CN105343008A - Pitavastatin calcium composition - Google Patents
Pitavastatin calcium composition Download PDFInfo
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- CN105343008A CN105343008A CN201510927708.6A CN201510927708A CN105343008A CN 105343008 A CN105343008 A CN 105343008A CN 201510927708 A CN201510927708 A CN 201510927708A CN 105343008 A CN105343008 A CN 105343008A
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- pitavastatin calcium
- calcium composition
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
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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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic 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
- A61K31/47—Quinolines; Isoquinolines
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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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic 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
- A61K31/47—Quinolines; Isoquinolines
- A61K31/4709—Non-condensed quinolines and containing further heterocyclic rings
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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
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- Health & Medical Sciences (AREA)
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- Pharmacology & Pharmacy (AREA)
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- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention relates to a pitavastatin calcium composition, and belongs to the technical field of medicine. The pitavastatin calcium composition contains pitavastatin calcium solid dispersoids, can obviously improve the stability of pitavastatin calcium and has higher dissolution rate. The pitavastatin calcium composition is uniform in content, good in dissolution effect, good in stability, simple and easy to implement in preparing method and favorable for industrialized application.
Description
Technical field
The present invention relates to a kind of Pitavastatin calcium composition, belong to medical art.
Background technology
Pitavastatin Calcium, English pitavastatin by name, chemical name is (+)-bis-{ (3R, 5S, 6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyl]-3,5-dihydroxy-6-enanthic acid } single calcium salt, it is the novel statins antilipemic drugs of Japanese Nissan chemical industry Co., Ltd. and Kowa company Ltd's joint development, listing is got permission first in Japan in July, 2003, listing dosage form is tablet, the pitavastatin calcium tablet commodity of domestic import " power clear it " by name, indication is hypercholesterolemia, familial hypercholesterolemia.Pitavastatin Calcium belongs to third generation statins, compares with other statinses, has and can effectively reduce LDL-C, TG level, pharmacokinetic indicator " excellence ", long half time, drug interaction potentiality are low, the features such as safety is good, are called as " superstatin ".
Pitavastatin Calcium, by suppressing the HMG-CoA reductase in liver, suppresses the synthesis of cholesterol to reduce the concentration of Blood Cholesterol.HMG-CoA reductase is the rate-limiting enzyme in Biosynthesis of cholesterol process, and Pitavastatin Calcium suppresses this enzyme, can reduce hepatocyte inner cholesterol content, and cell cultured supernatant surface LDL receptors is expressed to be increased, and promotes that LDL and LDL precursor is removed from circulation; In addition, by continuing the synthesis suppressing cholesterol in liver, reducing the secretion of VLDL, the concentration of triglyceride in blood can be reduced, meanwhile, enhance the reducing effect to LDL-C concentration in blood plasma.The a large amount of clinical researches carried out abroad show that Pitavastatin Calcium is to improvement treatment hypercholesterolemiapatients patients, comprise familial hyperlipidemia patient, heterozygous Familial HypercholesterolemicPatients Patients, and be safely and effectively with the hyperlipidemia patient of noninsulindependent diabetes and the status of blood lipid of hypertriglyceridemia patient, to the patient of elderly patient and hepatic insufficiency, also there is same effect.Life-time service stable curative effect, does not have serious untoward reaction and the generation of the phenomena of mortality.
Pitavastatin Calcium is unstable when pH is low, has report to be made into the preparation that pH is 8 or higher, can obtain metastable compositions.The pH value of its aqueous solution or suspension controls as being greater than 7 by Chinese patent 96192065.3, is less than 8, to solve its compositions poor stability and outward appearance variation issue in time.Chinese patent 200510110676 takes compressing dry granulation, does not add binding agent, in the hope of obtaining stable compositions.
Solid dispersion technology refers to and makes medicine be highly dispersed at solid dispersion technology in suitable carrier material with molecule, crystallite or amorphous state by certain method.With solid dispersion prepared by hydrophilic carrier, the dissolution rate of insoluble drug may be accelerated, improve the bioavailability of medicine; Medicine, under the bag of carrier material covers effect, can be avoided contacting with the direct of air, thus the oxidation slowed down in drug manufacture, storage and hydrolysis, zest and the bad smell of medicine can also be hidden.
Present inventor has carried out long-term research to the pharmaceutical composition of Pitavastatin Calcium and production technology, result forms the solid dispersion containing Pitavastatin Calcium by solid dispersion technology, not only can improve the dissolution rate of Pitavastatin Calcium, the stability of Pitavastatin Calcium can also be improved.
Summary of the invention
The object of the invention is not need to consider that additional basic auxiliary is as stabilizing agent, a kind of stable, reliable pharmaceutical composition is provided.
The technical issues that need to address of the present invention are to provide a kind of pharmaceutical composition of the solid dispersion containing Pitavastatin Calcium, said composition good stability, and active component content is even, and dissolution rate is higher.
For achieving the above object, present inventor has performed a series of test, the carrier of solid dispersion selects at least one in the good PEG4000 of water-soluble material, PEG6000, PLURONICS F87 (F68), PVPK30 to be the carrier of solid dispersion, the carrier of solid dispersion and the mass ratio of Pitavastatin Calcium are 5:1, the preparation method of solid dispersion adopts solvent method, fusion method, solvent-fusion method, and solvent-fusion method is more suitable for the present invention.
Pharmaceutical composition of the present invention, wherein Pitavastatin Calcium solid dispersion adopts solvent method preparation, it is characterized in that carrier (in PVPk30, PEG4000, PEG6000, F68 at least one) is added in dehydrated alcohol, be stirred to and dissolve completely, add after Pitavastatin Calcium is stirred to fully mixing, removing ethanol, low-temperature setting, dry, porphyrize, sieve, preserve.
Pharmaceutical composition of the present invention, wherein Pitavastatin Calcium solid dispersion adopts fusion method preparation, it is characterized in that carrier (in PEG4000, PEG6000, F68 at least one) melting completely, add after Pitavastatin Calcium is stirred to fully mixing, low-temperature setting, dry, porphyrize, sieve, preserve.
Pharmaceutical composition of the present invention, wherein Pitavastatin Calcium solid dispersion adopts solvent-fusion method preparation, it is characterized in that Pitavastatin Calcium dehydrated alcohol dissolves completely, carrier (in PEG4000, PEG6000, F68 at least one) completely melting, add after Pitavastatin Calcium alcoholic solution is stirred to fully mixing, removing ethanol, low-temperature setting, dry, porphyrize, sieve, preserve.
Pitavastatin determination of calcium content:
1, chromatographic condition: be filler with octadecylsilane chemically bonded silica; With acetonitrile-water (containing 0.1% triethylamine) (40:60) for mobile phase; Determined wavelength is 244nm.Number of theoretical plate calculates by Pitavastatin Calcium peak and is not less than 5000.
2, algoscopy: compositions of getting it filled is appropriate, accurately weighed, porphyrize, add acetonitrile-water (40:60) and dissolve and make every 1ml about containing the solution of 0.04mg, filter, precision measures subsequent filtrate 20 μ l, injection liquid chromatography, record chromatogram; Separately get Pitavastatin Calcium reference substance appropriate, be measured in the same method.By external standard method with calculated by peak area, to obtain final product.
Pitavastatin Calcium determination of related substances:
1, chromatographic condition: be filler with octadecylsilane chemically bonded silica; With acetonitrile-water (containing 0.1% triethylamine) (40:60) for mobile phase; Determined wavelength is 244nm.Number of theoretical plate calculates by Pitavastatin Calcium peak and is not less than 5000.
2, algoscopy: compositions of getting it filled is appropriate, adds acetonitrile-water (40:60) and makes the solution containing 0.2mg in every 1ml, filter, get subsequent filtrate as need testing solution; It is appropriate that precision measures need testing solution, adds acetonitrile-water (40:60) and make the solution solution in contrast containing 1 μ g in every 1ml; Measure contrast solution 20 μ l, injection liquid chromatography, regulate detection sensitivity, make the peak height of main constituent chromatographic peak be about the 15%-20% of full scale; Another precision measures need testing solution 20 μ l, injection liquid chromatography, and record chromatogram is to 3.5 times of main constituent peak retention time.In the chromatogram of need testing solution, single impurity peak area calculates with Self-control method, calculates maximum single impurity peak area and total assorted peak area respectively.
Pitavastatin Calcium dissolution determination:
To get it filled compositions (capsule one or tablet a slice), according to dissolution method (Chinese Pharmacopoeia version in 2010 two annex XC second methods), with water 900ml for dissolution medium, rotating speed is 50 turns per minute, operate in accordance with the law, through 30 minutes time, get solution 5ml, filter, get subsequent filtrate as need testing solution; Separately get Pitavastatin Calcium reference substance appropriate, quantitatively dilute the solution made about containing 1 μ g in every 1ml with dissolution medium, product solution in contrast.Measure, by external standard method with the stripping quantity of the every sheet of calculated by peak area according to the method under assay item.
Pharmaceutical composition of the present invention can prepare various oral solid formulation, and such as, said composition can make tablet, capsule, granule, pill, and the film-coat of these preparations or sugar-coated preparation.
When pharmaceutical composition of the present invention is configured to various oral solid formulation, the pharmaceutical carrier of preparation industry can be added wherein, at least one in filler, disintegrating agent, binding agent, lubricant.
Described filler comprises calcium phosphate, lactose, mannitol, microcrystalline Cellulose, starch, sorbitol, and can be used alone also can be used in combination.When aforementioned filler is lactose, its consumption is about the 10-90% of pharmaceutical composition gross weight.
Described disintegrating agent comprises low-substituted hydroxypropyl cellulose, polyvinylpyrrolidone, starch, cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone, and can be used alone also can be used in combination.When aforementioned disintegrating agent is low-substituted hydroxypropyl cellulose, its consumption is about the 0-40% of pharmaceutical composition gross weight.
Described lubricant comprises magnesium stearate, stearic acid, Pulvis Talci, silicon dioxide, and can be used alone also can be used in combination.When aforementioned lubricants is magnesium stearate, its consumption is about the 0.01-10% of pharmaceutical composition gross weight.
Described binding agent comprises the alcoholic solution of hyprolose, hypromellose, polyvinylpyrrolidone, starch slurry, water, various concentration, and can be used alone also can be used in combination.Aforementioned adhesion agent be hypromellose and water time, its consumption is about the 0-20% of pharmaceutical composition gross weight.
As needs, other adjuvants can also be added, as coloring agent, sweeting agent, correctives, stabilizing agent.
The present invention discloses a kind of method preparing Pitavastatin calcium composition, comprises the following steps:
Can according to the conventional method pharmaceutical compositions prepared oral solid formulation and adopt.Preparation process is that the first step adopts solvent method, fusion method or solvent-fusion method to prepare the solid dispersion of Pitavastatin Calcium; Second step accurately takes the Liprevil calcium solid dispersion containing recipe quantity Pitavastatin Calcium, preparation industry conventional method pharmaceutical compositions is pressed, as filled capsules, the direct filled capsules of powder after wet granule compression tablet, direct powder compression, granulation with other adjuvant in prescription.
Beneficial effect of the present invention is, the present invention forms stable solid dispersion by hydrophilic carrier and Pitavastatin Calcium, improve the dissolution rate of Pitavastatin Calcium, improve the stability of Pitavastatin Calcium, expand the pharmaceutical carrier scope of application, preparation method of the present invention can be directly used in suitability for industrialized production.
Specific embodiment
embodiment 1:
Solvent method prepares Pitavastatin Calcium solid dispersion: take Pitavastatin Calcium 1.0g and carrier (in PVPk30, PEG4000, PEG6000, F68 at least one) 5.0g respectively, first carrier is joined in 50.0mL dehydrated alcohol, be stirred to after dissolving completely, add after Pitavastatin Calcium Keep agitation 1h fully mixes, 60 DEG C of concentrating under reduced pressure removing ethanol, product is 48h in the underlying vacuum desiccator of room temperature, porphyrize, cross 80 mesh sieves, save backup.
Prepared by pharmaceutical composition: take the Pitavastatin Calcium solid dispersion being equivalent to Pitavastatin Calcium 1g, hydroxypropyl cellulose 12.0g, hydroxypropyl emthylcellulose 2.0g, magnesium stearate 1.2g, by pharmaceutical industry conventional method tabletting, make 1000.
comparison example 1:
Prepare Pitavastatin Calcium physical mixture: accurate Pitavastatin Calcium 1.0g and carrier (in PVPk30, PEG4000, PEG6000, F68 at least one) 5.0g taking 80 mesh sieves respectively, mix in mortar with equivalent method of progressively increasing, put in exsiccator and save backup.
Prepared by pharmaceutical composition: take the Pitavastatin Calcium physical mixture being equivalent to Pitavastatin Calcium 1g, hydroxypropyl cellulose 12.0g, hydroxypropyl emthylcellulose 2.0g, magnesium stearate 1.2g, by pharmaceutical industry conventional method tabletting, make 1000.
Embodiment 1 and comparison example 1 sample are investigated 6 months in accelerated test condition (40 DEG C ± 2 DEG C, RH75% ± 5%) calorstat, and observe the situation of change of tablet appearance, content, dissolution and related substance, experimental result is in table 1.
embodiment 2:
Fusion method prepares Pitavastatin Calcium solid dispersion: take Pitavastatin Calcium 1.0g and carrier (in PEG4000, PEG6000, F68 at least one) 5.0g respectively, first carrier to be placed in 60 DEG C of water-baths after dissolving completely, add after Pitavastatin Calcium Keep agitation 1h fully mixes, be transferred to rapidly-20 DEG C of solidification 12h, take out, 48h in the underlying vacuum desiccator of room temperature, porphyrize, cross 80 mesh sieves, save backup.
Prepared by pharmaceutical composition: take the Pitavastatin Calcium solid dispersion being equivalent to Pitavastatin Calcium 1g, hydroxypropyl cellulose 12.0g, hydroxypropyl emthylcellulose 2.0g, magnesium stearate 1.2g, by pharmaceutical industry conventional method tabletting, make 1000.
comparison example 2:
Prepare Pitavastatin Calcium physical mixture: accurate Pitavastatin Calcium 1.0g and carrier (in PEG4000, PEG6000, F68 at least one) 5.0g taking 80 mesh sieves respectively, mix in mortar with equivalent method of progressively increasing, put in exsiccator and save backup.
Prepared by pharmaceutical composition: take the Pitavastatin Calcium physical mixture being equivalent to Pitavastatin Calcium 1g, hydroxypropyl cellulose 12g, hydroxypropyl emthylcellulose 2g, magnesium stearate 1.2g, by pharmaceutical industry conventional method tabletting, make 1000.
Embodiment 2 and comparison example 2 sample are investigated 6 months in accelerated test condition (40 DEG C ± 2 DEG C, RH75% ± 5%) calorstat, and observe the situation of change of tablet appearance, content, dissolution and related substance, experimental result is in table 1.
embodiment 3:
Solvent-fusion method prepares Pitavastatin Calcium solid dispersion: take Pitavastatin Calcium 1.0g and carrier (in PEG4000, PEG6000, F68 at least one) 5.0g respectively, first Pitavastatin Calcium 20mL dehydrated alcohol is dissolved completely, carrier to be placed in 60 DEG C of water-baths after dissolving completely, add after Pitavastatin Calcium alcoholic solution Keep agitation 1h fully mixes, 60 DEG C of concentrating under reduced pressure removing ethanol, be transferred to rapidly-20 DEG C of solidification 12h, take out, 48h in the underlying vacuum desiccator of room temperature, porphyrize, cross 80 mesh sieves, save backup.
Prepared by pharmaceutical composition: take the Pitavastatin Calcium solid dispersion being equivalent to Pitavastatin Calcium 1g, hydroxypropyl cellulose 12.0g, hydroxypropyl emthylcellulose 2.0g, magnesium stearate 1.2g, by pharmaceutical industry conventional method tabletting, make 1000.
comparison example 3:
Prepare Pitavastatin Calcium physical mixture: accurate Pitavastatin Calcium 1.0g and carrier (in PEG4000, PEG6000, F68 at least one) 5.0g taking 80 mesh sieves respectively, mix in mortar with equivalent method of progressively increasing, put in exsiccator and save backup.
Prepared by pharmaceutical composition: take the Pitavastatin Calcium physical mixture being equivalent to Pitavastatin Calcium 1g, hydroxypropyl cellulose 12.0g, hydroxypropyl emthylcellulose 2.0g, magnesium stearate 1.2g, by pharmaceutical industry conventional method tabletting, make 1000.
Embodiment 3 and comparison example 3 sample are investigated 6 months in accelerated test condition (40 DEG C ± 2 DEG C, RH75% ± 5%) calorstat, and observe the situation of change of tablet appearance, content, dissolution and related substance, experimental result is in table 1.
Table 1 pharmaceutical composition study on the stability result
Result shows: use the tablet prepared by Pitavastatin Calcium solid dispersion, compared with the tablet prepared with routine, dissolution be improved significantly, and related substance has no remarkable growth, and stability is better.
Claims (8)
1. a Pitavastatin calcium composition, is characterized in that: described compositions contains the solid dispersion of Pitavastatin Calcium, and wherein the carrier of solid dispersion and the mass ratio of Pitavastatin Calcium are 5:1.
2. Pitavastatin calcium composition as claimed in claim 1, is characterized in that: one or more also containing filler, in disintegrating agent, binding agent, lubricant of described compositions.
3. Pitavastatin calcium composition as claimed in claim 2, is characterized in that: described filler comprise calcium phosphate, lactose, mannitol, microcrystalline Cellulose, starch, sorbitol one or more.
4. Pitavastatin calcium composition as claimed in claim 2, is characterized in that: described disintegrating agent comprise low-substituted hydroxypropyl cellulose, polyvinylpyrrolidone, starch, cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone one or more.
5. Pitavastatin calcium composition as claimed in claim 2, is characterized in that: described lubricant comprise magnesium stearate, stearic acid, Pulvis Talci, silicon dioxide one or more.
6. Pitavastatin calcium composition as claimed in claim 2, is characterized in that: described binding agent comprise hyprolose, hypromellose, polyvinylpyrrolidone, starch slurry, water, various concentration alcoholic solution one or more.
7. Pitavastatin calcium composition as claimed in claim 1, is characterized in that: the carrier of described solid dispersion is one or more in PEG4000, PEG6000, PLURONICS F87, PVPK30.
8. the Pitavastatin calcium composition as described in any one of claim 1-7, is characterized in that: described compositions is for the preparation of one-tenth oral solid formulation.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510927708.6A CN105343008A (en) | 2015-12-15 | 2015-12-15 | Pitavastatin calcium composition |
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| CN201510927708.6A CN105343008A (en) | 2015-12-15 | 2015-12-15 | Pitavastatin calcium composition |
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Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1189098A (en) * | 1995-12-22 | 1998-07-29 | 兴和株式会社 | Pharmaceutical composition stablilized with basic agent |
| CN1969849A (en) * | 2005-11-24 | 2007-05-30 | 上海药明康德新药开发有限公司 | Stable pharmaceutical composition containing pitavastatin calcium and preparation process thereof |
| CN101829044A (en) * | 2009-03-13 | 2010-09-15 | 北京本草天源药物研究院 | Tamibarotene solid preparation and preparation method thereof |
| CN102091048A (en) * | 2009-12-09 | 2011-06-15 | 汪昌瑞 | Preparation method and quality control method of arbidol hydrochloride tablet |
| KR20110092804A (en) * | 2010-02-10 | 2011-08-18 | 고원팜 주식회사 | Pharmaceutical composition containing pitavastatin calcium salt |
| CN105125545A (en) * | 2015-10-13 | 2015-12-09 | 杨献美 | Medicine composition containing pitavastatin calcium and preparing method thereof |
-
2015
- 2015-12-15 CN CN201510927708.6A patent/CN105343008A/en not_active Withdrawn
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1189098A (en) * | 1995-12-22 | 1998-07-29 | 兴和株式会社 | Pharmaceutical composition stablilized with basic agent |
| CN1969849A (en) * | 2005-11-24 | 2007-05-30 | 上海药明康德新药开发有限公司 | Stable pharmaceutical composition containing pitavastatin calcium and preparation process thereof |
| CN101829044A (en) * | 2009-03-13 | 2010-09-15 | 北京本草天源药物研究院 | Tamibarotene solid preparation and preparation method thereof |
| CN102091048A (en) * | 2009-12-09 | 2011-06-15 | 汪昌瑞 | Preparation method and quality control method of arbidol hydrochloride tablet |
| KR20110092804A (en) * | 2010-02-10 | 2011-08-18 | 고원팜 주식회사 | Pharmaceutical composition containing pitavastatin calcium salt |
| CN105125545A (en) * | 2015-10-13 | 2015-12-09 | 杨献美 | Medicine composition containing pitavastatin calcium and preparing method thereof |
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