CN108272752A - A kind of farnoquinone drops and preparation method thereof - Google Patents
A kind of farnoquinone drops and preparation method thereof Download PDFInfo
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- CN108272752A CN108272752A CN201810243606.6A CN201810243606A CN108272752A CN 108272752 A CN108272752 A CN 108272752A CN 201810243606 A CN201810243606 A CN 201810243606A CN 108272752 A CN108272752 A CN 108272752A
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- farnoquinone
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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
- A61K9/08—Solutions
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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
- A61K31/12—Ketones
- A61K31/122—Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
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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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
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Abstract
The present invention relates to a kind of farnoquinone drops, are prepared by the following raw material：Farnoquinone, medium chain triglyceride, conjugated linoleic acid, alginate, tragacanth, antioxidant, emulsifier.The present invention also provides the preparation methods of this farnoquinone drops.Farnoquinone drops provided by the invention is suitable for infant replenishing vitamins K2, and dosage is accurate, easy to use.
Description
Technical field
The present invention relates to drug fields, and in particular to a kind of farnoquinone drops and preparation method thereof.
Background technology
Vitamin K is one of indispensable important vitamin in human body.However due to vitamin K and intestines in many foods
Road bacterium can generate vitamin K, and health adult remembers that older children will not generally supply lacking for insufficient generation vitamin K because of diet
It is weary.But ewborn infant is easy to happen out because because physical efficiency enteric bacteria is less, causing endogenous microbes vitamin K insufficient in vivo
Blood.The breakthrough of Serum Vitamin K and protein induced by vitamin K absence Ⅱ detection technique in recent years reports numerous in succession both at home and abroad
The article to cause bleeding by the shortage of vitamin K in relation to baby, it is believed that the shortage of vitamin K be worldwide baby's hemorrhagic disease and
Dead major reason.Vitamin K preparation can effectively restore factor to normal level and control bleeding.
The preparation of current replenishing vitamins K single on the market is less, and generally tablet, adult type soft capsule and injection
Agent.And the dosage of tablet and soft capsule is not suitable for being applied to infant, only injection agent dose is accurate, but injection application is not square
Just, safety is not as good as oral preparation.
Invention content
In view of the above-mentioned defects in the prior art, the object of the present invention is to provide one kind being suitable for infant's replenishing vitamins
K2, and dosage is accurate, farnoquinone drops easy to use；
It is a further object of the present invention to provide a kind of preparation methods of farnoquinone drops.
The purpose of the present invention is what is realized by following technical solution：
Farnoquinone drops of the present invention, it is prepared by the raw material of following parts by weight：
10-13 parts of farnoquinone, 60-78 parts of medium chain triglyceride, 25-38 parts of conjugated linoleic acid, 1-3 parts of alginate,
Tragacanth 3-7,0.2-0.5 parts of antioxidant, 0.5-2 parts of emulsifier.
Preferably：
11-12 parts of farnoquinone, 65-70 parts of medium chain triglyceride, 28-32 parts of conjugated linoleic acid, 1-2 parts of alginate,
Tragacanth 4-6,0.3-0.4 parts of antioxidant, 1-1.5 parts of emulsifier.
Preferably, the alginate is sodium alginate and/or potassium alginate.
The antioxidant is in butylhydroxy anisaldehyde, dibutyl hydroxy toluene, Vitamin C palmitate, sodium ascorbate
One or more kinds of mixtures.
The emulsifier is polyglyceryl fatty acid ester, Tween-80, citric acid fatty acid glycerine
One or more kinds of mixtures in ester.
The farnoquinone drops, preparation method includes the following steps：
(1) farnoquinone is added in medium chain triglyceride, tragacanth is added under conditions of temperature is 38-42 DEG C and stirs
It mixes uniformly, is cooled to room temperature, obtains mixed liquor A；
(2) conjugated linoleic acid and alginate are added in mixed liquor A at room temperature, are stirred evenly；
(3) antioxidant and emulsifier are continuously added, is stirred evenly, mixed oil liquid is obtained.
The farnoquinone drops, preparation method are further comprising the steps of：
It will be prepared into capsule-type drops in the mixed oil liquid injection capsule skin of gained.
It, will more with caution, in the present invention for the selection of auxiliary material as infant's oral medication：
Medium chain triglyceride：As solvent, compared with common grease and hydrogenated oil and fat, medium chain triglyceride unsaturated lipid
The content of fat acid is extremely low, and oxidation stability is very good, is entirely odorless, colourless transparency liquid；Since its carbochain is short, so,
Its emulsion stability, dissolubility, extensibility and lubricity is better than common grease, is functionality nontoxic, that safety is high
Grease.
Conjugated linoleic acid：Can not only be used for solvent and nutrient needed by human, can enhance human body oxidation resistance and
Immunocompetence, enhancing development.
Alginate：The emulsifier and thickener of food-grade, it is nontoxic.
Tragacanth：Odorless, tasteless, mouthfeel stick-slip coordinate with alginate, assign the glutinous profit of solution, suitable for baby mouth
Sense, and have emulsification, the effect of stablizing solution state concurrently.
Antioxidant selected by the present invention and emulsifier are drops auxiliary material specified in health products systems for recording, as baby
The auxiliary material of child's medication is safe and stable.
A kind of farnoquinone drops provided by the invention and preparation method thereof has the following advantages：
1, farnoquinone drops provided by the invention is designed for infant, and dosage and dosage form have fully considered baby children
Suitability, accuracy and the convenience of youngster's medication can safely and effectively supplement the K2 elements of infant's shortage；
2, the invention coordinates medium chain triglyceride and conjugated linoleic acid jointly, as farnoquinone drops
Solvent, not only palatability is good, and each side's surface properties of drops are superior, and can also supplement substance necessary to infant's body simultaneously,
Enhance the oxidation resistance and immunocompetence of human body, enhancing development；
3, the addition sequence of supplementary material has a significant impact to the stability of preparation, the preparation method of farnoquinone of the present invention,
Farnoquinone, medium chain triglyceride and tragacanth are stirred evenly in suitable temperature range first, increases farnoquinone and exists
Solubility in solvent, reaches a dissolution equilibrium, adds conjugated linoleic acid and alginate, does not just interfere with dimension life so
Plain K2 is eventually adding emulsifier and antioxidant, further improves oiliness in the stability and dissolubility of two kinds of in the mixed solvents
The stability of solvent and the stability of farnoquinone.
Specific implementation mode
It is further illustrated the present invention below by embodiment.It should be understood that the embodiment of the present invention is for illustrating
The present invention is rather than limiting the invention.The simple modifications that essence according to the present invention carries out the present invention belong to the present invention
Claimed range.
Embodiment 1
Farnoquinone drops of the present invention, it is prepared by the following raw material and auxiliary material：
Farnoquinone 10g, medium chain triglyceride 60g, conjugated linoleic acid 38g, sodium alginate 1g, tragacanth 3g, butyl
Hydroxyl anisaldehyde 0.2g, polyglyceryl fatty acid ester 0.5g.
The farnoquinone drops, preparation method includes the following steps：
(1) farnoquinone is added in medium chain triglyceride, tragacanth stirring is added under conditions of temperature is 38 DEG C
Uniformly, it is cooled to room temperature, obtains mixed liquor A；
(2) conjugated linoleic acid and sodium alginate are added in mixed liquor A at room temperature, are stirred evenly；
(3) butylhydroxy anisaldehyde and polyglyceryl fatty acid ester are continuously added, is stirred evenly, mixed oil liquid is obtained.
Embodiment 2
Farnoquinone drops of the present invention, it is prepared by the following raw material and auxiliary material：
Farnoquinone 13g, medium chain triglyceride 78g, conjugated linoleic acid 25g, potassium alginate 3g, tragacanth 7g, two fourths
Base hydroxy-methylbenzene 0.5g, emulsifier 2g.
The emulsifier is the mixture of Tween-80, citric acid fatty glyceride.
The farnoquinone drops, preparation method includes the following steps：
(1) farnoquinone is added in medium chain triglyceride, tragacanth stirring is added under conditions of temperature is 42 DEG C
Uniformly, it is cooled to room temperature, obtains mixed liquor A；
(2) conjugated linoleic acid and potassium alginate are added in mixed liquor A at room temperature, are stirred evenly；
(3) dibutyl hydroxy toluene and Tween-80, citric acid fatty acid glycerine are continuously added
The mixture of ester, stirs evenly, and obtains mixed oil liquid.
Embodiment 3
Farnoquinone drops of the present invention, it is prepared by the following raw material and auxiliary material：
Farnoquinone 11g, medium chain triglyceride 65g, conjugated linoleic acid 32g, sodium alginate 1.2g, tragacanth 4g, resist
Oxygen agent 0.3g, citric acid fatty glyceride 1g.
The antioxidant is the mixture of Vitamin C palmitate, sodium ascorbate.
The farnoquinone drops, preparation method includes the following steps：
(1) farnoquinone is added in medium chain triglyceride, tragacanth stirring is added under conditions of temperature is 39 DEG C
Uniformly, it is cooled to room temperature, obtains mixed liquor A；
(2) conjugated linoleic acid and sodium alginate are added in mixed liquor A at room temperature, are stirred evenly；
(3) Vitamin C palmitate, the mixture of sodium ascorbate and citric acid fatty glyceride are continuously added, is stirred
Uniformly, mixed oil liquid is obtained；
(4) mixed oil liquid of gained is injected in capsule skin and is prepared into capsule-type drops.
Embodiment 4
Farnoquinone drops of the present invention, it is prepared by the following raw material and auxiliary material：
Farnoquinone 12, medium chain triglyceride 70g, conjugated linoleic acid 28g, potassium alginate 1.5g, tragacanth 6g, antioxygen
Agent 0.4g, emulsifier 1.5g.
The antioxidant is the mixture of Vitamin C palmitate, sodium ascorbate.
The emulsifier is the mixture of polyglyceryl fatty acid ester, Tween-80.
The farnoquinone drops, preparation method includes the following steps：
(1) farnoquinone is added in medium chain triglyceride, tragacanth stirring is added under conditions of temperature is 41 DEG C
Uniformly, it is cooled to room temperature, obtains mixed liquor A；
(2) conjugated linoleic acid and potassium alginate are added in mixed liquor A at room temperature, are stirred evenly；
(3) antioxidant and emulsifier are continuously added, is stirred evenly, mixed oil liquid is obtained；
(4) mixed oil liquid of gained is injected in capsule skin and is prepared into capsule-type drops.
Embodiment 5
Farnoquinone drops of the present invention, it is prepared by the following raw material and auxiliary material：
Farnoquinone 11.2g, medium chain triglyceride 68g, conjugated linoleic acid 30g, sodium alginate 2g, tragacanth 4g, fourth
Base hydroxyl anisaldehyde 0.35g, polyglyceryl fatty acid ester 1.5g.
The farnoquinone drops, preparation method includes the following steps：
(1) farnoquinone is added in medium chain triglyceride, tragacanth stirring is added under conditions of temperature is 40 DEG C
Uniformly, it is cooled to room temperature, obtains mixed liquor A；
(2) conjugated linoleic acid and sodium alginate are added in mixed liquor A at room temperature, are stirred evenly；
(3) butylhydroxy anisaldehyde and polyglyceryl fatty acid ester are continuously added, is stirred evenly, mixed oil liquid is obtained.
Embodiment 6
Clinical test
1, research object：Ewborn infant 120, gestational age 38-41 weeks, weight 2500g-4000g, Pure breast feeding, apgar
Scoring >=8, no congenital malformations and other important diseases.
2, experiment grouping：Randomized by 120 babies be divided into experimental group I (selective farnoquinone injection intervention group),
Three groups, each 40 of experimental group II (selective farnoquinone drops intervention group) and control group (conventional vitamin K2 intervention groups).It adopts
Collection baby's bleeding of the umbilicus 1ml is set in disinfection anticoagulant tube, carries out the detection of II concentration of blood plasma PIVKA-.
Three groups of whole 120 subjects measure II positives of bleeding of the umbilicus PIVKA- 52, positive rate 43.3% altogether.52 sun
The equal 64 μ g/ml of ＜ of II concentration of PIVKA- of property person；Experimental group I, experimental group II and II positives of control group bleeding of the umbilicus PIVKA- difference
It it is 17,17,18, positive rate is respectively 42.5%, 42.5%, 45%.The positive situations of three groups of bleeding of the umbilicus PIVKA- II are through system
Count credit analysis, no significant difference.
3, dosage regimen
Experimental group I:According to II testing results of bleeding of the umbilicus PIVKA-, it is resolved that each baby's vitamin K selective application is specific
Method.Specific method:1. the intervention of II positives of PIVKA-:The 1st day intramuscular injection farnoquinone injection 1mg that be born is primary, and the 10th
It rises and is changed to take orally, and farnoquinone tablet half is dissolved in water and feeds, about 2.5mg, and Isodose takes orally once × 9 times for every 10 days,
Totally 10 times；2. II negative patients of PIVKA-:21 negative patients not supplement；3. when baby (though its II concentration of PIVKA- normally with
It is no) there are special circumstances such as diarrhea, infection, disease in the liver and gallbladder etc., then additional replenishing vitamins K2 is primary；4. when there is allergic reaction
When, it is discontinued at once.
Experimental group II:According to II testing results of bleeding of the umbilicus PIVKA-, it is resolved that each baby's vitamin K selective application is specific
Method.Specific method:1. the intervention of II positives of PIVKA-:It being born the 1st day 5 drops of the oral embodiment of the present invention, 2ml is primary,
Isodose takes orally once × 9 times, 10 times totally for every 10 days from 10th day；2. II negative patients of PIVKA-:22 negative patients are not mended
It fills；3. when special circumstances such as diarrhea, infection, disease in the liver and gallbladder etc. occurs in baby (no matter its II concentration of PIVKA- normally whether), then
Additional replenishing vitamins K2 is primary；4. when there is allergic reaction, it is discontinued at once.
Control group:All 40 baby dues, first day conventional disposable intramuscular injection farnoquinone 1mg, are not mended again later
It fills.
4, it manages
The same day after selecting tested baby's last to take medicine draws blood review time on the 90th day after that is, raw for last, and with its 1/2
Age in days 45d is done to be checked for the first time.Three groups of II concentration of baby's venous blood blood plasma PIVKA- are detected, are observed in two different days three groups
II concentration of baby's blood plasma PIVKA- and its variation.The follow-up of all babies has special messenger to be responsible for, and whether there is or not bleeding, vitamin Ks to lack for observation
The abnormal conditions such as weary, infection simultaneously supervise dispensing situation.Without mixed feeding or artificial feeding situation in the babies 3 months of whole 120
Occur.
5, result
II positive events of blood plasma PIVKA- compare when 1 three groups of baby's different days of table
Three groups in different ways after replenishing vitamins K2, venous blood blood plasma PIVKA- II is positive when birth the 45th, 90 day, hair
Raw situation is in apparent difference, and experimental group I, experimental group II, control group positive rate are reduced to 2.5%, 0%, 35% respectively after 45d；
Three groups of positive rates are respectively 0%, 0%, 15% after 90d, experimental group I, II and control group difference have statistical significance, and try
It tests positive rate of the group II in 45d and has fallen to 0.In addition, during the experiment, control group and experimental group I have an example injection
After farnoquinone injection, there is allergic reaction, be discontinued immediately.By experimental result it is found that the drops of the embodiment of the present invention 5 with
Farnoquinone injection and tablet can be such that II positive rates of Neonates PIVKA- decline, but the effect of the present invention is more preferable, and
Occur when in use without allergic phenomena, safely and effectively.
Embodiment 7
Stability test
1, test method
Drops sample is placed under 4 DEG C of environment and is placed, the solution conditions after observing 0,1,2,3,6,12,18,24 month.
2, test specimen
Sample 1：Commercially available domestic farnoquinone drops
Sample 2：Commercially available Germany's production farnoquinone drops
Sample 3：2 drops of the embodiment of the present invention
3, test result
The observation result of 1 three kinds of samples of table
As seen from the results in Table 1, under low temperature, in three samples, the stability of sample 1 is worst, and stability of the invention is best,
Place 24 months still clears.
Claims (7)
1. a kind of farnoquinone drops, which is characterized in that it is prepared by the raw material of following parts by weight：
10-13 parts of farnoquinone, 60-78 parts of medium chain triglyceride, 25-38 parts of conjugated linoleic acid, 1-3 parts of alginate, west are yellow
Stilbene glue 3-7,0.2-0.5 parts of antioxidant, 0.5-2 parts of emulsifier.
2. farnoquinone drops as described in claim 1, which is characterized in that it is prepared by the raw material of following parts by weight
's：
11-12 parts of farnoquinone, 65-70 parts of medium chain triglyceride, 28-32 parts of conjugated linoleic acid, 1-2 parts of alginate, west are yellow
Stilbene glue 4-6,0.3-0.4 parts of antioxidant, 1-1.5 parts of emulsifier.
3. farnoquinone drops as claimed in claim 1 or 2, which is characterized in that the alginate be sodium alginate and/or
One kind in potassium alginate.
4. farnoquinone drops as claimed in claim 1 or 2, which is characterized in that the antioxidant be butylhydroxy anisaldehyde,
One or more kinds of mixtures in dibutyl hydroxy toluene, Vitamin C palmitate, sodium ascorbate.
5. farnoquinone drops as claimed in claim 1 or 2, which is characterized in that the emulsifier be polyglyceryl fatty acid ester,
One or more kinds of mixtures in Tween-80, citric acid fatty glyceride.
6. farnoquinone drops as claimed in claim 1 or 2, which is characterized in that preparation method includes the following steps：
（1）Farnoquinone is added in medium chain triglyceride, it is equal that tragacanth stirring is added under conditions of temperature is 38-42 DEG C
It is even, it is cooled to room temperature, obtains mixed liquor A；
（2）Conjugated linoleic acid and alginate are added in mixed liquor A at room temperature, stirred evenly；
（3）Antioxidant and emulsifier are continuously added, is stirred evenly, mixed oil liquid is obtained.
7. farnoquinone drops as claimed in claim 6, which is characterized in that preparation method is further comprising the steps of：
It will be prepared into capsule-type drops in the mixed oil liquid injection capsule skin of gained.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201810243606.6A CN108272752A (en) | 2018-03-23 | 2018-03-23 | A kind of farnoquinone drops and preparation method thereof |
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| CN201810243606.6A CN108272752A (en) | 2018-03-23 | 2018-03-23 | A kind of farnoquinone drops and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110898027A (en) * | 2019-12-12 | 2020-03-24 | 陕西鹤鸣健康科技有限公司 | Vitamin K2 (MK-7) soft capsule for promoting calcium in blood to enter bone and preparation method thereof |
| CN111602820A (en) * | 2020-05-28 | 2020-09-01 | 广州富诺营养科技有限公司 | Drop containing vitamin A and vitamin D and its preparation method |
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|---|---|---|---|---|
| JP2002104958A (en) * | 2000-09-29 | 2002-04-10 | Sumitomo Chem Co Ltd | Lipophilic vitamin preparation |
| CN1593393A (en) * | 2004-07-09 | 2005-03-16 | 沈阳药科大学 | Prescription of liquid status of Vitamin K1 and its preparation |
| 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 |
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2018
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| Publication number | Priority date | Publication date | Assignee | Title |
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| JP2002104958A (en) * | 2000-09-29 | 2002-04-10 | Sumitomo Chem Co Ltd | Lipophilic vitamin preparation |
| CN1593393A (en) * | 2004-07-09 | 2005-03-16 | 沈阳药科大学 | Prescription of liquid status of Vitamin K1 and its preparation |
| 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 |
| CN104825471A (en) * | 2015-04-16 | 2015-08-12 | 王冬 | Vitamin K2 soft capsule and manufacturing process thereof |
Non-Patent Citations (1)
| Title |
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| 张会丰，等: "维生素K滴剂口服改善新生儿维生素K缺乏状况的临床实验研究", 《中国儿童保健杂志》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110898027A (en) * | 2019-12-12 | 2020-03-24 | 陕西鹤鸣健康科技有限公司 | Vitamin K2 (MK-7) soft capsule for promoting calcium in blood to enter bone and preparation method thereof |
| CN111602820A (en) * | 2020-05-28 | 2020-09-01 | 广州富诺营养科技有限公司 | Drop containing vitamin A and vitamin D and its preparation method |
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Application publication date: 20180713 |