WO2021036656A1 - Odor-masking composition, preparation method therefor, and use thereof - Google Patents

Odor-masking composition, preparation method therefor, and use thereof Download PDF

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Publication number
WO2021036656A1
WO2021036656A1 PCT/CN2020/105382 CN2020105382W WO2021036656A1 WO 2021036656 A1 WO2021036656 A1 WO 2021036656A1 CN 2020105382 W CN2020105382 W CN 2020105382W WO 2021036656 A1 WO2021036656 A1 WO 2021036656A1
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taste
masking
component
preparation
masking composition
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PCT/CN2020/105382
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French (fr)
Chinese (zh)
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张贵民
杨梅
高艳红
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鲁南厚普制药有限公司
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Publication of WO2021036656A1 publication Critical patent/WO2021036656A1/en

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    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/46—Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles

Definitions

  • the invention belongs to the field of pharmaceutical preparations, and specifically relates to a taste-masking composition, a preparation method and application thereof.
  • the taste-masking composition can effectively mask the special odor of Chinese medicinal materials or Chinese medicinal preparations, especially fishy or fishy odors.
  • the traditional method is to wrap the sugar coating on the outer test of the pharmaceutical preparation or to fill the drug into a capsule, which can mask the bad taste of the drug when taken orally, or by mixing the drug with corrective particles or adding a large amount of sucrose, To cover up the special taste of Chinese medicine.
  • Chinese invention patent CN100584341C discloses a method for masking the fishy smell of animal Chinese medicine formula particles.
  • the method is to fully mix animal Chinese medicine dry extract powder with micronized silica gel, pregelatinized starch, peppermint flavor, and lemon flavor, and then granulate . That is, the edible essence is used to cover up the fishy odor and make particles without fishy odor, which solves the discomfort of the patient when the medicine is taken in.
  • Chinese invention patent CN104906046A discloses a method for masking the fishy taste of traditional Chinese medicine particles. The method is to enclose the fishy crude drug powder or extract with inclusion auxiliary materials, and then add sweeteners and flavors, mix uniformly, dry, and granulate forming.
  • the above method can solve the uncomfortable feeling of the user when taking the medicine, it cannot avoid the adverse gastrointestinal reactions such as hiccups, nausea, and vomiting caused by the patient after taking the medicine.
  • the present invention provides a new taste-masking composition, which can not only mask the bad smell at the entrance of traditional Chinese medicine preparations, but also eliminate gastrointestinal adverse reactions such as vomiting and other gastrointestinal reactions caused by patients after taking the medicine. .
  • One of the objectives of the present invention is to provide a taste-masking composition, which comprises the following three components:
  • Component A one of menthamide or N, 2, 3-trimethyl-2-isopropylbutanamide;
  • Component B Raspberry flavor
  • Component C Sucralose or Aspartame.
  • the preparation method of the taste-masking composition is: dissolving component B, encapsulating the cyclodextrin and drying at low temperature, and then mixing with component A and component C to obtain the taste-masking composition.
  • the taste-masking composition contains the following three components:
  • Component B2-8 parts by weight
  • Component C 2-7 parts by weight
  • the taste-masking composition contains the following three components:
  • Component A 3 parts by weight
  • Component B 5 parts by weight
  • Component C 3 parts by weight.
  • the cyclodextrin in the method for preparing the taste-masking composition is one or more of ⁇ -cyclodextrin, hydroxypropyl- ⁇ -cyclodextrin or ⁇ -cyclodextrin.
  • the drying temperature in the method for preparing the taste-masking composition is 15°C to 45°C.
  • the second object of the present invention is to provide the use of the above-mentioned taste-masking composition, specifically: the use of the taste-masking composition in masking the smell of Chinese medicinal materials, Chinese medicinal material extracts and/or preparations containing Chinese medicinal materials, especially It has a good effect in masking the stench of animal medicinal materials.
  • the animal medicinal materials include, but are not limited to, one or more of leeches, scorpions, centipedes, earthworms, soil turtles, rigid silkworms, geckos, cantharidin, black snakes, golden snakes, snake slugs, and cymbals.
  • the third objective of the present invention is to provide a traditional Chinese medicine preparation containing the above-mentioned taste-masking composition.
  • the traditional Chinese medicine preparations especially the Chinese medicine preparations containing the above-mentioned animal medicinal materials, can effectively mask the fishy smell of the animal medicinal materials after being added to the taste-masking composition, and avoid adverse gastrointestinal reactions such as vomiting after taking the medicine.
  • the preparation method of the traditional Chinese medicine preparation is as follows: after preparing the traditional Chinese medicinal material or the Chinese medicinal material composition into a dry plaster powder, adding the taste-masking composition or adding other conventional medicinal auxiliary materials to prepare the traditional Chinese medicine preparation.
  • the added amount of the taste-masking composition per 1000 g of the traditional Chinese medicine preparation is 0.5%-2.0%.
  • the added amount of the taste-masking composition is 1.0%-1.5%.
  • the added amount of the taste-masking composition is 1.1%.
  • the taste-masking composition provided by the present invention has unexpected technical effects, such as:
  • Advantage 1 It can cover up the bad smell of Chinese medicinal materials and does not affect the medicinal properties.
  • Advantage 2 It can not only cover up the smell of the entrance of Chinese medicinal materials, but also basically eliminate gastrointestinal adverse reactions such as belching, hiccups, and vomiting after taking the medicine, alleviate the discomfort of the patient's medication, and improve the patient's medication compliance.
  • the taste-masking composition of the present invention can be widely used in plant medicinal materials or preparations with special odor, especially in the preparation or production of animal medicinal materials or animal medicinal preparations, with good taste-masking effect and suitable for further industrial production.
  • step (3) Mix the distilled aqueous solution and medicinal residue obtained in step (2), the remaining prescription amount of leeches, centipedes, scorpion, and prescription amount of astragalus, phellodendron, coix seed, and licorice, add water to decoct twice, and combine them twice After filtering, the filtrate is concentrated to a clear ointment with a relative density of 1.15 to 1.2 (80°C); the obtained clear ointment is added with ethanol to make the alcohol content reach 60%, stand, filter, and the filtrate recovers the ethanol and depressurizes Concentrate to a thick paste with a relative density of 1.30 to 1.35 (80°C), vacuum dry, and pulverize into fine powder to obtain a dry paste powder for use;
  • step (3) After mixing the fine powder obtained in step (1) and the dry paste powder obtained in step (3) uniformly, add the taste-masking composition obtained above, mix well, and then add the formula amount of sodium hydroxypropyl starch and mannitol (Weight ratio 3:1) Mix, granulate, and dry to obtain granules for use;
  • step (2) Dissolve the volatile oil obtained in step (2) with an appropriate amount of ethanol, spray it into the granules obtained in step (4), and mix them to make 1000 g to obtain taste-masking Mailuo Shutong granules.
  • step (1) Combine the centipede and angelica powder obtained in step (1) with the fine powder I obtained in step (2) and the fine powder II obtained in step (3), add the taste-masking composition obtained above, and mix it evenly, then Add formula amount of dextrin, granulate, dry to make 1000g granules, and get it.
  • step (3) Mix the leech freeze-dried powder obtained in step (1) and the medicinal material mixture powder obtained in step (2), add the taste-masking composition obtained above, and then add the formula amount of starch and micronized silica gel, mix well, and after sieving, Pack it in enteric-coated capsules and get it.
  • step (3) Mix the distilled aqueous solution and medicinal residue obtained in step (2), the remaining prescription amount of leeches, centipedes, scorpion, and prescription amount of astragalus, phellodendron, coix seed, and licorice, add water to decoct twice, and combine them twice After filtering, the filtrate is concentrated to a clear ointment with a relative density of 1.15 to 1.2 (80°C); the obtained clear ointment is added with ethanol to make the alcohol content reach 60%, stand, filter, and the filtrate recovers the ethanol and depressurizes Concentrate to a thick paste with a relative density of 1.30 to 1.35 (80°C), vacuum dry, and pulverize into fine powder to obtain a dry paste powder, and then add ⁇ -cyclodextrin for inclusion to obtain inclusion compound B for use;
  • step (3) After mixing the clathrate compound A obtained in step (1) and the clathrate compound B obtained in step (3) uniformly, add the above-mentioned taste-masking composition; then add the formula amount of sodium hydroxypropyl starch and mannitol ( Weight ratio 3:1) Mix well, granulate and dry.
  • step (2) Dissolve the volatile oil obtained in step (2) with an appropriate amount of ethanol, spray it into the granules obtained in step (4), and mix them to make 1000 g to obtain taste-masking Mailuo Shutong granules.
  • mice 18-22 g, half male and half male, were divided into 10 groups, 10 mice/group, respectively, groups of Examples 5-8 and Groups of Comparative Examples 1-6, and the mice in each group were raised in separate cages.
  • mice Each group of mice was given the corresponding drug solution by intragastric administration at a dose of 0.5ml/10g, and the nausea and vomiting of the mice after 5min, 10min, and 20min were observed.
  • Example 7 of the present invention showed gastrointestinal reactions after taking the medicine, and in the remaining examples, only 3 cases of mice had nausea reactions in total, and no vomiting occurred; and Comparative Example 1- 6 After 5 minutes of self-administration, the mice experienced nausea and vomiting continuously.
  • Example 5-8 and Comparative Examples 1-6 were respectively taken and prepared into a solution with a concentration of 0.02 g/ml, and the prepared solutions were respectively numbered 1-10 in order.
  • the subjects were divided into 10 groups, 10 persons/group, and each took 10ml of the solution numbered 1-10, and the gastrointestinal adverse reactions of the subjects were observed 0.5 hour after taking the medicine and 1 hour after taking the medicine.
  • Adverse gastrointestinal reactions are as follows:
  • Severe severe reactions such as hiccups and scope, and vomiting.
  • Example 7 of the present invention there was no gastrointestinal adverse reaction in Example 7 of the present invention, and one mild gastrointestinal adverse reaction occurred in each of the remaining examples. However, according to the subject's description, the gastrointestinal reaction can be ignored Excluding. However, in each comparative example, gastrointestinal adverse reactions occurred to varying degrees within 0.5 hours of taking the medicine, and after 1 hour of taking the medicine, the number of adverse reactions increased, and individual adverse reactions were aggravated.
  • the taste-masking composition of the present invention has a better effect of masking the fishy odor of traditional Chinese medicine preparations containing animal medicinal materials, not only can mask the fishy odor at the entrance, but also can significantly eliminate or reduce the gastrointestinal odor after taking the medicine.
  • Adverse reactions such as tract, reduce the discomfort of patients when taking animal medicines, and improve the compliance of patients with medication.

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Abstract

An odor-masking composition and a preparation method therefor. The odor-masking composition contains three components, i.e., component A: either n-ethyl-p-menthane-3-carboxamide or N,2,3-trimethyl-2-isopropylbutamide, component B: raspberry flavor, and component C: either sucralose or aspartame. The odor-masking composition can effectively mask special odor of Chinese herbal medicine or Chinese herbal preparation, especially fishy smell or odor of animal medicine, eliminates adverse reactions of a patient after medicine taking, and improves medication compliance.

Description

一种掩味组合物及其制备方法、用途Taste masking composition and preparation method and application thereof 技术领域Technical field
本发明属于药物制剂领域，具体涉及一种掩味组合物、制备方法及其用途，所述的掩味组合物可以有效的掩盖中药材或中药制剂的特殊气味，尤其是腥或腥臭味。The invention belongs to the field of pharmaceutical preparations, and specifically relates to a taste-masking composition, a preparation method and application thereof. The taste-masking composition can effectively mask the special odor of Chinese medicinal materials or Chinese medicinal preparations, especially fishy or fishy odors.
背景技术Background technique
中药材种类繁多，应用广泛，但是在中药服用过程中，中药的特殊味道很容易引起味觉逆反，进而影响服用者的服药顺应性。尤其是动物药材化学成分复杂，并且药材中大多含有大量的蛋白质、脂肪及生物碱等成分，这些成分经氧化、分解后，会产生令人厌恶、难闻的不良气味，尤其是腥臭味。特别的，对于一些含有动物药材的中成药制剂，如脉络舒通颗粒、脉络舒通丸、川蛭通络胶囊等，因其组方中含有水蛭、蜈蚣、全蝎等动物药材，在药材加工和制剂过程中，虽然对这些动物药材进行了处理，但是仍不能完全消除其腥臭味，患者服药时会有不良口感，在服药时或服药后产生恶心、呕吐等不良反应，患者用药依从性较差，影响临床使用效果。There are many kinds of Chinese medicinal materials and they are widely used. However, during the process of taking Chinese medicine, the special taste of Chinese medicine can easily cause taste reversal, which in turn affects the compliance of the user. In particular, the chemical composition of animal medicinal materials is complex, and most of the medicinal materials contain a large amount of protein, fat, alkaloids and other ingredients. After these ingredients are oxidized and decomposed, they will produce unpleasant and unpleasant odors, especially fishy odors. In particular, for some proprietary Chinese medicine preparations containing animal medicinal materials, such as Mailuoshutong granules, Mailuoshutong pills, Chuanzhitongluo capsules, etc., because their prescriptions contain animal medicinal materials such as leech, centipede, and scorpion, they are used in the processing of medicinal materials. During the preparation process, although these animal medicinal materials are processed, the fishy smell cannot be completely eliminated. The patient will have a bad taste when taking the medicine, and adverse reactions such as nausea and vomiting may occur during or after the medicine. The patient's medication compliance is relatively high. Poor, affecting the effect of clinical use.
针对上述问题，传统的做法是在药物制剂的外测包裹糖衣或将药物装入胶囊中，口服时可掩盖药物的不良味道，或者通过在药物中掺杂矫味剂颗粒或加入大量的蔗糖，以掩盖中药的特殊味道。To solve the above problems, the traditional method is to wrap the sugar coating on the outer test of the pharmaceutical preparation or to fill the drug into a capsule, which can mask the bad taste of the drug when taken orally, or by mixing the drug with corrective particles or adding a large amount of sucrose, To cover up the special taste of Chinese medicine.
中国发明专利CN100584341C公开了一种动物类中药配方颗粒腥臭味的掩盖方法，该方法是将动物类中药干浸膏粉与微粉硅胶、预胶化淀粉、薄荷香精、柠檬香精充分混合后，制粒。即采用食用香精来掩盖腥臭味，制成无腥臭味的颗粒，解决了患者药物入口时的不适感。Chinese invention patent CN100584341C discloses a method for masking the fishy smell of animal Chinese medicine formula particles. The method is to fully mix animal Chinese medicine dry extract powder with micronized silica gel, pregelatinized starch, peppermint flavor, and lemon flavor, and then granulate . That is, the edible essence is used to cover up the fishy odor and make particles without fishy odor, which solves the discomfort of the patient when the medicine is taken in.
中国发明专利CN104906046A公开了一种掩盖中药颗粒腥味的方法，该方法为用包合的辅料将腥味生药粉或提取物包合，再加入甜味剂和香精，混合均匀，干燥，制粒成型。Chinese invention patent CN104906046A discloses a method for masking the fishy taste of traditional Chinese medicine particles. The method is to enclose the fishy crude drug powder or extract with inclusion auxiliary materials, and then add sweeteners and flavors, mix uniformly, dry, and granulate forming.
上述方法虽然可以解决服药者用药入口时的不适感，但却不能避免患者服药后产生的呃逆、反胃、呕吐等胃肠道不良反应。Although the above method can solve the uncomfortable feeling of the user when taking the medicine, it cannot avoid the adverse gastrointestinal reactions such as hiccups, nausea, and vomiting caused by the patient after taking the medicine.
技术解决方案Technical solutions
针对现有技术中存在的缺陷与不足，本发明提供了一种新的掩味组合物，不但能掩盖中药制剂入口时的不良气味，还能够消除患者服药后产生的呕吐等胃肠道不良反应。In view of the shortcomings and deficiencies in the prior art, the present invention provides a new taste-masking composition, which can not only mask the bad smell at the entrance of traditional Chinese medicine preparations, but also eliminate gastrointestinal adverse reactions such as vomiting and other gastrointestinal reactions caused by patients after taking the medicine. .
本发明目的之一在于提供一种掩味组合物，所述的掩味组合物包括以下三种组分：One of the objectives of the present invention is to provide a taste-masking composition, which comprises the following three components:
组分A：薄荷酰胺或N, 2, 3-三甲基-2-异丙基丁酰胺中的一种；Component A: one of menthamide or N, 2, 3-trimethyl-2-isopropylbutanamide;
组分B：覆盆子香精；Component B: Raspberry flavor;
组分C：三氯蔗糖或阿斯巴甜。Component C: Sucralose or Aspartame.
所述掩味组合物的制备方法为：将组分B溶解，环糊精包合后低温烘干，再与组分A、组分C混匀，即得掩味组合物。The preparation method of the taste-masking composition is: dissolving component B, encapsulating the cyclodextrin and drying at low temperature, and then mixing with component A and component C to obtain the taste-masking composition.
优选的，所述掩味组合物含有以下三种组分：Preferably, the taste-masking composition contains the following three components:
组分A1-5重量份Component A1-5 parts by weight
组分B2-8重量份Component B2-8 parts by weight
组分C        2-7重量份；Component C 2-7 parts by weight;
进一步优选的，所述掩味组合物含有以下三种组分：Further preferably, the taste-masking composition contains the following three components:
组分A       3重量份Component A 3 parts by weight
组分B       5重量份Component B 5 parts by weight
组分C       3重量份。Component C 3 parts by weight.
此外，作为优选的，上述掩味组合物制备方法中环糊精为β-环糊精、羟丙基-β-环糊精或γ-环糊精中的一种或多种。In addition, as a preference, the cyclodextrin in the method for preparing the taste-masking composition is one or more of β-cyclodextrin, hydroxypropyl-β-cyclodextrin or γ-cyclodextrin.
优选的，上述掩味组合物制备方法中烘干温度为15℃～45℃。Preferably, the drying temperature in the method for preparing the taste-masking composition is 15°C to 45°C.
本发明目的之二在于提供上述掩味组合物的用途，具体为：所述掩味组合物在掩盖中药材、中药材提取物和/或含有中药材的制剂等的气味中的用途，尤其是在掩盖动物药材腥臭味时具有良好的效果。The second object of the present invention is to provide the use of the above-mentioned taste-masking composition, specifically: the use of the taste-masking composition in masking the smell of Chinese medicinal materials, Chinese medicinal material extracts and/or preparations containing Chinese medicinal materials, especially It has a good effect in masking the stench of animal medicinal materials.
所述动物药材包括但不限于水蛭、全蝎、蜈蚣、地龙、土鳖虫、僵蚕、蛤蚧、斑蝥、乌鞘蛇、金钱白花蛇、蛇蜕、蕲蛇中的一种或几种。The animal medicinal materials include, but are not limited to, one or more of leeches, scorpions, centipedes, earthworms, soil turtles, rigid silkworms, geckos, cantharidin, black snakes, golden snakes, snake slugs, and cymbals.
本发明的目的之三在于提供一种中药制剂，所述的中药制剂含有上述掩味组合物。The third objective of the present invention is to provide a traditional Chinese medicine preparation containing the above-mentioned taste-masking composition.
所述的中药制剂，尤其是含有上述动物药材的中药制剂在加入掩味组合物后，可以有效的掩盖动物药材的腥臭味，避免服药后产生呕吐等不良的胃肠道反应。The traditional Chinese medicine preparations, especially the Chinese medicine preparations containing the above-mentioned animal medicinal materials, can effectively mask the fishy smell of the animal medicinal materials after being added to the taste-masking composition, and avoid adverse gastrointestinal reactions such as vomiting after taking the medicine.
所述中药制剂的制备方法为：将中药材或中药材组合物制备成干膏粉后，加入所述掩味组合物或再加入其他常规药用辅料后制备中药制剂。The preparation method of the traditional Chinese medicine preparation is as follows: after preparing the traditional Chinese medicinal material or the Chinese medicinal material composition into a dry plaster powder, adding the taste-masking composition or adding other conventional medicinal auxiliary materials to prepare the traditional Chinese medicine preparation.
其中，每1000g中药制剂中掩味组合物的加入量为0.5%-2.0%。Among them, the added amount of the taste-masking composition per 1000 g of the traditional Chinese medicine preparation is 0.5%-2.0%.
进一步优选的，所述的掩味组合物的加入量为1.0%-1.5%。Further preferably, the added amount of the taste-masking composition is 1.0%-1.5%.
最佳的，掩味组合物的加入量为1.1%。Most preferably, the added amount of the taste-masking composition is 1.1%.
有益效果Beneficial effect
本发明所提供的掩味组合物，具有预料不到的技术效果，如：The taste-masking composition provided by the present invention has unexpected technical effects, such as:
优点一：能够掩盖中药材的不良气味且不影响药性。Advantage 1: It can cover up the bad smell of Chinese medicinal materials and does not affect the medicinal properties.
优点二：不但能掩盖了中药材入口时的气味，还能够基本消除患者服药后产生的嗳气、呃逆、呕吐等胃肠道不良反应，缓解患者用药的不适感，提高患者用药的依从性。Advantage 2: It can not only cover up the smell of the entrance of Chinese medicinal materials, but also basically eliminate gastrointestinal adverse reactions such as belching, hiccups, and vomiting after taking the medicine, alleviate the discomfort of the patient's medication, and improve the patient's medication compliance.
优点三：本发明的掩味组合物可以广泛应用到具有特殊气味的植物药材或制剂中，尤其是动物药材或含动物药材制剂的制备或生产中，掩味效果良好，适合进一步工业化大生产。Advantage 3: The taste-masking composition of the present invention can be widely used in plant medicinal materials or preparations with special odor, especially in the preparation or production of animal medicinal materials or animal medicinal preparations, with good taste-masking effect and suitable for further industrial production.
本发明的实施方式Embodiments of the present invention
以下通过具体实施方式对本发明作进一步说明，但这并非是对本发明的限制，本领域技术人员根据本发明的基本思想所做出的各种修改或改进，均在本发明的保护范围之内。The present invention will be further explained by specific embodiments below, but this is not a limitation of the present invention. Various modifications or improvements made by those skilled in the art based on the basic idea of the present invention are all within the protection scope of the present invention.
实施例Example 11 掩味脉络舒通颗粒制备Preparation of Masking Mailuoshutong Granules
掩味组合物配方及制备方法：Taste masking composition formula and preparation method:
薄荷酰胺1gMenthamide 1g
覆盆子香精4gRaspberry flavor 4g
三氯蔗糖5gSucralose 5g
取配方量的覆盆子香精，乙醇溶解后用β-环糊精包合，15℃下烘干，再与配方量的薄荷酰胺、三氯蔗糖混匀，得掩味组合物。Take a formula amount of raspberry essence, dissolve in ethanol and then clathrate with β-cyclodextrin, dry at 15°C, and then mix with formula amount of menthamide and sucralose to obtain a taste-masking composition.
掩味脉络舒通颗粒制备方法：The preparation method of taste-masking Mailuoshutong granules:
（1）取脉络舒通组方中水蛭、蜈蚣、全蝎（各1/2处方量），粉碎成细粉，备用；(1) Take the leech, centipede, and scorpion (1/2 the prescription amount of each) from the Mailuo Shutong prescription, crush them into fine powder, and set aside;
（2）取处方量的金银花、苍术、玄参、当归、白芍混合均匀，水蒸气蒸馏，提取挥发油，挥发油另器保存，备用；蒸馏后的水溶液及药渣，备用；(2) Take the prescription amount of honeysuckle, atractylodes, scrophulariaceae, angelica, and white peony and mix them evenly, steam distillation, extract the volatile oil, and store the volatile oil separately for later use; the distilled aqueous solution and medicine residue for later use;
（3）将步骤（2）所得蒸馏后的水溶液及药渣、剩余处方量的水蛭、蜈蚣、全蝎及处方量的黄芪、黄柏、薏苡仁、甘草混合，加水煎煮2次，合并两次的煎煮液，滤过，滤液浓缩至相对密度为1.15-1.2（80℃）的清膏；所得清膏加乙醇使含醇量达60%，静置，滤过，滤液回收乙醇并减压浓缩至相对密度为1.30-1.35（80℃）的稠膏，真空干燥，粉碎成细粉，得干膏粉，备用；(3) Mix the distilled aqueous solution and medicinal residue obtained in step (2), the remaining prescription amount of leeches, centipedes, scorpion, and prescription amount of astragalus, phellodendron, coix seed, and licorice, add water to decoct twice, and combine them twice After filtering, the filtrate is concentrated to a clear ointment with a relative density of 1.15 to 1.2 (80°C); the obtained clear ointment is added with ethanol to make the alcohol content reach 60%, stand, filter, and the filtrate recovers the ethanol and depressurizes Concentrate to a thick paste with a relative density of 1.30 to 1.35 (80°C), vacuum dry, and pulverize into fine powder to obtain a dry paste powder for use;
（4）将步骤（1）中所得细粉、步骤（3）中所得干膏粉混合均匀后，加入上述所得掩味组合物，混匀，再加入配方量的羟丙基淀粉钠、甘露醇（重量比3:1）混匀，制粒，干燥，得颗粒，备用；(4) After mixing the fine powder obtained in step (1) and the dry paste powder obtained in step (3) uniformly, add the taste-masking composition obtained above, mix well, and then add the formula amount of sodium hydroxypropyl starch and mannitol (Weight ratio 3:1) Mix, granulate, and dry to obtain granules for use;
（5）用适量的乙醇溶解步骤（2）所得挥发油，喷入步骤（4）所得颗粒中，混匀，制成1000g，即得掩味脉络舒通颗粒。(5) Dissolve the volatile oil obtained in step (2) with an appropriate amount of ethanol, spray it into the granules obtained in step (4), and mix them to make 1000 g to obtain taste-masking Mailuo Shutong granules.
实施例Example 22 掩味脉络舒通颗粒制备Preparation of Masking Mailuoshutong Granules
掩味组合物配方及制备方法：Taste masking composition formula and preparation method:
N,2,3-三甲基-2-异丙基丁酰胺5gN,2,3-Trimethyl-2-isopropylbutanamide 5g
覆盆子香精          2gRaspberry flavor 2g
阿斯巴甜2gAspartame 2g
取配方量的覆盆子香精，乙醇溶解后用羟丙基-β-环糊精包合，45℃下烘干，再与配方量的薄荷酰胺、阿斯巴甜混匀，得掩味组合物。Take formula amount of raspberry essence, dissolve in ethanol and clathrate with hydroxypropyl-β-cyclodextrin, dry at 45°C, then mix with formula amount of menthamide and aspartame to obtain a taste-masking composition .
掩味脉络舒通颗粒制备方法：同实施例1。The preparation method of taste-masking Mailuoshutong granules: the same as in Example 1.
实施例Example 33 掩味脉络舒通颗粒制备Preparation of Masking Mailuoshutong Granules
掩味组合物配方及制备方法：Taste masking composition formula and preparation method:
薄荷酰胺1gMenthamide 1g
覆盆子香精2gRaspberry flavor 2g
三氯蔗糖2gSucralose 2g
取配方量的覆盆子香精，乙醇溶解后用将羟丙基-β-环糊精包合，35℃下烘干，再与配方量的薄荷酰胺、三氯蔗糖混匀，即得掩味组合物。Take the formulated amount of raspberry flavor, dissolve in ethanol and then clathrate it with hydroxypropyl-β-cyclodextrin, dry it at 35℃, and mix it with the formulated amount of menthamide and sucralose to obtain a taste-masking combination Things.
掩味脉络舒通颗粒制备方法：同实施例1。The preparation method of taste-masking Mailuoshutong granules: the same as in Example 1.
实施例Example 44 掩味脉络舒通颗粒制备Preparation of Masking Mailuoshutong Granules
掩味组合物配方及制备方法：Taste masking composition formula and preparation method:
薄荷酰胺5gMenthamide 5g
覆盆子香精   8gRaspberry flavor 8g
阿斯巴甜 7gAspartame 7g
取配方量的覆盆子香精，乙醇溶解后用将羟丙基-β-环糊精包合，30℃下烘干，再与配方量的薄荷酰胺、阿斯巴甜混匀，即得掩味组合物。Take the formulated amount of raspberry flavor, dissolve in ethanol and then clathrate it with hydroxypropyl-β-cyclodextrin, dry it at 30℃, and mix it with the formulated amount of menthamide and aspartame to mask the taste. combination.
掩味脉络舒通颗粒制备方法：同实施例1。The preparation method of taste-masking Mailuoshutong granules: the same as in Example 1.
实施例Example 55 掩味脉络舒通颗粒制备Preparation of Masking Mailuoshutong Granules
掩味组合物配方及制备方法：Taste masking composition formula and preparation method:
薄荷酰胺10gMenthamide 10g
覆盆子香精   8gRaspberry flavor 8g
三氯蔗糖 7gSucralose 7g
取配方量的覆盆子香精，乙醇溶解后用将羟丙基-β-环糊精包合，35℃下烘干，再与配方量的薄荷酰胺、三氯蔗糖混匀，即得掩味组合物。Take the formulated amount of raspberry flavor, dissolve in ethanol and then clathrate it with hydroxypropyl-β-cyclodextrin, dry it at 35℃, and mix it with the formulated amount of menthamide and sucralose to obtain a taste-masking combination Things.
掩味脉络舒通颗粒制备方法：同实施例1。The preparation method of the taste-masking Mailuoshutong granules: the same as in Example 1.
实施例Example 66 掩味脉络舒通颗粒制备Preparation of Masking Mailuoshutong Granules
掩味组合物配方及制备方法：Taste masking composition formula and preparation method:
薄荷酰胺5gMenthamide 5g
覆盆子香精   5gRaspberry flavor 5g
三氯蔗糖 5gSucralose 5g
取配方量的覆盆子香精，乙醇溶解后用γ-环糊精包合，35℃下烘干，再与配方量的薄荷酰胺、三氯蔗糖混匀，即得掩味组合物。Take the formulated amount of raspberry essence, dissolve in ethanol, and clathrate with γ-cyclodextrin, dry at 35°C, and then mix with the formulated amount of menthamide and sucralose to obtain a taste-masking composition.
掩味脉络舒通颗粒制备方法：同实施例1。The preparation method of the taste-masking Mailuoshutong granules: the same as in Example 1.
实施例Example 77 掩味脉络舒通颗粒制备Preparation of Masking Mailuoshutong Granules
掩味组合物配方及制备方法：Taste masking composition formula and preparation method:
薄荷酰胺3gMenthamide 3g
覆盆子香精   5gRaspberry flavor 5g
三氯蔗糖 3gSucralose 3g
取配方量的覆盆子香精，乙醇溶解后用将羟丙基-β-环糊精包合，35℃下烘干，再与配方量的薄荷酰胺、三氯蔗糖混匀，即得掩味组合物。Take the formulated amount of raspberry flavor, dissolve in ethanol and then clathrate it with hydroxypropyl-β-cyclodextrin, dry it at 35℃, and mix it with the formulated amount of menthamide and sucralose to obtain a taste-masking combination Things.
掩味脉络舒通颗粒制备方法：同实施例1。The preparation method of the taste-masking Mailuoshutong granules: the same as in Example 1.
实施例Example 88 掩味脉络舒通颗粒制备Preparation of Masking Mailuoshutong Granules
掩味组合物配方及制备方法：Taste masking composition formula and preparation method:
薄荷酰胺4gMenthamide 4g
覆盆子香精   5gRaspberry flavor 5g
三氯蔗糖 7gSucralose 7g
取配方量的覆盆子香精，乙醇溶解后用将羟丙基-β-环糊精包合，35℃下烘干，再与配方量的薄荷酰胺、三氯蔗糖混匀，即得掩味组合物。Take the formulated amount of raspberry flavor, dissolve in ethanol and then clathrate it with hydroxypropyl-β-cyclodextrin, dry it at 35℃, and mix it with the formulated amount of menthamide and sucralose to obtain a taste-masking combination Things.
掩味脉络舒通颗粒制备方法：同实施例1。The preparation method of the taste-masking Mailuoshutong granules: the same as in Example 1.
实施例Example 9 9 掩味金藤清痹颗粒制备Preparation of Jinteng Qingbi Granules
掩味组合物配方及制备方法：Taste masking composition formula and preparation method:
薄荷酰胺4gMenthamide 4g
覆盆子香精   5gRaspberry flavor 5g
三氯蔗糖 7gSucralose 7g
取配方量的覆盆子香精，乙醇溶解后用将羟丙基-β-环糊精包合，35℃下烘干，再与配方量的薄荷酰胺、三氯蔗糖混匀，即得掩味组合物。Take the formulated amount of raspberry flavor, dissolve in ethanol and then clathrate it with hydroxypropyl-β-cyclodextrin, dry it at 35℃, and mix it with the formulated amount of menthamide and sucralose to obtain a taste-masking combination Things.
掩味金藤清痹颗粒制备方法：The preparation method of taste-masking Jinteng Qingbi granules:
（1）取金藤清痹组方中蜈蚣（处方量）、当归（1/2处方量），分别粉碎成细粉，过筛，灭菌，备用；(1) Take centipede (prescription amount) and angelica (1/2 prescription amount) from the Jinteng Qingbi prescription, crush them into fine powder, sieve, sterilize, and set aside;
（2）取组方中处方量的金银花加水，加热至沸，保温热浸，提取2次，提取液合并，滤过，浓缩至相对密度为1.15-1.20的清膏，放冷，加乙醇，是含醇量达70%，静置，取上清液回收乙醇并浓缩至相对密度为1.25-1.30的稠膏，真空干燥，粉碎，过筛，得细粉Ⅰ备用；(2) Take the prescription amount of honeysuckle in the formula and add water, heat to boiling, heat preservation and soak, extract twice, combine the extracts, filter, and concentrate to a clear ointment with a relative density of 1.15 to 1.20, let it cool, and add ethanol. It is a thick paste with an alcohol content of 70%, standing, taking the supernatant to recover ethanol and concentrating it to a thick paste with a relative density of 1.25-1.30, vacuum drying, crushing, and sieving to obtain fine powder I for later use;
（3）取组方中处方量的青风藤、白花蛇舌草，70%乙醇回流提取2次，提取液合并，过滤，回收乙醇后为药液Ⅰ；取组方中剩余药材加水煎煮2次，提取液合并，滤过，浓缩至相对密度为1.15-1.20的清膏，放冷，加乙醇使含醇量达60%，静置，取上清液回收乙醇后为药液Ⅱ；合并药液Ⅰ、药液Ⅱ，浓缩至相对密度为1.25-1.30的稠膏，真空干燥，粉碎，过筛，得细粉Ⅱ备用；(3) Take the prescription amount of Qingfengteng and Hedyotis diffusa in the prescription, 70% ethanol reflux extraction for 2 times, combine the extracts, filter, and recover the ethanol as liquid medicine I; take the remaining medicinal materials in the prescription and decoct with water Twice, the extracts are combined, filtered, concentrated to a clear ointment with a relative density of 1.15 to 1.20, let cool, add ethanol to make the alcohol content reach 60%, stand still, take the supernatant to recover the ethanol and make it into liquid medicine II; Combine medicinal liquid I and medicinal liquid II, concentrate to a thick paste with a relative density of 1.25-1.30, vacuum dry, pulverize, and sieve to obtain fine powder II for later use;
（4）将步骤（1）中所得蜈蚣、当归细粉与步骤（2）中所得细粉Ⅰ、步骤（3）中所得细粉Ⅱ合并，加入上述所得掩味组合物，混合均匀后，再加入配方量的糊精，制粒，干燥，制成1000g的颗粒，即得。(4) Combine the centipede and angelica powder obtained in step (1) with the fine powder I obtained in step (2) and the fine powder II obtained in step (3), add the taste-masking composition obtained above, and mix it evenly, then Add formula amount of dextrin, granulate, dry to make 1000g granules, and get it.
实施例Example 1010 掩味金藤清痹颗粒制备Preparation of Jinteng Qingbi Granules
掩味组合物配方及制备方法：Taste masking composition formula and preparation method:
N, 2, 3-三甲基-2-异丙基丁酰胺（WS-23）0.5gN, 2, 3-Trimethyl-2-isopropylbutanamide (WS-23) 0.5g
覆盆子香精20gRaspberry flavor 20g
三氯蔗糖0.5gSucralose 0.5g
取配方量的覆盆子香精，乙醇溶解后用将羟丙基-β-环糊精包合，35℃下烘干，再与配方量的WS-23、三氯蔗糖混匀，即得掩味组合物。Take formula amount of raspberry essence, dissolve in ethanol, clathrate with hydroxypropyl-β-cyclodextrin, dry at 35℃, and mix with formula amount of WS-23 and sucralose to obtain taste masking combination.
掩味金藤清痹颗粒制备方法：同实施例9。The preparation method of the taste-masking Jinteng Qingbi granules: the same as in Example 9.
 To
实施例Example 1111 掩味川蛭通络胶囊制备Preparation of Masking Chuanzhitongluo Capsules
掩味组合物配方及制备方法：Taste masking composition formula and preparation method:
薄荷酰胺3gMenthamide 3g
覆盆子香精   5gRaspberry flavor 5g
三氯蔗糖3gSucralose 3g
取配方量的覆盆子香精，乙醇溶解后用将羟丙基-β-环糊精包合，35℃下烘干，再与配方量的薄荷酰胺、三氯蔗糖混匀，即得掩味组合物。Take the formulated amount of raspberry flavor, dissolve in ethanol and then clathrate it with hydroxypropyl-β-cyclodextrin, dry it at 35℃, and mix it with the formulated amount of menthamide and sucralose to obtain a taste-masking combination Things.
掩味川蛭通络胶囊制备方法：Preparation method of masking Chuanzhitongluo capsules:
（1）取川蛭通络胶囊组方中处方量的水蛭药材粗粉或鲜水蛭，加水，37℃下搅拌提取，离心，取上清液过滤，滤液浓缩并冷冻干燥，得水蛭冻干粉；(1) Take the leech medicinal powder or fresh leech in the prescription of Chuanzhitongluo capsule, add water, stir and extract at 37℃, centrifuge, take the supernatant and filter, concentrate the filtrate and freeze-dried to obtain freeze-dried leech powder ；
（2）取组方中处方量的川芎、丹参、黄芪，乙醇回流提取，提取液过滤，滤液浓缩得醇浓缩液；醇提后的药渣加水，煎煮提取，提取液过滤，浓缩，得水浓缩液；将所得醇浓缩液、水浓缩液合并，喷雾干燥，得药材混合粉；(2) Take the prescription amount of Ligusticum chuanxiong, Salvia miltiorrhiza, and Astragalus in the prescription, extract by reflux with ethanol, filter the extract, and concentrate the filtrate to obtain an alcohol concentrate; add water to the dregs after alcohol extraction, decoct and extract, filter and concentrate the extract to obtain Water concentrate; combine the obtained alcohol concentrate and water concentrate, and spray dry to obtain medicinal material mixture powder;
（3）将步骤（1）所得水蛭冻干粉、步骤（2）所得药材混合粉混匀，加入上述所得掩味组合物，再加入配方量的淀粉、微粉硅胶，混匀，过筛后，装肠溶胶囊，即得。(3) Mix the leech freeze-dried powder obtained in step (1) and the medicinal material mixture powder obtained in step (2), add the taste-masking composition obtained above, and then add the formula amount of starch and micronized silica gel, mix well, and after sieving, Pack it in enteric-coated capsules and get it.
实施例Example 1212 掩味川蛭通络胶囊制备Preparation of Masking Chuanzhitongluo Capsules
掩味组合物配方及制备方法：Taste masking composition formula and preparation method:
薄荷酰胺15gMenthamide 15g
覆盆子香精0.5gRaspberry flavor 0.5g
三氯蔗糖15gSucralose 15g
取配方量的覆盆子香精，乙醇溶解后用将羟丙基-β-环糊精包合，35℃下烘干，再与配方量的薄荷酰胺、三氯蔗糖混匀，即得掩味组合物。Take the formulated amount of raspberry flavor, dissolve in ethanol and then clathrate it with hydroxypropyl-β-cyclodextrin, dry it at 35℃, and mix it with the formulated amount of menthamide and sucralose to obtain a taste-masking combination Things.
掩味川蛭通络胶囊制备方法：同实施例11。The preparation method of Mianwei Chuanzhitongluo Capsules: Same as in Example 11.
对比实施例Comparative example 1  1 掩味脉络舒通颗粒制备Preparation of Masking Mailuoshutong Granules
掩味组合物配方及制备方法：Taste masking composition formula and preparation method:
薄荷酰胺3gMenthamide 3g
覆盆子香精   5gRaspberry flavor 5g
三氯蔗糖 3gSucralose 3g
取配方量的WS-3、覆盆子香精、三氯蔗糖混合均匀，即得掩味组合物。Take the formula amount of WS-3, raspberry flavor, and sucralose and mix evenly to obtain a taste-masking composition.
掩味脉络舒通颗粒制备方法：The preparation method of taste-masking Mailuoshutong granules:
（1）取脉络舒通组方中水蛭、蜈蚣、全蝎（各1/2处方量）混匀，粉碎成细粉，加入β-环糊精进行包合，得包合物A，备用；(1) Take the leech, centipede, and scorpion (1/2 prescription amount each) from the Mailuoshutong formula, mix them, pulverize them into fine powder, add β-cyclodextrin for inclusion, and obtain inclusion compound A for use;
（2）取处方量的金银花、苍术、玄参、当归、白芍混合均匀，水蒸气蒸馏，提取挥发油，挥发油另器保存，备用；蒸馏后的水溶液及药渣，备用；(2) Take the prescription amount of honeysuckle, atractylodes, scrophulariaceae, angelica, and white peony and mix them evenly, steam distillation, extract the volatile oil, and store the volatile oil separately for later use; the distilled aqueous solution and medicine residue for later use;
（3）将步骤（2）所得蒸馏后的水溶液及药渣、剩余处方量的水蛭、蜈蚣、全蝎及处方量的黄芪、黄柏、薏苡仁、甘草混合，加水煎煮2次，合并两次的煎煮液，滤过，滤液浓缩至相对密度为1.15-1.2（80℃）的清膏；所得清膏加乙醇使含醇量达60%，静置，滤过，滤液回收乙醇并减压浓缩至相对密度为1.30-1.35（80℃）的稠膏，真空干燥，粉碎成细粉，得干膏粉，再加入β-环糊精进行包合，得包合物B，备用；(3) Mix the distilled aqueous solution and medicinal residue obtained in step (2), the remaining prescription amount of leeches, centipedes, scorpion, and prescription amount of astragalus, phellodendron, coix seed, and licorice, add water to decoct twice, and combine them twice After filtering, the filtrate is concentrated to a clear ointment with a relative density of 1.15 to 1.2 (80°C); the obtained clear ointment is added with ethanol to make the alcohol content reach 60%, stand, filter, and the filtrate recovers the ethanol and depressurizes Concentrate to a thick paste with a relative density of 1.30 to 1.35 (80°C), vacuum dry, and pulverize into fine powder to obtain a dry paste powder, and then add β-cyclodextrin for inclusion to obtain inclusion compound B for use;
（4）将步骤（1）中所得包合物A、步骤（3）中所得包合物B混合均匀后，加入上述掩味组合物；再加入配方量的羟丙基淀粉钠、甘露醇（重量比3:1）混匀，制粒，干燥。(4) After mixing the clathrate compound A obtained in step (1) and the clathrate compound B obtained in step (3) uniformly, add the above-mentioned taste-masking composition; then add the formula amount of sodium hydroxypropyl starch and mannitol ( Weight ratio 3:1) Mix well, granulate and dry.
（5）用适量的乙醇溶解步骤（2）所得挥发油，喷入步骤（4）所得颗粒中，混匀，制成1000g，即得掩味脉络舒通颗粒。(5) Dissolve the volatile oil obtained in step (2) with an appropriate amount of ethanol, spray it into the granules obtained in step (4), and mix them to make 1000 g to obtain taste-masking Mailuo Shutong granules.
对比实施例Comparative example 2 2 掩味脉络舒通颗粒制备Preparation of Masking Mailuoshutong Granules
掩味组合物配方及制备方法：Taste masking composition formula and preparation method:
薄荷酰胺3gMenthamide 3g
覆盆子香精   5gRaspberry flavor 5g
三氯蔗糖 3gSucralose 3g
取配方量的WS-3、覆盆子香精、三氯蔗糖混合均匀，即得掩味组合物。Take the formula amount of WS-3, raspberry flavor, and sucralose and mix evenly to obtain a taste-masking composition.
掩味脉络舒通颗粒制备方法：同实施例1。The preparation method of the taste-masking Mailuoshutong granules: the same as in Example 1.
对比实施例Comparative example 3 3 掩味脉络舒通颗粒制备Preparation of Masking Mailuoshutong Granules
掩味组合物配方及制备方法：Taste masking composition formula and preparation method:
覆盆子香精   5gRaspberry flavor 5g
三氯蔗糖 3gSucralose 3g
取配方量的覆盆子香精，乙醇溶解后用将羟丙基-β-环糊精包合，35℃下烘干，再与配方量的三氯蔗糖混匀，即得掩味组合物。Take a formula amount of raspberry flavor, dissolve in ethanol, clathrate with hydroxypropyl-β-cyclodextrin, dry at 35°C, and mix with formula amount of sucralose to obtain a taste-masking composition.
掩味脉络舒通颗粒制备方法：同实施例1。The preparation method of the taste-masking Mailuoshutong granules: the same as in Example 1.
对比实施例Comparative example 4  4 掩味脉络舒通颗粒制备Preparation of Masking Mailuoshutong Granules
掩味组合物配方及制备方法：Taste masking composition formula and preparation method:
薄荷酰胺3gMenthamide 3g
三氯蔗糖 3gSucralose 3g
取配方量的WS-3、三氯蔗糖混匀，即得掩味组合物。Take the formula amount of WS-3 and sucralose and mix well to obtain a taste-masking composition.
掩味脉络舒通颗粒制备方法：同实施例1。The preparation method of the taste-masking Mailuoshutong granules: the same as in Example 1.
对比实施例Comparative example 5  5 掩味脉络舒通颗粒制备Preparation of Masking Mailuoshutong Granules
掩味组合物配方及制备方法：Taste masking composition formula and preparation method:
薄荷酰胺10gMenthamide 10g
覆盆子香精   1gRaspberry flavor 1g
三氯蔗糖 1gSucralose 1g
取配方量的覆盆子香精，乙醇溶解后用将羟丙基-β-环糊精包合，35℃下烘干，再与配方量的WS-3、三氯蔗糖混匀，即得掩味组合物。Take the formulated amount of raspberry flavor, dissolve in ethanol, clathrate with hydroxypropyl-β-cyclodextrin, dry at 35°C, and then mix with the formulated amount of WS-3 and sucralose to obtain taste masking combination.
掩味脉络舒通颗粒制备方法：同实施例1。The preparation method of the taste-masking Mailuoshutong granules: the same as in Example 1.
对比实施例Comparative example 6  6 掩味脉络舒通颗粒制备Preparation of Masking Mailuoshutong Granules
掩味组合物配方及制备方法：Taste masking composition formula and preparation method:
薄荷酰胺10gMenthamide 10g
覆盆子香精   10gRaspberry flavor 10g
三氯蔗糖 10gSucralose 10g
取配方量的覆盆子香精，乙醇溶解后用将羟丙基-β-环糊精包合，35℃下烘干，再与配方量的WS-3、三氯蔗糖混匀，即得掩味组合物。Take the formulated amount of raspberry flavor, dissolve in ethanol, clathrate with hydroxypropyl-β-cyclodextrin, dry at 35°C, and then mix with the formulated amount of WS-3 and sucralose to obtain taste masking combination.
掩味脉络舒通颗粒制备方法：同实施例1。The preparation method of the taste-masking Mailuoshutong granules: the same as in Example 1.
为验证本发明所述掩味组合物的掩味效果，以脉络舒通颗粒为例，进行了以下掩味效果的实验，值得说明的是，本发明人亦对其他掩味产品进行了掩味效果的评价，其他产品亦可达到与脉络舒通掩味颗粒相同的掩味效果，服用后无胃肠道不良反应的发生。In order to verify the taste-masking effect of the taste-masking composition of the present invention, the following taste-masking effect experiments were carried out using Mailuoshutong granules as an example. It is worth noting that the inventors also performed taste-masking on other taste-masking products. In effect evaluation, other products can also achieve the same taste-masking effect as Mailuoshutong taste-masking granules, and no gastrointestinal adverse reactions occur after taking it.
工业实用性Industrial applicability
验证实验例Verification experiment example 11 ：:
1. 受试物1. Test substance
实施例5-8、对比实施例1-6所得掩味脉络舒通颗粒。The taste-masking Mailuoshutong granules obtained in Examples 5-8 and Comparative Examples 1-6.
   2. 药物配置2. Drug configuration
分别取实施例5-8、对比实施例1-6所得颗粒，配置成浓度为0.05g/ml的溶液。The particles obtained in Examples 5-8 and Comparative Examples 1-6 were respectively taken and prepared into a solution with a concentration of 0.05 g/ml.
3. 实验动物3. Laboratory animals
取SD小鼠，18-22g，雌雄各半，分为10组，10只/组，分别为实施例5-8组、对比实施例1-6组，各组小鼠分笼饲养。SD mice, 18-22 g, half male and half male, were divided into 10 groups, 10 mice/group, respectively, groups of Examples 5-8 and Groups of Comparative Examples 1-6, and the mice in each group were raised in separate cages.
4. 测试4. Testing
每组小鼠按照0.5ml/10g的剂量灌胃给予相应的药物溶液，观察小鼠服药5min、10 min、20 min后的反胃、呕吐情况。Each group of mice was given the corresponding drug solution by intragastric administration at a dose of 0.5ml/10g, and the nausea and vomiting of the mice after 5min, 10min, and 20min were observed.
   5. 实验结果5. Experimental results
Figure dest_path_image001
Figure dest_path_image001
从表1中可以看出，本发明实施例7小鼠服药后均未出现胃肠道反应，其余实施例仅共计出现3例小鼠反胃反应，无呕吐现象的发生；而对比实施例1-6自服药5min后，持续不断的有小鼠出现反胃及呕吐现象。It can be seen from Table 1 that none of the mice in Example 7 of the present invention showed gastrointestinal reactions after taking the medicine, and in the remaining examples, only 3 cases of mice had nausea reactions in total, and no vomiting occurred; and Comparative Example 1- 6 After 5 minutes of self-administration, the mice experienced nausea and vomiting continuously.
以上结果表明，本发明所述的掩味组合物具有较好的掩盖中药制剂中动物药材腥臭味，明显消除或减少胃肠道等不良反应。The above results show that the taste-masking composition of the present invention can better mask the fishy odor of animal medicinal materials in traditional Chinese medicine preparations, and obviously eliminate or reduce adverse reactions such as gastrointestinal tract.
 To
验证实验例Verification experiment example 22 ：:
1. 受试物1. Test substance
实施例5-8、对比实施例1-6所得掩味脉络舒通颗粒。The taste-masking Mailuoshutong granules obtained in Examples 5-8 and Comparative Examples 1-6.
2. 口尝评价2. Oral evaluation
采用排序+评分法，受试者进行样品测试时，采用随机、单盲法对样品进行测试。Using the sorting + scoring method, when subjects are testing samples, they are tested by random, single-blind method.
3. 测试过程3. Test process
3.1 药物配置3.1 Drug configuration
分别取实施例5-8、对比实施例1-6所得颗粒，配置成浓度为0.02g/ml的溶液，配制成的溶液按照顺序，分别编号为1-10。The particles obtained in Examples 5-8 and Comparative Examples 1-6 were respectively taken and prepared into a solution with a concentration of 0.02 g/ml, and the prepared solutions were respectively numbered 1-10 in order.
3.2 测试3.2 Test
受试者分为10组，10人/组，分别服用编号1-10的溶液10ml，观察受试者服药后0.5小时、服药后1小时的胃肠道不良反应。The subjects were divided into 10 groups, 10 persons/group, and each took 10ml of the solution numbered 1-10, and the gastrointestinal adverse reactions of the subjects were observed 0.5 hour after taking the medicine and 1 hour after taking the medicine.
胃肠道不良反应如下：Adverse gastrointestinal reactions are as follows:
无反应：无呃逆、反胃、呕吐等胃肠道不良反应；No reaction: no adverse gastrointestinal reactions such as hiccups, nausea, vomiting, etc.;
轻度：略有呃逆、反胃等感觉，但不呕吐；Mild: slight hiccups and nausea, but not vomiting;
中度：有呃逆、反胃等反应，但不呕吐；Moderate: have hiccups, nausea and other reactions, but do not vomit;
重度：呃逆、范围等反应严重，呕吐。Severe: severe reactions such as hiccups and scope, and vomiting.
4. 测试结果4. Test results
Figure 654263dest_path_image002
Figure 654263dest_path_image002
从表2中可以看出，本发明实施例7未发生胃肠道不良反应，其余实施例各出现1例轻度的胃肠道不良反应，但据受试者描述，胃肠道反应可以忽略不计。而各对比实施例在服药0.5小时就不同程度的出现胃肠道不良反应，且在服药1小时后，不良反应人数增加，且个别不良反应情况加重。It can be seen from Table 2 that there was no gastrointestinal adverse reaction in Example 7 of the present invention, and one mild gastrointestinal adverse reaction occurred in each of the remaining examples. However, according to the subject's description, the gastrointestinal reaction can be ignored Excluding. However, in each comparative example, gastrointestinal adverse reactions occurred to varying degrees within 0.5 hours of taking the medicine, and after 1 hour of taking the medicine, the number of adverse reactions increased, and individual adverse reactions were aggravated.
以上结果表明，本发明所述的掩味组合物具有较好的掩盖含动物药材的中药制剂腥臭味的作用，不仅可以掩盖其入口时的腥臭味，还可以在服药后明显消除或减少胃肠道等不良反应，减少患者服用动物药材时的不适感，提高患者用药的依从性。The above results show that the taste-masking composition of the present invention has a better effect of masking the fishy odor of traditional Chinese medicine preparations containing animal medicinal materials, not only can mask the fishy odor at the entrance, but also can significantly eliminate or reduce the gastrointestinal odor after taking the medicine. Adverse reactions such as tract, reduce the discomfort of patients when taking animal medicines, and improve the compliance of patients with medication.

Claims (10)

  1. 一种掩味组合物，其特征在于，所述掩味组合物含有以下三种组分： 组分A：薄荷酰胺或N, 2, 3-三甲基-2-异丙基丁酰胺中的一种；A taste-masking composition, characterized in that the taste-masking composition contains the following three components: Component A: Menthamide or N, 2, 3-trimethyl-2-isopropylbutanamide One kind
    组分B：覆盆子香精；Component B: Raspberry flavor;
    组分C：三氯蔗糖或阿斯巴甜中的一种。Component C: one of sucralose or aspartame.
  2. 如权利要求1所述的掩味剂组合物，其特征在于，所述掩味组合物含有以下三种组分：The taste-masking composition of claim 1, wherein the taste-masking composition contains the following three components:
    组分A：0.5-15重量份，组分B：0.5-20重量份，组分C：0.5-15重量份；Component A: 0.5-15 parts by weight, Component B: 0.5-20 parts by weight, Component C: 0.5-15 parts by weight;
    优选为：组分A：1-5重量份，组分B：2-8重量份，组分C：2-7重量份；Preferably: component A: 1-5 parts by weight, component B: 2-8 parts by weight, and component C: 2-7 parts by weight;
    进一步优选为：组分A：3重量份，组分B：5重量份，组分C：3重量份。More preferably: Component A: 3 parts by weight, Component B: 5 parts by weight, and Component C: 3 parts by weight.
  3. 如权利要求1或2所述的掩味剂组合物，其特征在于，所述掩味组合物的制备方法为：将组分B用环糊精包合，再与组分A、组分C混合，即得。The taste-masking composition according to claim 1 or 2, wherein the preparation method of the taste-masking composition is: inclusion of component B with cyclodextrin, and then with component A and component C Mix it and get it.
  4. 如权利要求1-3任一项所述的掩味组合物在掩盖中药材、中药材提取物和/或含有中药材的制剂等的气味中的用途。Use of the taste-masking composition according to any one of claims 1 to 3 for masking the odors of Chinese medicinal materials, Chinese medicinal materials extracts and/or preparations containing Chinese medicinal materials.
  5. 一种中药制剂，其特征在于，所述中药制剂含有权利要求1-3任一项所述的掩味组合物。A traditional Chinese medicine preparation, characterized in that it contains the taste-masking composition according to any one of claims 1-3.
  6. 如权利要求5所述的中药制剂，其特征在于，每1000g中药制剂中掩味组合物的加入量为0.5%-2.5%。The traditional Chinese medicine preparation according to claim 5, wherein the added amount of the taste-masking composition per 1000 g of the traditional Chinese medicine preparation is 0.5%-2.5%.
  7. 如权利要求6所述的中药制剂，其特征在于，每1000g中药制剂中掩味组合物的加入量为1.0%-1.5%。The traditional Chinese medicine preparation according to claim 6, wherein the added amount of the taste-masking composition per 1000 g traditional Chinese medicine preparation is 1.0%-1.5%.
  8. 如权利要求6所述的中药制剂，其特征在于，每1000g中药制剂中掩味组合物的加入量为1.1%。7. The traditional Chinese medicine preparation according to claim 6, wherein the added amount of the taste-masking composition per 1000 g of the traditional Chinese medicine preparation is 1.1%.
  9. 如权利要求5-8任一项所述的中药制剂，其特征在于，所述中药制剂为含有动物药材的制剂。8. The traditional Chinese medicine preparation according to any one of claims 5-8, wherein the traditional Chinese medicine preparation is a preparation containing animal medicinal materials.
  10. 如权利要求9所述的中药制剂，其特征在于，所述的动物药材包括但不限于水蛭、全蝎、蜈蚣、地龙、土鳖虫、僵蚕、蛤蚧、斑蝥、乌鞘蛇、金钱白花蛇、蛇蜕、蕲蛇中的一种或多种。The Chinese medicinal preparation according to claim 9, wherein the animal medicinal materials include, but are not limited to, leeches, scorpions, centipedes, earthworms, soil turtles, rigid silkworms, geckos, cantharis, black snakes, and golden snakes One or more of, snake slough, and cymbal snake.
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