CN112494466A - Preparation process of eye-protecting soft capsule - Google Patents
Preparation process of eye-protecting soft capsule Download PDFInfo
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- CN112494466A CN112494466A CN202011456039.6A CN202011456039A CN112494466A CN 112494466 A CN112494466 A CN 112494466A CN 202011456039 A CN202011456039 A CN 202011456039A CN 112494466 A CN112494466 A CN 112494466A
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- 239000007901 soft capsule Substances 0.000 title claims abstract description 34
- 238000002360 preparation method Methods 0.000 title claims abstract description 12
- 239000006187 pill Substances 0.000 claims abstract description 44
- 235000012680 lutein Nutrition 0.000 claims abstract description 28
- 229960005375 lutein Drugs 0.000 claims abstract description 28
- 239000001656 lutein Substances 0.000 claims abstract description 28
- KBPHJBAIARWVSC-RGZFRNHPSA-N lutein Chemical compound C([C@H](O)CC=1C)C(C)(C)C=1\C=C\C(\C)=C\C=C\C(\C)=C\C=C\C=C(/C)\C=C\C=C(/C)\C=C\[C@H]1C(C)=C[C@H](O)CC1(C)C KBPHJBAIARWVSC-RGZFRNHPSA-N 0.000 claims abstract description 28
- ORAKUVXRZWMARG-WZLJTJAWSA-N lutein Natural products CC(=C/C=C/C=C(C)/C=C/C=C(C)/C=C/C1=C(C)CCCC1(C)C)C=CC=C(/C)C=CC2C(=CC(O)CC2(C)C)C ORAKUVXRZWMARG-WZLJTJAWSA-N 0.000 claims abstract description 28
- KBPHJBAIARWVSC-XQIHNALSSA-N trans-lutein Natural products CC(=C/C=C/C=C(C)/C=C/C=C(C)/C=C/C1=C(C)CC(O)CC1(C)C)C=CC=C(/C)C=CC2C(=CC(O)CC2(C)C)C KBPHJBAIARWVSC-XQIHNALSSA-N 0.000 claims abstract description 28
- FJHBOVDFOQMZRV-XQIHNALSSA-N xanthophyll Natural products CC(=C/C=C/C=C(C)/C=C/C=C(C)/C=C/C1=C(C)CC(O)CC1(C)C)C=CC=C(/C)C=CC2C=C(C)C(O)CC2(C)C FJHBOVDFOQMZRV-XQIHNALSSA-N 0.000 claims abstract description 28
- 108010010803 Gelatin Proteins 0.000 claims abstract description 25
- 229920000159 gelatin Polymers 0.000 claims abstract description 25
- 239000008273 gelatin Substances 0.000 claims abstract description 25
- 235000019322 gelatine Nutrition 0.000 claims abstract description 25
- 235000011852 gelatine desserts Nutrition 0.000 claims abstract description 25
- 238000001035 drying Methods 0.000 claims abstract description 17
- 238000002844 melting Methods 0.000 claims abstract description 17
- 230000008018 melting Effects 0.000 claims abstract description 17
- 239000000463 material Substances 0.000 claims abstract description 8
- 238000004806 packaging method and process Methods 0.000 claims abstract description 7
- 238000003825 pressing Methods 0.000 claims abstract description 7
- 239000003292 glue Substances 0.000 claims description 50
- 235000019198 oils Nutrition 0.000 claims description 36
- GVJHHUAWPYXKBD-UHFFFAOYSA-N (±)-α-Tocopherol Chemical compound OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 claims description 30
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 30
- 238000003756 stirring Methods 0.000 claims description 30
- 238000010438 heat treatment Methods 0.000 claims description 25
- 239000007788 liquid Substances 0.000 claims description 25
- 238000005303 weighing Methods 0.000 claims description 25
- 239000000243 solution Substances 0.000 claims description 22
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 claims description 20
- XLOMVQKBTHCTTD-UHFFFAOYSA-N Zinc monoxide Chemical compound [Zn]=O XLOMVQKBTHCTTD-UHFFFAOYSA-N 0.000 claims description 20
- 239000000049 pigment Substances 0.000 claims description 18
- MIDXCONKKJTLDX-UHFFFAOYSA-N 3,5-dimethylcyclopentane-1,2-dione Chemical compound CC1CC(C)C(=O)C1=O MIDXCONKKJTLDX-UHFFFAOYSA-N 0.000 claims description 17
- 235000013736 caramel Nutrition 0.000 claims description 17
- 235000012730 carminic acid Nutrition 0.000 claims description 17
- 239000004106 carminic acid Substances 0.000 claims description 17
- 229940080423 cochineal Drugs 0.000 claims description 17
- CYQFCXCEBYINGO-IAGOWNOFSA-N delta1-THC Chemical compound C1=C(C)CC[C@H]2C(C)(C)OC3=CC(CCCCC)=CC(O)=C3[C@@H]21 CYQFCXCEBYINGO-IAGOWNOFSA-N 0.000 claims description 17
- 235000020660 omega-3 fatty acid Nutrition 0.000 claims description 17
- 229940012843 omega-3 fatty acid Drugs 0.000 claims description 17
- 238000004519 manufacturing process Methods 0.000 claims description 16
- 239000000203 mixture Substances 0.000 claims description 16
- OCUCCJIRFHNWBP-IYEMJOQQSA-L Copper gluconate Chemical compound [Cu+2].OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O.OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O OCUCCJIRFHNWBP-IYEMJOQQSA-L 0.000 claims description 15
- 229930003427 Vitamin E Natural products 0.000 claims description 15
- 229940108925 copper gluconate Drugs 0.000 claims description 15
- WIGCFUFOHFEKBI-UHFFFAOYSA-N gamma-tocopherol Natural products CC(C)CCCC(C)CCCC(C)CCCC1CCC2C(C)C(O)C(C)C(C)C2O1 WIGCFUFOHFEKBI-UHFFFAOYSA-N 0.000 claims description 15
- 238000002156 mixing Methods 0.000 claims description 15
- 239000008213 purified water Substances 0.000 claims description 15
- 235000019165 vitamin E Nutrition 0.000 claims description 15
- 229940046009 vitamin E Drugs 0.000 claims description 15
- 239000011709 vitamin E Substances 0.000 claims description 15
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 15
- 238000007599 discharging Methods 0.000 claims description 12
- 238000000034 method Methods 0.000 claims description 12
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims description 10
- ZZZCUOFIHGPKAK-UHFFFAOYSA-N D-erythro-ascorbic acid Natural products OCC1OC(=O)C(O)=C1O ZZZCUOFIHGPKAK-UHFFFAOYSA-N 0.000 claims description 10
- 229930003268 Vitamin C Natural products 0.000 claims description 10
- 235000013871 bee wax Nutrition 0.000 claims description 10
- 239000012166 beeswax Substances 0.000 claims description 10
- 238000001914 filtration Methods 0.000 claims description 10
- 239000011259 mixed solution Substances 0.000 claims description 10
- 238000012858 packaging process Methods 0.000 claims description 10
- 239000011550 stock solution Substances 0.000 claims description 10
- 238000003860 storage Methods 0.000 claims description 10
- 235000020238 sunflower seed Nutrition 0.000 claims description 10
- 235000019154 vitamin C Nutrition 0.000 claims description 10
- 239000011718 vitamin C Substances 0.000 claims description 10
- 239000011787 zinc oxide Substances 0.000 claims description 10
- 239000000047 product Substances 0.000 claims description 9
- 238000004321 preservation Methods 0.000 claims description 6
- 239000002775 capsule Substances 0.000 claims description 5
- 238000001816 cooling Methods 0.000 claims description 5
- 238000011049 filling Methods 0.000 claims description 5
- 239000012535 impurity Substances 0.000 claims description 5
- 238000000465 moulding Methods 0.000 claims description 5
- 229910052757 nitrogen Inorganic materials 0.000 claims description 5
- 239000002244 precipitate Substances 0.000 claims description 5
- 230000008569 process Effects 0.000 claims description 5
- 238000007789 sealing Methods 0.000 claims description 5
- 238000007711 solidification Methods 0.000 claims description 5
- 230000008023 solidification Effects 0.000 claims description 5
- 238000012546 transfer Methods 0.000 claims description 5
- 239000002699 waste material Substances 0.000 claims description 5
- 229960001296 zinc oxide Drugs 0.000 claims description 5
- 230000000694 effects Effects 0.000 abstract description 5
- 230000003111 delayed effect Effects 0.000 abstract description 4
- 210000001525 retina Anatomy 0.000 abstract description 4
- 230000015556 catabolic process Effects 0.000 abstract description 3
- 238000006731 degradation reaction Methods 0.000 abstract description 3
- 230000004436 pseudomyopia Effects 0.000 abstract description 3
- 235000021323 fish oil Nutrition 0.000 abstract description 2
- 230000009978 visual deterioration Effects 0.000 abstract description 2
- 238000012360 testing method Methods 0.000 description 6
- 230000004438 eyesight Effects 0.000 description 5
- 230000000052 comparative effect Effects 0.000 description 3
- 238000007873 sieving Methods 0.000 description 3
- 230000008901 benefit Effects 0.000 description 2
- 239000003153 chemical reaction reagent Substances 0.000 description 2
- 230000007850 degeneration Effects 0.000 description 2
- -1 DHA unsaturated fatty acid Chemical class 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 235000021466 carotenoid Nutrition 0.000 description 1
- 150000001747 carotenoids Chemical class 0.000 description 1
- 239000013078 crystal Substances 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 230000035876 healing Effects 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 230000001590 oxidative effect Effects 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 239000013589 supplement Substances 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 235000021122 unsaturated fatty acids Nutrition 0.000 description 1
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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
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
- A61K31/047—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates having two or more hydroxy groups, e.g. sorbitol
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
- A61K31/202—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids having three or more double bonds, e.g. linolenic
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
- A61P27/10—Ophthalmic agents for accommodation disorders, e.g. myopia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
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- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Epidemiology (AREA)
- Ophthalmology & Optometry (AREA)
- Urology & Nephrology (AREA)
- Vascular Medicine (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses a preparation process of eye-protecting soft capsules, which comprises the following steps: preparing materials, melting gelatin, pressing into pills, drying, selecting pills, performing spot check and packaging. Under the precondition that main functional components, namely lutein and fish oil coexist, the degradation of the functional components is delayed by using a unique preparation process, the function of the functional components is greatly reserved, the effect is improved, the retina is protected, and the visual deterioration is delayed. The eye-protecting soft capsule of the invention is especially suitable for teenagers with pseudomyopia to take.
Description
Technical Field
The invention relates to the technical field of eye-protecting health products, in particular to a process for preparing an eye-protecting soft capsule.
Background
Lutein is the only carotenoid found in eye crystals, plays an important role in preventing lens oxidative degeneration, supplements lutein to benefit retina from pigment degeneration, and becomes the focus of recent eye protection products on how to continuously provide lutein required by eyes.
The retina contains rich DHA unsaturated fatty acid, the matching of the lutein and the Omega-3 fatty acid inevitably makes eye protection products more and more beautiful, and the Omega-3 fatty acid is very easy to oxidize and is rarely added into the lutein soft capsule products in the traditional soft capsule, so the invention provides the preparation process of the eye protection soft capsule, and the process not only can well match various raw materials, but also can greatly relieve the degradation of functional components and improve the efficacy.
Disclosure of Invention
Based on the technical problems in the background art, the invention provides a preparation process of an eye-protecting soft capsule.
The technical scheme adopted by the invention for solving the technical problems is as follows:
a process for preparing eye-protecting soft capsules comprises the following steps:
s1, mixing the materials according to the proportion;
a1, crushing copper gluconate twice by using a 80-mesh screen and sealing for later use;
b1, keeping out of the sun during the production of the lutein oil, and weighing the lutein oil after fully shaking up;
c1, ensuring that the natural vitamin E does not have flocculent precipitates, fully shaking up after solidification, and weighing;
d1, weighing beeswax according to the formula ratio, sunflower seed oil and natural vitamin E according to the formula ratio, heating the mixture in a heat-preservation barrel to 65-75 ℃ to completely dissolve the mixture to obtain a standby solution 1, and keeping the heating state;
e1, slowly adding Omega-3 fatty acid into the stock solution 1 for a plurality of times to obtain a stock solution 2, and stopping heating;
1, then quickly transferring the standby liquid 2 to a mixing tank, adding Omega-3 fatty acid while stirring, then sequentially adding copper gluconate, zinc oxide and vitamin C while stirring, adding lutein oil while stirring when cooling to a temperature below 35 ℃, stirring at a speed of 150-250rpm, starting the coin mill when the liquid is uniformly mixed, adding an 80-mesh filter bag at the outlet of a discharge pipeline of the coin mill, repeatedly passing through the coin mill if the content does not reach the fineness requirement, transferring the content to the mixing tank after ensuring that the content fineness reaches the requirement, vacuumizing for more than 60 minutes, filtering by 80 meshes, putting the content into a temporary storage barrel, homogenizing for 30-45 minutes by a rapid flow mixer, and hermetically filling nitrogen at normal temperature for storage to obtain the liquid;
s2 glue melting:
a2, weighing the caramel pigment and the cochineal in the formula amount, adding purified water in an amount which is 4-6 times the mass of the caramel pigment and the cochineal, uniformly stirring, and filtering by a 200-mesh sieve to obtain a mixed solution of the caramel pigment and the cochineal;
b2, weighing glycerol and purified water according to the formula proportion, adding the glycerol and the purified water into a gelatin melting tank, heating the mixture to 70-80 ℃, adding gelatin, keeping the negative pressure of the gelatin melting tank at the vacuum degree of not less than-0.06 MPa, and continuously heating the sol for 25-65 minutes, wherein the sol temperature is not more than 75 ℃;
c2, fully dissolving gelatin, adding the mixed solution of caramel pigment and cochineal, stirring uniformly, and vacuumizing at a vacuum degree of not less than-0.086 MPa for 30-60 min;
d2, after defoaming, preparing glue discharging at the viscosity of 23000-25000mpa.s measured at 58-62 ℃, passing the glue discharging through a double-layer 200-mesh sieve, transferring the glue discharging to a glue heat-insulating barrel, wherein the glue discharging pressure is not more than 0.04 MPa; after the glue is discharged, keeping the temperature of the glue solution at 59 +/-7 ℃, and keeping the temperature for 4-4.5 hours, and then entering the next procedure for use; keeping the temperature for no more than 24 hours to obtain glue solution;
s3, pelleting; the soft capsule is prepared by pressing and molding the feed liquid and the glue solution, and the technological parameters are as follows: the humidity between pelleting is less than or equal to 40 percent; the model of the mould is 9 OV; the thickness of the rubber is 0.80-0.90 mm; the setting time is 100-150 min; the seam rate is more than or equal to 40 percent; the internal control range of the contents is as follows: 0.640g-0.670 g;
s4, drying, wherein the specific parameters are as follows: the temperature of the drying room is 18-28 ℃; the humidity in the drying room is less than or equal to 30 percent; the hardness is 78-85;
s5, pill picking: sorting out waste pills such as special-shaped pills, oil leakage pills, bubble pills, impurity pills and the like, putting the qualified capsules into a clean transfer basket, and then transferring into a packaging process;
and S6, performing spot check and packaging.
Preferably, in step S1, the feed liquid is composed of the following components by weight percent: 0.5-1.5% of copper gluconate, 1.5-2.5% of zinc oxide, 20-30% of vitamin C, 5-8% of lutein oil, 3-8% of natural vitamin E, 4-8% of beeswax, 0.5-3.8% of sunflower seed oil and 40-60% of Omega-3 fatty acid.
Preferably, the manufacturing process is completed in a hundred thousand grade clean area.
Preferably, the temperature in the S3 is 18-28 ℃, and the relative humidity is less than or equal to 40%.
Preferably, the temperature in the S3 is 18-26 ℃, and the relative humidity is less than or equal to 30%.
Preferably, the soft capsules after pill picking are spot checked: and (4) informing QA of spot check of AQL of the qualified products after pill picking, and transferring to a packaging process after the AQL value is qualified.
The invention has the advantages that: the invention relates to a preparation process of eye-protecting soft capsules, which comprises the following steps: preparing materials, melting gelatin, pressing into pills, drying, selecting pills, performing spot check and packaging. Under the precondition that main functional components, namely lutein and fish oil coexist, the degradation of the functional components is delayed by using a unique preparation process, the function of the functional components is greatly reserved, the effect is improved, the retina is protected, and the visual deterioration is delayed. The eye-protecting soft capsule of the invention is especially suitable for teenagers with pseudomyopia to take.
Drawings
Fig. 1 is a process flow diagram of a specific embodiment of the process for preparing the eye-protecting soft capsule provided by the invention.
Detailed Description
The technical solution of the present invention will be further specifically described below by way of specific examples. It is to be understood that the practice of the invention is not limited to the following examples, and that any variations and/or modifications may be made thereto without departing from the scope of the invention. In the present invention, all parts and percentages are by weight, unless otherwise specified, and the equipment and materials used are commercially available or commonly used in the art. The methods in the following examples are conventional in the art unless otherwise specified.
The reagents used in the following examples, unless otherwise specified, were purchased from conventional biochemical reagent stores.
Example 1
A preparation process of an eye-protecting soft capsule comprises the following specific steps:
s1, mixing the materials according to the proportion;
a1, crushing copper gluconate twice by using a 80-mesh screen and sealing for later use;
b1, keeping out of the sun during the production of the lutein oil, and weighing the lutein oil after fully shaking up;
c1, ensuring that the natural vitamin E does not have flocculent precipitates, fully shaking up after solidification, and weighing;
d1, weighing beeswax according to the formula ratio, sunflower seed oil and natural vitamin E according to the formula ratio, heating the mixture in a heat-preservation barrel to 65-75 ℃ to completely dissolve the mixture to obtain a standby solution 1, and keeping the heating state;
e1, slowly adding Omega-3 fatty acid into the stock solution 1 for a plurality of times to obtain a stock solution 2, and stopping heating;
1, then quickly transferring the standby liquid 2 to a mixing tank, adding Omega-3 fatty acid, stirring while adding, then sequentially adding copper gluconate, zinc oxide and vitamin C, stirring while adding, adding lutein oil when cooling to a temperature below 35 ℃, stirring while adding, stirring at a speed of 220rpm, starting a coin mill when the liquid is uniformly mixed, adding an 80-mesh filter bag at a discharge pipeline opening of the coin mill, discharging the contents out of the fineness after the coin mill, if the fineness does not meet the requirement, repeatedly passing through the coin mill, ensuring that the fineness of the contents meets the requirement, transferring to the mixing tank, vacuumizing for more than 60 minutes, filtering by 80 meshes, putting into a temporary storage barrel, transferring to a rapid flow mixer for 35 minutes, and hermetically filling nitrogen at normal temperature for storage to obtain the liquid;
s2 glue melting:
a2, weighing the caramel pigment and the cochineal in the formula amount, adding 5 times of purified water by mass, uniformly stirring, and filtering by a 200-mesh sieve to obtain a mixed solution of the caramel pigment and the cochineal;
b2, weighing glycerol and purified water according to the formula proportion, adding the glycerol and the purified water into a gelatin melting tank, heating the mixture to 75 ℃, adding gelatin, keeping the negative pressure of the gelatin melting tank at the vacuum degree of not less than-0.06 MPa, dissolving the gelatin for 35 minutes, and continuously heating the sol, wherein the sol temperature is not more than 75 ℃;
c2, fully dissolving gelatin, adding the mixed solution of caramel pigment and cochineal, uniformly stirring, and vacuumizing at a vacuum degree of not less than-0.086 MPa for 45 minutes;
d2, when defoaming is completed, testing the viscosity at 60 ℃ of 2450 mpa.s, preparing glue, sieving the glue with a double-layer 200-mesh sieve, transferring the glue to a glue heat-insulating barrel, and ensuring that the glue discharging pressure does not exceed 0.04 MPa; after the glue is discharged, keeping the temperature of the glue solution at 59 +/-7 ℃, and keeping the temperature for 4.2 hours, and then entering the next procedure for use; keeping the temperature for no more than 24 hours to obtain glue solution;
s3, pelleting; the soft capsule is prepared by pressing and molding the feed liquid and the glue solution, and the technological parameters are as follows: the humidity between pelleting is less than or equal to 40 percent; the model of the mould is 9 OV; the thickness of the rubber is 0.87 mm; setting time is 120 min; the seam rate is more than or equal to 40 percent; the internal control range of the contents is as follows: 0.655 g;
s4, drying, wherein the specific parameters are as follows: the temperature of the drying room is 25 ℃; the humidity in the drying room is less than or equal to 30 percent; the hardness is 80;
s5, pill picking: sorting out waste pills such as special-shaped pills, oil leakage pills, bubble pills, impurity pills and the like, putting the qualified capsules into a clean transfer basket, and then transferring into a packaging process;
and S6, performing spot check and packaging.
In the step S1, the feed liquid is composed of the following components by weight percent: 1.23% of copper gluconate, 2.056% of zinc oxide, 27.228% of vitamin C, 5.469% of lutein oil, 4.825% of natural vitamin E, 6.406% of beeswax, 0.582% of sunflower seed oil and 52.204% of Omega-3 fatty acid.
The manufacturing process is completed in a hundred thousand grade clean area.
The temperature in the S3 is 20 ℃, and the relative humidity is less than or equal to 30%.
Performing spot check on the soft capsules after pill picking: and (4) informing QA of spot check of AQL of the qualified products after pill picking, and transferring to a packaging process after the AQL value is qualified.
Example 2
A preparation process of an eye-protecting soft capsule comprises the following specific steps:
s1, mixing the materials according to the proportion;
a1, crushing copper gluconate twice by using a 80-mesh screen and sealing for later use;
b1, keeping out of the sun during the production of the lutein oil, and weighing the lutein oil after fully shaking up;
c1, ensuring that the natural vitamin E does not have flocculent precipitates, fully shaking up after solidification, and weighing;
d1, weighing beeswax according to the formula ratio, sunflower seed oil and natural vitamin E according to the formula ratio, heating the mixture in a heat-preservation barrel to 65-75 ℃ to completely dissolve the mixture to obtain a standby solution 1, and keeping the heating state;
e1, slowly adding Omega-3 fatty acid into the stock solution 1 for a plurality of times to obtain a stock solution 2, and stopping heating;
1, then quickly transferring the standby liquid 2 to a mixing tank, adding Omega-3 fatty acid, stirring while adding, then sequentially adding copper gluconate, zinc oxide and vitamin C, stirring while adding, adding lutein oil after cooling to a temperature below 35 ℃, stirring while adding, stirring at a speed of 250rpm, starting a coin mill when the liquid is uniformly mixed, adding an 80-mesh filter bag at a discharge pipeline opening of the coin mill, discharging the contents out of the fineness after the coin mill, if the fineness does not meet the requirement, repeatedly passing through the coin mill, ensuring that the fineness of the contents meets the requirement, transferring to the mixing tank, vacuumizing for more than 60 minutes, filtering by 80 meshes, putting into a temporary storage barrel, transferring to a rapid flow mixer for 30 minutes, and hermetically filling nitrogen at normal temperature for storage to obtain the liquid;
s2 glue melting:
a2, weighing the caramel pigment and the cochineal in the formula amount, adding 6 times of purified water by mass, uniformly stirring, and filtering by a 200-mesh sieve to obtain a mixed solution of the caramel pigment and the cochineal;
b2, weighing glycerol and purified water according to the formula proportion, adding the glycerol and the purified water into a gelatin melting tank, heating the mixture to 70 ℃, adding gelatin, keeping the negative pressure of the gelatin melting tank at the vacuum degree of not less than-0.06 MPa, dissolving the gelatin for 65 minutes, and continuously heating the sol, wherein the sol temperature is not more than 75 ℃;
c2, fully dissolving gelatin, adding the mixed solution of caramel pigment and cochineal, uniformly stirring, and vacuumizing at a vacuum degree of not less than-0.086 MPa for 60 minutes;
d2, after defoaming, testing the viscosity at 58 ℃ to 24900mpa.s, preparing to discharge the glue, sieving the discharged glue by a double-layer 200-mesh sieve, transferring the glue to a glue heat-insulating barrel, and ensuring the glue discharge pressure not to exceed 0.04 MPa; after the glue is discharged, keeping the temperature of the glue solution at 59 +/-7 ℃, and keeping the temperature for 4 hours and then entering the next procedure for use; keeping the temperature for no more than 24 hours to obtain glue solution;
s3, pelleting; the soft capsule is prepared by pressing and molding the feed liquid and the glue solution, and the technological parameters are as follows: the humidity between pelleting is less than or equal to 40 percent; the model of the mould is 9 OV; the thickness of the rubber is 0.90 mm; setting time is 100 min; the seam rate is more than or equal to 40 percent; the internal control range of the contents is as follows: 0.670 g;
s4, drying, wherein the specific parameters are as follows: the temperature of the drying room is 18 ℃; the humidity in the drying room is less than or equal to 30 percent; the hardness is 78-85;
s5, pill picking: sorting out waste pills such as special-shaped pills, oil leakage pills, bubble pills, impurity pills and the like, putting the qualified capsules into a clean transfer basket, and then transferring into a packaging process;
and S6, performing spot check and packaging.
In the step S1, the feed liquid is composed of the following components by weight percent: 1.5% of copper gluconate, 1.5% of zinc oxide, 30% of vitamin C, 5% of lutein oil, 8% of natural vitamin E, 4% of beeswax, 3.8% of sunflower seed oil and 46.2% of Omega-3 fatty acid.
The manufacturing process is completed in a hundred thousand grade clean area.
The temperature in the S3 is 26 ℃, and the relative humidity is less than or equal to 30%.
Performing spot check on the soft capsules after pill picking: and (4) informing QA of spot check of AQL of the qualified products after pill picking, and transferring to a packaging process after the AQL value is qualified.
Example 3
A preparation process of an eye-protecting soft capsule comprises the following specific steps:
s1, mixing the materials according to the proportion;
a1, crushing copper gluconate twice by using a 80-mesh screen and sealing for later use;
b1, keeping out of the sun during the production of the lutein oil, and weighing the lutein oil after fully shaking up;
c1, ensuring that the natural vitamin E does not have flocculent precipitates, fully shaking up after solidification, and weighing;
d1, weighing beeswax according to the formula ratio, sunflower seed oil and natural vitamin E according to the formula ratio, heating the mixture in a heat-preservation barrel to 65-75 ℃ to completely dissolve the mixture to obtain a standby solution 1, and keeping the heating state;
e1, slowly adding Omega-3 fatty acid into the stock solution 1 for a plurality of times to obtain a stock solution 2, and stopping heating;
1, then quickly transferring the standby liquid 2 to a mixing tank, adding Omega-3 fatty acid, stirring while adding, then sequentially adding copper gluconate, zinc oxide and vitamin C, stirring while adding, adding lutein oil after cooling to a temperature below 35 ℃, stirring while adding, stirring at a speed of 150rpm, starting a coin mill when the liquid is uniformly mixed, adding an 80-mesh filter bag at a discharge pipeline opening of the coin mill, discharging the contents out of the fineness after the coin mill, if the fineness does not meet the requirement, repeatedly passing through the coin mill, ensuring that the fineness of the contents meets the requirement, transferring to the mixing tank, vacuumizing for more than 60 minutes, filtering with 80 meshes, putting into a temporary storage barrel, transferring to a rapid flow type homogenizing mixer for 45 minutes, and hermetically filling nitrogen at normal temperature for storage to obtain the liquid;
s2 glue melting:
a2, weighing the caramel pigment and the cochineal in the formula amount, adding 4 times of purified water by mass, uniformly stirring, and filtering by a 200-mesh sieve to obtain a mixed solution of the caramel pigment and the cochineal;
b2, weighing glycerol and purified water according to the formula proportion, adding the glycerol and the purified water into a gelatin melting tank, heating the mixture to 80 ℃, adding gelatin, keeping the negative pressure of the gelatin melting tank at the vacuum degree of not less than-0.06 MPa, dissolving the gelatin for 25 minutes, and continuously heating the sol, wherein the sol temperature is not more than 75 ℃;
c2, fully dissolving gelatin, adding the mixed solution of caramel pigment and cochineal, uniformly stirring, and vacuumizing at a vacuum degree of not less than-0.086 MPa for 60 minutes;
d2, after defoaming, testing the viscosity at 62 ℃ for 23150mpa.s, preparing to discharge the glue, sieving the discharged glue by a double-layer 200-mesh sieve, transferring the glue to a glue heat-preservation barrel, and ensuring that the glue discharge pressure does not exceed 0.04 MPa; after the glue is discharged, keeping the temperature of the glue solution at 59 +/-7 ℃, and keeping the temperature for 4.5 hours, and then entering the next procedure for use; keeping the temperature for no more than 24 hours to obtain glue solution;
s3, pelleting; the soft capsule is prepared by pressing and molding the feed liquid and the glue solution, and the technological parameters are as follows: the humidity between pelleting is less than or equal to 40 percent; the model of the mould is 9 OV; the thickness of the rubber is 0.80 mm; setting time is 150 min; the seam rate is more than or equal to 40 percent; the internal control range of the contents is as follows: 0.640 g;
s4, drying, wherein the specific parameters are as follows: the temperature of the drying room is 28 ℃; the humidity in the drying room is less than or equal to 30 percent; the hardness is 78-85;
s5, pill picking: sorting out waste pills such as special-shaped pills, oil leakage pills, bubble pills, impurity pills and the like, putting the qualified capsules into a clean transfer basket, and then transferring into a packaging process;
and S6, performing spot check and packaging.
In the step S1, the feed liquid is composed of the following components by weight percent: 1.23% of copper gluconate, 2.056% of zinc oxide, 27.228% of vitamin C, 5.469% of lutein oil, 4.825% of natural vitamin E, 6.406% of beeswax, 0.582% of sunflower seed oil and 52.204% of Omega-3 fatty acid.
The manufacturing process is completed in a hundred thousand grade clean area.
The temperature in the S3 is 18 ℃, and the relative humidity is less than or equal to 30 percent.
Performing spot check on the soft capsules after pill picking: and (4) informing QA of spot check of AQL of the qualified products after pill picking, and transferring to a packaging process after the AQL value is qualified.
Comparative example 1
The lutein oil in example 1 was removed, and the rest of the formulation and the manufacturing process were unchanged.
The beneficial effects of the present invention are further illustrated by clinical experiments as follows:
the test method comprises the following steps: in each example, 50 cases of pseudomyopia patients (12 to 16 years old, half of both men and women) with 0.8 to 0.9 vision were selected and tested, and the eye-protecting soft capsules obtained in examples 1 to 3 and comparative example 1 were used twice a day, morning and evening.
The test is carried out 30 days later, the number of the healed, effective, improved and ineffective patients is counted, and the total effective rate (%) is calculated. The therapeutic effect judgment standard is as follows: firstly, healing: the vision is recovered to 1.2 and above; secondly, effect is displayed: vision is restored to 1.0-1.2 (excluding 1.0 and 1.2); ③ improving: vision is restored to 0.95-1.0 (including 0.95 and 1.0); fourthly, invalidation: the vision is lower than 0.95.
The test results are shown in Table 1.
TABLE 1
| Patient (example) | Recovery method | Show effect | Improvement of life | Invalidation | The total effective rate% | Average number of days required to heal patient | |
| Example 1 | 50 | 28 | 15 | 7 | 0 | 100 | 15 |
| Example 2 | 50 | 29 | 13 | 8 | 0 | 100 | 12 |
| Example 3 | 50 | 24 | 15 | 11 | 0 | 100 | 17 |
| Comparative example 1 | 50 | 10 | 18 | 9 | 13 | 82 | 22 |
The test data show that the eye-protecting soft capsule has obvious curative effect.
The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art should be considered to be within the technical scope of the present invention, and the technical solutions and the inventive concepts thereof according to the present invention should be equivalent or changed within the scope of the present invention.
Claims (6)
1. A preparation process of an eye-protecting soft capsule is characterized by comprising the following steps:
s1, mixing the materials according to the proportion;
a1, crushing copper gluconate twice by using a 80-mesh screen and sealing for later use;
b1, keeping out of the sun during the production of the lutein oil, and weighing the lutein oil after fully shaking up;
c1, ensuring that the natural vitamin E does not have flocculent precipitates, fully shaking up after solidification, and weighing;
d1, weighing beeswax according to the formula ratio, sunflower seed oil and natural vitamin E according to the formula ratio, heating the mixture in a heat-preservation barrel to 65-75 ℃ to completely dissolve the mixture to obtain a standby solution 1, and keeping the heating state;
e1, slowly adding Omega-3 fatty acid into the stock solution 1 for a plurality of times to obtain a stock solution 2, and stopping heating;
1, then quickly transferring the standby liquid 2 to a mixing tank, adding Omega-3 fatty acid while stirring, then sequentially adding copper gluconate, zinc oxide and vitamin C while stirring, adding lutein oil while stirring when cooling to a temperature below 35 ℃, stirring at a speed of 150-250rpm, starting the coin mill when the liquid is uniformly mixed, adding an 80-mesh filter bag at the outlet of a discharge pipeline of the coin mill, repeatedly passing through the coin mill if the content does not reach the fineness requirement, transferring the content to the mixing tank after ensuring that the content fineness reaches the requirement, vacuumizing for more than 60 minutes, filtering by 80 meshes, putting the content into a temporary storage barrel, homogenizing for 30-45 minutes by a rapid flow mixer, and hermetically filling nitrogen at normal temperature for storage to obtain the liquid;
s2 glue melting:
a2, weighing the caramel pigment and the cochineal in the formula amount, adding purified water in an amount which is 4-6 times the mass of the caramel pigment and the cochineal, uniformly stirring, and filtering by a 200-mesh sieve to obtain a mixed solution of the caramel pigment and the cochineal;
b2, weighing glycerol and purified water according to the formula proportion, adding the glycerol and the purified water into a gelatin melting tank, heating the mixture to 70-80 ℃, adding gelatin, keeping the negative pressure of the gelatin melting tank at the vacuum degree of not less than-0.06 MPa, and continuously heating the sol for 25-65 minutes, wherein the sol temperature is not more than 75 ℃;
c2, fully dissolving gelatin, adding the mixed solution of caramel pigment and cochineal, stirring uniformly, and vacuumizing at a vacuum degree of not less than-0.086 MPa for 30-60 min;
d2, after defoaming, preparing glue discharging at the viscosity of 23000-25000mpa.s measured at 58-62 ℃, passing the glue discharging through a double-layer 200-mesh sieve, transferring the glue discharging to a glue heat-insulating barrel, wherein the glue discharging pressure is not more than 0.04 MPa; after the glue is discharged, keeping the temperature of the glue solution at 59 +/-7 ℃, and keeping the temperature for 4-4.5 hours, and then entering the next procedure for use; keeping the temperature for no more than 24 hours to obtain glue solution;
s3, pelleting; the soft capsule is prepared by pressing and molding the feed liquid and the glue solution, and the technological parameters are as follows: the humidity between pelleting is less than or equal to 40 percent; the model of the mould is 9 OV; the thickness of the rubber is 0.80-0.90 mm; the setting time is 100-150 min; the seam rate is more than or equal to 40 percent; the internal control range of the contents is as follows: 0.640g-0.670 g;
s4, drying, wherein the specific parameters are as follows: the temperature of the drying room is 18-28 ℃; the humidity in the drying room is less than or equal to 30 percent; the hardness is 78-85;
s5, pill picking: sorting out waste pills such as special-shaped pills, oil leakage pills, bubble pills, impurity pills and the like, putting the qualified capsules into a clean transfer basket, and then transferring into a packaging process;
and S6, performing spot check and packaging.
2. The process for making eye-protecting soft capsules according to claim 1, wherein the process is carried out in a clean zone of one hundred thousand grades.
3. The process for preparing an eye-protecting soft capsule of claim 1, wherein in step S1, the feed liquid comprises the following components by weight percent: 0.5-1.5% of copper gluconate, 1.5-2.5% of zinc oxide, 20-30% of vitamin C, 5-8% of lutein oil, 3-8% of natural vitamin E, 4-8% of beeswax, 0.5-3.8% of sunflower seed oil and 40-60% of Omega-3 fatty acid.
4. The process for preparing an eye-protecting soft capsule of claim 1, wherein the temperature in S3 is 18-28 ℃, and the relative humidity is less than or equal to 40%.
5. The process for preparing an eye-protecting soft capsule of claim 1, wherein the temperature in S3 is 18-26 ℃ and the relative humidity is less than or equal to 30%.
6. The process for making eye-protecting soft capsules according to claim 1, wherein the soft capsules after pill picking are spot checked: and (4) informing QA of spot check of AQL of the qualified products after pill picking, and transferring to a packaging process after the AQL value is qualified.
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| CN113412941A (en) * | 2021-07-06 | 2021-09-21 | 江苏艾兰得营养品有限公司 | Lutein astaxanthin capsule and preparation method thereof |
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