprofen trometamol

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
郑超华等: "复方伤痛胶囊治疗腰肌劳损56例疗效观察", 《河北中医》 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114864906A (en) * 2022-05-31 2022-08-05 焦作熔创石墨科技有限公司 Carbon cathode material of lithium ion battery and preparation method and system thereof
CN114864906B (en) * 2022-05-31 2023-11-21 焦作熔创石墨科技有限公司 Lithium ion battery carbon negative electrode material, and preparation method and system thereof

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Application publication date: 20210406