CN104825471A - Vitamin K2 soft capsule and manufacturing process thereof - Google Patents
Vitamin K2 soft capsule and manufacturing process thereof Download PDFInfo
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- CN104825471A CN104825471A CN201510182072.7A CN201510182072A CN104825471A CN 104825471 A CN104825471 A CN 104825471A CN 201510182072 A CN201510182072 A CN 201510182072A CN 104825471 A CN104825471 A CN 104825471A
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- vitamin
- soft capsule
- linoleic acid
- conjugated linoleic
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Abstract
The present invention relates to a vitamin K2 soft capsule and a manufacturing process thereof. The vitamin K2 soft capsule contains various vitamins the bones of the human being require. According to the specific technical solution of the invention, the vitamin K2 soft capsule contains a capsule shell and a content material solution inside the capsule shell. The content material solution comprises the following raw materials in part by weight: 0.098 part of vitamin K2, 0.24 part of vitamin D3 and 499.662 parts of conjugated linoleic acid. When the above raw materials are well weighed, the vitamin D3 and one-tenth amount of the above conjugated linoleic acid are mixed together to obtain a mixed oil I. After that, the mixed oil I is mixed with the vitamin K2 to obtain the mixed oil II. The rest conjugated linoleic acid is mixed with the mixed oil II to obtain a total mixed oil. The total mixed oil is subjected to the colloid mill firstly, and then is subjected to vacuum-pumping, degassing, and screening by a 100-mesh screen to obtain the content material solution. The above soft capsule is a compound functional product based on the medicine compatibility of vitamin K2, vitamin D3 and conjugated linoleic acid. In this way, the problem that each nutrient is unitary in function can be solved.
Description
Technical field
The present invention relates to a kind of vitamine soft capsule and processing technology.
Background technology
The whole world about has people more than 200,000,000 suffering osteoporosis the puzzlement of disease.In China, in more than 50 years old crowd there is Low BMD in about 21,390 ten thousand people, and in more than 60 years old crowd, suffer from osteoporosis close to four one-tenth, sickness rate occupies world's commonly encountered diseases the 4th.People engendered osteoporosis and sclerotin atrophy after 40 years old, and bone density reduces, and people's bone density of 70 years old is only equivalent to about 50% of nonage.With advancing age, due to vitamin D
3synthesis capability declines, and makes intestinal absorption calcium enter the scarce capacity of blood; And vitamin K
2shortage, calcareous being difficult to more making in blood enters skeleton deposition mineralising, and cause the loss of sclerotin to be accelerated, bone amount minimizing, makes skeleton become fragile, easily fracture.
At present, market is no lack of vitamin K
2deng the product of single component, although all have certain effect, limited use, is difficult to the needs meeting bone health.
Summary of the invention
In order to overcome the deficiencies in the prior art, the object of the present invention is to provide a kind of soft capsule and the processing technology that contain vitamin needed for multiple human body normal development of skeleton.
For solving the problem, the technical solution adopted in the present invention is as follows: a kind of vitamin K
2soft capsule, comprises the content feed liquid in softgel shell and softgel shell, and described content feed liquid is made up of the raw material of following weight parts: the vitamin K of 0.098 part
2, the vitamin D of 0.24 part
3and the conjugated linoleic acid of 499.662 parts.
Preferably: a kind of vitamin K as claimed in claim 1
2the processing technology of soft capsule, described content feed liquid is made by following steps:
Step one, takes vitamin K in proportion
2, vitamin D
3and conjugated linoleic acid is for subsequent use;
Step 2, gets vitamin D
3and 1/10 component conjugated linoleic acid mixing, obtain mixed oil liquid I;
Step 3, mixed oil liquid I and vitamin K
2mixing, obtains mixed oil liquid II;
Step 4, mixes remaining conjugated linoleic acid with mixed oil liquid II, obtains total contaminated product liquid;
Step 5, total contaminated product liquid first passes through colloid mill 2-3 time, then vacuumize degassing, finally crosses 100 eye mesh screens and obtains content feed liquid.
Preferably: foregoing a kind of vitamin K
2the processing technology of soft capsule, further comprising the steps of:
Step one, ratio takes the making raw material of softgel shell by weight: the gelatin of 300 parts, the purified water of the glycerol of 120 parts and 300 parts;
Step 2, heats in glycerol, adding of purified water glue tank, adding gelatin, obtaining the glue for making softgel shell after melting under stirring, by its vacuumize degassing to without obvious bubble, then crosses after 100 eye mesh screens filter and puts into the insulation of glue bucket;
Step 3, is made into rubber after glue cooling, content feed liquid is infused between two-layer rubber, then is pressed into soft capsule by mould.
Preferably: further comprising the steps of: sent in rotating cage by the aforementioned soft capsule made and carry out drying setting, temperature is 18-24 degree, and relative humidity is 30%-45%, and the time is 3-4 hour.
Preferably: after soft capsule setting, the edible ethanol with 95% cleans the oil stain on soft capsule surface; Send into hothouse after having cleaned dry, the temperature of hothouse is 25-35 degree, relative humidity≤40%, and the time is 12-24 hour, treats that the pliability of soft capsule is suitable for, takes out.
Compared to existing technology, beneficial effect of the present invention is: the present invention relates to a kind ofly provides vitamine soft capsule needed for skeleton normal development and preparation method thereof, be a kind of nutritious foods for bone avoiding causing skeletal diseases to occur due to vitamin deficiency or loss, it is with vitamin K
2be equipped with quantitative vitamin D
3, conjugated linoleic acid is the compound nutritional formula of main component, utilize the synergism of each nutrient can promote calcareous absorption and utilization, and promote the mineralization process of skeleton, more be conducive to effective utilization of calcium and the full nutrition of skeleton, the present invention has positive effect for promotion skeleton health.Vitamin K
2, vitamin D
3with the compound recipe functional product that conjugated linoleic acid is compatible, solve the single defect of each nutrient effect and deficiency, represent main flow and the developing direction of bone health health food, there is unique advantage, wide market.
Accompanying drawing explanation
Fig. 1 is complete fabrication processing figure of the present invention.
Detailed description of the invention
Below in conjunction with the drawings and specific embodiments, the present invention is described in further detail.
A kind of vitamin K
2soft capsule, comprise the content feed liquid in softgel shell and softgel shell, wherein content feed liquid is made up of the raw material of following weight parts: the vitamin K of 0.098 part
2, the vitamin D of 0.24 part
3and the conjugated linoleic acid of 499.662 parts.
Research display, vitamin K
2can promote that the calcium ion in blood enters skeleton, form bone calcium.Vitamin K
2be multiple protein dependency vitamin in bone, increase the synthesis of osteoblast Bone Gla protein, meanwhile, the γ of Bone Gla protein Glutamic Acid base-carboxylated is rear just has biological effect, and carboxylated Bone Gla protein can be combined with Ca and hydroxyapatite, makes bone mineralising.And thisly carboxylatedly must have vitamin K
2participate in, therefore, vitamin K
2can treat and prevention of osteoporosis disease, increase bone density.
Vitamin D
3there is very important effect in the mineralization process of skeletal tissue in vivo: the absorption of human body to calcium, phosphorus can be improved, the level of plasma calcium and blood plasma phosphorus is reached capacity degree; Growth promoting effects and skeleton calcification, promote that tooth perfects; Increased the absorption of phosphorus by intestinal wall, and increase absorbing again of phosphorus by renal tubules; Maintain the normal level of citrate in blood; Prevent aminoacid from being lost by kidney.
Conjugated linoleic acid can promote that the type-1 insulin like growth factor (IGF-1) in body increases, and the latter can promote the formation of bone matrix.Promote the formation of ossein, thus reduce the absorption of bone, improve bone density, enhances skeletal toughness, promote the formation of skeleton, the generation of releasing osteoporosis disease.Conjugated linoleic acid has obvious non-oxidizability, can protect vitamin K
2and vitamin D
3structure and stable in properties, penetration enhancement, be conducive to preserve.
Vitamin K
2, vitamin D
3with conjugated linoleic acid three mutual synergism in calcium metabolism, bone formation, raising bone density etc., more remarkable than single component effect.Meanwhile, vitamin K
2, vitamin D
3be fatsoluble vitamin, conjugated linoleic acid can promote both absorbing, and conjugated linoleic acid also has certain non-oxidizability, is conducive to vitamin K
2and vitamin D
3store and character stable.
The softgel shell of vitamine soft capsule can be in prior art conventional, the raw material of following weight portion also can be adopted to form: the gelatin of 300 parts, the glycerol of 120 parts, the purified water of 300 parts.Soft capsule shell is thick compared with hard capsule case, and elasticity is large, and plasticity is strong.The elasticity size of soft capsule depends on the weight ratio between gelatin in softgel shell, glycerol and purified water three, and the dry product weight of gelatin and glycerol determines the hardness of glue shell.Usually comparatively suitable weight ratio is glycerol: gelatin=0.4-0.6:1.0, and water is 1:1 with the ratio of gelatin.If glue shell hardens when the weight ratio between glycerol and gelatin is 0.3:1.0, if glue shell deliquescing during 0.8:1.In softgel shell, the proportioning of various material determines with requiring according to the character of medicine.Glycerol in this product softgel shell: gelatin is 0.4: 1, when gelatin is 1: 1 with the ratio of purified water, the hardness of glue shell is moderate, and elasticity is better, and disintegration conforms with the regulations.
As shown in Figure 1, with 1000 vitamin Ks
2soft capsule is example, takes: 0.098 gram of vitamin K
2, 0.24 gram of vitamin D
3, 499.662 grams of conjugated linoleic acids; 300 grams of gelatin, 120 grams of glycerol, 300 grams of purified water.
Content feed liquid is prepared: get vitamin D
3, 1/10 conjugated linoleic acid mixing, obtain mixed oil liquid I, then by the mixed oil liquid I that obtains and vitamin K
2mixing, mixes residue conjugated linoleic acid with mixed oil liquid II, and mixing, the time is preferably 30 minutes, obtains total contaminated product liquid.Pass through colloid mill 2 ~ 3 times again, vacuumize degassing 40min (-0.06Mpa to-0.08Mpa), crosses 100 mesh sieves, obtains content feed liquid.
Colloidal sol: by take glycerol, in adding of purified water glue tank, be heated to 70 DEG C, slowly gelatin is added under stirring, stirring, melting, evacuation (-0.06Mpa to-0.08Mpa) is degassed, extremely without obvious bubble, 100 eye mesh screens filter puts into the insulation of glue bucket, set temperature 60 DEG C, is incubated 3 hours, stand-by.
Pelleting: glue is made adhesive tape through cooling, the content feed liquid prepared quantitatively is injected between two layers of adhesive tape, the thickness of adjustment both sides adhesive tape, makes it be evenly arranged.Content feed liquid adds loading hopper, is pressed into soft capsule by the pressure of mould matched moulds, and every containing content feed liquid 0.5g.
Setting is dry: the soft capsule tape transport suppressed is shaped in rotating cage.Rotating cage temperature 18-24 DEG C, relative humidity 30%-45%, the time is about 3-4 hour.
Wash ball: the oil stain washing away soft capsule surface with 95% edible ethanol, proceeds to next procedure after qualified.95% ethanol meets regular grade standard in GB 10343-2002 " edible ethanol ".
Dry: to wash the soft capsule after ball and send into hothouse drying, preferably control hothouse temperature 25-35 DEG C, relative humidity≤40%, treat that the pliability of soft capsule is suitable for, stop dry, the time is 12-24 hour, also needs to regulate and control temperature, humidity at any time according to practical situation.
Pick ball: sort out the underproof soft capsule such as seepage, deformity, the certified products detected indicate the items such as numbering, title, specification, lot number, enter make-up room.
The cleanliness factor of aforementioned production process environment is 100,000 grades, meets GB 17405-1995 requirement.
Various oils can be filled in soft capsule.Soft capsule can cover the bad smell of raw material, reduces zest, and the stability increasing medicine prevents oxidation and the decomposition of some drugs; Bioavailability is high; Applied widely; Swallow conveniently, to the inflexible old man of swallowing act or child also very suitable.This product is soft capsule preparation, and filler should be liquid, considers the solute effect of raw material, selects conjugated linoleic acid to be Contents Fill agent.
The content feed liquid of soft capsule should be homogeneous, for ensureing the uniformity of feed liquid, fully need be mixed for 3 times by colloid mill; Feed liquid can be made to produce a small amount of bubble in feed liquid stirring, mixed process, so vacuum (-0.06Mpa to-0.08Mpa) is degassed again, to ensure the even of loading amount.
Vitamin K
2the laboratory report of soft capsule is as follows:
Sample, the vitamin K described in the present invention
2soft capsule 1kg, sample appearance is pale yellow oily liquid (soft capsule content feed liquid), and room temperature is preserved.Human body recommended dose is 0.5g/ people/day, not calcic in sampling, and belong to the sample based on not calcic, choosing is not tested, using vegetable oil as solvent based on the tested material of replenishing the calcium.
Laboratory animal and raising: SPF level female sd inbred rats 67 (the rat quality certification number: SCXK (river) 2008-24), by Chengdu, Da Shuo bio tech ltd provides.Animal feeding: animal is raised in barrier level (IVC) Animal House (credit number: No. 2011-011, management of laboratory animal committee of Sichuan Province SYXK (river)).In whole process of the test, animal freely ingests and drinks water, room temperature 21 DEG C-25 DEG C, relative humidity 50%-60%.
Feedstuff: normal feedstuff is provided by Da Shuo bio tech ltd, Chengdu.
Key instrument and reagent: atomic absorption spectrophotometer, single photon bone mineral instrument (SD-1000C), electronic balance.
Experimental technique: rat according to body weight, is divided into following six groups: sham operated rats, model control group, vegetable oil matched group, K after feeding with normal feedstuff adaptability at random
2soft capsule three dosage groups, every treated animal 10-12 only.
Sham operated rats: with 3% pentobarbital sodium intraperitoneal anesthesia, under strict aseptic technique, gets the other dorsal part two incision of lumbar vertebra and enters abdominal cavity, after extracing a little mesostenium, and carefully hemostasis layer-by-layer suture otch; Model control group, vegetable oil matched group and K
2soft capsule three dosage group operations: anesthesia is the same, under strict aseptic technique, remove the other dorsal part two incision of lumbar vertebra, enter abdominal cavity dorsal part, after complete excision bilateral ovaries, and carefully hemostasis layer-by-layer suture otch; Postoperative three days, sham-operation built-up pattern matched group one distilled water gavage; Vegetable oil matched group pours into solvent control vegetable oil by 5ml/kg.bw per os.K
2soft capsule three dosage groups, namely 41.67mg/kg.bw group, 83.33mg/kg.bw combine 250mg/kg.bw group and (are equivalent to vitamin K respectively
25,10 and 30 times of soft capsule human intaking amount 8.33mg/kg.bw), with the sample liquid gavage (preparation of gavage liquid: get vitamin K respectively of preparing
2soft capsule 0.833g, 1.667g, 5g, add vegetable oil and be settled to 100ml, is mixed with the gavage liquid of 41.67mg/kg.bw, 83.33mg/kg.bw, 250mg/kg.bw).All animal gavage amounts are 5ml/kg.bw, and once a day, continuous gavage 90 days, weighs weekly and adjust gavage amount by body weight.Test last euthanasia and put to death animal, take out right side femur, in 105 DEG C of baking ovens, bake to constant weight, weigh bone weight.Rat fl sample adopts single photon bone mineral instrument (SD-1000C) to measure the bone density of central point and distal end.Adopt the right femur calcium content of atomic absorption spectroscopy determination.
Experimental data is added up: use PEMS3.1 statistical package, does t inspection and variance analysis to the group difference of each index.Heterogeneity of variance then adopts rank test to analyze.
Result:
Table 1 vitamin K
2the impact that soft capsule weighs rat body weight, bone
#, compares P<0.01 with sham operated rats
From table 1, body weight there was no significant difference (P>0.05) before each group experiment; Experiment mid-term and latter stage, model control group body weight is significantly higher than sham operated rats (P<0.01), illustrates that castration model is successfully set up.The right femur bone of model control group weighs and sham operated rats there was no significant difference (P>0.05).Vitamin K
2the body weight of soft capsule three dosage groups, right femur bone are heavy with vegetable oil matched group with model control group there are no significant difference (P>0.05).
Table 2 vitamin K
2the impact of Capsule in Rats bone density and calcium content of bone
# compares P<0.05 with sham operated rats, ★ ★ compares P<0.01 with vegetable oil matched group, ★ P<0.05, ▲ ▲ compare P<0.01 with model control group, ▲, P<0.05.
From table 2, model control group fl distal end bone density and right bone calcium content of femur all remarkable in sham operated rats (P<0.05), explanation modeling success, all comparatively model control group and vegetable oil matched group obviously increase (P<0.05 to the fl distal end bone density of each dosage group of tested material, P<0.01), the right bone calcium content of femur of tested material each dosage group all comparatively model control group obviously increases (P<0.01), difference (P>0.05) that fl central point bone density compares with two matched groups that there are no significant.
Can be found out by experiment, vitamin K
2bone density and the calcium content of bone of each dosage group of soft capsule are all significantly higher than matched group, and have no adverse effects to growth promoter, have the function increasing bone density.
Above-mentioned embodiment is only the preferred embodiment of the present invention; can not limit the scope of protection of the invention with this, change and the replacement of any unsubstantiality that those skilled in the art does on basis of the present invention all belong to the present invention's scope required for protection.
Claims (5)
1. a vitamin K soft capsule, comprise the content feed liquid in softgel shell and softgel shell, it is characterized in that: described content feed liquid is made up of the raw material of following weight parts: the vitamin K of 0.098 part, the conjugated linoleic acid of the vitamin D of 0.24 part and 499.662 parts.
2. a processing technology for vitamin K soft capsule as claimed in claim 1, is characterized in that: described content feed liquid is made by following steps:
Step one, takes vitamin K, vitamin D and conjugated linoleic acid for subsequent use in proportion;
Step 2, gets the conjugated linoleic acid mixing of vitamin D and 1/10 component, obtains mixed oil liquid I;
Step 3, mixed oil liquid I mixes with vitamin K, obtains mixed oil liquid II;
Step 4, mixes remaining conjugated linoleic acid with mixed oil liquid II, obtains total contaminated product liquid;
Step 5, total contaminated product liquid first passes through colloid mill 2-3 time, then vacuumize degassing, finally crosses 100 eye mesh screens and obtains content feed liquid.
3. the processing technology of a kind of vitamin K soft capsule as claimed in claim 2, is characterized in that: further comprising the steps of:
Step one, ratio takes the making raw material of softgel shell by weight: the gelatin of 300 parts, the purified water of the glycerol of 120 parts and 300 parts;
Step 2, heats in glycerol, adding of purified water glue tank, adding gelatin, obtaining the glue for making softgel shell after melting under stirring, by its vacuumize degassing to without obvious bubble, then crosses after 100 eye mesh screens filter and puts into the insulation of glue bucket;
Step 3, is made into rubber after glue cooling, content feed liquid is infused between two-layer rubber, then is pressed into soft capsule by mould.
4. the processing technology of a kind of vitamin K soft capsule as claimed in claim 3, further comprising the steps of: sent into by soft capsule in rotating cage and carry out drying setting, temperature is 18-24 degree, and relative humidity is 30%-45%, and the time is 3-4 hour.
5. the processing technology of vitamin K soft capsule as claimed in claim 4, further comprising the steps of: after soft capsule setting, with the oil stain on the edible ethanol cleaning soft capsule surface of 95%; Send into hothouse after having cleaned dry, the temperature of hothouse is 25-35 degree, relative humidity≤40%, and the time is 12-24 hour, treats that the pliability of soft capsule is suitable for, takes out.
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Cited By (6)
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| 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 |
| CN109602020A (en) * | 2018-12-26 | 2019-04-12 | 广东润源中天生物科技有限公司 | A kind of vitamin K soft capsule and preparation method thereof |
| CN113115954A (en) * | 2019-12-31 | 2021-07-16 | 北京司晨扬帆国际管理咨询有限公司 | Calcium vitamin D3Vitamin K2Health food and its preparation method |
| CN115154448A (en) * | 2022-08-04 | 2022-10-11 | 谭竞 | Medicine for treating restless legs syndrome and preparation method and application thereof |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
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| 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 |
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| CN109602020A (en) * | 2018-12-26 | 2019-04-12 | 广东润源中天生物科技有限公司 | A kind of vitamin K soft capsule and preparation method thereof |
| CN113115954A (en) * | 2019-12-31 | 2021-07-16 | 北京司晨扬帆国际管理咨询有限公司 | Calcium vitamin D3Vitamin K2Health food and its preparation method |
| CN115154448A (en) * | 2022-08-04 | 2022-10-11 | 谭竞 | Medicine for treating restless legs syndrome and preparation method and application thereof |
| CN115154448B (en) * | 2022-08-04 | 2024-01-30 | 谭竞 | Medicine for treating restless leg syndrome and preparation method and application thereof |
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