WO2020078036A1 - 一种口腔微泡腾片及其制备方法 - Google Patents

一种口腔微泡腾片及其制备方法 Download PDF

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Publication number
WO2020078036A1
WO2020078036A1 PCT/CN2019/092936 CN2019092936W WO2020078036A1 WO 2020078036 A1 WO2020078036 A1 WO 2020078036A1 CN 2019092936 W CN2019092936 W CN 2019092936W WO 2020078036 A1 WO2020078036 A1 WO 2020078036A1
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Prior art keywords
parts
effervescent tablet
micro
vitamin
oral micro
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PCT/CN2019/092936
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English (en)
French (fr)
Inventor
韦经强
黄远英
刘美娟
麦文琼
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汤臣倍健股份有限公司
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Application filed by 汤臣倍健股份有限公司 filed Critical 汤臣倍健股份有限公司
Priority to US17/286,322 priority Critical patent/US20220000770A1/en
Priority to EP19872826.3A priority patent/EP3868367A4/en
Priority to AU2019362348A priority patent/AU2019362348B2/en
Priority to JP2021546412A priority patent/JP7141542B2/ja
Publication of WO2020078036A1 publication Critical patent/WO2020078036A1/zh

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    • 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
    • A23L27/00—Spices; Flavouring agents or condiments; Artificial sweetening agents; Table salts; Dietetic salt substitutes; Preparation or treatment 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
    • A23L27/00—Spices; Flavouring agents or condiments; Artificial sweetening agents; Table salts; Dietetic salt substitutes; Preparation or treatment thereof
    • A23L27/30—Artificial sweetening agents
    • A23L27/31—Artificial sweetening agents containing amino acids, nucleotides, peptides or derivatives
    • A23L27/32—Artificial sweetening agents containing amino acids, nucleotides, peptides or derivatives containing dipeptides or 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
    • 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
    • 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
    • A23L27/36—Terpene glycosides
    • 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
    • A23L29/015—Inorganic 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
    • A23L29/03—Organic compounds
    • A23L29/035—Organic compounds containing oxygen as heteroatom
    • 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
    • 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
    • A23L33/155—Vitamins A or D
    • 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
    • A23L5/30—Physical treatment, e.g. electrical or magnetic means, wave energy or irradiation
    • 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
    • A23P10/20—Agglomerating; Granulating; Tabletting
    • A23P10/28—Tabletting; Making food bars by compression of a dry powdered mixture
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
    • 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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0007—Effervescent
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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 relates to the field of health food preparations, in particular to an oral micro-effervescent tablet and a preparation method thereof.
  • Vitamins are a type of trace organic substances that humans and animals must obtain from food in order to maintain normal physiological functions. They play an important role in human growth, metabolism, and development. This kind of substance is neither a raw material constituting body tissue nor a source of energy in the body, but a kind of regulating substance, which plays an important role in the metabolism of substances.
  • the human body is like an extremely complex chemical plant, constantly carrying out various biochemical reactions. The reaction is closely related to the catalytic effect of enzymes. For enzymes to produce activity, they must have coenzymes. Many vitamins are known to be coenzymes or coenzymes of enzymes. Composition molecule. Therefore, vitamins are important substances for maintaining and regulating the body's normal metabolism.
  • Effervescent tablets are a relatively new health food and pharmaceutical dosage form in China. They contain organic acids and basic (hydrogen) carbonate salts as effervescent disintegrants. Put the effervescent tablet into the water, and the organic acid and basic carbonate (hydrogen) salt react immediately to generate and release a large amount of carbon dioxide gas, like boiling.
  • effervescent tablets Compared with ordinary tablets, effervescent tablets have the following advantages: 1 easy to take and rapid onset; 2 good taste, good patient compliance, especially suitable for children, the elderly and patients who have difficulty swallowing solid preparations; 3 1 ⁇ 5min Rapid disintegration within the body; 4High bioavailability, which can improve clinical efficacy; 5Some acidity, which can increase the stability and solubility of some drugs; Efficient use of the effect, so effervescent tablets can also be used for the prevention and treatment of oral diseases, vaginal diseases, etc .; 7 easy to carry, transport and store.
  • the single vitamin or multivitamins are made into effervescent tablet type, which is welcomed by consumers.
  • effervescent tablets need to be dissolved in water before they can be taken. In the absence of water or drinking water, taking effervescent tablets will cause many inconveniences to consumers.
  • the oral micro-effervescent tablet is a new dosage form that can produce micro-effervescence under the action of saliva in the oral cavity Phenomenon, good taste and strong experience, thus providing the following inventions:
  • the present application provides an oral micro-effervescent tablet comprising nutrients, sugar alcohol, acid source, alkali source, magnesium stearate, flavor and sweetener; wherein,
  • the sugar alcohol is lactose, maltitol, sorbitol, isomalt, mannitol, erythritol or any combination thereof;
  • the sweetener is sucralose, aspartame, stevioside Glycoside, fructose, granulated sugar, mogroside or any combination thereof;
  • the content of each component in the oral micro-effervescent tablet is:
  • the weight ratio of the acid source in the oral micro-effervescent tablet does not exceed 19% (for example, 1% to 5%, 5% to 10%, 10% to 15%, or 15% to 19%); alkali
  • the weight ratio of the source in the oral micro-effervescent tablet does not exceed 18% (for example, 1% to 5%, 5% to 10%, 10% to 15%, or 15% to 18%).
  • the oral micro-effervescent tablet contains 48 to 63 parts of sugar alcohol by weight. In some embodiments, the oral micro-effervescent tablet contains 0.8 to 1.5 parts of magnesium stearate in parts by weight.
  • the oral micro-effervescent tablet contains 11 to 19 parts of acid source by weight.
  • the oral micro-effervescent tablet contains 11 to 18 parts of alkali source by weight.
  • the content of each component in the oral micro-effervescent tablet is:
  • the content of each component in the oral micro-effervescent tablet is:
  • the nutrient is a vitamin.
  • the vitamin is vitamin A, vitamin B family, vitamin C, vitamin D, vitamin E, vitamin K, or any combination thereof.
  • the micro-effervescent tablet of the present invention comprises vitamin A.
  • Vitamin A is an anti-dry eye vitamin, also known as a beauty vitamin, and is fat-soluble.
  • Vitamin A is not a single compound, but a series of retinol (also known as vitamin A alcohol or rosin oil) derivatives, vitamin A can be used to prevent or treat night blindness.
  • the micro-effervescent tablet of the present invention comprises vitamin B 1 .
  • Vitamin B 1 is thiamine, also known as anti-beriberi factor, anti-neuritis factor, etc. It is a water-soluble vitamin. Vitamin B 1 can be used to prevent or treat seborrheic dermatitis or eczema.
  • the micro-effervescent tablet of the present invention comprises vitamin B 2 .
  • Vitamin B 2 is riboflavin, also known as vitamin G, and is water soluble. Vitamin B 2 can be used to prevent or treat mouth and tongue inflammation (oral ulcers).
  • the micro-effervescent tablets of the present invention comprise vitamin C.
  • Vitamin C ascorbic acid, is water-soluble and can be used to prevent or treat scurvy.
  • the micro-effervescent tablets of the present invention comprise vitamin D.
  • Vitamin D calcified alcohol, is fat-soluble and can be used to prevent or treat rickets.
  • the sugar alcohol is lactose, maltitol, sorbitol, isomalt, or any combination thereof.
  • the sugar alcohol is lactose and maltitol.
  • the ratio of lactose to maltitol is 1: 0.2 to 4.5 (eg, 1: 0.2, 1: 2.2, or 1: 4.5) by weight.
  • the sugar alcohol is sorbitol and lactose.
  • the ratio of sorbitol to lactose is 1: 0.39 to 4.2 (eg, 1: 0.39, 1: 0.74, 1: 0.85, or 1: 4.2) by weight.
  • the sugar alcohol is isomalt and lactose.
  • the ratio of isomalt to lactose is 1: 0.46 to 1.6 in parts by weight.
  • the sweetener is sucralose, aspartame, stevioside, or any combination thereof.
  • the acid source is citric acid, tartaric acid, fumaric acid, malic acid, or any combination thereof;
  • the alkali source is sodium bicarbonate, sodium carbonate, potassium bicarbonate, potassium carbonate, or any combination thereof .
  • the oral micro-effervescent tablet further includes silica, and the weight ratio of silica in the oral micro-effervescent tablet is 0.1% to 1%.
  • the oral micro-effervescent tablet further includes silica, and the weight ratio of silica in the oral micro-effervescent tablet is 0.5%.
  • the micro-effervescent tablet of the present invention comprises: lactose, maltitol, vitamin C, anhydrous citric acid, sodium bicarbonate, flavor, sucralose, aspartame, stevioside and stearin Magnesium acid, optionally also containing silica.
  • the micro-effervescent tablet of the present invention comprises: lactose 9.8-48.8 parts (for example 9.8-16.1 parts or 16.1-48.8 parts), maltitol 10-42.5 parts (for example 10 ⁇ 35 parts or 35 to 42.5 parts), Vitamin C 10 to 10.5 parts, anhydrous citric acid 14 to 17.5 parts, sodium bicarbonate 14 to 16.25 parts, flavor 1.7 to 2 parts, sucralose 0.025 to 0.03 parts, aspart Sweet 0.12 to 0.6 parts, stevioside 0.05 to 0.3 parts, magnesium stearate 0.8 to 1.5 parts (for example 0.8 to 1 or 1 to 1.5 parts), optionally also containing 0.1 to 1 parts of silica (for example 0.1 to 0.5 parts or 0.5 to 1 part).
  • lactose 9.8-48.8 parts for example 9.8-16.1 parts or 16.1-48.8 parts
  • maltitol 10-42.5 parts for example 10 ⁇ 35 parts or 35 to 42.5 parts
  • Vitamin C 10 to 10.5 parts anhydrous citric acid
  • the microeffervescent tablet of the present invention comprises: maltitol, vitamin C, anhydrous citric acid, sodium bicarbonate, flavor, sucralose, aspartame, stevioside, magnesium stearate And silica.
  • the micro-effervescent tablet of the present invention comprises: maltitol 10 to 80 parts (for example, 10 to 62.7 parts or 62.7 to 80 parts), vitamin C 1 to 30 parts (for example, 1 ⁇ 10.5 parts or 10.5-30 parts), anhydrous citric acid 10-40 parts (for example 10-11.3 parts or 11.3-40 parts), sodium bicarbonate 10-40 parts (for example 10-11.25 parts or 11.25-40 parts) , 1 to 5 parts of essence (for example, 1 to 1.5 parts or 1.5 to 5 parts), sucralose, stevioside and aspartame total 0.1 to 3 parts (for example, sucralose 0.025 to 0.03 parts, stevioside 0.3 ⁇ 0.4 parts, aspartame 0.4 ⁇ 0.5 parts), magnesium stearate 0.1 ⁇ 3 parts (for example 0.1 ⁇ 1.5 parts or 1.5 ⁇ 3 parts), silica 0.1 ⁇ 1 part (for example 0.1 ⁇ 0.5 parts or 0.5 ⁇ 1 serving).
  • maltitol 10 to 80 parts for example, 10
  • the micro-effervescent tablet of the present invention comprises: sorbitol, lactose, vitamin C, anhydrous citric acid, sodium bicarbonate, flavor, sucralose, aspartame, stevioside and hard Magnesium fatate, optionally also containing silica.
  • the micro-effervescent tablet of the present invention comprises: sorbitol 10 to 35 parts (for example, 10 to 30 parts or 30 to 35 parts), lactose 13.6 to 41.7 parts (for example, 13.6 to 22.3 parts, 22.3 to 25.4 parts or 25.4-41.6 parts), Vitamin C 10-10.5 parts, anhydrous citric acid 15-18.75 parts (for example 15-17.5 parts or 17.5-18.75 parts), sodium bicarbonate 15-17.5 parts (for example 15-16.25 parts Or 16.25 to 17.5 parts), flavors 1 to 5 parts (for example 1 to 1.7 parts or 1.7 to 5 parts), sucralose, stevioside and aspartame total 0.1 to 3 parts (for example sucralose 0.025 to 0.03) Parts, aspartame 0.6-0.7 parts, steviol glycosides 0.3-0.4 parts), magnesium stearate 0.8-1.5 parts, optionally also containing 0.1-1 parts of silica (for example 0.1-0.5 parts or 0.5- 1 serving).
  • the micro-effervescent tablet of the present invention comprises: lactose, vitamin C, anhydrous citric acid, sodium bicarbonate, flavor, sucralose, aspartame, stevioside, magnesium stearate and Silica.
  • the micro-effervescent tablet of the present invention comprises: 10 to 80 parts of lactose (for example, 10 to 59.4 parts or 59.4 to 80 parts), and 1 to 30 parts of vitamin C (for example, 1 to 10.5 parts or 10.5-30 parts), anhydrous citric acid 10-40 parts (for example 10-15.25 parts or 15.25-40 parts), sodium bicarbonate 10-40 parts (for example 10-11.25 parts or 11.25-40 parts), Fragrance 1 to 5 parts (for example, 1 to 1.5 parts or 1.5 to 5 parts), sucralose, stevioside and aspartame total 0.1 to 3 parts (for example, sucralose 0.025 to 0.03 parts, stevioside 0.3 to 0.4 parts, aspartame 0.8 to 0.9 parts), magnesium stearate 0.1 to 3 parts (for example 0.1 to 0.5 parts or 0.5 to 3 parts), silica 0.1 to 1 parts (for example 0.1 to 0.5 parts or 0.5 to 1 serving).
  • vitamin C for example, 1 to 10.5 parts or 10.5-30 parts
  • the microeffervescent tablet of the present invention comprises: isomalt, lactose, vitamin C, anhydrous citric acid, sodium bicarbonate, flavor, sucralose, aspartame, stevioside And magnesium stearate, optionally also containing silica.
  • the micro-effervescent tablet of the present invention comprises: isomalt 20-35 parts, lactose 16.075-32.275 parts, and vitamin C 1-30 parts (for example, 1-10.5 parts) Or 10.5-30 parts), anhydrous citric acid 10-40 parts (for example 10-17.5 parts or 17.5-40 parts), sodium bicarbonate 10-40 parts (for example 10-16.25 parts or 16.25-40 parts), flavor 1 ⁇ 5 parts (eg 1 ⁇ 1.7 parts or 1.7 ⁇ 5 parts), sucralose, stevioside and aspartame total 0.1 ⁇ 3 parts (eg sucralose 0.025 ⁇ 0.03 parts, stevioside 0.35 ⁇ 0.4 parts) , Aspartame 0.6-0.7 parts), magnesium stearate 0.8-1.5 parts, optionally also containing 0.1-1 parts of silica (for example 0.1-0.5 parts or 0.5-1 parts).
  • vitamin C 1-30 parts for example, 1-10.5 parts or Or 10.5-30 parts
  • anhydrous citric acid 10-40 parts for
  • the microeffervescent tablet of the present invention comprises: isomalt, vitamin C, anhydrous citric acid, sodium bicarbonate, flavor, sucralose, aspartame, stevioside, hard Magnesium fatty acid and silicon dioxide.
  • the micro-effervescent tablet of the present invention comprises: isomalt 10 to 80 parts (for example, 10 to 51.35 parts or 51.35 to 80 parts), and vitamin C 1 to 30 parts by weight ratio (For example 1 to 10.5 parts or 10.5 to 30 parts), anhydrous citric acid 10 to 40 parts (for example 10 to 17.5 parts or 17.5 to 40 parts), sodium bicarbonate 10 to 40 parts (for example 10 to 16.25 parts or 16.25 to 40 parts), flavors 1 to 5 parts (for example 1 to 1.7 parts or 1.7 to 5 parts), sucralose, stevioside and aspartame total 0.1 to 3 parts (for example sucralose 0.025 to 0.03 parts, stevia) Glycoside 0.3-0.4 parts, aspartame 0.6-0.7 parts), magnesium stearate 0.1-3 parts (for example 0.1-1.5 parts or 1.5-3 parts), silica 0.1-1 parts (for example 0.1-0.5 Parts or 0.5 to 1 part).
  • isomalt 10 to 80 parts for example, 10 to 51.35 parts
  • the micro-effervescent tablets of the present invention may contain other nutrients besides vitamins, such as: blueberry extract, zeaxanthin, lutein, lutein esters, taurine, caffeine, melon Lana, r-aminobutyric acid, tea theanine, melatonin, milk mineral salt, grape seed extract, olive fruit extract, collagen powder, elastic collagen, probiotics, enzymes, dietary fiber, prebiotics , Phosphatidylserine, DHA, etc.
  • vitamins such as: blueberry extract, zeaxanthin, lutein, lutein esters, taurine, caffeine, melon Lana, r-aminobutyric acid, tea theanine, melatonin, milk mineral salt, grape seed extract, olive fruit extract, collagen powder, elastic collagen, probiotics, enzymes, dietary fiber, prebiotics , Phosphatidylserine, DHA, etc.
  • the present application provides a method for preparing an oral micro-effervescent tablet of the present invention, comprising the following steps: mixing nutrients, sugar alcohol, acid source, alkali source, magnesium stearate, flavor and sweetener to obtain a mixture And tablet the mixture.
  • An oral micro-effervescent tablet which is characterized by including nutrients, sugar alcohol, acid source, alkali source, magnesium stearate, flavor and sweetener;
  • the sugar alcohol is one or a combination of lactose, maltitol, sorbitol, isomalt, mannitol, and erythritol;
  • the sweetener is sucralose, aba One or a combination of stearin, stevioside, fructose, white granulated sugar, mogroside;
  • the dosage of each component in the oral micro-effervescent tablet is:
  • the weight proportion of the acid source in the oral micro-effervescent tablet does not exceed 19%; the weight proportion of the alkali source in the oral micro-effervescent tablet does not exceed 18%.
  • Solution 2 The oral micro-effervescent tablet according to solution 1, wherein the amount of each component in the oral micro-effervescent tablet is:
  • Solution 3 The oral micro-effervescent tablet according to solution 1, wherein the dosage of each component in the oral micro-effervescent tablet is:
  • Solution 4 The oral micro-effervescent tablet according to solution 1, wherein the nutrients are vitamins.
  • Embodiment 5 The oral micro-effervescent tablet according to embodiment 4, wherein the vitamin is one or more of vitamin A, vitamin B group, vitamin C, vitamin D, vitamin E, and vitamin K.
  • Solution 7 The oral micro-effervescent tablet according to solution 1, wherein the sweetener is one or a combination of sucralose, aspartame and stevioside.
  • the micro-effervescent tablet of the present invention slowly generates small and few bubbles after contacting with water without violent effervescence. Therefore, the micro-effervescent tablet of the present invention can be directly placed in the oral cavity for oral administration, which is convenient for taking, and can avoid the hidden safety hazards caused by a large amount of carbon dioxide gas generated in the oral cavity. At the same time, the micro-effervescent tablets of the present invention can also be dissolved in water, and can be taken in a similar manner to conventional effervescent tablets.
  • the present invention solves the problem of serious moisture absorption in the production process or accelerated test by selecting the ingredients in the micro-effervescent tablet and adjusting the ratio.
  • the formula of the oral micro-effervescent tablet in this embodiment is as follows:
  • Tablets are used for tableting and the tablet size is 40 mg.
  • the formula of the oral micro-effervescent tablet in this embodiment is as follows:
  • the formula of the oral micro-effervescent tablet in this embodiment is as follows:
  • the formula of the oral micro-effervescent tablet in this embodiment is as follows:
  • the formula of the oral micro-effervescent tablet in this embodiment is as follows:
  • the formula of the oral micro-effervescent tablet in this embodiment is as follows:
  • the formula of the oral micro-effervescent tablet in this embodiment is as follows:
  • the formula of the oral micro-effervescent tablet in this embodiment is as follows:
  • the formula of the oral micro-effervescent tablet in this embodiment is as follows:
  • the formula of the oral micro-effervescent tablet in this embodiment is as follows:
  • the formula of the oral micro-effervescent tablet in this embodiment is as follows:
  • the formula of the oral micro-effervescent tablet in this embodiment is as follows:
  • the formula of the oral micro-effervescent tablet of this comparative example is as follows:
  • the formula of the oral micro-effervescent tablet of this comparative example is as follows:
  • the formula of the oral micro-effervescent tablet of this comparative example is as follows:
  • the formula of the oral micro-effervescent tablet of this comparative example is as follows:
  • vitamin C oral micro-effervescent tablets Based on the combination of maltitol and lactose, the ratio of the two is adjusted to prepare vitamin C oral micro-effervescent tablets.
  • the formula is shown in Table 1 below.
  • the performance indexes of each group of oral micro-effervescent tablets were tested, such as angle of repose, hygroscopicity, hardness, friability, etc.
  • the test results are shown in Table 2.
  • Example 1 and Comparative Example 1 of the present invention were invited to 14 senior sensory assessors, and the tablets of Example 1 and Comparative Example 1 were evaluated with five sensory indicators of appearance, smell, mouthfeel, eating convenience, and novelty. For evaluation, each indicator has a perfect score of 5 points, and the overall perfect score is 25 points. The evaluation results are averaged.
  • the sensory index score results are as follows:
  • Example 1 the appearance of the product of Example 1 can be designed to be more Q, with good aroma, sweet and sour dissolved in the oral cavity, high acceptance of eating convenience, very novel, packaging design can be snacked, and high acceptance.
  • Comparative Example 1 The product is more common in appearance, with ordinary flakes, good aroma, sweet and sour dissolved in water, and easy to eat; the packaging is designed as medicine and the acceptance is average. In Comparative Example 1, the amount of acid and alkali is larger, effervescence is more intense, and the taste is not good.

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Abstract

一种口腔微泡腾片及其制备方法，该口腔泡腾片包含营养素、糖醇、酸源、碱源、硬脂酸镁、香精和甜味剂。其中所述糖醇为乳糖、麦芽糖醇、山梨糖醇、异麦芽酮糖醇、甘露糖醇、赤藓糖醇或其任意组合；所述甜味剂为三氯蔗糖、阿巴斯甜、甜菊糖甙、果糖、白砂糖、罗汉果苷或其任意组合。该微泡腾片可以在口腔中唾液作用下发生微泡腾。

Description

一种口腔微泡腾片及其制备方法 技术领域
本发明涉及保健食品制剂领域，特别涉及一种口腔微泡腾片及其制备方法。
背景技术
维生素是人和动物为维持正常的生理功能而必须从食物中获得的一类微量有机物质，在人体生长、代谢、发育过程中发挥着重要的作用。这类物质在体内既不是构成身体组织的原料，也不是能量的来源，而是一类调节物质，在物质代谢中起重要作用。人体犹如一座极为复杂的化工厂，不断地进行着各种生化反应，其反应与酶的催化作用有密切关系，酶要产生活性，必须有辅酶参加，已知许多维生素是酶的辅酶或者是辅酶的组成分子。因此，维生素是维持和调节机体正常代谢的重要物质。
泡腾片在我国是一种较新的保健食品和药物剂型，其包含有机酸和碱式碳酸(氢)盐作为泡腾崩解剂。将泡腾片置入水中，有机酸和碱式碳酸(氢)盐即刻发生反应，生成并释放大量的二氧化碳气体，状如沸腾。相比于普通片剂，泡腾片具有以下优点：①服用方便、起效迅速；②口感好，患者依从性好，特别适用于儿童、老年人以及吞服固体制剂困难的患者；③1～5min内快速崩解；④生物利用度高，能提高临床疗效；⑤偏酸性，可增加部分药物稳定性和溶解性；⑥由于崩解产生的大量泡沫增加了药物与病变部位的直接接触，可以更好地发挥疗效，所以泡腾片还可用于口腔疾病、阴道疾病等的防治用药；⑦便于携带、运输和贮存。
将单一维生素或多种维生素做成泡腾片剂型，受到广大消费者的欢迎。但泡腾片需要溶解于水后才能服用，在没有水具或饮用水的条件下，服用泡腾片会给消费者带来许多不便。
发明内容
为了解决现有技术中存在的问题，本申请提供了一种口腔微泡腾片及其制备方法，该口腔微泡腾片为一种新的剂型，可以在口腔中唾液作用下产生微泡腾现象，口感好，体验感强，由此提供了下述发明：
在一个方面，本申请提供了一种口腔微泡腾片，其包含营养素、糖醇、酸源、碱源、硬脂酸镁、香精和甜味剂；其中，
所述糖醇为乳糖、麦芽糖醇、山梨糖醇、异麦芽酮糖醇、甘露糖醇、赤藓糖醇或其任意组合；所述甜味剂为三氯蔗糖、阿巴斯甜、甜菊糖甙、果糖、白砂糖、罗汉果苷或其任意组合；
以重量份计，所述口腔微泡腾片中各组分的含量为：
营养素1～30份，糖醇10～80份，酸源10～40份，碱源10～40份，硬脂酸镁0.1～3份，香精1～5份，甜味剂0.1～3份；
其中，酸源在所述口腔微泡腾片中的重量占比不超过19％(例如为1％～5％、5％～10％、10％～15％或15％～19％)；碱源在所述口腔微泡腾片中的重量占比不超过18％(例如为1％～5％、5％～10％、10％～15％或15％～18％)。
在某些实施方案中，以重量份计，所述口腔微泡腾片包含的糖醇为48～63份。在某些实施方案中，以重量份计，所述口腔微泡腾片包含的硬脂酸镁为0.8～1.5份。
在某些实施方案中，以重量份计，所述口腔微泡腾片包含的酸源为11～19份。
在某些实施方案中，以重量份计，所述口腔微泡腾片包含的碱源为11～18份。
在某些实施方案中，以重量份计，所述口腔微泡腾片中各组分的含量为：
营养素8～12份，糖醇10～80份，酸源10～40份，碱源10～40份，硬脂酸镁0.1～3份，香精1～5份，甜味剂0.1～3份。
在某些实施方案中，以重量份计，所述口腔微泡腾片中各组分的含量为：
营养素10～11份，糖醇48～63份，酸源11～19份，碱源11～18份，硬脂酸镁0.8～1.5份，香精1.5～2份，甜味剂0.2～1.2份。
在某些实施方案中，所述营养素为维生素。
在某些实施方案中，所述维生素为维生素A、维生素B族、维生素C、维生素D、维生素E、维生素K或其任意组合。
在某些实施方案中，本发明的微泡腾片包含维生素A。维生素A即抗干眼病维生素，也被称为美容维生素，为脂溶性。维生素A不是单一的化合物，而是一系列视黄醇(也被称为维生素A醇或松香油)的衍生物，维生素A可用于预防或治疗夜盲症。
在某些实施方案中，本发明的微泡腾片包含维生素B 1。维生素B 1即硫胺素，也被称为抗脚气病因子、抗神经炎因子等，是水溶性维生素。维生素B 1可以用于预防或治疗脂溢性皮炎或湿疹。
在某些实施方案中，本发明的微泡腾片包含维生素B 2。维生素B 2即核黄素，也被称为维生素G，为水溶性。维生素B 2可以用于预防或治疗口舌炎症(口腔溃疡)。
在某些实施方案中，本发明的微泡腾片包含维生素C。维生素C即抗坏血酸，为水溶 性，可用于预防或治疗坏血病。
在某些实施方案中，本发明的微泡腾片包含维生素D。维生素D即钙化醇，为脂溶性，可用于预防或治疗佝偻病。
在某些实施方案中，所述糖醇为乳糖、麦芽糖醇、山梨糖醇、异麦芽酮糖醇或其任意组合。
在某些实施方案中，所述糖醇为乳糖和麦芽糖醇。在某些实施方案中，以重量份计，所述乳糖与麦芽糖醇的比例为1:0.2～4.5(例如1:0.2、1:2.2或1:4.5)。
在某些实施方案中，所述糖醇为山梨糖醇和乳糖。在某些实施方案中，以重量份计，所述山梨糖醇与乳糖的比例为1:0.39～4.2(例如1:0.39、1:0.74、1:0.85或1:4.2)。
在某些实施方案中，所述糖醇为异麦芽酮糖醇和乳糖。在某些实施方案中，以重量份计，所述异麦芽酮糖醇与乳糖的比例为1:0.46～1.6。
在某些实施方案中，所述甜味剂为三氯蔗糖、阿巴斯甜、甜菊糖甙或其任意组合。
在某些实施方案中，所述酸源为柠檬酸、酒石酸、富马酸、苹果酸或其任意组合；所述碱源为碳酸氢钠、碳酸钠、碳酸氢钾、碳酸钾或其任意组合。
在某些实施方案中，所述口腔微泡腾片还包括二氧化硅，二氧化硅在口腔微泡腾片中的重量占比为0.1％～1％。
在某些实施方案中，所述口腔微泡腾片还包括二氧化硅，二氧化硅在口腔微泡腾片中的重量占比为0.5％。
在某些实施方案中，本发明的微泡腾片包含：乳糖、麦芽糖醇、维生素C、无水柠檬酸、碳酸氢钠、香精、三氯蔗糖、阿斯巴甜、甜菊糖甙和硬脂酸镁，任选地还包含二氧化硅。在某些实施方案中，以重量占比计，本发明的微泡腾片包含：乳糖9.8～48.8份(例如9.8～16.1份或16.1～48.8份)、麦芽糖醇10～42.5份(例如10～35份或35～42.5份)、维生素C 10～10.5份、无水柠檬酸14～17.5份、碳酸氢钠14～16.25份、香精1.7～2份、三氯蔗糖0.025～0.03份、阿斯巴甜0.12～0.6份、甜菊糖甙0.05～0.3份、硬脂酸镁0.8～1.5份(例如0.8～1或1～1.5份)，任选地还包含二氧化硅0.1～1份(例如0.1～0.5份或0.5～1份)。
在某些实施方案中，本发明的微泡腾片包含：麦芽糖醇、维生素C、无水柠檬酸、碳酸氢钠、香精、三氯蔗糖、阿斯巴甜、甜菊糖甙、硬脂酸镁和二氧化硅。在某些实施方案中，以重量占比计，本发明的微泡腾片包含：麦芽糖醇10～80份(例如10～62.7份或62.7～80份)、维生素C 1～30份(例如1～10.5份或10.5～30份)、无水柠檬酸10～40份(例如10～11.3份或11.3～40份)、碳酸氢钠10～40份(例如10～11.25份或11.25～40份)、香精1～5份(例如1～1.5份或1.5～5份)、三氯蔗糖、甜菊糖甙和阿斯巴甜合计0.1～3份(例 如三氯蔗糖0.025～0.03份、甜菊糖甙0.3～0.4份、阿斯巴甜0.4～0.5份)、硬脂酸镁0.1～3份(例如0.1～1.5份或1.5～3份)、二氧化硅0.1～1份(例如0.1～0.5份或0.5～1份)。
在某些实施方案中，本发明的微泡腾片包含：山梨糖醇、乳糖、维生素C、无水柠檬酸、碳酸氢钠、香精、三氯蔗糖、阿斯巴甜、甜菊糖甙和硬脂酸镁，任选地还包含二氧化硅。在某些实施方案中，本发明的微泡腾片包含：山梨糖醇10～35份(例如10～30份或30～35份)、乳糖13.6～41.7份(例如13.6～22.3份、22.3～25.4份或25.4～41.6份)、维生素C 10～10.5份、无水柠檬酸15～18.75份(例如15～17.5份或17.5～18.75份)、碳酸氢钠15～17.5份(例如15～16.25份或16.25～17.5份)、香精1～5份(例如1～1.7份或1.7～5份)、三氯蔗糖、甜菊糖甙和阿斯巴甜合计0.1～3份(例如三氯蔗糖0.025～0.03份、阿斯巴甜0.6～0.7份、甜菊糖甙0.3～0.4份)、硬脂酸镁0.8～1.5份，任选地还包含二氧化硅0.1～1份(例如0.1～0.5份或0.5～1份)。
在某些实施方案中，本发明的微泡腾片包含：乳糖、维生素C、无水柠檬酸、碳酸氢钠、香精、三氯蔗糖、阿斯巴甜、甜菊糖甙、硬脂酸镁和二氧化硅。在某些实施方案中，以重量占比计，本发明的微泡腾片包含：乳糖10～80份(例如10～59.4份或59.4～80份)、维生素C 1～30份(例如1～10.5份或10.5～30份)、无水柠檬酸10～40份(例如10～15.25份或15.25～40份)、碳酸氢钠10～40份(例如10～11.25份或11.25～40份)、香精1～5份(例如1～1.5份或1.5～5份)、三氯蔗糖、甜菊糖甙和阿斯巴甜合计0.1～3份(例如三氯蔗糖0.025～0.03份、甜菊糖甙0.3～0.4份、阿斯巴甜0.8～0.9份)、硬脂酸镁0.1～3份(例如0.1～0.5份或0.5～3份)、二氧化硅0.1～1份(例如0.1～0.5份或0.5～1份)。
在某些实施方案中，本发明的微泡腾片包含：异麦芽酮糖醇、乳糖、维生素C、无水柠檬酸、碳酸氢钠、香精、三氯蔗糖、阿斯巴甜、甜菊糖甙和硬脂酸镁，任选地还包含二氧化硅。在某些实施方案中，以重量占比计，本发明的微泡腾片包含：异麦芽酮糖醇20～35份、乳糖16.075～32.275份、维生素C 1～30份(例如1～10.5份或10.5～30份)、无水柠檬酸10～40份(例如10～17.5份或17.5～40份)、碳酸氢钠10～40份(例如10～16.25份或16.25～40份)、香精1～5份(例如1～1.7份或1.7～5份)、三氯蔗糖、甜菊糖甙和阿斯巴甜合计0.1～3份(例如三氯蔗糖0.025～0.03份、甜菊糖甙0.35～0.4份、阿斯巴甜0.6～0.7份)、硬脂酸镁0.8～1.5份，任选地还包含二氧化硅0.1～1份(例如0.1～0.5份或0.5～1份)。
在某些实施方案中，本发明的微泡腾片包含：异麦芽酮糖醇、维生素C、无水柠檬酸、碳酸氢钠、香精、三氯蔗糖、阿斯巴甜、甜菊糖甙、硬脂酸镁和二氧化硅。在某些实施方案中，以重量占比计，本发明的微泡腾片包含：异麦芽酮糖醇10～80份(例如10～51.35份或51.35～80份)、维生素C 1～30份(例如1～10.5份或10.5～30份)、无水柠檬酸10～40 份(例如10～17.5份或17.5～40份)、碳酸氢钠10～40份(例如10～16.25份或16.25～40份)、香精1～5份(例如1～1.7份或1.7～5份)、三氯蔗糖、甜菊糖甙和阿斯巴甜合计0.1～3份(例如三氯蔗糖0.025～0.03份、甜菊糖甙0.3～0.4份、阿斯巴甜0.6～0.7份)、硬脂酸镁0.1～3份(例如0.1～1.5份或1.5～3份)、二氧化硅0.1～1份(例如0.1～0.5份或0.5～1份)。
在某些实施方案中，本发明的微泡腾片可以包含除维生素以外的其他营养素，例如：蓝莓提取物、玉米黄质、叶黄素、叶黄素酯、牛磺酸、咖啡因、瓜拉纳、r-氨基丁酸、茶叶茶氨酸、褪黑素、乳矿物盐、葡萄籽提取物、橄榄果提取物、胶原蛋白粉、弹性胶原蛋白、益生菌、酵素、膳食纤维、益生元、磷脂酰丝氨酸、DHA等。
在另一个方面，本申请提供了本发明的口腔微泡腾片的制备方法，包括以下步骤：将营养素、糖醇、酸源、碱源、硬脂酸镁、香精和甜味剂混合得到混合物，并对所述混合物进行压片。
本申请还涉及以下方案：
方案1、一种口腔微泡腾片，其特征在于，包括营养素、糖醇、酸源、碱源、硬脂酸镁、香精和甜味剂；
所述糖醇为乳糖、麦芽糖醇、山梨糖醇、异麦芽酮糖醇、甘露糖醇、赤藓糖醇中的一种或几种的组合；所述甜味剂为三氯蔗糖、阿巴斯甜、甜菊糖甙、果糖、白砂糖、罗汉果苷中的一种或几种的组合；
以重量份计，所述口腔微泡腾片中各组分的用量为：
营养素1～30份，糖醇10～80份，酸源10～40份，碱源10～40份，硬脂酸镁0.1～3份，香精1～5份，甜味剂0.1～3份；
所述酸源在口腔微泡腾片中的重量占比不超过19％；所述碱源在口腔微泡腾片中的重量占比不超过18％。
方案2、根据方案1所述的口腔微泡腾片，其特征在于，以重量份计，所述口腔微泡腾片中各组分的用量为：
营养素8～12份，糖醇10～80份，酸源10～40份，碱源10～40份，硬脂酸镁0.1～3份，香精1～5份，甜味剂0.1～3份。
方案3、根据方案1所述的口腔微泡腾片，其特征在于，以重量份计，所述口腔微泡腾片中各组分的用量为：
营养素10～11份，糖醇48～63份，酸源11～19份，碱源11～18份，硬脂酸镁0.8～1.5份，香精1.5～2份，甜味剂0.2～1.2份。
方案4、根据方案1所述的口腔微泡腾片，其特征在于，所述营养素为维生素。
方案5、根据方案4所述的口腔微泡腾片，其特征在于，所述维生素为维生素A、维生素B族、维生素C、维生素D、维生素E、维生素K中的一种或几种。
方案6、根据方案1所述的口腔微泡腾片，其特征在于，所述糖醇为乳糖、麦芽糖醇、山梨糖醇、异麦芽酮糖醇中的一种或几种的组合。
方案7、根据方案1所述的口腔微泡腾片，其特征在于，所述甜味剂为三氯蔗糖、阿巴斯甜、甜菊糖甙中的一种或几种的组合。
有益效果
与常规泡腾片相比，本发明的微泡腾片与水接触后，缓慢地产生小而少的气泡，而不会出现剧烈的泡腾现象。因此，本发明的微泡腾片可以被直接置于口腔中含服，既方便服用，又可以避免在口腔中产生大量二氧化碳气体而带来的安全隐患。同时，本发明的微泡腾片也可以溶解于水中，可以按照与常规泡腾片类似的方法服用。
进一步地，本发明通过对微泡腾片中的成分进行选择，并对其比例进行调节，解决了泡腾片在生产过程中或加速试验中吸湿严重的问题。
具体实施方式
下面将结合实施例对本发明的实施方案进行详细描述，但是本领域技术人员将会理解，下列实施例仅用于说明本发明，而不应视为限定本发明的范围。实施例中所用原料或辅料均可由市场购得。
实施例1
以重量占比计，本实施例口腔微泡腾片配方如下：
Figure PCTCN2019092936-appb-000001
Figure PCTCN2019092936-appb-000002
工艺：
1、称量、备料
将所有物料按配方量称量，根据物料性状选择是否粉碎、预混或过筛。
2、混合
将营养素、甜味剂、糖醇、柠檬酸、碳酸氢钠、香精、硬脂酸镁置于混合机中，混合至混合物料色泽质地均匀。
3、压片
用压片机进行压片，片剂的规格为40mg。
实施例2
以重量占比计，本实施例口腔微泡腾片配方如下：
乳糖 16.125
麦芽糖醇 35
维生素C 10.5
无水柠檬酸 17.5
碳酸氢钠 16.25
食用香精 1.7
三氯蔗糖 0.025
阿斯巴甜 0.6
甜菊糖甙 0.3
硬脂酸镁 1.5
二氧化硅 0.5
工艺：混合、压片，参见实施例1。
实施例3
以重量占比计，本实施例口腔微泡腾片配方如下：
乳糖 9.825
麦芽糖醇 42.5
维生素C 10.5
无水柠檬酸 17.5
碳酸氢钠 16.25
食用香精 1.7
三氯蔗糖 0.025
阿斯巴甜 0.6
甜菊糖甙 0.3
硬脂酸镁 0.8
工艺：混合、压片，参见实施例1。
实施例4
以重量占比计，本实施例口腔微泡腾片配方如下：
麦芽糖醇 62.725
维生素C 10.5
无水柠檬酸 11.3
碳酸氢钠 11.25
食用香精 1.5
三氯蔗糖 0.025
阿斯巴甜 0.4
甜菊糖甙 0.3
硬脂酸镁 1.5
二氧化硅 0.5
工艺：混合、压片，参见实施例1。
实施例5
以重量占比计，本实施例口腔微泡腾片配方如下：
山梨糖醇 10
乳糖 41.625
维生素C 10
无水柠檬酸 17.5
碳酸氢钠 16.25
食用香精 1.7
三氯蔗糖 0.025
阿斯巴甜 0.6
甜菊糖甙 0.3
硬脂酸镁 1.5
二氧化硅 0.5
工艺：混合、压片，参见实施例1。
实施例6
以重量占比计，本实施例口腔微泡腾片配方如下：
山梨糖醇 30
乳糖 25.375
维生素C 10
无水柠檬酸 15
碳酸氢钠 15
香精 1.7
三氯蔗糖 0.025
阿斯巴甜 0.6
甜菊糖甙 0.3
硬脂酸镁 1.5
二氧化硅 0.5
工艺：混合、压片，参见实施例1。
实施例7
以重量占比计，本实施例口腔微泡腾片配方如下：
山梨糖醇 30
乳糖 22.325
维生素C 10.5
无水柠檬酸 17.5
碳酸氢钠 16.25
香精 1.7
三氯蔗糖 0.025
阿斯巴甜 0.6
甜菊糖甙 0.3
硬脂酸镁 0.8
工艺：混合、压片，参见实施例1。
实施例8
以重量占比计，本实施例口腔微泡腾片配方如下：
山梨糖醇 35
乳糖 13.625
维生素C 10.5
无水柠檬酸 18.75
碳酸氢钠 17.5
香精 1.7
三氯蔗糖 0.025
阿斯巴甜 0.6
甜菊糖甙 0.3
硬脂酸镁 1.5
二氧化硅 0.5
工艺：混合、压片，参见实施例1。
实施例9
以重量占比计，本实施例口腔微泡腾片配方如下：
乳糖 59.375
维生素C 10.5
无水柠檬酸 15.25
碳酸氢钠 11.25
香精 1.5
三氯蔗糖 0.025
阿斯巴甜 0.8
甜菊糖甙 0.3
硬脂酸镁 0.5
二氧化硅 0.5
工艺：混合、压片，参见实施例1。
实施例10
以重量占比计，本实施例口腔微泡腾片配方如下：
异麦芽酮糖醇 20
乳糖 32.275
维生素C 10.5
无水柠檬酸 17.5
碳酸氢钠 16.25
香精 1.7
三氯蔗糖 0.025
阿斯巴甜 0.6
甜菊糖甙 0.35
硬脂酸镁 0.8
工艺：混合、压片，参见实施例1。
实施例11
以重量占比计，本实施例口腔微泡腾片配方如下：
异麦芽酮糖醇 35
乳糖 16.075
维生素C 10.5
无水柠檬酸 17.5
碳酸氢钠 16.25
香精 1.7
三氯蔗糖 0.025
阿斯巴甜 0.6
甜菊糖甙 0.35
硬脂酸镁 1.5
二氧化硅 0.5
工艺：混合、压片，参见实施例1。
实施例12
以重量占比计，本实施例口腔微泡腾片配方如下：
异麦芽酮糖醇 51.35
维生素C 10.5
无水柠檬酸 17.5
碳酸氢钠 16.25
香精 1.7
三氯蔗糖 0.025
阿斯巴甜 0.6
甜菊糖甙 0.3
硬脂酸镁 1.5
二氧化硅 0.5
工艺：混合、压片，参见实施例1。
对比例1
以重量占比计，本对比例口腔微泡腾片配方如下：
异麦芽酮糖醇 34.1
维生素C 10.5
无水柠檬酸 27
碳酸氢钠 24
香精 1.7
三氯蔗糖 0.025
阿斯巴甜 0.6
甜菊糖甙 0.3
硬脂酸镁 1.5
二氧化硅 0.5
工艺：混合、压片，片剂的规格为4g。
对比例2
以重量占比计，本对比例口腔微泡腾片配方如下：
异麦芽酮糖醇 27.1
维生素C 10.5
无水柠檬酸 30
碳酸氢钠 28
香精 1.7
三氯蔗糖 0.025
阿斯巴甜 0.6
甜菊糖甙 0.3
硬脂酸镁 1.5
二氧化硅 0.5
工艺：混合、压片。
对比例3
以重量占比计，本对比例口腔微泡腾片配方如下：
乳糖 16.125
微晶纤维素 35
维生素C 10.5
无水柠檬酸 17.5
碳酸氢钠 16.25
食用香精 1.7
三氯蔗糖 0.025
阿斯巴甜 0.6
甜菊糖甙 0.3
硬脂酸镁 1.5
二氧化硅 0.5
工艺：混合、压片。
对比例4
以重量占比计，本对比例口腔微泡腾片配方如下：
乳糖 16.35
麦芽糖醇 35
维生素C 10.5
无水柠檬酸 17.5
碳酸氢钠 16.25
食用香精 1.7
阿斯巴甜 0.5
甜菊糖甙 0.2
硬脂酸镁 1.5
二氧化硅 0.5
工艺：混合、压片。
试验例1
在糖醇为麦芽糖醇和乳糖组合的基础上，调整两者的比例关系制备维生素C口腔微泡腾片，配方如下表1。检测各组口腔微泡腾片的性能指标，如休止角、吸湿性、硬度、脆碎度等，试验结果见表2。
表1口腔微泡腾片的配方
Figure PCTCN2019092936-appb-000003
表2口腔微泡腾片的性能指标检测结果
Figure PCTCN2019092936-appb-000004
由上述试验结果可知，本试验例中，随着麦芽糖醇使用量增加，配方的引湿性加强，导致压片易出现粘冲现象，硬脂酸镁可改善配方引湿导致的粘冲现象。
试验例2
在糖醇为山梨糖醇和乳糖组合的基础上，调整两者的比例关系制备维生素C口腔微泡腾片，配方如下表3，同时检测各组口腔微泡腾片的性能指标，如休止角、吸湿性、硬度、脆碎度等，试验结果见表4。
表3口腔微泡腾片的配方
Figure PCTCN2019092936-appb-000005
Figure PCTCN2019092936-appb-000006
表4口腔微泡腾片的性能指标检测结果
Figure PCTCN2019092936-appb-000007
由上述试验结果可知，本试验例中，随着山梨糖醇使用量增加，配方的引湿性加强，导致压片易出现粘冲现象，硬脂酸镁可改善配方引湿导致的粘冲现象。
试验例3
在糖醇为异麦芽酮糖醇和乳糖组合的基础上，调整两者的比例关系制备维生素C口腔微泡腾片，配方如下表5，同时检测各组口腔微泡腾片的性能指标，如休止角、吸湿性、硬度、脆碎度等，试验结果见表6。
表5口腔微泡腾片的配方
Figure PCTCN2019092936-appb-000008
Figure PCTCN2019092936-appb-000009
表6口腔微泡腾片的性能指标检测结果
Figure PCTCN2019092936-appb-000010
Figure PCTCN2019092936-appb-000011
由上述试验结果可知，本试验例中，随着异麦芽酮糖醇使用量增加，配方的引湿性加强，导致压片易出现粘冲现象，硬脂酸镁可改善配方引湿导致的粘冲现象。
试验例4
将本发明实施例1和对比例1的产品，请14位资深的感官评定人员，以外观、气味、口感、食用便利性、新颖性5项感官指标对实施例1和对比例1片剂进行评定，每项指标满分5分，总体满分为25分。评定结果取平均值。感官指标评分结果如下：
表7实施例1口腔微泡腾片感官评价
人员编号 外观 气味 口感 食用便利性 新颖性 总分
1 4 4 4 5 5 22
2 3 4 4 5 5 21
3 4 4 4 4 4 20
4 4 3 3 5 5 20
5 4 3 4 4 4 19
6 3 4 4 5 5 21
7 2 4 4 4 4 18
8 3 4 5 5 5 22
9 4 3 3 5 4 19
10 3 3 4 5 5 20
11 3 4 4 4 4 19
12 2 4 4 5 5 20
13 2 3 3 5 4 17
14 2 3 4 4 5 18
平均分 3.07 3.57 3.86 4.64 4.57 19.71
表8对比例1泡腾片感官评价
人员编号 外观 气味 口感 食用便利性 新颖性 总分
1 4 4 4 4 4 20
2 3 4 4 3 4 18
3 4 4 4 3 3 18
4 3 3 3 4 3 16
5 3 2 3 3 3 14
6 3 3 3 3 4 16
7 3 3 4 4 3 17
8 2 4 4 3 3 16
9 4 3 3 4 4 18
10 2 2 3 3 3 13
11 3 3 3 4 3 16
12 2 4 4 3 4 17
13 4 2 4 3 3 16
14 4 3 3 3 4 17
平均分 3.14 3.14 3.5 3.36 3.43 16.57
由上述结果可知，实施例1产品外观可以设计得更Q，香气佳，溶解在口腔酸甜可口，食用便利性接受度高，非常新颖，包装设计可为零食化，可接受度高。
对比例1产品外观较普通，为普通片型，香气佳，溶解在水中酸甜可口，食用便利性一般；包装设计为药品，接受度一般。对比例1中酸碱用量较大，泡腾较剧烈，口感欠佳。
试验例5
对实施例1-12和对比例1-4的产品进行粘冲现象的检测，同时，以口感体验进行描述评定。
试验结果如下：
表9各泡腾片粘冲性能和口感体验
Figure PCTCN2019092936-appb-000012
以上所述仅是本发明的部分实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也应视为本发明的保护范围。

Claims (11)

  1. 一种口腔微泡腾片，包含营养素、糖醇、酸源、碱源、硬脂酸镁、香精和甜味剂；
    其中，所述糖醇为乳糖、麦芽糖醇、山梨糖醇、异麦芽酮糖醇、甘露糖醇、赤藓糖醇或其任意组合；所述甜味剂为三氯蔗糖、阿巴斯甜、甜菊糖甙、果糖、白砂糖、罗汉果苷或其任意组合；
    以重量份计，所述口腔微泡腾片中各组分的含量为：
    营养素1～30份，糖醇10～80份，酸源10～40份，碱源10～40份，硬脂酸镁0.1～3份，香精1～5份，甜味剂0.1～3份；
    所述酸源在口腔微泡腾片中的重量占比不超过19％；所述碱源在口腔微泡腾片中的重量占比不超过18％。
  2. 根据权利要求1所述的口腔微泡腾片，以重量份计，所述口腔微泡腾片中各组分的含量为：
    营养素8～12份，糖醇10～80份，酸源10～40份，碱源10～40份，硬脂酸镁0.1～3份，香精1～5份，甜味剂0.1～3份。
  3. 根据权利要求1或2所述的口腔微泡腾片，以重量份计，所述口腔微泡腾片中各组分的含量为：
    营养素10～11份，糖醇48～63份，酸源11～19份，碱源11～18份，硬脂酸镁0.8～1.5份，香精1.5～2份，甜味剂0.2～1.2份。
  4. 根据权利要求1至3任一项所述的口腔微泡腾片，其中，所述营养素为维生素。
  5. 根据权利要求4所述的口腔微泡腾片，其中，所述维生素为维生素A、维生素B族、维生素C、维生素D、维生素E、维生素K或其任意组合。
  6. 根据权利要求1至5任一项所述的口腔微泡腾片，其中，所述糖醇为乳糖、麦芽糖醇、山梨糖醇、异麦芽酮糖醇或其任意组合。
  7. 根据权利要求1至6任一项所述的口腔微泡腾片，其中，所述甜味剂为三氯蔗糖、阿巴斯甜、甜菊糖甙或其任意组合。
  8. 根据权利要求1至7任一项所述的口腔微泡腾片，其中，所述酸源为柠檬酸、酒石酸、富马酸、苹果酸或其任意组合；所述碱源为碳酸氢钠、碳酸钠、碳酸氢钾、碳酸钾或其任意组合。
  9. 根据权利要求1至8任一项所述的口腔微泡腾片，其中，所述口腔微泡腾片还包含二氧化硅，所述二氧化硅在口腔微泡腾片中的重量占比为0.1％～1％。
  10. 根据权利要求1至9任一项所述的口腔微泡腾片，所述营养素包括以下任意一种或多种：蓝莓提取物、玉米黄质、叶黄素、叶黄素酯、牛磺酸、咖啡因、瓜拉纳、r-氨基丁酸、茶叶茶氨酸、褪黑素、乳矿物盐、葡萄籽提取物、橄榄果提取物、胶原蛋白粉、弹性胶原蛋白、益生菌、酵素、膳食纤维、益生元、磷脂酰丝氨酸、DHA。
  11. 如权利要求1至10中任一项所述口腔微泡腾片的制备方法，包括以下步骤：将营养素、糖醇、酸源、碱源、硬脂酸镁、香精和甜味剂混合得到混合物，并对所述混合物进行压片。
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