CN114568708B - Lactoferrin preparation and preparation method thereof - Google Patents
Lactoferrin preparation and preparation method thereof Download PDFInfo
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- CN114568708B CN114568708B CN202011383825.8A CN202011383825A CN114568708B CN 114568708 B CN114568708 B CN 114568708B CN 202011383825 A CN202011383825 A CN 202011383825A CN 114568708 B CN114568708 B CN 114568708B
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- lactoferrin
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- adhesive
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- CSSYQJWUGATIHM-IKGCZBKSSA-N l-phenylalanyl-l-lysyl-l-cysteinyl-l-arginyl-l-arginyl-l-tryptophyl-l-glutaminyl-l-tryptophyl-l-arginyl-l-methionyl-l-lysyl-l-lysyl-l-leucylglycyl-l-alanyl-l-prolyl-l-seryl-l-isoleucyl-l-threonyl-l-cysteinyl-l-valyl-l-arginyl-l-arginyl-l-alanyl-l-phenylal Chemical compound C([C@H](N)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CS)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)NCC(=O)N[C@@H](C)C(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CS)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](C)C(=O)N[C@@H](CC=1C=CC=CC=1)C(O)=O)C1=CC=CC=C1 CSSYQJWUGATIHM-IKGCZBKSSA-N 0.000 title claims abstract description 127
- 108010063045 Lactoferrin Proteins 0.000 title claims abstract description 118
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- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical group OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 12
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- 239000004480 active ingredient Substances 0.000 description 6
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 description 6
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- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 6
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- VQHSOMBJVWLPSR-JVCRWLNRSA-N lactitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@@H]1O[C@H](CO)[C@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-JVCRWLNRSA-N 0.000 description 3
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- HTTJABKRGRZYRN-UHFFFAOYSA-N Heparin Chemical compound OC1C(NC(=O)C)C(O)OC(COS(O)(=O)=O)C1OC1C(OS(O)(=O)=O)C(O)C(OC2C(C(OS(O)(=O)=O)C(OC3C(C(O)C(O)C(O3)C(O)=O)OS(O)(=O)=O)C(CO)O2)NS(O)(=O)=O)C(C(O)=O)O1 HTTJABKRGRZYRN-UHFFFAOYSA-N 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/17—Amino acids, peptides or proteins
- A23L33/19—Dairy proteins
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
- A23L29/03—Organic compounds
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
- A23L29/30—Foods or foodstuffs containing additives; Preparation or treatment thereof containing carbohydrate syrups; containing sugars; containing sugar alcohols, e.g. xylitol; containing starch hydrolysates, e.g. dextrin
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
- A23L29/30—Foods or foodstuffs containing additives; Preparation or treatment thereof containing carbohydrate syrups; containing sugars; containing sugar alcohols, e.g. xylitol; containing starch hydrolysates, e.g. dextrin
- A23L29/35—Degradation products of starch, e.g. hydrolysates, dextrins; Enzymatically modified starches
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
- A23L29/30—Foods or foodstuffs containing additives; Preparation or treatment thereof containing carbohydrate syrups; containing sugars; containing sugar alcohols, e.g. xylitol; containing starch hydrolysates, e.g. dextrin
- A23L29/37—Sugar alcohols
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/17—Amino acids, peptides or proteins
- A23L33/175—Amino acids
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Abstract
The invention relates to the technical field of foods and health-care foods, in particular to a lactoferrin preparation and a preparation method thereof. The invention relates to a lactoferrin preparation, which is mainly prepared from the following components in parts by weight: 3-5 parts of lactoferrin, 10-30 parts of skeleton supporting agent, 8-30 parts of adhesive and 2-4 parts of aromatic. The composition can better improve the immunity of human bodies through the coordination and coordination of the components, promote the iron absorption, quickly disintegrate within 10 seconds after entering the mouth, and is suitable for the old, children and people with dysphagia. And the lactoferrin preparation prepared by the preparation method can ensure that the content of the lactoferrin in the unit preparation is accurate and uniform.
Description
Technical Field
The invention relates to the technical field of foods and health-care foods, in particular to a lactoferrin preparation and a preparation method thereof.
Background
Lactoferrin (LF), also known as Lactotransferrin (LTF), is a multifunctional glycoprotein in transferrin. It is a globular glycoprotein with a molecular weight of 80kDa, which is widely present in various secretions such as milk, saliva, tears and nasal discharge, and also in neutrophils in the metaphase, and is secreted by some acinar cells. Lactoferrin may be extracted from milk or obtained using recombinant DNA technology. The human colostrum has the highest concentration of lactoferrin, followed by human milk, the lowest concentration in milk (150 mg/l). Lactoferrin not only participates in the transportation of iron, but also has powerful biological functions of broad-spectrum antibiosis, antioxidation, anticancer, immune system regulation and the like, and is listed in GB14880-2012 in China, national food safety Standard-food nutrient enhancer use Standard, 3 months and 30 days, and is considered as a food nutrient enhancer.
The prior commercial lactoferrin supplements are prepared by directly mixing lactoferrin into milk powder, and the technology can cause the uneven content of the lactoferrin in unit products, inaccurate dosage of each time and excessive or insufficient dosage, thereby affecting the action of the lactoferrin on human bodies.
In view of this, the present invention has been made.
Disclosure of Invention
The invention aims to provide a lactoferrin preparation, which can better strengthen the resistance of a human body, regulate the immunity of the human body and promote the iron absorption through the coordination and coordination of the components, and is particularly convenient to take without drinking water and can be dissolved in the mouth.
Another object of the present invention is to provide a method for preparing a lactoferrin preparation, which can make the lactoferrin content of a unit product accurate and uniform, and can avoid the occurrence of overdose or insufficient replenishment.
In order to achieve the above object of the present invention, the following technical solutions are specifically adopted:
the lactoferrin preparation is mainly prepared from the following components in parts by weight:
3-5 parts of lactoferrin, 10-30 parts of skeleton supporting agent, 8-30 parts of adhesive and 2-4 parts of aromatic.
Preferably, the composition is mainly prepared from the following components in parts by weight:
3.5 to 4.5 parts of lactoferrin, 15 to 25 parts of skeleton supporting agent, 15 to 25 parts of adhesive and 2 to 3 parts of aromatic.
Preferably, the backbone support comprises at least one of mannitol, glycine, maltitol, xylitol, lactitol and dextrin.
Preferably, the binder comprises gelatin and/or pullulan.
Preferably, the fragrance comprises a natural fragrance and/or a synthetic fragrance;
preferably, the raw materials of the flavoring agent include at least one of peppermint, strawberry and orange;
preferably, the raw materials of the lactoferrin preparation further comprise 400-470 parts of water.
Preferably, the dosage form of the lactoferrin formulation comprises a tablet.
A method of preparing a lactoferrin formulation as described above, comprising the steps of:
mixing the lactoferrin, the skeleton supporting agent, the adhesive and the aromatic with water, homogenizing and emulsifying, and pre-freezing and drying the homogenized and emulsified emulsion.
Preferably, the rotational speed of the homogenizing emulsification is 3000-5000 rpm, and the time is 30-60 min.
Preferably, the drying is vacuum freeze drying;
preferably, the vacuum freeze-drying comprises the steps of: freezing the emulsion at-28 to-35 ℃ for 30-65 min, keeping the temperature at-25 to 20 ℃ for 2-3 h, and keeping the temperature at 20 to 26 ℃ for 1.8-2.2 h;
preferably, the pre-freezing temperature is-80 to-100 ℃ and the time is 5 to 10 minutes.
Preferably, the method further comprises degassing the emulsified emulsion;
preferably, the degassing time is 8 to 12 minutes.
Compared with the prior art, the invention has the beneficial effects that:
(1) The lactoferrin preparation can better improve the immunity of human bodies and promote the iron absorption through the coordination and coordination of the components.
(2) The lactoferrin preparation prepared by the preparation method of the invention has accurate and uniform lactoferrin content of unit product, and can avoid the problems of overdose or insufficient replenishment.
Detailed Description
Embodiments of the present invention will be described in detail below with reference to examples, but it will be understood by those skilled in the art that the following examples are only for illustrating the present invention and should not be construed as limiting the scope of the present invention. The specific conditions are not noted in the examples and are carried out according to conventional conditions or conditions recommended by the manufacturer. The reagents or apparatus used were conventional products commercially available without the manufacturer's attention.
The lactoferrin preparation is mainly prepared from the following components in parts by weight:
3-5 parts of lactoferrin, 10-30 parts of skeleton supporting agent, 8-30 parts of adhesive and 2-4 parts of aromatic.
Lactoferrin is one of the components of the human immune system, it has antibacterial activity (antibacterial, antifungal), is part of the innate defenses, and is mainly present in mucous membranes. Lactoferrin protects infants from pathogens such as bacteria. Lactoferrin also interacts with DNA and RNA, polysaccharides and heparin and exhibits certain physiological functions in these receptor-ligand complexes.
Lactoferrin has the following effects: (1) pregnant and lying-in women: the pregnant and lying-in women can supplement lactoferrin, can improve the resistance of the pregnant and lying-in women, and can effectively prevent or treat bacterial and viral infections during pregnancy and lactation; meanwhile, promote iron absorption and prevent anemia of pregnant and lying-in women; (2) non-breast-fed, mixed-fed infants: lactoferrin is a core immunity protein in breast milk, and can help infants resist harmful microorganisms such as bacteria and viruses, and prevent common diseases of infants such as respiratory tract infection and diarrhea caused by the viruses; meanwhile, the infant's growth and development can be promoted, the hematopoietic function can be enhanced, a first defense line for healthy growth is constructed for the infant, and the ' baby who eats breast milk is ill ' is the reason. Therefore, when the formula milk powder is eaten by non-breast-fed infants and mixed-fed infants, the deficiency of the formula milk powder can be greatly improved by additionally supplementing lactoferrin, so that the nutritional ingredients of the formula milk powder tend to breast milk. (3) iron deficiency anemia: the lactoferrin can efficiently promote iron absorption, and clinical experiments prove that the absorption rate of the combined iron and the lactoferrin is 4 times that of pure iron supplement; the iron deficiency anemia person can reduce the intake of iron preparation and enhance the iron supplementing effect by taking lactoferrin together during iron supplementing, and simultaneously, the stimulation of iron to intestinal tracts can be obviously relieved due to the intake of the lactoferrin. (4) immunocompromised: most of weak and sick people have low resistance, and lactoferrin can help them to excite, build, repair and perfect immune systems and enhance disease resistance.
The lactoferrin preparation obtained by matching the components can better strengthen the immunity of human bodies and strengthen the iron supplementing effect.
In one embodiment, the lactoferrin may be 3-5 parts, 3.5 parts, 4 parts, 4.5 parts, or 5 parts.
In one embodiment, 10 to 30 parts of the skeletal support agent may be selected from 10 parts, 11 parts, 13 parts, 15 parts, 18 parts, 20 parts, 21 parts, 22 parts, 23 parts, 24 parts, 25 parts, 27 parts, and 30 parts.
In one embodiment, 8 to 30 parts of the adhesive may be selected from 8 parts, 9 parts, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 18.5 parts, 19 parts, 20 parts, 23 parts, 25 parts, 27 parts, or 30 parts.
In one embodiment, the fragrance is 2-4 parts, and 2 parts, 3 parts, or 4 parts may also be selected.
Preferably, the composition is mainly prepared from the following components in parts by weight:
3.5 to 4.5 parts of lactoferrin, 15 to 25 parts of skeleton supporting agent, 15 to 25 parts of adhesive and 2 to 3 parts of aromatic.
The immunity improving and iron supplementing effects of the lactoferrin preparation are further improved by further optimizing the proportion of each component.
Preferably, the backbone support comprises at least one of mannitol, glycine, maltitol, xylitol, lactitol and dextrin.
In one embodiment, the backbone support of the present invention is selected from mannitol and glycine.
In one embodiment, the backbone support of the present invention is selected from glycine, maltitol.
In one embodiment, the backbone support of the present invention is selected from maltitol and xylitol.
In one embodiment, the backbone support of the present invention is selected from maltitol, xylitol and lactitol.
Preferably, the binder comprises gelatin and/or pullulan.
The gelatin has the functions of absorbing water and supporting framework, after the gelatin particles are dissolved in water, the gelatin particles can be mutually attracted and interweaved to form a net structure of overlapped layers, and the net structure is condensed along with the temperature reduction, so that sugar and water are completely filled in a gel gap, and the soft candy can keep a stable form and is not deformed even if bearing a larger load.
Pullulan has the characteristics of good film forming, fiber forming, gas blocking, bonding, easy processing, no toxicity and the like.
Preferably, the fragrance comprises a natural fragrance and/or a synthetic fragrance.
Preferably, the raw materials of the flavoring agent include at least one of peppermint, strawberry and orange.
The invention can obtain lactoferrin preparations with different tastes by adopting different fragrances.
Preferably, the raw materials of the lactoferrin preparation further comprise 400-470 parts of water.
Preferably, the water is purified water.
Preferably, the dosage form of the lactoferrin formulation comprises a tablet.
The lactoferrin preparation can be in the form of a tablet, does not need to drink water when being taken, can be rapidly disintegrated within a few seconds after being taken, and is suitable for the old, children and people with dysphagia.
A method of preparing a lactoferrin formulation as described above, comprising the steps of:
mixing the lactoferrin, the skeleton supporting agent, the adhesive and the aromatic with water, homogenizing and emulsifying, and pre-freezing and drying the homogenized and emulsified emulsion.
In one embodiment, the binder is mixed with water, heated in a water bath, and stirred, followed by the lactoferrin, the skeletal support agent, and the fragrance.
Preferably, the temperature of the water bath is 48-52 ℃.
Preferably, the rotational speed of the emulsification is 3000-5000 rpm, and the time is 8-12 min.
In one embodiment, the speed of emulsification is 3000 to 5000rpm, and 3000rpm, 3500rpm, 4000rpm, 4500rpm, or 5000rpm may be selected.
In one embodiment, the emulsifying time is 30-60 min, and 30min, 35min, 40min, 45min, 50min, 55min or 60min may be selected.
Preferably, the drying is vacuum freeze drying.
Preferably, the vacuum freeze-drying comprises the steps of: freezing the emulsion at-28 to-35 ℃ for 30-65 min, keeping the temperature at-25 to 20 ℃ for 2-3 h, and keeping the temperature at 20 to 26 ℃ for 1.8-2.2 h.
Preferably, the drying is preceded by prefreezing.
Preferably, the pre-freezing temperature is-80 to-100 ℃ and the time is 5 to 10 minutes.
In one embodiment, the pre-frozen temperature is-80 to-100 ℃, and can be selected from-80 ℃, -85 ℃, -90 ℃, -95 ℃ or-100 ℃.
In one embodiment, the pre-freezing time is 5min to 10min, and may be 5min, 6min, 7min, 8min, 9min or 10min.
Preferably, the method further comprises degassing the emulsified emulsion.
Preferably, the degassing time is 8 to 12 minutes.
In one embodiment, the degassing time is 8-12 min, and 8min, 9min, 10min, 11min or 12min may be selected.
The lactoferrin preparation (lactoferrin contained sugar tablet) is produced by adopting a high-precision metering pump, and the lactoferrin content of each tablet is accurate, so that the situation of insufficient or excessive supplementation of people is avoided.
In one embodiment, the method of preparing the lactoferrin formulation comprises the steps of:
(a) And (3) dissolving an adhesive: weighing a proper amount of purified water, heating in a beaker at 50 ℃ in a water bath, and heating and stirring the gelatin with a prescription dosage to completely dissolve the gelatin;
(b) Weighing lactoferrin, a flavoring agent and a skeleton supporting agent with the prescription amount, adding the lactoferrin, the flavoring agent and the skeleton supporting agent into the step (a), stirring the materials to a certain volume until the scales are uniformly stirred;
(c) Emulsifying and degassing: emulsifying for 30min at 3000-5000 rpm of an emulsifying machine; vacuum degassing is carried out for 8-12 min after emulsification.
(d) And (3) filling: sub-packaging into the foam holes of the aluminum plastic foam cover plate according to the volume of 0.5 ml/piece;
(e) Pre-freezing: prefreezing in a liquid nitrogen refrigerator at the temperature of-80 to-100 ℃ for 6min;
(f) And (3) freeze-drying: transferring the pre-frozen mold into a freeze dryer for 50-65 min at the temperature of minus 28 to minus 35 ℃; running for 1.5-2.5 h at the temperature of 25 ℃ below zero to 20 ℃ below zero and keeping for 1.8-2.2 h at the temperature of 20 ℃ below zero to 26 ℃;
(g) And (3) sealing: and taking out the freeze-dried sheet from the freeze dryer, and performing film coating sealing and slitting on the aluminum plastic bubble cap machine to obtain a finished product.
The present invention will be further explained below with reference to specific examples and comparative examples.
Example 1
A lactoferrin preparation is mainly prepared from the following raw materials:
lactoferrin 4.00g, gelatin 8.30g, mannitol 23.00g, essence 2.00g, purified water 462.70g; 1000 tablets are prepared;
the preparation method of the lactoferrin preparation comprises the following steps:
(a) Gelatin dissolution: weighing a proper amount of purified water, heating in a beaker at 50 ℃ in a water bath, and heating and stirring the gelatin with a prescription dosage to completely dissolve the gelatin;
(b) Weighing lactoferrin, sweet orange essence and mannitol with prescription amount, adding into the solution (a), fixing the volume to 500ml scale, and stirring uniformly;
(c) Emulsifying and degassing: emulsifying for 30 minutes at 5000rpm of an emulsifying machine; vacuum degassing for 10 minutes after emulsification;
(d) And (3) filling: sub-packaging into the foam holes of the aluminum plastic foam cover plate according to the volume of 0.5 ml/piece;
(e) Pre-freezing: prefreezing in a liquid nitrogen refrigerator at the temperature of-80 to-100 ℃ for 6min;
(f) And (3) freeze-drying: transferring the pre-frozen mold into a freeze dryer to be kept at the temperature of minus 30 ℃ for 1 hour; -25 ℃ to 20 ℃ for 2 hours, and 25 ℃ for 2 hours;
(g) And (3) sealing: and taking out the freeze-dried sheet from the freeze dryer, and performing film coating sealing and slitting on the aluminum plastic bubble cap machine to obtain a finished product.
Example 2
A lactoferrin preparation, in the form of a pharmaceutical preparation,
lactoferrin 4.00g, gelatin 18.50g, mannitol 25.00g, essence 4.00g and purified water 448.50g; 1000 tablets are prepared;
the preparation method of the lactoferrin preparation comprises the following steps:
(a) Gelatin dissolution: weighing a proper amount of purified water, heating in a beaker at 50 ℃ in a water bath, and heating and stirring the gelatin with a prescription dosage to completely dissolve the gelatin;
(b) Weighing active ingredients and other auxiliary materials: weighing lactoferrin, sweet orange essence and mannitol with prescription amount, adding into the solution (a), fixing the volume to 500ml scale, and stirring uniformly;
(c) Emulsifying and degassing: emulsifying for 30 minutes at 5000rpm of an emulsifying machine; vacuum degassing for 10 minutes after emulsification;
(d) And (3) filling: sub-packaging into the foam holes of the aluminum plastic foam cover plate according to the volume of 0.5 ml/piece;
(e) Pre-freezing: prefreezing in a liquid nitrogen refrigerator at the temperature of-80 to-100 ℃ for 6min;
(f) And (3) freeze-drying: transferring the pre-frozen mold into a freeze dryer to be kept at the temperature of minus 35 ℃ for 30 minutes; -25 ℃ to 20 ℃ for 3 hours, and 25 ℃ for 1 hour;
(g) And (3) sealing: and taking out the freeze-dried sheet from the freeze dryer, and performing film coating sealing and slitting on the aluminum plastic bubble cap machine to obtain a finished product.
Example 3
A lactoferrin preparation is mainly prepared from the following raw materials:
lactoferrin 4.00g, gelatin 10g, glycine 15g, essence 2g and purified water 433g; 1000 tablets are prepared;
the preparation method of the lactoferrin preparation comprises the following steps:
(a) Gelatin dissolution: weighing a proper amount of purified water, heating in a beaker at 50 ℃ in a water bath, and heating and stirring the gelatin with a prescription dosage to completely dissolve the gelatin;
(b) Weighing active ingredients and other auxiliary materials: weighing lactoferrin, sweet orange essence and glycine with the prescription amount, adding the lactoferrin, the sweet orange essence and the glycine into the step (a), fixing the volume to 500ml, and uniformly stirring;
(c) Emulsifying and degassing: emulsifying for 50 minutes at 4000rpm of an emulsifying machine; vacuum degassing for 10 minutes after emulsification;
(d) And (3) filling: sub-packaging into the foam holes of the aluminum plastic foam cover plate according to the volume of 0.5 ml/piece;
(e) Pre-freezing: pre-freezing in a liquid nitrogen refrigerator at the temperature of-80 to-100 ℃ for 7min;
(f) And (3) freeze-drying: transferring the pre-frozen mold into a freeze dryer to be kept at the temperature of minus 35 ℃ for 40 minutes; -25 ℃ to 25 ℃ for 3.5 hours, and 25 ℃ for 2 hours;
(g) And (3) sealing: and taking out the freeze-dried sheet from the freeze dryer, and performing film coating sealing and slitting on the aluminum plastic bubble cap machine to obtain a finished product.
Example 4
A lactoferrin preparation is mainly prepared from the following raw materials:
lactoferrin 4.00g, gelatin 15g, glycine 15g, maltitol 10g, essence 2g and purified water 448g; 1000 tablets are prepared;
the preparation method of the lactoferrin preparation comprises the following steps:
(a) Gelatin dissolution: weighing a proper amount of purified water, heating in a beaker at 50 ℃ in a water bath, and heating and stirring the gelatin with a prescription dosage to completely dissolve the gelatin;
(b) Weighing active ingredients and other auxiliary materials: weighing lactoferrin, sweet orange essence, glycine and maltitol with the prescription amount, adding the lactoferrin, the sweet orange essence, the glycine and the maltitol into the step (a), fixing the volume to 500ml scale, and uniformly stirring;
(c) Emulsifying and degassing: emulsifying for 50 minutes at 3000rpm of an emulsifying machine; vacuum degassing for 10 minutes after emulsification;
(d) And (3) filling: sub-packaging into the foam holes of the aluminum plastic foam cover plate according to the volume of 0.5 ml/piece;
(e) Pre-freezing: pre-freezing in a liquid nitrogen refrigerator at-90 ℃ for 5min;
(f) And (3) freeze-drying: transferring the pre-frozen mold into a freeze dryer to be kept at the temperature of minus 40 ℃ for 120 minutes; -25-10 ℃ for 3 hours, 20 ℃ for 3 hours;
(g) And (3) sealing: and taking out the freeze-dried sheet from the freeze dryer, and performing film coating sealing and slitting on the aluminum plastic bubble cap machine to obtain a finished product.
Example 5
A lactoferrin preparation is mainly prepared from the following raw materials:
lactoferrin 4.00g, pullulan 20g, mannitol 23g, essence 2g and purified water 450g; 1000 tablets are prepared;
the preparation method of the lactoferrin preparation comprises the following steps:
(a) Pullulan is dissolved: weighing a proper amount of purified water, heating in a beaker at 50 ℃ in a water bath, and weighing the pullulan with a prescription amount, heating and stirring to completely dissolve the pullulan;
(b) Weighing active ingredients and other auxiliary materials: weighing lactoferrin, sweet orange essence and mannitol with prescription amount, adding into the solution (a), fixing the volume to 500ml scale, and stirring uniformly;
(c) Emulsifying and degassing: emulsifying for 60 minutes at 5000rpm of an emulsifying machine; vacuum degassing for 8 minutes after emulsification;
(d) And (3) filling: sub-packaging into the foam holes of the aluminum plastic foam cover plate according to the volume of 0.5 ml/piece;
(e) Pre-freezing: pre-freezing in a liquid nitrogen freezer at-100deg.C for 10min;
(f) And (3) freeze-drying: transferring the pre-frozen mold into a freeze dryer to be kept at the temperature of minus 35 ℃ for 30 minutes; -25 ℃ to 15 ℃ for 2.5 hours, and 20 ℃ for 1.5 hours;
(g) And (3) sealing: and taking out the freeze-dried sheet from the freeze dryer, and performing film coating sealing and slitting on the aluminum plastic bubble cap machine to obtain a finished product.
Example 6
A lactoferrin preparation is mainly prepared from the following raw materials:
lactoferrin 4.00g, pullulan 30g, glycine 12g, essence 2g and purified water 443g; 1000 tablets are prepared;
the preparation method of the lactoferrin preparation comprises the following steps:
(a) Weighing a proper amount of purified water, heating in a beaker at 50 ℃ in a water bath, and weighing the pullulan with a prescription amount, heating and stirring to completely dissolve the pullulan;
(b) Weighing active ingredients and other auxiliary materials: weighing lactoferrin, sweet orange essence and glycine with the prescription amount, adding the lactoferrin, the sweet orange essence and the glycine into the step (a), fixing the volume to 500ml, and uniformly stirring;
(c) Emulsifying and degassing: emulsifying for 40 minutes at 5000rpm of an emulsifying machine; vacuum degassing for 10 minutes after emulsification;
(d) And (3) filling: sub-packaging into the foam holes of the aluminum plastic foam cover plate according to the volume of 0.5 ml/piece;
(e) Pre-freezing: pre-freezing in a liquid nitrogen freezer at-100deg.C for 6min;
(f) And (3) freeze-drying: transferring the pre-frozen mold into a freeze dryer to be kept at the temperature of minus 35 ℃ for 60 minutes; -25-20 ℃ for 4 hours, 20 ℃ for 2 hours;
(g) And (3) sealing: and taking out the freeze-dried sheet from the freeze dryer, and performing film coating sealing and slitting on the aluminum plastic bubble cap machine to obtain a finished product.
Example 7
A lactoferrin preparation is mainly prepared from the following raw materials:
lactoferrin 4.00g, pullulan 15g, glycine 10g, xylitol 10g, essence 2g and purified water 423g; 1000 tablets are prepared;
the preparation method of the lactoferrin preparation comprises the following steps:
(a) Weighing a proper amount of purified water, heating in a beaker at 50 ℃ in a water bath, and weighing the pullulan with a prescription amount, heating and stirring to completely dissolve the pullulan;
(b) Weighing active ingredients and other auxiliary materials: weighing lactoferrin, sweet orange essence, glycine and xylitol with prescription amount, adding into the solution (a), fixing the volume to 500ml scale, and stirring uniformly;
(c) Emulsifying and degassing: emulsifying for 50 minutes at 5000rpm by an emulsifying machine; vacuum degassing for 10 minutes after emulsification;
(d) And (3) filling: sub-packaging into the foam holes of the aluminum plastic foam cover plate according to the volume of 0.5 ml/piece;
(e) Pre-freezing: pre-freezing in a liquid nitrogen freezer at-100deg.C for 7min;
(f) And (3) freeze-drying: transferring the pre-frozen mold into a freeze dryer to be kept at the temperature of minus 35 ℃ for 30 minutes; -25 ℃ to 15 ℃ for 3 hours, and 25 ℃ for 2 hours;
(g) And (3) sealing: and taking out the freeze-dried sheet from the freeze dryer, and performing film coating sealing and slitting on the aluminum plastic bubble cap machine to obtain a finished product.
Comparative example 1
A lactoferrin preparation is mainly prepared from the following raw materials:
lactoferrin 4.00g, gelatin 8g, mannitol 35g, essence 6.00g and purified water 455.00g; 1000 tablets are prepared;
the preparation method of the lactoferrin preparation is the same as in example 1.
Comparative example 2
A lactoferrin preparation is mainly prepared from the following raw materials:
lactoferrin 4.00g, gelatin 35g, mannitol 7g, essence 2.00g and purified water 468.5g; 1000 tablets are prepared;
the preparation method of the lactoferrin preparation is the same as in example 1.
Comparative example 3
A lactoferrin preparation, which is emulsified for 10 minutes at 2500rpm of an emulsion removing machine; vacuum degassing for 5 minutes after emulsification; prefreezing in a liquid nitrogen freezer at-70deg.C for 6min; -25 ℃ for 20 minutes; the procedure is followed for 0.5 hour at 25℃to 15℃and for 0.5 hour at 25℃under the same conditions as in example 1.
Experimental example
1. Shaping experiments of lactoferrin preparations according to the invention
Taking the lactoferrin contained sugar tablets prepared in the examples and the comparative examples, observing the formability: and after the sample is taken out of the box, visually observing whether the sample collapses and contracts. As shown in table 1.
TABLE 1 results of molding experiments
2. Taste experiment
The package is opened, the freeze-dried tablet is taken out and placed on the tongue without chewing and without taking with water until the tablet is completely disintegrated and then all suspended matters in the oral cavity are spitted out. 3 test persons taste the products and evaluate the products, and the products are obtained by taking average grades.
The evaluation grades are classified as follows:
1) "+++++": the product is instant in mouth, has disintegration time of <5 seconds, no lump, no gritty sticky feeling, and moderate smell.
2) "++++": the product is instant in mouth, has disintegration time of less than 10s, no lump and no gritty sticky feel, and has moderate smell.
3) "+++": any 1 of the four occurrences of disintegration time, lump, gritty, sticky feel and smell were scored as this grade.
4) "++": any 2-3 of four occurrences of disintegration time, lumps, gritty sticky feel and smell are scored as such.
5) "+": the product has the advantages of no collapse in mouth, lump formation, strong gritty sticky feeling and excessive smell.
The results are shown in Table 2.
Table 2 results of taste experiments
3. Experiment of disintegration Rate
Taking 1 tablet of lactoferrin preparation of each example, placing in a 10ml beaker (2 ml of water is added in advance, the temperature is 37+/-1 ℃), starting to count time by using a stopwatch until the tablet is completely disintegrated, and recording the time of complete disintegration; the disintegrated medicinal liquid should pass through 710 μm sieve, and if necessary, the sieve should be washed with water drop from dropper, and the water consumption should not exceed 5ml. The results are shown in Table 3.
TABLE 3 disintegration rate experiment
Sample of | Disintegration time |
Example 1 | 3S |
Example 2 | 7S |
Example 3 | 8S |
Example 4 | 7S |
Example 5 | 5S |
Example 6 | 5S |
Example 7 | 7S |
Comparative example 1 | 6S |
Comparative example 2 | 3S |
Comparative example 3 | 10S |
Finally, it should be noted that: the above embodiments are only for illustrating the technical solution of the present invention, and not for limiting the same; although the invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some or all of the technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit of the invention.
Claims (8)
1. The lactoferrin preparation is characterized by being prepared from the following components in parts by weight:
3-5 parts of lactoferrin, 10-30 parts of a skeleton supporting agent, 8-30 parts of an adhesive and 2-4 parts of a flavoring agent; the skeleton supporting agent is mannitol or glycine; the adhesive is gelatin and/or pullulan;
the preparation method of the lactoferrin preparation comprises the following steps: fully mixing the adhesive with water under the condition of heating and stirring to completely dissolve the adhesive, adding lactoferrin, a framework supporting agent and a flavoring agent, homogenizing and emulsifying, and pre-freezing and drying the homogenized and emulsified emulsion;
the rotational speed of the homogenizing emulsification is 3000-5000 rpm, and the time is 30-60 min;
the drying is vacuum freeze drying;
the vacuum freeze drying comprises the following steps: freezing the emulsion at-28 to-35 ℃ for 30-65 min, keeping the temperature at-25 to 20 ℃ for 2-3 h, and keeping the temperature at 20 to 26 ℃ for 1.8-2.2 h;
the pre-freezing temperature is-80 to-100 ℃ and the pre-freezing time is 5min to 10min.
2. Lactoferrin preparation as in claim 1, characterized in that it is mainly prepared from the following components in parts by weight:
3.5-4.5 parts of lactoferrin, 15-25 parts of skeleton supporting agent, 15-25 parts of adhesive and 2-3 parts of aromatic.
3. Lactoferrin preparation as in claim 1 or 2, characterized in that said fragrances comprise natural fragrances and/or artificial fragrances.
4. Lactoferrin formulation as in claim 1 or 2, characterized in that the raw materials of the aroma comprise at least one of peppermint, strawberry and orange.
5. The lactoferrin preparation as in claim 1 or 2, wherein the amount of water used in the preparation method of lactoferrin preparation is 400-470 parts.
6. The lactoferrin formulation of claim 1 or 2, wherein the dosage form of the lactoferrin formulation comprises a tablet.
7. Lactoferrin formulation as in claim 1 or 2, characterized in that it further comprises degassing the emulsified emulsion.
8. The lactoferrin preparation of claim 7, wherein the degassing time is 8-12 min.
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