WO2020248295A1 - 一种植物软胶囊及其制备方法与用途 - Google Patents

一种植物软胶囊及其制备方法与用途 Download PDF

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WO2020248295A1
WO2020248295A1 PCT/CN2019/091929 CN2019091929W WO2020248295A1 WO 2020248295 A1 WO2020248295 A1 WO 2020248295A1 CN 2019091929 W CN2019091929 W CN 2019091929W WO 2020248295 A1 WO2020248295 A1 WO 2020248295A1
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Prior art keywords
soft capsule
glue
vegetable
carrageenan
rubber
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PCT/CN2019/091929
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English (en)
French (fr)
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张国栋
洪靖
夏旭东
张兴
史解矛
商琛栋
丁报荣
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江苏艾兰得营养品有限公司
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Priority to US16/758,728 priority Critical patent/US11523991B2/en
Priority to GB2106703.8A priority patent/GB2593334B/en
Publication of WO2020248295A1 publication Critical patent/WO2020248295A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material
    • 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
    • A23L29/20—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents
    • A23L29/206—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents of vegetable origin
    • A23L29/256—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents of vegetable origin from seaweeds, e.g. alginates, agar or carrageenan
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23F—COFFEE; TEA; THEIR SUBSTITUTES; MANUFACTURE, PREPARATION, OR INFUSION THEREOF
    • A23F3/00—Tea; Tea substitutes; Preparations thereof
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23F—COFFEE; TEA; THEIR SUBSTITUTES; MANUFACTURE, PREPARATION, OR INFUSION THEREOF
    • A23F5/00—Coffee; Coffee substitutes; Preparations thereof
    • 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
    • A23L2/00—Non-alcoholic beverages; Dry compositions or concentrates therefor; Their preparation
    • A23L2/52—Adding ingredients
    • 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
    • A23L27/00—Spices; Flavouring agents or condiments; Artificial sweetening agents; Table salts; Dietetic salt substitutes; Preparation or treatment thereof
    • A23L27/30—Artificial sweetening agents
    • A23L27/33—Artificial sweetening agents containing sugars or derivatives
    • A23L27/34—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
    • A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
    • A23L29/10—Foods or foodstuffs containing additives; Preparation or treatment thereof containing emulsifiers
    • 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
    • A23L29/20—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents
    • A23L29/206—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents of vegetable origin
    • A23L29/212—Starch; Modified starch; Starch derivatives, e.g. esters or ethers
    • 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
    • A23L33/105—Plant extracts, their artificial duplicates or their derivatives
    • 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
    • A23L33/115—Fatty acids or derivatives thereof; Fats or oils
    • 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
    • A23L33/15—Vitamins
    • 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
    • A23L33/16—Inorganic salts, minerals or trace elements
    • 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
    • A23L33/30—Dietetic or nutritional methods, e.g. for losing weight
    • 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
    • A23L5/00—Preparation or treatment of foods or foodstuffs, in general; Food or foodstuffs obtained thereby; Materials therefor
    • A23L5/40—Colouring or decolouring of foods
    • A23L5/42—Addition of dyes or pigments, e.g. in combination with optical brighteners
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
    • A23P10/00—Shaping or working of foodstuffs characterised by the products
    • A23P10/30—Encapsulation of particles, e.g. foodstuff additives
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
    • A23P10/00—Shaping or working of foodstuffs characterised by the products
    • A23P10/30—Encapsulation of particles, e.g. foodstuff additives
    • A23P10/35—Encapsulation of particles, e.g. foodstuff additives with oils, lipids, monoglycerides or diglycerides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
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    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • A—HUMAN NECESSITIES
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    • A61K9/4833—Encapsulating processes; Filling of capsules
    • 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

Definitions

  • the invention belongs to the technical field of soft capsules, and specifically relates to a plant soft capsule and a preparation method and application thereof.
  • Soft capsules are widely used in medical and pharmaceutical products and food fields.
  • the rubber skins of commonly used soft capsule products use gelatin as the main raw material.
  • Gelatin is mainly derived from the collagen in animal skin, bone, muscle membrane and other connective tissues.
  • the most commonly used gelatin in industry is from pigs and cattle.
  • industrial gelatin contains more heavy metal ions, it is extremely harmful; although gelatin is low in cost, it has cross-linking problems and easily makes soft capsules unstable. , Affecting the storage and transportation of soft capsule products.
  • soft capsules with gelatin as the main ingredient do not meet the halal or vegetarian dietary habits and requirements. Based on the above reasons, the development of plant-based soft capsules is of great significance.
  • hydroxypropyl starch is used as the main raw material and supplemented with gelling agents, softeners and film forming agents that can improve the properties of soft capsules.
  • the starch-based rubber is prepared.
  • the disadvantage is that compared with other gum raw materials, the rubber mainly made of hydroxypropyl starch is more brittle , The elasticity and toughness deviation of the rubber skin will be more likely to be broken into pellets; and one or more of calcium chloride, potassium chloride, potassium citrate plasma must be added in the preparation process.
  • pullulan is used as the main raw material, and it is mixed with a variety of biological polysaccharides or seaweed polysaccharides. After several processes, the film is formed, and the pill is compressed by a rotating film soft capsule machine.
  • the characteristic is that the prepared Soft capsule pills can reach a level similar to gelatin capsules in terms of transparency, elasticity and mechanical strength, and completely disintegrate within the relevant prescribed time; the disadvantage is that pullulan is expensive and expensive, and does not replace gelatin soft The possibility of capsules; and the drying time after the glue is formed into a film is long, and it needs to be dried at 60-70°C for 10-18h, which is low in production efficiency.
  • CN 105434397 B in order to reduce the cost of pullulan in CN 102670563 A plan, hydroxypropyl starch and hydroxypropyl methylcellulose are used to replace part of pullulan.
  • This patent can reduce part of the production cost and prepare soft
  • the capsule rubber has low fragility and excellent disintegration performance, which is no different from gelatin soft capsules; moreover, the rubber composition does not need to be pre-spread and dried. After the prepared glue reaches a controlled viscosity, the glue can be directly combined with the pellet
  • the glue feeding equipment of the machine is connected to directly press pellets to prepare soft capsules, which improves production efficiency.
  • hydroxypropyl starch, hydroxypropyl methylcellulose and pullulan are indispensable, otherwise it will affect the friability and disintegration time limit of the soft capsule (see CN 105434397 B, page 9 of the specification) Examples 9-14 in Table 2); and the addition amount of hydroxypropyl starch, hydroxypropyl methylcellulose and pullulan must be strictly controlled. The addition amount of pullulan must meet certain conditions, and insufficient addition will cause Lead to the phenomenon of brittle crumbs. Therefore, although the patent uses hydroxypropyl starch and hydroxypropyl methylcellulose to replace part of pullulan to reduce part of the production cost, it still cannot fundamentally circumvent the use of pullulan. Reduce production costs; and the patent also uses calcium chloride, potassium chloride, potassium citrate plasma to achieve excellent film-forming properties to achieve a certain rubber toughness.
  • CN 104721167 A a combination of ordinary starch and modified starch is used as the starch matrix, supplemented by plasticizers, gelling agents and deionized water to prepare soft starch capsules.
  • the prepared soft capsules have high transparency, good toughness, and disintegration time limit. Shorten and other advantages.
  • the preparation process used in the preparation process is a conventional preparation method, it is necessary to pre-spread and dry the film, and the drying time of the film is often longer.
  • the vegetable soft capsules reported in the prior art have the disadvantages of high raw material cost, long rubber drying time during the preparation process, low production efficiency, poor encapsulation, and the need to add additional metal ions to ensure film formation; they cannot simultaneously solve the plant soft capsules
  • the two key factors of medium cost and quality cannot achieve the level of industrialization of vegetable soft capsules to replace gelatin soft capsules.
  • the purpose of the present invention is to solve the problems of low cost and high quality in the existing plant soft capsule technology, and to provide a plant soft capsule with industrial applications and a preparation method thereof;
  • the present invention controls the weight average molecular weight of carrageenan, and
  • a vegetable soft capsule with excellent performance is prepared from starch, plasticizer and water;
  • the vegetable soft capsule of the present invention has a lower production cost than the vegetable soft capsule in the prior art, and the product quality meets the requirements of the gelatin soft capsule;
  • USP United States Pharmacopoeia
  • the present invention provides a vegetable soft capsule, comprising carrageenan, starch, plasticizer and water, and the carrageenan has a weight average molecular weight Mw of 1.20 ⁇ 10 6 to 2.00 ⁇ 10 6 .
  • the weight-average molecular weight Mw of conventional carrageenan is 2.0 ⁇ 10 5 or more.
  • the glue prepared by using the carrageenan with the defined weight-average molecular weight range of the present invention as a gelling agent has excellent fluidity and film-forming properties, and it can eliminate metal ion additives such as calcium chloride, potassium chloride or lemon Under the premise of potassium acid potassium), it can be prepared to meet the requirements of soft capsule film formation and rubber toughness, and the rupture time is significantly shortened to meet the requirements of USP standards.
  • the vegetable soft capsule includes 3-20 parts by weight of carrageenan, 10-50 parts by weight of starch, 10-35 parts by weight of plasticizer, and 30-70 parts by weight of water;
  • carrageenan 3-20 parts by weight of carrageenan, 10-50 parts by weight of starch, 10-35 parts by weight of plasticizer, and 30-70 parts by weight of water;
  • those skilled in the art can adjust the proportion of the vegetable soft capsule of the present invention according to the performance of the product in combination with known techniques.
  • the carrageenan is any combination of one or more of K-type (Kappa), I-type (Iota) and L-type (Lambda); more preferably, it is I-type (Iota) or I-type (Iota). ) And K-type (Kappa) combination.
  • the glue made from L-type carrageenan had poor film-forming properties, while the glue made from pure K-type carrageenan had better film-forming properties, but its viscosity was poor.
  • pure type I or type I+K carrageenan the glue produced is easy to spread into a film, has moderate viscosity, good rubber toughness, and is not easy to break.
  • the produced capsules have low oil leakage and high production efficiency.
  • the plasticizer is one or any combination of two or more of glycerol, sorbitol, xylitol, and polyethylene glycol, and more preferably glycerol;
  • the starch is modified starch, and the modified starch is oxidized starch, acid starch, hydroxypropyl starch, oxidized hydroxypropyl starch, and a combination of one or more of two or more in any weight ratio, more preferably hydroxy Propyl starch or oxidized hydroxypropyl starch;
  • the vegetable soft capsule also includes pigments, sunscreens or fragrances
  • the pigments are natural pigments and synthetic pigments
  • the natural pigments are brown (caramel color), blue (phyco blue), or purple-red (Purple potato red) or orange (annatto)
  • synthetic pigments are one or more of carmine, lemon yellow, sunset yellow, indigo, etc.
  • Natural pigments are more green and safer than synthetic pigments, but due to the high temperature of the production process of vegetable soft capsules, natural pigments are easily faded at high temperatures.
  • the present invention tested the effect of various pigments on the performance of the glue, and found that when the caramel color was added in a higher proportion, the glue was extremely viscous, but the glue had poor performance and could not be flattened into a film.
  • purple sweet potato red can meet the production needs, the natural pigment is easily faded under high temperature. Although red iron oxide does not fade under high temperature, the glue performance is poor. After many screenings, we found that annatto and algae blue pigments do not affect the performance of the glue, and can be colorless under high temperature for a certain period of time, which is extremely important for our rich product variety.
  • the present invention studies different types of color retention agents, and finally screens meglumine as color retention agent. The prepared soft capsules will not fade even when placed at high temperature for a long time. Have practical industrial application prospects.
  • the present invention provides a method for preparing a vegetable soft capsule, which includes the following steps:
  • a certain hardness means that the hardness is between 50 and 70N.
  • the heating temperature in step 1) is 80-90°C; the heat preservation time is 20-120 min;
  • the thickness of the rubber in step 2) is less than 1.0mm, and more preferably 0.30mm to 0.60mm; currently in the industry, the thickness of the soft capsule rubber is increased (0.70mm to 0.90mm) and the speed of the pellet mill (1.5rpm) is sacrificed
  • the present invention can control the rubber thickness to be 0.30mm to 0.60mm on the basis of achieving high rotation speed and low oil leakage rate.
  • the plant soft capsule process of the present invention can reduce the thickness of the rubber skin to half of the normal level or even lower, while ensuring the hardness of the capsule and a very low oil leakage rate (less than 1%), which is extremely important for controlling the cost of soft capsules Meaning.
  • the temperature of heating the plastic box of the blasting machine is 80-95°C; the heating temperature of the drum is 20-40°C.
  • the drum of the pellet mill in the industry is refrigerated, and the purpose of refrigeration is to cool the gelatin glue liquid as soon as possible; although the purpose of cooling and shaping can be achieved as soon as possible by refrigeration, the vegetable glue liquid of the present invention has a higher moisture content, and the refrigeration method It is difficult to dry to form a rubber with good toughness, resulting in a small amount of content and a high oil leakage rate.
  • the invention heats the drum, and the vegetable rubber after the heated drum can be quickly dried, has good toughness and viscosity, saves the drying time in the early stage, ensures the rubber quality, thereby increases the machine speed and ensures the production efficiency.
  • the present invention provides a use of vegetable soft capsules, which are filled with active ingredients as content for preparing medicines, functional foods or dietary nutritional supplements.
  • the medicine, functional food or dietary nutritional supplement is Danqi soft capsule, linseed oil vegetable soft capsule, vitamin E vegetable soft capsule, evening primrose oil vegetable soft capsule, biotin vegetable soft capsule, lutein vegetable soft capsule Capsules, coenzyme Q10 vegetable soft capsules, vitamin K2 vegetable soft capsules, phospholipid vegetable soft capsules, conjugated linoleic acid vegetable soft capsules, coconut oil vegetable soft capsules, multivitamin and mineral vegetable soft capsules, DHA algae oil vegetable soft capsules, Fish oil vegetable soft capsule.
  • the content of the linseed oil is linseed oil, a linseed oil vegetable soft capsule made of carrageenan, hydroxypropyl starch, glycerin, and water as the main rubber components.
  • the linseed oil contains a high content of ⁇ -linolenic acid , ⁇ -linolenic acid has the effects of anti-tumor, anti-thrombosis, lowering blood fat, nourishing brain cells, and regulating autonomic nerves.
  • the vitamin E vegetable soft capsule is a vitamin E vegetable soft capsule made of vitamin E and soybean oil as the content and carrageenan, hydroxypropyl starch, glycerin, and water as the main rubber components.
  • Vitamin E is a fat-soluble vitamin
  • the hydrolyzate is tocopherol, which is one of the most important antioxidants.
  • the evening primrose oil vegetable soft capsule is an evening primrose oil vegetable soft capsule made with evening primrose oil as the content and carrageenan, hydroxypropyl starch, glycerin, and water as the main rubber components. Oil can prevent cardiovascular disease, premenstrual syndrome, and menopausal syndrome.
  • the biotin vegetable soft capsule is a biotin vegetable soft capsule made with biotin, rice bran oil, phospholipids, and beeswax as the content and carrageenan, hydroxypropyl starch, glycerin, and water as the main rubber components.
  • Biotin is A nutrient necessary to maintain the human body's natural growth, development and normal human body function and health. It not only prevents hair loss and the top of the head from seeing light, but also prevents juvenile gray hair that is common in modern people.
  • the vitamin D3 vegetable soft capsule is a vitamin D3 vegetable soft capsule made of vitamin D3 and rice bran oil with carrageenan, hydroxypropyl starch, glycerin, and water as the main rubber components. Vitamin D3 can promote the body's calcium , Phosphorus absorption, so that plasma calcium and plasma phosphorus levels reach saturation, promote growth and bone calcification, and promote healthy teeth.
  • the lutein vegetable soft capsule is a lutein vegetable soft capsule made with lutein, rice bran oil, beeswax, and phospholipids as the content and carrageenan, hydroxypropyl starch, glycerin, and water as the main rubber components.
  • Natural lutein is an excellent antioxidant, which can resist free radicals causing cell and organ damage in the human body, thereby preventing cardiovascular sclerosis, coronary heart disease and tumor diseases caused by body aging.
  • the coenzyme Q10 vegetable soft capsule is made of coenzyme Q10, rice bran oil, beeswax, and phospholipid as the content and carrageenan, hydroxypropyl starch, glycerin, and water as the main rubber components. It can provide power to the heart. It also has excellent anti-oxidation and free radical scavenging functions. It can prevent lipid peroxidation of blood vessel walls and prevent atherosclerosis without any side effects.
  • the vitamin K2 vegetable soft capsule is a vitamin K2 vegetable soft capsule made of vitamin K2, rice bran oil and carrageenan, hydroxypropyl starch, glycerin, and water as the main rubber ingredients.
  • Vitamin K2 is a fat-soluble Vitamin, a derivative of the naphthoquinone group with phylloquinone biological activity, is one of the indispensable and important vitamins in the human body, and can treat and prevent osteoporosis.
  • the phospholipid vegetable soft capsule is a phospholipid vegetable soft capsule made of carrageenan, hydroxypropyl starch, glycerin, and water as the main rubber components. Phospholipids can decompose high blood fat and high cholesterol. Sweeping blood vessels, so that blood vessels circulate smoothly, is recognized as "vascular scavenger".
  • the conjugated linoleic acid vegetable soft capsule is a conjugated linoleic acid vegetable soft capsule made with conjugated linoleic acid as the content and carrageenan, hydroxypropyl starch, glycerin, and water as the main rubber components.
  • Conjugated linoleic acid has many important physiological functions such as anti-tumor, anti-oxidation, anti-atherosclerosis, improving immunity, increasing bone density, and preventing and treating diabetes; it can also reduce animal and human cholesterol, triglycerides and low-density lipids. Protein cholesterol can also reduce animal and human fat and increase muscle.
  • the coconut oil vegetable soft capsule is a coconut oil vegetable soft capsule made of coconut oil as the content and carrageenan, hydroxypropyl starch, glycerin, and water as the main rubber ingredients.
  • coconut oil is the only medium-chain Fats composed of fatty acids can increase the efficiency of metabolism.
  • the multi-vitamin-mineral plant soft capsule is mainly composed of vitamins such as vitamin A, vitamin B 2 , vitamin B 6 , vitamin B 12 , vitamin C, vitamin D 3 , and vitamin E, and minerals such as calcium, iron, zinc, and selenium.
  • the active ingredients are made of soybean oil, phospholipids, and beeswax to make the content, and a multi-vitamin mineral soft capsule made of carrageenan, hydroxypropyl starch, glycerin, and water as the main rubber ingredients to supplement the various needs of the human body. Vitamins and minerals.
  • the DHA algae oil vegetable soft capsule is a DHA algae oil vegetable soft capsule made with DHA algae oil as its content and carrageenan, hydroxypropyl starch, glycerin, and water as the main rubber components.
  • DHA is the growth and development of nervous system cells.
  • One of the main elements for maintenance is the important constituent fatty acids of the brain and retina.
  • the content in the human cerebral cortex is as high as 20%, and it accounts for the largest proportion in the retina of the eye, accounting for about 50%. It is essential for the development of infant intelligence and vision.
  • the fish oil vegetable soft capsule is a fish oil vegetable soft capsule made of fish oil as its content and carrageenan, hydroxypropyl starch, glycerin, and water as the main rubber components.
  • Fish oil is a kind of oil extracted from fatty fish. Rich in omega-3 polyunsaturated fatty acids (DHA and EPA), it has health benefits such as anti-inflammatory and blood lipid regulation.
  • the present invention surprisingly discovered when developing vegetable soft capsules that when the molecular weight of carrageenan is limited to a certain range, the glue composed of hydroxypropyl starch, plasticizer and water has good film-forming properties. Compared with the prior art, the present invention The invention has the following beneficial effects:
  • the plant soft capsules of the present invention have simple raw materials. Under the premise of controlling the molecular weight of carrageenan, only starch, plasticizer and water need to be added, without adding expensive pullulan, which greatly reduces the cost of plant soft capsules. Cost of production;
  • the vegetable soft capsule prepared by the present invention can achieve excellent film-forming properties, stronger rubber toughness, and cracking Time is greatly shortened;
  • the present invention can achieve high rolling speed and low oil leakage rate of vegetable soft capsules on the basis of controlling the thickness of the rubber skin to be 0.30mm ⁇ 0.60mm; there is no need to sacrifice production efficiency and Increase rubber thickness to ensure low oil leakage rate;
  • the thickness of the vegetable soft capsule rubber prepared by the present invention is much lower than half of the normal level or even lower, while ensuring the hardness of the capsule and extremely low oil leakage rate, which is extremely significant for controlling the cost of the soft capsule;
  • the pure starch rubber has a high oil leakage rate due to insufficient toughness, and has a large limitation on the machine speed, which is only 1.5 rpm.
  • the invention can be produced at a machine speed of 1.5 rpm-5.0 rpm, which is completely comparable to gelatin; and greatly saves the drying time after the capsule is formed, and solves the coexistence problem of many plant soft capsules-the drying time is too long;
  • the rupture time of vegetable soft capsules is about 30 minutes; the present invention can reduce the rupture time of soft capsules by removing the soluble salt film-forming agent and reducing the thickness of the rubber. 15 minutes, in line with USP standards;
  • Mn stands for number average molecular weight
  • Mw stands for weight average molecular weight
  • Mz stands for average molecular weight
  • Mw/Mn stands for polydispersity index
  • the horizontal axis represents the logarithm of the molecular weight; the vertical axis represents a point on the curve.
  • the vertical axis value is a value related to the content of sample molecules at each molecular weight.
  • the equipment involved in the examples the glue tank TRRJ-10, from Wenzhou Tianrui Pharmaceutical Machinery Co., Ltd.; the automatic soft capsule machine BCM-GB6, from BOCHANG CO, L, td; the SLX-A hardness tester: from At Wenzhou Shandu Instrument Co., Ltd.
  • Rubber seam rate the ratio of rubber seam thickness to rubber thickness
  • Oil leakage rate the percentage of oil leaking soft capsules in all soft capsules
  • Content loading refers to the maximum loading of the mold
  • Rupture time Refer to the Rupture Test in USP ⁇ 2040>
  • Hardness The hardness of the soft capsule after drying, which measures the drying effect of the soft capsule.
  • the weight-average molecular weight of type I is 1.2 ⁇ 10 6
  • the weight-average molecular weight of type K is 2.0 ⁇ 10 6
  • the weight-average molecular weight of type L is 1.8 ⁇ 10 6
  • type I+K refers to the use of Type I and Type K carrageenan are used as raw materials
  • the weight ratio of Type I: Type K can be in the range of 9.9:0.1 to 7.0:3.0 based on the weight ratio, which is 8:1 in this embodiment.
  • the glue made from L-type carrageenan had no gel properties and could not be flattened into a film.
  • the glue made from pure K-type carrageenan had better film-forming properties, but poor viscosity. Only pure type I or type I+K carrageenan can make the glue liquid that is easy to spread into a film, with moderate viscosity, good rubber toughness, not easy to break, the produced capsules have low oil leakage rate and high production efficiency.
  • Drum temperature 15°C 20°C 30°C 40°C 50°C Rubber joint rate 50% 60% 70% 70% 40% Contents loading 600mg 800mg 850mg 850mg 700 Oil leakage rate 20% less than 1% less than 1% less than 1% 40%
  • Plasticizers have a greater impact on the toughness of the rubber.
  • the toughness of the rubber determines the filling range of the capsule. The better the toughness, the larger the filling.
  • the capsule can be filled with 850mg.
  • the same mold uses sorbitol, xylitol or As a plasticizer, polyethylene glycol has insufficient rubber toughness and low capsule capacity.
  • Xylitol and polyethylene glycol have a high oil leakage rate as plasticizers. Therefore, glycerin is the first choice as a rubber plasticizer.
  • starch Oxidized starch Acid starch Hydroxypropyl starch Oxidized hydroxypropyl starch Rubber joint rate 10% 20% 70% 70% Contents loading 300mg 500mg 850mg 900mg Oil leakage rate 80% 60% less than 1% less than 1%
  • Starch has a great influence on the viscosity of the rubber.
  • the viscosity of the rubber is too low, the seam thickness is insufficient, the oil leakage rate is high, and the rubber is too viscous, and it is easy to stick to the surface of the drum, which affects the production efficiency. Therefore, we screened oxidized starch, acidic starch, hydroxypropyl starch, and oxidized hydroxypropyl starch for experiments.
  • We found that the rubbers made from oxidized starch and acid starch were not sufficiently viscous, and the capsules made were easy to leak oil.
  • Starch and oxidized hydroxypropyl starch have good viscosity and meet the production requirements, so we prefer hydroxypropyl starch or oxidized hydroxypropyl starch.
  • the present invention can prepare a rubber skin with a thickness of 0.30 mm to 0.60 mm under the premise of meeting the above performance indicators.
  • the thickness of the rubber skin can be 0.30 mm to 0.60 mm.
  • the rubber thickness is thick, the oil leakage rate of the capsule is low, but the rupture time is too long and the rubber cost is too high.
  • the preferred rubber thickness is 0.30mm to 0.60mm.
  • the oil leakage rate is considered.
  • the machine speed is relatively low.
  • the low-speed production efficiency is low, and the plant soft capsule production process of the present invention can achieve a similar rubber seam rate at a machine speed of 1.5 to 5.0 rpm, and the oil leakage rate is less than 1%, which has extremely high production efficiency. .
  • Purple sweet potato red (also known as purple sweet potato red pigment) in Table 9 is a natural red pigment extracted from the roots, stems and leaves of purple sweet potato, and its structure contains multiple phenolic hydroxyl groups.
  • Existing technology Food Processing, 2016 Vol. 41, Issue 2, Pages 38-41, Study on the Stability of Purple Sweet Potato Red Pigment
  • the most stable ones are Al3 + , Ca2 + , Sn2 + , but the addition of metal ions in the system of the present invention has a greater impact on the rupture time of the soft capsule, and the article shows that the type of metal ions may accelerate the color fade It’s counterproductive, so the reference is of little significance.
  • the present invention has studied different types of food additives as color protectants of purple sweet potato red, and found that meglumine can effectively solve the problem of purple sweet potato fading
  • the method for preparing soft capsules with color-preserving agent is the same as the above-mentioned method for screening pigments. The difference is that the pigment is selected purple sweet potato red, and the color-preserving agent-purple sweet potato red 50wt% (that is, 500g) by weight, is prepared with different color-preserving agents
  • the color of the soft capsule shell is used as a measure of the color protection effect of the color protection agent. The results are shown in Table 9-A:
  • ND means that no color protection agent is added, as a control; "——” means that no test has been carried out; 0 days refers to the soft capsules prepared on the same day; 40°C acceleration for 3 months refers to the prepared soft capsules Use PVC plastic bottle packaging (simulating commercial packaging), place it in the dark at (40 ⁇ 2)°C for 3 months, and observe the color change of the capsule shell.
  • the resulting product has a rupture time of 5 minutes, and the oil leakage rate is controlled below 1%.
  • the process has extremely high production efficiency and meets USP standards.

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Abstract

一种植物软胶囊及其制备方法与用途。通过控制卡拉胶重均分子量在1.2×10 6-2.0×10 6，与淀粉、增塑剂和水制备而得，可填充活性组分作为内容物，用于制备多种药品、功能性食品或膳食营养补充剂。

Description

一种植物软胶囊及其制备方法与用途 技术领域
本发明属于软胶囊技术领域，具体涉及一种植物软胶囊及其制备方法与用途。
背景技术
软胶囊广泛应用于诸如医疗及其医药产品和食品领域，目前常用的软胶囊产品的胶皮均以明胶作为主要原料，明胶主要来源于动物皮肤、骨、肌膜等结缔组织中的胶原部分，食品工业上常用的明胶以猪和牛的来源较多。近年来，屡见胶囊的食用安全事件报道，由于工业用明胶含有较多的重金属离子，危害性极大；明胶虽然成本低，但是其本身存在交联的问题，容易使软胶囊变得不稳定，影响软胶囊产品的存储和运输。同时，由于明胶的动物源性，以明胶为主要成分的软胶囊也不符合清真或素食主义的饮食习惯和要求，基于以上原因，开发植物性软胶囊具有重要的意义。
目前有大量植物软胶囊相关主题的专利文献报道，如CN 103893771 B中以羟丙基淀粉为主要原料，并辅加凝胶剂、柔化剂和成膜剂组成的能够改善软胶囊性质的辅料以及可以改变软胶囊外观和气味的遮光剂、着色剂和香味剂等制备成淀粉基的胶皮，其缺点在于，与其它胶质原料相比，其主要采用羟丙基淀粉制备的胶皮显得更脆，胶皮的弹性和韧性偏差，最终成丸破碎的可能性更大；而且在制备过程中必须加入氯化钙、氯化钾、柠檬酸钾等离子中的一种或多种。
CN 102670563 A中以普鲁兰多糖为主要原料，分别与多种生物多糖或海藻多糖混合，经过数道工序后成膜，采用旋转膜法软胶囊机压制成丸，其特点是在于所制备的软胶囊丸在透明度、弹性和机械强度等方面均能达到与明胶胶囊相近的水平，并在相关规定的时间完全崩解；缺点在于，普鲁兰多糖价格高，成本昂贵，不具有替代明胶软胶囊的可能性；而且其胶液成膜后干燥时间长，需在60-70℃下干燥10-18h，生产效率低。
CN 105434397 B中为了降低CN 102670563 A方案中普鲁兰多糖成本，采用羟丙基淀粉和羟丙基甲基纤维素来替代部分普鲁兰多糖，该专利中能够降低部分生产成本，制备出的软胶囊胶皮脆碎度低，崩解性能优良，与明胶软胶囊无异；而且，胶皮组合物无需预先铺膜干燥，制备好的胶液达到控制的粘度后，即可将胶液直接与压丸机的进胶设备连接，直接进行压丸制备软胶囊，提高了生产效率。但是该专利中羟丙基淀粉、羟丙基甲基纤维素和普鲁兰多糖三者缺一不可，否则会影响软胶囊的脆碎度和崩解时限(见CN 105434397 B中说明书第9页表2中实施例9-14)；而且必须严格控制羟丙基淀粉、羟丙基甲基纤维素和普鲁兰多糖的添加量，普鲁兰多糖添加量必须满足一定条件，添加量不足会导致脆化碎粒现象。所以，该专利中虽然在一定程度上采用羟丙基淀粉和羟丙基甲基纤维素来替代部分普鲁兰多糖降低了部分生产成本，但是仍然无法从根本上规避普鲁兰多糖的使用，以降低生产成本；而且该专利中也同样使用了氯化钙、氯化钾、柠檬酸钾等离子才能实现优异的成膜性，以达到一定的胶皮韧性。
CN 104721167 A中以普通淀粉和变性淀粉的组合作为淀粉基质，辅以增塑剂、凝胶剂和去离子水制备出淀粉软胶囊，制备出的软胶囊具有透明度高、韧性良好、崩解时限缩短等优点。但是其制备过程中由于采用的制备工艺为常规制备方法，所以需要预先铺膜干燥，而铺膜干燥时间往往较长。
综上，现有技术报道的植物软胶囊存在原料成本高、制备过程中胶皮干燥时间长、生产效率低、包封性差、需额外加入金属离子保证成膜性等缺陷；无法同时解决植物软胶囊中成本和质量两个关键因素，无法达到实现植物软胶囊工业化替代明胶软胶囊的程度。
发明内容
本发明的目的是解决现有植物软胶囊技术中无法同时满足低成本、高质量的问题，提供一种具备工业化应用的植物软胶囊及其制备方法；本发明通过控制卡拉胶重均分子量，与淀粉、增塑剂和水制备出性能优异的植物软胶囊；本发明植物软胶囊较现有技术中的植物软胶囊具有更低的生产成本，且产品质量达到了明胶软胶囊的要求；可 在高生产效率的前提下，实现低漏油率且破裂时间达到美国药典(USP)标准。
根据本发明的第一个方面，本发明提供了一种植物软胶囊，包括卡拉胶、淀粉、增塑剂和水，所述卡拉胶为的重均分子量Mw为1.20×10 6～2.00×10 6。常规卡拉胶重均分子量Mw为2.0×10 5以上，申请人在研究过程中发现小分子量分布卡拉胶占比过高时制备出的胶液过于黏稠，没有很好的成膜性，占比过低时粘性不足；而大分子量卡拉胶分布占比过高时胶液吸水性过强，没有韧性，占比过低时没有成膜性；过高或过低均无法制备出符合要求的植物软胶囊。申请人惊奇的发现，采用本发明限定重均分子量范围的卡拉胶作为凝胶剂制备出的胶液流动性和成膜性能优异，在革除金属离子添加剂(如氯化钙、氯化钾或柠檬酸钾)的前提下，即可制备出的满足软胶囊成膜性和胶皮韧性的要求，而且破裂时间显著缩短达到USP标准的要求。
优选的，按照重量份数计算，所述植物软胶囊包括3-20重量份的卡拉胶、10-50重量份的淀粉、10-35重量份的增塑剂、30-70重量份的水；在限定卡拉胶重均分子量的前提下，本领域技术人员可以根据产品的性能结合公知技术对本发明植物软胶囊配比进行调节。
优选的，所述卡拉胶为K型(Kappa)、I型(Iota)和L型(Lambda)中的一种或两种以上的任意组合；进一步优选为I型(Iota)或I型(Iota)与K型(Kappa)的组合。所述I型与K型的组合中，按重量比计算I型∶K型＝9.9∶0.1～7.0∶3.0，例如I型∶K型＝8∶1。试验中发现L型卡拉胶制出的胶液成膜性差，纯K型卡拉胶制出的胶液成膜性较好，但是黏性较差。纯I型或者I型+K型的卡拉胶，制出的胶液容易平铺成膜，黏性适中，胶皮韧性良好，不易拉断，生产出的胶囊漏油率低，生产效率高。
优选的，所述增塑剂为甘油、山梨糖醇、木糖醇、聚乙二醇一种或两种以上的任意组合，进一步优选为甘油；
优选的，所述淀粉为改性淀粉，所述改性淀粉为氧化淀粉、酸性淀粉、羟丙基淀粉、氧化羟丙基淀粉中一种或两种以上的任意重量比例组合，进一步优选为羟丙基淀粉或氧化羟丙基淀粉；
优选的，所述植物软胶囊中还包括色素、遮光剂或香味剂，所述色素为天然色素与合成色素，所述天然色素为棕色(焦糖色)、蓝色(藻蓝)、或紫红色(紫薯红)或橙色(胭脂树橙)，合成色素为胭脂红、柠檬黄、日落黄、靛蓝等中的一种或几种。天然色素相对于合成色素更加绿色安全，但由于植物软胶囊的生产工艺的温度较高，天然色素在高温下极易褪色。本发明试验了各种色素对于胶液性能的影响，发现焦糖色添加比例较高时，胶液粘性极强，但胶液性能较差，无法平铺成膜。而紫薯红虽然能满足生产需求，但是该天然色素高温下极易褪色。红氧化铁虽然高温下不褪色，但是胶液性能较差。我们经过多次筛选，发现胭脂树橙与藻蓝色素不影响胶液性能，且在一定时间的高温下，可以做到不褪色，这对于我们丰富产品种类具备极其重要的意义。为了丰富软胶囊颜色，解决紫薯红的褪色问题，本发明研究了不同种类的护色剂，最终筛选出葡甲胺作为护色剂，制备出的软胶囊在高温长期放置中仍不褪色，具备实际工业应用前景。
根据本发明的一个方面，本发明提供了一种植物软胶囊的制备方法，包括如下步骤：
1)化胶工艺
称取配方量的卡拉胶、淀粉、增塑剂和水，加热至胶液溶胀后保温，脱气至胶液澄清透亮得胶液；
2)轧丸工艺
将轧丸机的胶盒加热，转鼓加热，供胶，设定胶皮厚度，设定轧丸机机速后进行轧丸，然后干燥至胶丸达到一定硬度，选丸，最后包装；所述一定硬度是指硬度在50～70N之间。
优选的，步骤1)所述加热的温度为80～90℃；所述保温的时间为20～120min；
优选的，步骤2)所述胶皮厚度小于1.0mm，进一步优选为0.30mm～0.60mm；目前行业内通过提高软胶囊胶皮厚度(0.70mm～0.90mm)和牺牲轧丸机的转速(1.5rpm)来保证胶囊的硬度和控制植物软胶囊的漏油率，本发明可以控制胶皮厚度为0.30mm～0.60mm的基础上，实现高转速和低漏油率。本发明植物软胶囊工艺，可以将 胶皮厚度降为正常水平的一半甚至更低，同时还能保证胶囊的硬度和极低的漏油率(小于1％)，这对于控制软胶囊成本具备极重的意义。
优选的，步骤2)中所述将轧丸机的胶盒加热的温度为80～95℃；转鼓加热温度为20～40℃。目前行业内轧丸机的转鼓均为制冷，制冷的目的在于使明胶胶液尽快冷却成型；采用制冷虽然可以达到尽快冷却成型的目的，但是本发明植物胶液水分含量较高，用制冷方法难以干燥形成韧性良好的胶皮，导致内容物装量少和漏油率偏高。本发明对转鼓进行加热，经过加热转鼓的植物胶皮能迅速干燥，具备良好的韧性与黏性，节省前期干燥时间，保证胶皮质量，从而提高机速，保证生产效率。
根据本发明的另一个方面，本发明提供了一种植物软胶囊的用途，植物软胶囊中填充活性组分为内容物，用于制备药品、功能性食品或膳食营养补充剂。
所述药品、功能性食品或膳食营养补充剂为丹七软胶囊、亚麻籽油植物软胶囊、维生素E植物软胶囊、月见草油植物软胶囊、生物素植物软胶囊、叶黄素植物软胶囊、辅酶Q10植物软胶囊、维生素K2植物软胶囊、磷脂植物软胶囊、共轭亚油酸植物软胶囊、椰子油植物软胶囊、多种维生素矿物质植物软胶囊、DHA藻油植物软胶囊、鱼油植物软胶囊。
所述亚麻籽油内容物为亚麻籽油，以卡拉胶、羟丙基淀粉、甘油、水为主要胶皮成分制成的亚麻籽油植物软胶囊，亚麻籽油中含有高含量的α-亚麻酸，α-亚麻酸有抗肿瘤，抗血栓，降血脂，营养脑细胞，调节植物神经等作用。
所述维生素E植物软胶囊以维生素E与大豆油为内容物，以卡拉胶、羟丙基淀粉、甘油、水为主要胶皮成分制成的维生素E植物软胶囊，维生素E是一种脂溶性维生素，其水解产物为生育酚，是最主要的抗氧化剂之一。
所述月见草油植物软胶囊，品以月见草油为内容物，以卡拉胶、羟丙基淀粉、甘油、水为主要胶皮成分制成的月见草油植物软胶囊，月见草油有预防心血管疾病，经前症候群，更年期综合症等作用。
所述生物素植物软胶囊，以生物素、米糠油、磷脂、蜂蜡为内容物，以卡拉胶、羟丙基淀粉、甘油、水为主要胶皮成分制成的生物素植物软胶囊，生物素是一种维持人体自然生长、发育和正常人体机能健康必要的营养素，不但防止落发及头顶见光颇见功效，还能预防现代人常见的少年白发。
所述维生素D3植物软胶囊，以维生素D3和米糠油为内容物，以卡拉胶、羟丙基淀粉、甘油、水为主要胶皮成分制成的维生素D3植物软胶囊，维生素D3可以促进机体对钙、磷的吸收，使血浆钙和血浆磷的水平达到饱和程度，促进生长和骨骼钙化，促进牙齿健全。
所述叶黄素植物软胶囊，以叶黄素、米糠油、蜂蜡、磷脂为内容物，以卡拉胶、羟丙基淀粉、甘油、水为主要胶皮成分制成的叶黄素植物软胶囊，天然叶黄素是一种优良的抗氧化剂，能抵御游离基在人体内造成细胞与器官损伤，从而可防止机体衰老引发的心血管硬化、冠心病和肿瘤病等。
所述辅酶Q10植物软胶囊，以辅酶Q10、米糠油、蜂蜡、磷脂为内容物，以卡拉胶、羟丙基淀粉、甘油、水为主要胶皮成分制成的辅酶Q10植物软胶囊，辅酶Q10不仅能给心脏提供动力，还具有卓越的抗氧化，清除自由基功能，能预防血管壁脂质过氧化，预防动脉粥样硬化，并且无任何毒副作用。
所述维生素K2植物软胶囊，以维生素K2、米糠油为内容物，以卡拉胶、羟丙基淀粉、甘油、水为主要胶皮成分制成的维生素K2植物软胶囊，维生素K2是一种脂溶性维生素，具有叶绿醌生物活性的萘醌基团的衍生物，是人体中不可缺少的重要维生素之一，可以治疗和预防骨质疏松症。
所述磷脂植物软胶囊，以磷脂为内容物，以卡拉胶、羟丙基淀粉、甘油、水为主要胶皮成分制成的磷脂植物软胶囊，磷脂可以分解过高的血脂和过高的胆固醇，清扫血管，使血管循环顺畅，被公认为“血管清道夫”。
所述共轭亚油酸植物软胶囊，以共轭亚油酸为内容物，以卡拉胶、羟丙基淀粉、甘油、水为主要胶皮成分制成的共轭亚油酸植物软胶囊， 共轭亚油酸具有抗肿瘤、抗氧化、抗动脉粥样硬化、提高免疫力、提高骨骼密度、防治糖尿病等多种重要生理功能；而且还能降低动物和人体胆固醇以及甘油三酯和低密度脂蛋白胆固醇、还可以降低动物和人体脂肪、增加肌肉。
所述椰子油植物软胶囊，以椰子油为内容物，以卡拉胶、羟丙基淀粉、甘油、水为主要胶皮成分制成的椰子油植物软胶囊，椰子油是日常食物中唯一由中链脂肪酸组成的油脂，进而能提高新陈代谢的效率。
所述复合维生素矿物质植物软胶囊，以维生素A、维生素B 2、维生素B 6、维生素B 12、维生素C、维生素D 3、维生素E等维生素与钙、铁、锌、硒等矿物质为主要活性成分，加入大豆油、磷脂、蜂蜡制成内容物，以卡拉胶、羟丙基淀粉、甘油、水为主要胶皮成分制成的多种维生素矿物质植物软胶囊，补充人体所需的各种维生素与矿物质。
所述DHA藻油植物软胶囊，以DHA藻油为内容物，以卡拉胶、羟丙基淀粉、甘油、水为主要胶皮成分制成的DHA藻油植物软胶囊，DHA是神经系统细胞生长及维持的一种主要元素，是大脑和视网膜的重要构成脂肪酸，在人体大脑皮层中含量高达20％，在眼睛视网膜中所占比例最大，约占50％。对婴儿智力和视力发育至关重要。
所述鱼油植物软胶囊，以鱼油为内容物，以卡拉胶、羟丙基淀粉、甘油、水为主要胶皮成分制成的鱼油植物软胶囊，鱼油是一种从多脂鱼类提取的油脂，富含ω-3系多不饱和脂肪酸(DHA和EPA)，具有抗炎、调节血脂等健康益处。
本发明在研发植物软胶囊时惊奇的发现，当限定卡拉胶分子量在一定范围与羟丙基淀粉、增塑剂和水组成的胶液具备良好的成膜性，与现有技术相比，本发明具有如下有益效果：
1)本发明植物软胶囊原料简单，在控制卡拉胶分子量的前提下，仅需要加入淀粉、增塑剂和水即可，无需加入昂贵的普鲁兰多糖，极大程度降低了植物软胶囊的生产成本；
2)本发明在革除氯化钙、氯化钾、柠檬酸钾等可溶性盐作为成 膜剂的前提下，制备出的植物软胶囊即可实现优异的成膜性，胶皮韧性更强，且破裂时间大大缩短；
3)本发明通过优化卡拉胶种类、分子量和淀粉种类，可以在控制胶皮厚度为0.30mm～0.60mm的基础上，实现高轧丸转速和植物软胶囊的低漏油率；无需牺牲生产效率和加大胶皮厚度来保证低漏油率；
4)本发明制备出的植物软胶囊胶皮厚度远低于正常水平的一半甚至更低，同时还能保证胶囊的硬度和极低的漏油率，这对于控制软胶囊成本具备极重的意义；
5)本发明与其他纯淀粉的植物胶相比，生产效率有极大的提升，纯淀粉的胶皮由于韧性不足，漏油率较高，对于机速有较大限制，机速只有1.5rpm，而本发明能以1.5rpm-5.0rpm的机速生产，完全能做到与明胶媲美；且大大节省胶囊成型后的干燥时间，解决了诸多植物软胶囊共存的问题-干燥时间过长；
6)淀粉和卡拉胶的粘性过大，通常植物软胶囊的破裂时间均在30分钟左右；本发明通过移除可溶性盐的成膜剂并降低胶皮厚度，可实现将软胶囊破裂时间做到了小于15分钟，符合USP标准；
7)普通的明胶软胶囊由于明胶原料的限制，温度过高，明胶会溶解，溶解后的明胶具备粘性，导致软胶囊互相黏连，因此常规明胶软胶囊均需要冷藏；本发明制备出的植物软胶囊则完美解决了这个问题，本发明制备的植物软胶囊胶皮耐高温，即使在夏天的高温天气下，依然能做到不溶解，不黏连；对于物流运输和贮藏条件要求较低，节约了大量的成本。
名词解释：Mn代表数均分子量，Mw代表重均分子量，Mz代表平均分子量，Mw/Mn代表多分散性指数。
附图说明
图1为市售典型高分子量卡拉胶的检测图，图中重均分子量Mw＝2.40×10 6；
图2为市售典型低分子量卡拉胶的检测图，图中重均分子量Mw＝1.12×10 6；
图3为本发明典型限定分子量卡拉胶的检测图，图中重均分子量 Mw＝1.78×10 6。
图1-3中横轴代表分子量对数；纵轴代表曲线上某一点纵轴值是每个分子量下样品分子的含量多少相关的数值。
具体实施方式
为使本发明的目的、技术方案和优点更加清楚明了，下面结合具体实施方式，对本发明进一步详细说明。应该理解，这些描述只是示例性的，而并非要限制本发明的范围。
实施例中所涉及设备：化胶罐TRRJ-10，来自于温州天瑞制药机械有限公司；全自动软胶囊机BCM-GB6，来自于BOCHANG CO，L，td；SLX-A型硬度仪：来自于温州山度仪器有限公司。
软胶囊主要检测指标：
1)胶皮接缝率：胶皮接缝厚度占胶皮厚度的比例；2)漏油率：漏油的软胶囊占所有软胶囊的比例；3)内容物装量：指该模具的最大装量；4)破裂时间：参照USP<2040>中破裂试验；5)硬度：干燥后软胶囊的硬度，衡量软胶囊的干燥效果。
实施例1
不同类型的卡拉胶对制备出的软胶囊的影响
1)化胶工艺
称取不同类型的卡拉胶8KG、30KG羟丙基淀粉、15KG甘油和47KG纯化水置于化胶罐中，加热至80～90℃使胶液溶胀后保温20～120min，脱气至胶液澄清透亮得胶液；
2)轧丸工艺
选用22量滴圆柱形软胶囊模具，将轧丸机的胶盒加热至80～95℃，转鼓加热20～40℃，供胶，设定胶皮厚度0.80mm，机速1.5rpm进行轧丸，内容物为亚麻籽油，然后干燥至胶丸硬度满足要求(50～70N)，选丸，最后包装。
对不同类型的卡拉胶制备出的软胶囊胶皮接缝率、内容物装量、漏油率进行检测，结果如表1所示：
表1卡拉胶类型对产品的影响
卡拉胶 I型 K型 L型 I型+K型
胶皮接缝率 70％ 0％ 0％ 75％
内容物装量 800mg 0 0 850mg
漏油率 小于1％ 100％ 100％ 小于1％
注：表1中I型的重均分子量为1.2×10 6、K型的重均分子量为2.0×10 6、L型的重均分子量为1.8×10 6；其中I型+K型是指采用I型和K型卡拉胶作为原料，按重量比计算I型∶K型重量比可在9.9∶0.1～7.0∶3.0范围内，本实施例为8∶1。
试验中发现L型卡拉胶制出的胶液无凝胶性能，无法平铺成膜，纯K型卡拉胶制出的胶液成膜性较好，但是黏性较差。只有纯I型或者I型+K型的卡拉胶，制出的胶液容易平铺成膜，黏性适中，胶皮韧性良好，不易拉断，生产出的胶囊漏油率低，生产效率高。
实施例2
不同重均分子量的卡拉胶对制备出的软胶囊的影响
1)化胶工艺
称取不同重均分子量的I型(Iota)卡拉胶8KG、30KG羟丙基淀粉、15KG甘油和47KG纯化水置于化胶罐中，加热至80～90℃使胶液溶胀后保温20～120min，脱气至胶液澄清透亮得胶液；
2)轧丸工艺
选用22量滴圆柱形软胶囊模具，将轧丸机的胶盒加热至80～95℃，转鼓加热20～40℃，供胶，设定胶皮厚度0.80mm，机速1.5rpm进行轧丸，内容物为亚麻籽油，然后干燥至胶丸硬度满足要求(50～70N)，选丸，最后包装。
对不同重均分子量的卡拉胶制备出的软胶囊胶皮接缝率、内容物装量、漏油率进行检测，结果如表2所示：
表2卡拉胶重均分子量对产品的影响
卡拉胶Mw 1.0×10 6 1.2×10 6 1.5×10 6 2.0×10 6 2.5×10 6
胶皮接缝率 40％ 60％ 70％ 50％ 20％
内容物装量 600mg 800mg 850mg 800mg 400mg
漏油率 20％ 小于1％ 小于1％ 小于1％ 50％
试验中发现小分子量的卡拉胶占过高时，胶皮的黏性较强，但是 成膜性差，导致装量偏低，且漏油率高。当大分子量卡拉胶占比过高时，胶液成膜性好，能均匀铺在转鼓表面，但是胶皮的黏性较差，接缝率低，导致轧丸漏油明显。只有当卡拉胶重均分子量稳定在1.20×10 6～2.00×10 6之间时，胶液容易平铺成膜，黏性适中，胶皮韧性良好，不易拉断，生产效率高。
实施例3
不同转鼓温度对制备出的软胶囊性质的影响：
1)化胶工艺
称取8KG I型(Iota)卡拉胶(卡拉胶重均分子量为1.50±0.1×10 6)、30KG羟丙基淀粉、15KG甘油和47KG纯化水置于化胶罐中，加热至80～90℃使胶液溶胀后保温20～120min，脱气至胶液澄清透亮得胶液；
2)轧丸工艺
选用22量滴圆柱形软胶囊模具，将轧丸机的胶盒加热至80～95℃，转鼓加热，供胶，设定胶皮厚度0.80mm，机速1.5rpm进行轧丸，内容物为亚麻籽油，然后干燥至胶丸硬度满足要求(50～70N)，选丸，最后包装。
对不同转鼓温度制备出的软胶囊胶皮接缝率、内容物装量、漏油率进行检测，结果如表3所示：
表3不同转鼓温度对产品的影响
转鼓温度 15℃ 20℃ 30℃ 40℃ 50℃
胶皮接缝率 50％ 60％ 70％ 70％ 40％
内容物装量 600mg 800mg 850mg 850mg 700
漏油率 20％ 小于1％ 小于1％ 小于1％ 40％
不同的转鼓温度对于胶皮的韧性有较大的影响，目前行业内轧丸机的转鼓均为制冷，这样可以使明胶胶液尽快冷却成型，但是本发明植物胶液水分含量较高，用常规制冷方法难以迅速干燥形成韧性良好的胶皮。我们对转鼓进行加热，经过具备加热功能的转鼓的植物胶皮能迅速干燥，具备良好的韧性与黏性，节省前期干燥时间。通过实验我们发现转鼓温度较低时，胶皮干燥较慢，韧性不够，导致装量较低， 且漏油率高。转鼓温度较高时，胶皮水分流失过快，导致胶皮黏性降低，接缝率低，最终导致漏油。故优选的转鼓温度范围为20～40℃。
实施例4
不同增塑剂对制备出的软胶囊性质的影响：
1)化胶工艺
称取8KG I型(Iota)卡拉胶(卡拉胶重均分子量为1.50±0.1×10 6)、30KG羟丙基淀粉、15KG增塑剂和47KG纯化水置于化胶罐中，加热至80～90℃使胶液溶胀后保温20～120min，脱气至胶液澄清透亮得胶液；
2)轧丸工艺
选用22量滴圆柱形软胶囊模具，将轧丸机的胶盒加热至80～95℃，转鼓加热20～40℃，供胶，设定胶皮厚度0.80mm，机速1.5rpm进行轧丸，内容物为亚麻籽油，然后干燥至胶丸硬度满足要求(50～70N)，选丸，最后包装。
对不同增塑剂制备出的软胶囊胶皮接缝率、内容物装量、漏油率进行检测，结果如表4所示：
表4不同增塑剂对产品的影响
增塑剂 甘油 山梨糖醇 木糖醇 聚乙二醇
胶皮接缝率 70％ 60％ 40％ 30％
内容物装量 850mg 700mg 500mg 400mg
漏油率 小于1％ 小于1％ 20％ 40％
增塑剂对于胶皮的韧性有较大的影响，胶皮的韧性决定了胶囊的装量范围，韧性越好，装量越大。我们试验了甘油和山梨糖醇、木糖醇、聚乙二醇作为增塑剂，发现甘油的胶皮韧性最好，胶囊装量可以做到850mg，同样的模具用山梨糖醇、木糖醇或聚乙二醇作为增塑剂，胶皮韧性不足，胶囊装量偏低，且木糖醇与聚乙二醇作为增塑剂，漏油率较高，故首选甘油作为胶皮增塑剂。
实施例5
不同淀粉种类对制备出的软胶囊性质的影响：
1)化胶工艺
称取8KG I型(Iota)卡拉胶(卡拉胶重均分子量为1.50±0.1×10 6)、30KG淀粉、15KG甘油和47KG纯化水置于化胶罐中，加热至80～90℃使胶液溶胀后保温20～120min，脱气至胶液澄清透亮得胶液；
2)轧丸工艺
选用22量滴圆柱形软胶囊模具，将轧丸机的胶盒加热至80～95℃，转鼓加热20～40℃，供胶，设定胶皮厚度0.80mm，机速1.5rpm进行轧丸，内容物为亚麻籽油，然后干燥至胶丸硬度满足要求(50～70N)，选丸，最后包装。
对不同淀粉制备出的软胶囊胶皮接缝率、内容物装量、漏油率进行检测，结果如表5所示：
表5不同增塑剂对产品的影响
淀粉 氧化淀粉 酸性淀粉 羟丙基淀粉 氧化羟丙基淀粉
胶皮接缝率 10％ 20％ 70％ 70％
内容物装量 300mg 500mg 850mg 900mg
漏油率 80％ 60％ 小于1％ 小于1％
淀粉对于胶皮的粘性有较大的影响，胶皮的粘性过低，接缝厚度不足，漏油率高，胶皮粘性过高，容易粘在转鼓表面，影响生产效率。因此我们筛选了氧化淀粉、酸性淀粉、羟丙基淀粉、氧化羟丙基淀粉分别进行试验，发现氧化淀粉与酸性淀粉制出的胶皮粘性不足，制出的胶囊极易漏油，而羟丙基淀粉与氧化羟丙基淀粉则具备良好的粘性，满足了生产需求，故我们优选羟丙基淀粉或氧化羟丙基淀粉。
实施例6
不同胶皮厚度对产品性能的影响：
1)化胶工艺
称取8KG I型(Iota)卡拉胶(卡拉胶分子量为卡拉胶重均分子量为1.50±0.1×10 6)、30KG羟丙基淀粉、15KG甘油、和47KG纯化水置于化胶罐中，加热至80～90℃使胶液溶胀后保温20～120min，脱气至胶液澄清透亮得胶液；
2)轧丸工艺
选用22量滴圆柱形软胶囊模具，将轧丸机的胶盒加热至80～95℃，转鼓加热20～40℃，供胶，设定不同的胶皮厚度，机速1.5rpm进行轧丸，内容物为亚麻籽油，然后干燥至胶丸硬度满足要求(50～70N)，选丸，最后包装。
对不同胶皮厚度制备出的软胶囊的胶皮接缝率、内容物装量、漏油率、破裂时间、硬度进行检测，结果如表6所示：
表6不同胶皮厚度对产品的影响
胶皮厚度 0.20 0.30 0.45 0.60 0.80
胶皮接缝率 70％ 70％ 70％ 70％ 70％
内容物装量 750mg 1000mg 1000mg 950mg 850mg
漏油率 5％ 小于1％ 小于1％ 小于1％ 小于1％
破裂时间 1min 3min 5min 13min 25min
硬度 30N 50N 70N 70N 70N
通过数据表明，本发明可以在满足上述性能指标的前提下，制备出厚度为0.30mm～0.60mm的胶皮。理论上胶皮厚度越薄越好，但是胶皮过薄，漏油的风险就高，所以为了控制漏油率，行业内常规胶皮厚度为0.70mm～0.90mm。但是我们通过调整软胶囊配方结合本发明生产工艺，在保证产品漏油率的前提下，可以把胶皮厚度做到0.30mm～0.60mm。胶皮厚度较厚时，胶囊漏油率低，但是破裂时间过长，且胶皮成本过高，胶皮厚度过薄时时，破裂时间短，但是胶囊漏油率较高，且胶囊太软，硬度不够。综合成本和漏油率考虑，优选的胶皮厚度为0.30mm～0.60mm。
实施例7
不同机速对产品性能的影响：
1)化胶工艺
称取8KG I型(Iota)卡拉胶(卡拉胶重均分子量为1.50±0.1×10 6)、30KG羟丙基淀粉、15KG甘油、和47KG纯化水置于化胶罐中，加热至80～90℃使胶液溶胀后保温20min～120min，脱气至胶液澄清透亮得胶液；
2)轧丸工艺
选用22量滴圆柱形软胶囊模具，将轧丸机的胶盒加热至80～95℃，转鼓加热20～40℃，供胶，设定胶皮厚度0.40mm，不同机速下进行轧丸，内容物为亚麻籽油，然后干燥至胶丸硬度满足要求(50～70N)，选丸，最后包装。
对不同机速制备出的软胶囊胶皮接缝率、内容物装量、漏油率进行检测，结果如表7所示：
表7不同机速对产品的影响
机速 1.5rpm 2.5rpm 3.0rpm 4.0rpm 5.0rpm
胶皮接缝率 80％ 75％ 70％ 60％ 50％
内容物装量 1000mg 1000mg 1000mg 1000mg 1000mg
漏油率 小于1％ 小于1％ 小于1％ 小于1％ 小于1％
常规植物软胶囊生产考虑到漏油率的问题，一般机速都比较低，我们从胶液接缝率中也能看出，确实接缝比较完美，漏油风险低。但是低速生产效率较低，而本发明的植物软胶囊生产工艺，可以在1.5～5.0rpm的机速下，做到近似胶皮接缝率，且漏油率小于1％，具备极高的生产效率。
实施例8
不同离子对产品性能的影响：
1)化胶工艺
称取8KG I型(Iota)卡拉胶(卡拉胶重均分子量为1.50±0.1×10 6)、30KG羟丙基淀粉、15KG甘油、0.1KG离子(如有必要)和47KG纯化水置于化胶罐中，加热至80～90℃使胶液溶胀后保温20～120min，脱气至胶液澄清透亮得胶液；
2)轧丸工艺
选用22量滴圆柱形软胶囊模具，将轧丸机的胶盒加热至80～95℃，转鼓加热20～40℃，供胶，设定胶皮厚度0.40mm，机速3.0rpm进行轧丸，内容物为亚麻籽油，然后干燥至胶丸硬度满足要求(50～70N)，选丸，最后包装。
对不同离子制备出的软胶囊胶皮接缝率、内容物装量、漏油率、破裂时间进行检测，结果如表8所示：
表8不同离子对产品的影响
离子 氯化钠 氯化钾 氯化钙 不加离子
胶皮接缝率 90％ 85％ 85％ 70％
内容物装量 1000mg 1000mg 1000mg 1000mg
漏油率 小于1％ 小于1％ 小于1％ 小于1％
破裂时间 18min 20min 25min 5min
现有技术中采用氯化钙、氯化钾、氯化钠等离子作为成膜剂，促进卡拉胶的交联，以实现优异的成膜性并保证胶皮的韧性；本发明研究中发现成膜剂的加入会导致胶囊破裂时间过长，远超15分钟。本发明不添加任何金属离子即可制备出性能等同甚至更优的软胶囊(由内容物装量衡量的韧性基本相同)，且破裂时间显著缩短，完全符合USP标准。
实施例9
不同色素对产品性能的影响：
1)化胶工艺
称取8KG I型(Iota)卡拉胶(卡拉胶重均分子量为1.50±0.1×10 6)、30KG羟丙基淀粉、15KG甘油、1KG色素和47KG纯化水置于化胶罐中，加热至80～90℃使胶液溶胀后保温20～120min，脱气至胶液澄清透亮得胶液；
2)轧丸工艺
选用22量滴圆柱形软胶囊模具，将轧丸机的胶盒加热至80～95℃，转鼓加热20～40℃，供胶，设定胶皮厚度0.40mm，机速3.0rpm进行轧丸，内容物为亚麻籽油，然后干燥至胶丸硬度满足要求(50～70N)，选丸，最后包装。
不同色素制备出的软胶囊性质的结果如表9所示：
表9不同色素对产品的影响
Figure PCTCN2019091929-appb-000001
Figure PCTCN2019091929-appb-000002
由于植物软胶囊的生产工艺的温度较高，常规的色素在高温下极易褪色，故筛选耐高温且满足生产需求的色素具备极其重要的意义。该发明试验了各种色素对于胶液性能的影响，发现焦糖色添加比例较高时，胶液粘性极强，但胶液性能较差，无法平铺成膜。而紫薯红虽然能满足生产需求，但是该天然色素高温下极易褪色。红氧化铁虽然高温下不褪色，但是胶液性能较差。我们经过多次筛选，发现胭脂树橙与藻蓝色素不影响胶液性能，且在一定时间的高温下，可以做到不褪色，这对于我们丰富产品种类具备极其重要的意义。
表9中紫薯红(又称紫甘薯红色素)是从紫甘薯的块根和茎叶中浸提出来的一种天然红色素，其结构中含多个酚羟基。现有技术(食品加工，2016年41卷第2期，38-41页，紫甘薯红色素稳定性的研究)对紫薯红色素的稳定性进行了详细的研究，研究表明对紫甘薯红色素稳定性最好的是Al3 +、Ca2 +、Sn2 +，但在本发明体系中金属离子的加入对软胶囊的破裂时间有较大影响，而且文章中表明金属离子种类可能起到加速颜色变淡的反作用，所以参考意义不大。
为了开发紫红色软胶囊，解决紫薯红在制备软胶囊变色的问题，本发明研究了不同种类的食品添加剂作为紫薯红的护色剂，发现葡甲胺能够有效解决紫薯红的褪色问题；添加护色剂软胶囊的制备方法同上述色素的筛选方法，区别在于色素选定紫薯红，且添加护色剂-紫薯红重量50wt％的(即500g)，以不同护色剂制备出的软胶囊壳颜色作为衡量护色剂的护色效果，结果如表9-A所示：
表9-A不同护色剂的护色效果
Figure PCTCN2019091929-appb-000003
Figure PCTCN2019091929-appb-000004
注：ND是指未加入任何护色剂，作为对照；“——”是指未进行试验；0天是指当天制备出的软胶囊；40℃加速3个月是指将制备出的软胶囊采用PVC塑料瓶包装(模拟市售包装)，于温度(40±2)℃下避光放置3个月，观察胶囊壳颜色变化。
试验结果表明，酸性护色剂(抗坏血酸、柠檬酸)和有机酸盐(苯甲酸钠)在体系中对紫薯红基本起不到任何护色作用；葡萄糖起到微弱的护色作用，仅L-盐酸半胱氨酸和葡甲胺护色作用较为明显，但当采用加速试验评估长期放置时，只有葡甲胺显示出了优异的长期护色作用，能够真正具有工业化应用的前景。
实施例10
1)化胶工艺
称取8KG I型(Iota)卡拉胶(卡拉胶重均分子量为1.50±0.1×10 6)、30KG羟丙基淀粉、15KG甘油、和47KG纯化水置于化胶罐中，加热至80～90℃使胶液溶胀后保温20～120min，脱气至胶液澄清透亮得胶液；
2)轧丸工艺
选用22量滴圆柱形软胶囊模具，将轧丸机的胶盒加热至80～95℃，转鼓加热20～40℃，供胶，设定胶皮厚度0.40mm，机速3.0rpm进行轧丸，内容物为亚麻籽油，然后干燥至胶丸硬度满足要求(50～70N)，选丸，最后包装。
所得的成品破裂时间5min，漏油率控制在1％以下，该工艺具备极高的生产效率，且符合USP标准。
实施例11
1)化胶工艺
称取3KG I型(Iota)卡拉胶(卡拉胶重均分子量为1.50±0.1×10 6)、40KG羟丙基淀粉、20KG甘油、和37KG纯化水置于化胶罐中，加热至80～90℃使胶液溶胀后保温20～120min，脱气至胶液澄清透亮得胶液；
2)轧丸工艺
选用22量滴圆柱形软胶囊模具，将轧丸机的胶盒加热至80～95℃，转鼓加热20～40℃，供胶，设定胶皮厚度0.40mm，机速3.0rpm进行轧丸，内容物为亚麻籽油，然后干燥至胶丸硬度满足要求(50～70N)，选丸，最后包装。
所得检测结果如表11所示：
表11软胶囊检测结果
胶皮接缝率 70％
内容物装量 800mg
漏油率 小于1％
破裂时间 3min
硬度 55N
实施例12
1)化胶工艺
称取15KG I型(Iota)卡拉胶(卡拉胶重均分子量为1.50±0.1×10 6)、20KG羟丙基淀粉、10KG甘油、和55KG纯化水置于化胶罐中，加热至80～90℃使胶液溶胀后保温20～120min，脱气至胶液澄清透亮得胶液；
2)轧丸工艺
选用22量滴圆柱形软胶囊模具，将轧丸机的胶盒加热至80～95℃，转鼓加热20～40℃，供胶，设定胶皮厚度0.40mm，机速3.0rpm进行轧丸，内容物为亚麻籽油，然后干燥至胶丸硬度满足要求(50～70N)，选丸，最后包装。
所得检测结果如表12所示：
表12软胶囊检测结果
胶皮接缝率 60％
内容物装量 750mg
漏油率 小于1％
破裂时间 6min
硬度 65N
尽管已经详细描述了本发明的实施方式，但是应该理解的是，在不偏离本发明的精神和范围的情况下，可以对本发明的实施方式做出各种改变、替换和变更。

Claims (13)

  1. 一种植物软胶囊，包括卡拉胶、淀粉、增塑剂和水，其特征在于：所述卡拉胶为的重均分子量Mw为1.2×10 6～2.0×10 6。
  2. 根据权利要求1所述的植物软胶囊，其特征在于：按照重量份数计算，所述植物软胶囊包括3-20重量份的卡拉胶、10-50重量份的淀粉、10-35重量份的增塑剂、30-70重量份的水。
  3. 根据权利要求1所述的植物软胶囊，其特征在于：所述卡拉胶为I型或I型与K型的组合；所述I型与K型的组合中，按重量比计算I型∶K型＝9.9∶0.1～7.0∶3.0。
  4. 根据权利要求1所述的植物软胶囊，其特征在于：所述增塑剂为甘油、山梨糖醇、木糖醇、聚乙二醇中的一种或两种以上的任意组合。
  5. 根据权利要求1所述的植物软胶囊，其特征在于：所述淀粉为改性淀粉，所述改性淀粉为羟丙基淀粉、氧化羟丙基淀粉中的一种或两种的任意重量比例组合。
  6. 根据权利要求1-5任一项所述的植物软胶囊，其特征在于：所述植物软胶囊中还可以包括色素、遮光剂或香味剂中的一种或多种。
  7. 根据权利要求6所述的植物软胶囊，其特征在于：所述色素为天然色素或合成色素，所述天然色素为藻蓝、胭脂树橙或紫薯红，所述合成色素为胭脂红、柠檬黄、日落黄或靛蓝；所述紫薯红中加入葡甲胺作为护色剂。
  8. 一种植物软胶囊的制备方法，包括如下步骤：
    1)化胶工艺
    称取配方量的卡拉胶、淀粉、增塑剂和水，加热至胶液溶胀后保温，脱气至胶液澄清透亮得胶液；
    2)轧丸工艺
    将轧丸机的胶盒加热，转鼓加热，供胶，设定胶皮厚度，设定轧丸机机速后进行轧丸，然后干燥至胶丸达到一定硬度，选丸，最后包装。
  9. 根据权利要求8所述的制备方法，其特征在于：步骤2)所述转鼓加热温度为20～40℃。
  10. 根据权利要求9所述的制备方法，其特征在于：步骤1)所述加热的温度为80～90℃；所述保温的时间为20～120min。
  11. 根据权利要求9所述的制备方法，其特征在于：步骤2)中所述将轧丸机的胶盒加热的温度为80～95℃。
  12. 一种权利要求1所述述植物软胶囊的用途，其特征在于：植物软胶囊中填充活性组分为内容物，用于制备药品、功能性食品或膳食营养补充剂。
  13. 根据权利要求12所述的用途，其特征在于：所述药品为丹七软胶囊；所述功能性食品或膳食营养补充剂为亚麻籽油植物软胶囊、维生素E植物软胶囊、月见草油植物软胶囊、生物素植物软胶囊、叶黄素植物软胶囊、辅酶Q10植物软胶囊、维生素K2植物软胶囊、磷脂植物软胶囊、共轭亚油酸植物软胶囊、椰子油植物软胶囊、复合维生素矿物质植物软胶囊、DHA藻油植物软胶囊或鱼油植物软胶囊。
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