CN111759814A - Fludrocortisone acetate tablet for resisting inflammation and processing technology - Google Patents

Fludrocortisone acetate tablet for resisting inflammation and processing technology Download PDF

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Publication number
CN111759814A
CN111759814A CN202010700674.8A CN202010700674A CN111759814A CN 111759814 A CN111759814 A CN 111759814A CN 202010700674 A CN202010700674 A CN 202010700674A CN 111759814 A CN111759814 A CN 111759814A
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parts
lactose
fludrocortisone acetate
type
magnesium stearate
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CN202010700674.8A
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Chinese (zh)
Inventor
高煜
操铖
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Huayi Pharmaceutical Anhui Co Ltd
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Huayi Pharmaceutical Anhui Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57Compounds 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
    • A61K31/573Compounds 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/38Drugs for disorders of the endocrine system of the suprarenal hormones
    • A61P5/40Mineralocorticosteroids, e.g. aldosterone; Drugs increasing or potentiating the activity of mineralocorticosteroids

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
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  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention discloses a fludrocortisone acetate tablet for anti-inflammation and a processing technology thereof, wherein the tablet comprises the following raw materials in parts by weight: 0.005-0.015 part of fludrocortisone acetate, 2.1-2.3 parts of first lactose, 7.34-7.54 parts of second lactose, 0.15-0.35 part of A-type carboxymethyl starch sodium, 0.04-0.06 part of I-type magnesium stearate, 0.04-0.06 part of II-type magnesium stearate, 6-10 parts of filler and 1-3 parts of lubricant, wherein the raw materials comprise the following components in parts by weight: the invention relates to the technical field of fludrocortisone acetate, and discloses the fludrocortisone acetate, which comprises 0.01 part of fludrocortisone acetate, 2.20 parts of first lactose, 7.44 parts of second lactose, 0.25 part of A-type carboxymethyl starch sodium and 0.05 part of I-type magnesium stearate. According to the fludrocortisone acetate tablet for resisting inflammation and the processing technology, the fludrocortisone acetate, the first lactose, the second lactose, the A-type carboxymethyl starch sodium, the I-type magnesium stearate, the II-type magnesium stearate, the filler and the lubricant are mixed for pharmacy, so that the tablet is stronger in anti-inflammation, and compared with a conventional anti-inflammatory drug, the tablet is quick in effect taking and shorter in recovery period after being used.

Description

Fludrocortisone acetate tablet for resisting inflammation and processing technology
Technical Field
The invention relates to the technical field of fludrocortisone acetate, in particular to a fludrocortisone acetate tablet for resisting inflammation and a processing technology thereof.
Background
Dermatitis is complex in etiology and may be associated with the following factors: 1. internal factors: it is related to chronic infection focus, endocrine and metabolism change, blood circulation disorder, neuropsychiatric factors, genetic factors, etc. 2. External factors: can be induced or aggravated by foods such as fish, shrimp, beef and mutton, inhalants such as pollen, dust mite, living environment such as cold, hot, dry, etc., animal fur, and various physicochemical substances such as cosmetics, soap, synthetic fiber, etc., and the existing dermatosis such as allergic dermatitis, contact dermatitis, seborrheic dermatitis, eczema, etc. can bring pain to patients and bring inconvenience to life.
Fludrocortisone acetate is mainly used for the replacement therapy of adrenocortical insufficiency, and can be externally used for treating dermatosis such as allergic dermatitis, contact dermatitis, seborrheic dermatitis, eczema and the like.
Disclosure of Invention
Aiming at the defects of the prior art, the invention provides a fludrocortisone acetate tablet for resisting inflammation and a processing technology thereof.
In order to achieve the purpose, the invention is realized by the following technical scheme: the fludrocortisone acetate tablet for resisting inflammation comprises the following raw materials in parts by weight: 0.005-0.015 part of fludrocortisone acetate, 2.1-2.3 parts of first lactose, 7.34-7.54 parts of second lactose, 0.15-0.35 part of A-type carboxymethyl starch sodium, 0.04-0.06 part of I-type magnesium stearate, 0.04-0.06 part of II-type magnesium stearate, 6-10 parts of filler and 1-3 parts of lubricant.
Preferably, the raw materials comprise the following components in parts by weight: 0.01 part of fludrocortisone acetate, 2.20 parts of first lactose, 7.44 parts of second lactose, 0.25 part of A-type carboxymethyl starch sodium, 0.05 part of I-type magnesium stearate, 0.05 part of II-type magnesium stearate, 8 parts of filler and 2 parts of lubricant.
Preferably, the raw materials comprise the following components in parts by weight: 0.005 part of fludrocortisone acetate, 2.1 parts of first lactose, 7.34 parts of second lactose, 0.15 part of A-type carboxymethyl starch sodium, 0.04 part of I-type magnesium stearate, 0.04 part of II-type magnesium stearate, 6 parts of filler and 1 part of lubricant.
Preferably, the lubricating agent comprises 0.015 part of fludrocortisone acetate, 2.3 parts of first lactose, 7.54 parts of second lactose, 0.35 part of A-type carboxymethyl starch sodium, 0.06 part of I-type magnesium stearate, 0.06 part of II-type magnesium stearate, 10 parts of a filling agent and 3 parts of a lubricating agent.
Preferably, the filler is a mixture of sugar alcohol compounds and microcrystalline cellulose, and the lubricant is one of magnesium stearate, sodium lauryl sulfate or hydrogenated vegetable oil.
Preferably, the first lactose has a size of 80 mesh and the second lactose has a size of 200 mesh.
The invention also discloses a processing technology of the fludrocortisone acetate tablet for resisting inflammation, and the preparation method specifically comprises the following steps:
step one, mixing type I magnesium stearate, fludrocortisone acetate and first lactose by a mixer for 10-20 min;
step two, adding the second lactose and the A-type carboxymethyl starch sodium into a mixer for mixing for 6-8 min;
adding type II magnesium stearate into a mixer, mixing for 3-5 min;
and step four, performing dry granulation on the mixed materials, and then preparing the obtained powdery solid, the filler and the lubricant by adopting a powder direct tabletting method.
The invention provides a fludrocortisone acetate tablet for resisting inflammation and a processing technology thereof. Compared with the prior art, the method has the following beneficial effects:
(1) the fludrocortisone acetate tablet for resisting inflammation and the processing technology are prepared by mixing fludrocortisone acetate, first lactose, second lactose, A-type carboxymethyl starch sodium, I-type magnesium stearate, II-type magnesium stearate, a filling agent and a lubricating agent, so that the tablet is stronger in anti-inflammation, and has a shorter recovery period after being used compared with a conventional anti-inflammatory drug.
Drawings
FIG. 1 is a statistical table of comparative experimental data according to the present invention.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Referring to fig. 1, the embodiment of the present invention provides three technical solutions: a fludrocortisone acetate tablet for anti-inflammation and a processing technology thereof specifically comprise the following embodiments:
example 1
The raw materials comprise the following components in parts by weight: 0.01 part of fludrocortisone acetate, 2.20 parts of first lactose, 7.44 parts of second lactose, 0.25 part of A-type carboxymethyl starch sodium, 0.05 part of I-type magnesium stearate, 0.05 part of II-type magnesium stearate, 8 parts of filler and 2 parts of lubricant.
The preparation method specifically comprises the following steps:
step one, mixing 0.05 part of type I magnesium stearate, 0.01 part of fludrocortisone acetate and 2.20 parts of first lactose by a mixer for 15 min;
step two, adding 7.44 parts of second lactose and 0.25 part of A-type carboxymethyl starch sodium into a mixer for mixing for 7 min;
adding 0.05 part of type II magnesium stearate into a mixer, mixing for 4 min;
and step four, performing dry granulation on the mixed materials, and then preparing the obtained powdery solid, 8 parts of filler and 2 parts of lubricant by adopting a powder direct tabletting method.
Example 2
0.005 part of fludrocortisone acetate, 2.1 parts of first lactose, 7.34 parts of second lactose, 0.15 part of A-type carboxymethyl starch sodium, 0.04 part of I-type magnesium stearate, 0.04 part of II-type magnesium stearate, 6 parts of filler and 1 part of lubricant.
The preparation method specifically comprises the following steps:
step one, mixing 0.04 parts of type I magnesium stearate, 0.005 parts of fludrocortisone acetate and 2.1 parts of first lactose by a mixer for 15 min;
step two, adding 7.34 parts of second lactose and 0.15 part of A-type carboxymethyl starch sodium into a mixer for mixing for 7 min;
adding 0.04 part of type II magnesium stearate into a mixer, mixing for 4 min;
and step four, performing dry granulation on the mixed materials, and then preparing the obtained powdery solid, 6 parts of filler and 1 part of lubricant by adopting a powder direct tabletting method.
Example 3
0.015 part of fludrocortisone acetate, 2.3 parts of first lactose, 7.54 parts of second lactose, 0.35 part of A-type carboxymethyl starch sodium, 0.06 part of I-type magnesium stearate, 0.06 part of II-type magnesium stearate, 10 parts of filler and 3 parts of lubricant.
The preparation method specifically comprises the following steps:
step one, mixing 0.06 part of type I magnesium stearate, 0.015 part of fludrocortisone acetate and 2.3 parts of first lactose by a mixer for 15 min;
step two, adding 7.54 parts of second lactose and 0.35 part of A-type carboxymethyl starch sodium into a mixer for mixing for 7 min;
adding 0.06 part of type II magnesium stearate into a mixer, mixing for 4 min;
and step four, performing dry granulation on the mixed materials, and then preparing the obtained powdery solid, 10 parts of filler and 3 parts of lubricant by adopting a powder direct tabletting method.
Comparative experiment
In a certain medical laboratory, 20 dermatitis patients are selected as volunteers, have no hypertension, liver disease and myxoedema, are not in the gestational period, and are respectively subjected to the medical test determination of example 1, example 2 and example 3 by taking a conventional fludrocortisone acetate tablet as a comparative example, 5 patients are taken as each example, and the recovery period and the erythema edema condition after one week of use are counted;
as shown in the table 1, the fludrocortisone acetate tablet for anti-inflammation helps the patient to recover, and the recovery period is shorter.
And those not described in detail in this specification are well within the skill of those in the art.
It is noted that, herein, relational terms such as first and second, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Also, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.
Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that changes, modifications, substitutions and alterations can be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.

Claims (7)

1. A fludrocortisone acetate tablet for anti-inflammation is characterized in that: the raw materials comprise the following components in parts by weight: 0.005-0.015 part of fludrocortisone acetate, 2.1-2.3 parts of first lactose, 7.34-7.54 parts of second lactose, 0.15-0.35 part of A-type carboxymethyl starch sodium, 0.04-0.06 part of I-type magnesium stearate, 0.04-0.06 part of II-type magnesium stearate, 6-10 parts of filler and 1-3 parts of lubricant.
2. The fludrocortisone acetate tablet for anti-inflammatory of claim 1, further comprising: the raw materials comprise the following components in parts by weight: 0.01 part of fludrocortisone acetate, 2.20 parts of first lactose, 7.44 parts of second lactose, 0.25 part of A-type carboxymethyl starch sodium, 0.05 part of I-type magnesium stearate, 0.05 part of II-type magnesium stearate, 8 parts of filler and 2 parts of lubricant.
3. The fludrocortisone acetate tablet for anti-inflammatory of claim 1, further comprising: the raw materials comprise the following components in parts by weight: 0.005 part of fludrocortisone acetate, 2.1 parts of first lactose, 7.34 parts of second lactose, 0.15 part of A-type carboxymethyl starch sodium, 0.04 part of I-type magnesium stearate, 0.04 part of II-type magnesium stearate, 6 parts of filler and 1 part of lubricant.
4. The fludrocortisone acetate tablet for anti-inflammatory of claim 1, further comprising: the raw materials comprise the following components in parts by weight: 0.015 part of fludrocortisone acetate, 2.3 parts of first lactose, 7.54 parts of second lactose, 0.35 part of A-type carboxymethyl starch sodium, 0.06 part of I-type magnesium stearate, 0.06 part of II-type magnesium stearate, 10 parts of filler and 3 parts of lubricant.
5. The fludrocortisone acetate tablet for anti-inflammatory of claim 1, further comprising: the filler is a mixture of sugar alcohol compounds and microcrystalline cellulose, and the lubricant is one of magnesium stearate, sodium dodecyl sulfate or hydrogenated vegetable oil.
6. The fludrocortisone acetate tablet for anti-inflammatory of claim 1, further comprising: the first lactose is 80 meshes in size, and the second lactose is 200 meshes in size.
7. The fludrocortisone acetate tablet for anti-inflammatory according to any of claims 1 to 6, further comprising: the preparation method specifically comprises the following steps:
step one, mixing type I magnesium stearate, fludrocortisone acetate and first lactose by a mixer for 10-20 min;
step two, adding the second lactose and the A-type carboxymethyl starch sodium into a mixer for mixing for 6-8 min;
adding type II magnesium stearate into a mixer, mixing for 3-5 min;
and step four, performing dry granulation on the mixed materials, and then preparing the obtained powdery solid, the filler and the lubricant by adopting a powder direct tabletting method.
CN202010700674.8A 2020-07-20 2020-07-20 Fludrocortisone acetate tablet for resisting inflammation and processing technology Pending CN111759814A (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109602728A (en) * 2019-01-18 2019-04-12 江苏福锌雨医药科技有限公司 A kind of fludrocortisone acetate oral quick-dissolving film preparation and preparation method thereof
CN109662949A (en) * 2017-10-16 2019-04-23 江苏福锌雨医药科技有限公司 A kind of fludrocortisone acetate oral disnitegration tablet and preparation method thereof
WO2019175703A1 (en) * 2018-03-12 2019-09-19 Syri Ltd Stable liquid suspension composition of fludrocortisone

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109662949A (en) * 2017-10-16 2019-04-23 江苏福锌雨医药科技有限公司 A kind of fludrocortisone acetate oral disnitegration tablet and preparation method thereof
WO2019175703A1 (en) * 2018-03-12 2019-09-19 Syri Ltd Stable liquid suspension composition of fludrocortisone
CN109602728A (en) * 2019-01-18 2019-04-12 江苏福锌雨医药科技有限公司 A kind of fludrocortisone acetate oral quick-dissolving film preparation and preparation method thereof

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
HTTP://ZY.YAOZH.COM/DATA/PDF/00055056.PDF: "《醋酸氟氢可的松片剂说明书》", 30 September 2017 *

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Application publication date: 20201013