CN1593393A - Prescription of liquid status of Vitamin K1 and its preparation - Google Patents

Prescription of liquid status of Vitamin K1 and its preparation Download PDF

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Publication number
CN1593393A
CN1593393A CN 200410020949 CN200410020949A CN1593393A CN 1593393 A CN1593393 A CN 1593393A CN 200410020949 CN200410020949 CN 200410020949 CN 200410020949 A CN200410020949 A CN 200410020949A CN 1593393 A CN1593393 A CN 1593393A
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China
Prior art keywords
vitamin
liquid
soft capsule
polyethylene glycol
gelatin
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CN 200410020949
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Chinese (zh)
Inventor
邓意辉
吴琼
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Shenyang Pharmaceutical University
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Shenyang Pharmaceutical University
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Priority to CN 200410020949 priority Critical patent/CN1593393A/en
Publication of CN1593393A publication Critical patent/CN1593393A/en
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Abstract

The invention discloses a liquid type composition of vitamin K1 and its preparation and method for making same, wherein the composition comprises vitamin K1 and solvent, the liquid type vitamin K1 can be prepared into the dosage forms of capsule, liquid type hard gelatin capsule and drop. The preparation process is also disclosed by the invention.

Description

Vitamin K 1Liquid type prescription and preparation thereof
Technical field:
The present invention relates to medical technical field, exactly it is a kind of vitamin K 1Liquid type prescription and preparation thereof.
Background technology:
Vitamin K 1, its chemical name is: 2-methyl-3-(3,7,11,15-tetramethyl-2-hexadecene base)-1,4-naphthalenedione.This product is a vitamin drug, is liver composition-factor,,, the necessary material of.Vitamin K deficiency can cause these thrombin dyssynthesises or unusual, clinical visible bleeding tendency and prolonged prothrombin.Vitamin K and blood coagulation are closely related, during shortage, can cause the dyssynthesis of liver to multiple thrombin, cause body cruor time extending and bleeding tendency, and in time vitimin supplement K can make coagulation function recover.Vitamin K 1Also have direct hepatoprotective and antiinflammation,, bilirubin level is descended, and reach and fall the enzyme effect jaundice and the ALT rising person due to the hepatitis.Clinical vitamin K commonly used is treated the digestive tract hemorrhage that liver cirrhosis causes.Fatsoluble vitamin K commonly used 1, intramuscular injection or intravenous drip, each 10 milligrams, every day 2 times.Indication: what be used for that vitamin K deficiency causes is hemorrhage, as hemorrhage due to obstructive jaundice, leak, the chronic diarrhea etc., vitamin K deficiency in the body due to the Hypoprothrombinemia due to Coumarins, the sodium salicylate etc., hemorrhage of newborn and prolonged application broad ectrum antibiotic.
Vitimin supplement K 1Optimal path be oral administration, existing peroral dosage form is a tablet, because vitamin K 1Be grease, have any problem during the preparation tablet, have problems such as leakage of oil, complex procedures, simultaneously, because vitamin K 1Insoluble in the water, tablet Chinese traditional medicine absorbtivity in vivo is few and fluctuation is big.With the exception of this, existing vitamin K 1Sheet is a coated tablet, and disintegrate is slow, and onset is slow, and is not suitable for the diabetics application.
Simple vitamin K 1The liquid type prescription of medicine does not appear in the newspapers, adopt prepared soft capsule, liquid type hard capsule and the drop technology of liquid type prescription, can improve the dispersion of medicine, consistent with original state-liquid condition of medicine, be more conducive to the preparation of pharmaceutical dosage form, be more conducive to the curative effect performance of medicine, also be suitable for diabetics and use.With vitamin K 1Existing Tabules is compared, and that the advantage of this product is that the accurate and effective composition stripping of loading amount absorbs is fast, steady quality, carry convenient drug administration etc.
Summary of the invention:
Vitamin K 1The prescription and the technology of soft capsule are as follows.
Constituent content (mg/ grain)
Vitamin K 12～20mg
Solvent 100～700mg
Gelatin 10～300mg
Glycerol 2～50mg
Antiseptic 0.01～0.1mg
Opacifier 0～5mg
Coloring agent 0～1mg
Said solvent is: oil phase or polyethylene glycol substances and other solvents, antioxidant.Described oil phase be in, long chain triglyceride, as Oleum Glycines, Oleum Camelliae, olive oil, safflower oil, C 8～C 10Triglyceride, C 8～C 18Fatty acid, ethyl oleate, spans (Span20,60,65,80) etc. in one or more mixture; Said polyethylene glycol substances and other solvents are: Macrogol 200-6000, one or more mixture in propylene glycol, glycerol, ethanol, Tween 80, HS15 (Polyethylene Glycol 12-hydroxy stearic acid ester, polyethylene glycol 660hydroxystearate), vitamin E polyethylene glycol succinic acid ester (TPGS), phospholipid and the water.Described antiseptic is one or more mixture of Nipagin ester apoplexy due to endogenous wind.Described vitamin K 1Soft capsule is characterized in that opacifier, coloring agent are titanium dioxide, ferrum oxide, one or more mixture in the pigment.Described antioxidant is one or more mixture in Butylated hydroxyanisole (BHA), dibenzylatiooluene (BHT), alpha-tocopherol, α-tocopheryl acetate, the sodium L-ascorbate-2-phosphate.Also can be made into the self emulsifying vitamin K 1Soft capsule, the ratio of the prescription of this self-emulsifying soft capsule is: vitamin K 1: the triglyceride of propylene glycol: C8～C10: ethyl oleate: Tween 80: HS15 (Polyethylene Glycol 12-hydroxy stearic acid ester, polyethylene glycol 660 hydroxystearate): vitamin E polyethylene glycol succinic acid ester (TPGS) (1: 1～50: 1～100: 1～50: 1～30: 0～30: 0～30).Vitamin K 1Assay analyze with HPLC:
The chromatographic condition of HPLC is: the chromatographic column octadecylsilane chemically bonded silica
The mobile phase dehydrated alcohol
Detect wavelength 254nm
Particle size analyzer: use PSS.NICOMP in this experiment TM380 as the instrument of measuring particle diameter.
Advantage of the present invention is:
Adopt the prepared liquid type vitamin K of above-mentioned solvent 1Can continue to make liquid type hard capsule and drop, solve the problem that conventional tablet exists.Because medicine is to exist with molecular state mode or high degree of dispersion attitude mode, the stripping of medicine, dispersion, absorption are faster, and the curative effect individual variation is littler, is beneficial to clinical treatment, is more suitable for children's Yu and takes with old man or seriously ill patient.
The specific embodiment:
Be illustrated with embodiment below, but be not limited to listed embodiment.
Embodiment 1
Composition weight (milligram)
Vitamin K 15
Oleum Glycines 150
Preparation technology:
Take by weighing the vitamin K1 and the Oleum Glycines of recipe quantity, place material-compound tank, promptly get vitamin K1 liquid behind the stirring and evenly mixing.Gained liquid can be prepared into soft capsule, liquid type hard capsule and drop.
Embodiment 2
Composition weight (milligram)
Vitamin K 12
Oleum Glycines 100
Sorbester p17 10
Alpha-tocopherol 1
Preparation technology:
Take by weighing sorbester p17, alpha-tocopherol and the Oleum Glycines of recipe quantity, place material-compound tank, fully mixing dissolving back adds vitamin K1, promptly gets vitamin K1 liquid behind the stirring and evenly mixing.Gained liquid can be prepared into soft capsule, liquid type hard capsule and drop.
Embodiment 3
Composition weight (milligram)
Vitamin K 15
Oleum Arachidis hypogaeae semen 200
Cera Flava 5
Dibenzylatiooluene 1
Preparation technology:
Take by weighing Cera Flava, dibenzylatiooluene and the Oleum Arachidis hypogaeae semen of recipe quantity, place material-compound tank, fully add vitamin K1 after the mixing heating for dissolving, stirring and evenly mixing promptly gets vitamin K1 liquid.Gained liquid can be prepared into soft capsule, liquid type hard capsule and drop.
Embodiment 4
Composition weight (milligram)
Vitamin K 110
Olive oil 400
α-tocopheryl acetate 5
Preparation technology:
Take by weighing the α-tocopheryl acetate and the olive oil of recipe quantity, place material-compound tank, fully mixing dissolving back adds vitamin K1, and stirring and evenly mixing promptly gets vitamin K1 liquid.Gained liquid can be prepared into soft capsule, liquid type hard capsule and drop.
Embodiment 5
Composition weight (milligram)
Vitamin K 120
Oleum Glycines 700
Butylated hydroxyanisole 2
Preparation technology:
Take by weighing the Butylated hydroxyanisole and the Oleum Glycines of recipe quantity, place material-compound tank, fully add vitamin K1 after the mixing heating for dissolving, stirring and evenly mixing promptly gets vitamin K1 liquid.Gained liquid can be prepared into soft capsule, liquid type hard capsule and drop.
Embodiment 6
Composition weight (milligram)
Vitamin K 15
Oleum Camelliae 300
Sodium L-ascorbate-2-phosphate 5
Preparation technology:
Take by weighing the sodium L-ascorbate-2-phosphate and the Oleum Camelliae of recipe quantity, place material-compound tank, fully add vitamin K1 after the mixing heating for dissolving, stirring and evenly mixing promptly gets vitamin K1 liquid.Gained liquid can be prepared into soft capsule, liquid type hard capsule and drop.
Embodiment 7
Composition weight (milligram)
Vitamin K 12
PEG?400 300
Propylene glycol 20
Water 5
Preparation technology:
Take by weighing the PEG 400 and the propylene glycol of recipe quantity, place material-compound tank, fully mixing dissolving back adds vitamin K1, adds the entry stirring and evenly mixing after the dissolving and promptly gets vitamin K1 liquid.Gained liquid can be prepared into soft capsule, liquid type hard capsule and drop.
Embodiment 8
Composition weight (milligram)
Vitamin K 15
PEG?400 100
Propylene glycol 50
PEG4000 5
Tween 80 10
Dibenzylatiooluene 1
Preparation technology:
Take by weighing PEG 400, glycerol, PEG4000, Tween 80 and the dibenzylatiooluene of recipe quantity, place material-compound tank, fully add vitamin K1 after the mixing heating for dissolving, add the entry stirring and evenly mixing and promptly get vitamin K1 liquid.Gained liquid can be prepared into soft capsule, liquid type hard capsule and drop.
Embodiment 9
Composition weight (milligram)
Vitamin K 110
PEG?200 400
Glycerol 10
PEG6000 4
Water 10
HS15 20
Hydroquinone 2
Preparation technology:
Take by weighing PEG 200, glycerol and PEG6000, hydroquinone, the HS15 of recipe quantity, place material-compound tank, fully add vitamin K1 after the mixing heating for dissolving, add the entry stirring and evenly mixing and promptly get vitamin K1 liquid.Gained liquid can be prepared into soft capsule, liquid type hard capsule and drop.
Embodiment 10
Composition weight (milligram)
Vitamin K 120
PEG?600 700
Propylene glycol 30
Water 5
TPGS 10
Preparation technology:
Take by weighing PEG600, propylene glycol and the TPGS of recipe quantity, place material-compound tank, fully add the vitamin K1 raw material after the mixing heating for dissolving, add the entry stirring and evenly mixing and promptly get vitamin K1 liquid.Gained liquid can be prepared into soft capsule, liquid type hard capsule and drop.
Embodiment 11
Composition weight (milligram)
Vitamin K 15
PEG?200 400
Glycerol 40
PEG800 20
Alpha-tocopherol 1
Preparation technology:
Take by weighing PEG 200, glycerol, alpha-tocopherol and the PEG800 of recipe quantity, place material-compound tank, fully add vitamin K1 after the mixing heating for dissolving, add the entry stirring and evenly mixing and promptly get vitamin K1 liquid.Gained liquid can be prepared into soft capsule, liquid type hard capsule and drop.
Embodiment 12
Composition weight (milligram/grain)
Vitamin K 15
Propylene glycol 100
The triglyceride 100 of C8～C10
HS15 50
Preparation technology:
Take by weighing propylene glycol, the triglyceride of C8～C10, the HS15 of recipe quantity, place material-compound tank, fully add vitamin K1 after the mixing heating for dissolving, stirring and evenly mixing promptly gets vitamin K1 liquid.Gained liquid can be prepared into self-emulsifying soft capsule agent and hard capsule.
The emulsion droplet particle mean size that self emulsifying forms in the water is 316nm.
Embodiment 13
Composition weight (milligram/grain)
Vitamin K 120
Propylene glycol 20
Ethyl oleate 100
HS15 50
TPGS 50
Preparation technology:
Take by weighing propylene glycol, ethyl oleate, HS15, the TPGS of recipe quantity, place material-compound tank, fully add vitamin K1 after the mixing heating for dissolving, stirring and evenly mixing promptly gets vitamin K1 liquid.Gained liquid can be prepared into self-emulsifying soft capsule agent and hard capsule.
The emulsion droplet particle mean size that self emulsifying forms in the water is 286nm.
Above embodiment vitamin K 1Preparation of soft capsule technology is:
Taking by weighing gelatin adds in the 100L rustless steel colloidal sol retort, it is airtight to add suitable quantity of water under stirring again, treat that gelatin dissolves the back fully and adds glycerol, an amount of antiseptic (adding opacifier, coloring agent in case of necessity), stir, vacuumize degassing 2 hours, put into 70 ℃ of insulations of gelatin heat-preserving container standing over night, stand-by.
Under room temperature, suspending agent is added in the diluent, take by weighing vitamin K 1With mixing diluents, treat to add antioxidant behind the complete mixing, stir, room temperature leaves standstill.
The gelatin heat-preserving container is hung certain altitude, the medicinal liquid for preparing is poured in the medicinal liquid bucket, change mould and begin to press soft capsule, regulate the soft capsule device to scope of design, drying at room temperature two days, the soft gelatin capsule of rejecting outward appearance matter difference is with soft gelatin capsule washing (removing the lubricating oil in the pelleting process), again in 20～34 ℃, relative humidity 20%～50% dry two days, vitamin K 1The soft capsule semi-finished product, are labelled, are packed at the packing of the qualified back of quality testing, promptly get vitamin K 1The soft capsule finished product.
Embodiment 14: carry out disintegration by Chinese Pharmacopoeia two appendix appendix X A inspection techniques disintegration in 2000 and check that the slaking test of different preparations the results are shown in Table 1.
Table 1: medicine slaking test result
Commercially available embodiment 1 embodiment 3 embodiment 5 embodiment 9 embodiment 12
Disintegration (branch) 43 8 12 15 11 10
Hence one can see that, with vitamin K 1After making soft capsule, shorten disintegration greatly.
Embodiment 15: the test of different dosage form domesticated dog peak reaching time of blood concentration
The oral different dosage form vitamin K of domesticated dog 1When calculating dosage by kg body weight, owing to there is the problem of artificial destruction dosage form integrity, make more untrue between dosage form, in order to ensure the integrity of dosage form, we determine 10mg/ only (specification of tablet is the 10mg/ sheet, the specification of made soft capsule is 5,10mg/ grain), measure blood drug level with HPLC, relatively different dosage form domesticated dog peak reaching time of blood concentration.The results are shown in Table 2.
Table 2, peak reaching time of blood concentration
Commercially available embodiment of group 1 embodiment 4 embodiment 9 embodiment 12
Peak time (hour) 3.6 2.1 1.9 1.6 1.1
Hence one can see that, with vitamin K 1After making soft capsule, peak time shortens greatly, and is rapid-action, is beneficial to clinical treatment.
Embodiment 16: 40 ℃ of accelerated tests of different preparations the results are shown in Table 3.
Table 3: medicine stability test result
Time (moon) embodiment 1 embodiment 3 embodiment 5 embodiment 7 embodiment 9 embodiment 13
0 98.9％ 99.6％ 98.3％ 99.2％ 97.6％ 98.8％
1 98.1％ 99.2％ 98.8％ 99.3％ 97.6％ 98.8％
2 99.6％ 98.6％ 99.2％ 98.6％ 98.2％ 98.0％
3 98.2％ 99.0％ 98.2％ 98.8％ 98.0％ 98.2％
Hence one can see that, vitamin K 1Liquid type prescription Chinese medicine is stable.

Claims (10)

1, a kind of vitamin K 1Liquid type prescription and preparation thereof is characterized in that: this prescription is by vitamin K 1With compositions such as solvents, adopt this liquid type vitamin K 1, can be made into soft capsule, liquid type hard capsule and drop.
2, vitamin K according to claim 1 1Formulation in liquid form, described soft capsule is made up of medicinal liquid and softgel shell two large divisions, it is characterized in that: medicinal liquid by weight every contain vitamin K 12～20mg, solvent 100～700mg, antioxidant is an amount of; Contain 10 parts of gelatin in the softgel shell, 3～4 parts of glycerol, an amount of opacifier, coloring agent, antiseptic.
3, vitamin K according to claim 1 1Formulation in liquid form is characterized in that: can add antioxidant 0～10mg in the described soft capsule medicinal liquid; Add gelatin 10～300mg in the softgel shell; Glycerol 2～50mg; Antiseptic 0.01～0.1mg; Opacifier 0～5mg; Coloring agent 0～1mg.
4, vitamin K according to claim 1 1Formulation in liquid form is characterized in that: solvent is oil phase or polyethylene glycol substances and other solvents.
5, vitamin K according to claim 3 1Formulation in liquid form is characterized in that: described oil phase be in, long chain triglyceride.
6, vitamin K according to claim 4 1Formulation in liquid form is characterized in that: in described, long chain triglyceride is triglyceride, the C of Oleum Glycines, Oleum Camelliae, olive oil, safflower oil, C8～C10 8～C 18Fatty acid, ethyl oleate, spans in one or more mixture.
7, vitamin K according to claim 3 1Formulation in liquid form, it is characterized in that: said polyethylene glycol substances and other solvents are: Macrogol 200-6000, one or more mixture in propylene glycol, glycerol, ethanol, Tween 80, HS15, Polyethylene Glycol 12-hydroxy stearic acid ester, polyethylene glycol 660 hydroxystearate, vitamin E polyethylene glycol succinic acid ester (TPGS), phospholipid and the water.
8, vitamin K according to claim 1 1Formulation in liquid form is characterized in that: antiseptic is one or more mixture of Nipagin ester apoplexy due to endogenous wind; Opacifier, coloring agent are titanium dioxide, ferrum oxide, one or more mixture in the pigment; Antioxidant is one or more mixture in Butylated hydroxyanisole (BHA), dibenzylatiooluene (BHT), alpha-tocopherol, α-tocopheryl acetate, the sodium L-ascorbate-2-phosphate.
9, vitamin K according to claim 1 1Formulation in liquid form is characterized in that: said preparation also can be made into the self emulsifying vitamin K 1The liquid type soft capsule, the weight ratio that this self-emulsifying soft capsule is formed is: vitamin K 1: the triglyceride of propylene glycol: C8～C10: ethyl oleate: Tween 80: HS15 (Polyethylene Glycol 12-hydroxy stearic acid ester, polyethylene glycol 660 hydroxystearate): vitamin E polyethylene glycol succinic acid ester (TPGS) is 1: 1～50: 1～100: 1～50: 1～30: 0～30: 0～30.
10, a kind of vitamin K as claimed in claim 1 1The preparation method of preparation, it is characterized in that: take by weighing gelatin and add in the 100L rustless steel colloidal sol retort, it is airtight to add suitable quantity of water under stirring again, treat that gelatin dissolves the back fully and adds glycerol, an amount of antiseptic, add opacifier, coloring agent in case of necessity, stir, vacuumize degassing 2 hours, put into 65 ℃～75 ℃ insulations of gelatin heat-preserving container standing over night, stand-by;
Under room temperature, suspending agent is added in the diluent, take by weighing vitamin K 1With mixing diluents, treat to add antioxidant behind the complete mixing, stir, room temperature leaves standstill;
The gelatin heat-preserving container is hung certain altitude, and the medicinal liquid for preparing is poured in the medicinal liquid bucket, changes mould and begins to press soft capsule, drying at room temperature two days, the soft gelatin capsule of rejecting outward appearance matter difference washs soft gelatin capsule, again in 20～34 ℃, relative humidity 20%～50% dry two days, vitamin K 1The soft capsule semi-finished product, are labelled, are packed at the packing of the qualified back of quality testing, promptly get vitamin K 1The soft capsule finished product.
CN 200410020949 2004-07-09 2004-07-09 Prescription of liquid status of Vitamin K1 and its preparation Pending CN1593393A (en)

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Application Number Priority Date Filing Date Title
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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101919831B (en) * 2007-08-15 2012-02-29 四川科伦药业股份有限公司 Method for inhibiting content decrease of Vit K1 after sterilization
CN102688191A (en) * 2012-06-20 2012-09-26 广州安健实业发展有限公司 Medicine composition containing vitamin K1 and oil
CN102697719A (en) * 2012-06-20 2012-10-03 广州安健实业发展有限公司 Oily drug composition containing vitamin K1
CN108272752A (en) * 2018-03-23 2018-07-13 广西铭磊维生药业有限公司 A kind of farnoquinone drops and preparation method thereof
CN108272751A (en) * 2018-03-23 2018-07-13 广西铭磊维生药业有限公司 A kind of vitamin K drops and preparation method thereof
CN108309951A (en) * 2018-03-23 2018-07-24 广西铭磊维生药业有限公司 A kind of vitamin K1 drops and preparation method thereof
CN111374982A (en) * 2020-02-27 2020-07-07 佛山手心制药有限公司 Pharmaceutical composition for eliminating phlegm and relieving asthma and application thereof

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101919831B (en) * 2007-08-15 2012-02-29 四川科伦药业股份有限公司 Method for inhibiting content decrease of Vit K1 after sterilization
CN102688191A (en) * 2012-06-20 2012-09-26 广州安健实业发展有限公司 Medicine composition containing vitamin K1 and oil
CN102697719A (en) * 2012-06-20 2012-10-03 广州安健实业发展有限公司 Oily drug composition containing vitamin K1
CN108272752A (en) * 2018-03-23 2018-07-13 广西铭磊维生药业有限公司 A kind of farnoquinone drops and preparation method thereof
CN108272751A (en) * 2018-03-23 2018-07-13 广西铭磊维生药业有限公司 A kind of vitamin K drops and preparation method thereof
CN108309951A (en) * 2018-03-23 2018-07-24 广西铭磊维生药业有限公司 A kind of vitamin K1 drops and preparation method thereof
CN111374982A (en) * 2020-02-27 2020-07-07 佛山手心制药有限公司 Pharmaceutical composition for eliminating phlegm and relieving asthma and application thereof

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