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CN107213351B - Dendrobium nobile buccal tablet and preparation method thereof - Google Patents

Dendrobium nobile buccal tablet and preparation method thereof Download PDF

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CN107213351B
CN107213351B CN201710442464.1A CN201710442464A CN107213351B CN 107213351 B CN107213351 B CN 107213351B CN 201710442464 A CN201710442464 A CN 201710442464A CN 107213351 B CN107213351 B CN 107213351B
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dendrobium
buccal tablet
powder
mixture
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CN107213351A (en
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李玉萍
戴好富
蔡彩虹
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Hainan Shiboli Biotechnology Co ltd
Institute of Tropical Bioscience and Biotechnology Chinese Academy of Tropical Agricultural Sciences
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Institute of Tropical Bioscience and Biotechnology Chinese Academy of Tropical Agricultural Sciences
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
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    • A61K2236/333Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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    • AHUMAN NECESSITIES
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    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
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    • A61K2236/55Liquid-liquid separation; Phase separation

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Abstract

The invention belongs to the technical field of medicine processing, and particularly relates to a dendrobium nobile buccal tablet and a preparation method thereof. The dendrobe buccal tablet is prepared from the following raw materials in parts by weight: 180-235 parts of dendrobium, 12-26 parts of menthol, 18-28 parts of rhizoma polygonati, 17-22 parts of honeysuckle, 5-7 parts of sorbitol, 12-15 parts of chitosan, 2-6 parts of glycerol, 8-12 parts of maltodextrin and 23-40 parts of magnesium stearate. The dendrobium nobile buccal tablet provided by the invention keeps proper sweet taste, color and smell of the medicine through reasonable compatibility, has the effects of clearing away heat and toxic materials, resisting bacteria and diminishing inflammation, promoting the production of body fluid and moistening the throat and the like, and has obvious effects on treating sphagitis, oral ulcer and the like; the preparation method of the dendrobium nobile buccal tablet can preserve the effective ingredients in the raw materials, has reasonable production process and is suitable for industrial production.

Description

一种石斛含片及其制备方法A kind of dendrobium buccal tablet and preparation method thereof

技术领域technical field

本发明涉及药品加工技术领域,尤其涉及一种石斛含片及其制备方法。The invention relates to the technical field of pharmaceutical processing, in particular to a dendrobium buccal tablet and a preparation method thereof.

背景技术Background technique

口含片指含于口腔内缓慢溶解的压制片,能对口腔及咽部产生持久的药效,用于局部的消炎、消毒、消肿、刺激粘膜分泌等,是治疗口腔和咽喉疾病的常用药物。口含片因其优良的口感及方便的服用方法而受到广大患者的欢迎。但中药口含片也存在以下问题:1、中药配伍不合理,药效不佳;2、糖类、香精色素等赋形成分较多,导致患者特别是儿童误将含片当做“糖”来食用,用药过量引起不良反应;3制备方法不够精制,不能完全发挥药效。Buccal tablets refer to compressed tablets that dissolve slowly in the oral cavity, which can produce lasting medicinal effects on the oral cavity and pharynx. They are used for local anti-inflammatory, disinfection, swelling, and mucosal secretion stimulation. drug. Buccal tablets are welcomed by the majority of patients because of their excellent taste and convenient taking method. However, there are also the following problems in traditional Chinese medicine buccal tablets: 1. The compatibility of traditional Chinese medicine is unreasonable and the efficacy is not good; 2. There are many excipients such as sugars, flavors and pigments, which cause patients, especially children, to mistake the lozenges as "sugar". Edible, overdose will cause adverse reactions; 3. The preparation method is not refined enough to fully exert the medicinal effect.

发明内容SUMMARY OF THE INVENTION

针对以上现有技术的不足之处,本发明提供一种石斛含片及其制备方法,通过合理的配伍,保持药物适当的甜味、色泽、气味,具有清热解毒、抗菌消炎、生津润喉等作用,在治疗咽喉炎和口腔溃疡等方面具有显著的效果。本发明石斛含片的制备方法能够保存原料中的有效成分,生产工艺合理,适合工业化生产。为解决以上技术问题,本发明采取的技术方案如下:Aiming at the deficiencies of the above prior art, the present invention provides a dendrobium lozenge and a preparation method thereof, through reasonable compatibility, maintaining the appropriate sweetness, color and smell of the medicine, and having the functions of clearing away heat and detoxifying, antibacterial and anti-inflammatory, promoting body fluid and moistening the throat, etc. It has a significant effect in the treatment of pharyngitis and oral ulcers. The preparation method of the dendrobium buccal tablet of the invention can preserve the effective components in the raw materials, has a reasonable production process, and is suitable for industrial production. In order to solve the above technical problems, the technical scheme adopted by the present invention is as follows:

一种石斛含片,由以下组份组成(重量份):石斛180-235份、薄荷脑12-26份、黄精18-28份、金银花17-22份、山梨醇5-7份、壳聚糖12-15份、甘油2-6份、麦芽糊精8-12份、硬脂酸镁23-40份。A dendrobium lozenge, which is composed of the following components (in parts by weight): 180-235 parts of dendrobium, 12-26 parts of menthol, 18-28 parts of Polygonatum chinensis, 17-22 parts of honeysuckle, 5-7 parts of sorbitol, chitosan 12-15 parts of sugar, 2-6 parts of glycerin, 8-12 parts of maltodextrin, 23-40 parts of magnesium stearate.

优选的,本发明所述的一种石斛含片,由以下组份组成(重量份):石斛200份、薄荷脑26份、黄精20份、金银花22份、山梨醇5份、壳聚糖15份、甘油6份、麦芽糊精8份、硬脂酸镁30份。Preferably, a dendrobium lozenge according to the present invention is composed of the following components (in parts by weight): 200 parts of dendrobium, 26 parts of menthol, 20 parts of Polygonatum chinensis, 22 parts of honeysuckle, 5 parts of sorbitol, 15 parts of chitosan parts, 6 parts of glycerin, 8 parts of maltodextrin, 30 parts of magnesium stearate.

相应的,本发明还提供了一种石斛含片的制备方法,其制备方法包含以下步骤:Correspondingly, the present invention also provides a preparation method of dendrobium lozenges, the preparation method comprising the following steps:

(1)a、称取处方量的石斛、黄精和金银花,粉碎,过400-500目筛,得超微粉末,采用40%-45%乙醇水溶液提取,提取液减压蒸去乙醇,得提取液和提取后的药渣;b、将a步骤的提取液上大孔树脂柱,依次用蒸馏水、碱液洗脱;其中,蒸馏水洗脱液为流出液A;碱液洗脱得流出液B;流出液B用酸中和至中性,用40%-50%乙醇水溶液浸提1.5-3h,减压蒸干得粉末①;c、按质量比1:5将a步骤所述的药渣与水混合,保持40℃-60℃水浴4-6h,冷却后与b步骤所述的流出液A合并,浓缩,加入无水乙醇产生沉淀,过滤,干燥,得粉末②;将粉末①与粉末②混合均匀,得中药混合物,备用;(1) a, take by weighing the dendrobium, Polygonatum chinensis and honeysuckle of the recipe quantity, pulverize, cross 400-500 mesh sieves, obtain ultrafine powder, adopt 40%-45% ethanol aqueous solution extraction, the extracting liquid is evaporated under reduced pressure to remove ethanol, obtain extraction liquid and the extracted medicinal residues; b. the extract of step a is placed on a macroporous resin column, and eluted with distilled water and alkali solution successively; wherein, the distilled water eluent is effluent A; the alkali solution is eluted to obtain effluent B The effluent B is neutralized to neutrality with acid, leached with 40%-50% ethanol aqueous solution for 1.5-3h, and evaporated to dryness under reduced pressure to obtain powder ①; c, by mass ratio 1:5, the medicinal residues described in step a are Mix it with water, keep it in a water bath at 40°C-60°C for 4-6 hours, combine it with the effluent A described in step b after cooling, concentrate, add anhydrous ethanol to produce precipitation, filter and dry to obtain powder ②; combine powder ① with powder ②Mix evenly to get the traditional Chinese medicine mixture for use;

(2)将步骤(1)的中药混合物与处方量的薄荷脑、山梨醇、壳聚糖、甘油混合均匀,备用;(2) the traditional Chinese medicine mixture of step (1) and the menthol, sorbitol, chitosan, glycerol of recipe quantity are mixed, for subsequent use;

(3)在步骤(2)的混合料中添加处方量的硬脂酸镁、麦芽糊精,混合均匀、干燥、过筛,得到组合物,压片,得石斛含片。(3) adding the magnesium stearate and maltodextrin of the recipe quantity to the mixture in step (2), mixing uniformly, drying, and sieving to obtain the composition, and tableting to obtain dendrobium buccal tablets.

优选的,本发明所述石斛含片中的石斛包括金钗石斛、铁皮石斛、霍山石斛、马鞭石斛中的一种或几种。Preferably, the dendrobium in the dendrobium buccal tablet of the present invention includes one or more of the group consisting of Dendrobium goldenchai, Dendrobium candidum, Dendrobium Huoshan, and Dendrobium dendrobium.

本发明一种石斛含片的各组分的配比机理如下:The proportioning mechanism of each component of a dendrobium buccal tablet of the present invention is as follows:

石斛(学名:Dendrobium nobile Lindl),又名万丈须、吊兰、林兰、禁生、金钗花等。石斛的主要活性成分为:石斛碱、石斛多糖、石斛胺、石斛次碱,研究表明石斛具有抗菌、抗氧化、抗肿瘤、提高免疫力和保护神经的作用。Dendrobium (scientific name: Dendrobium nobile Lindl), also known as Wanzhangxu, Chlorophytum, Linlan, forbidden life, golden hairpin flowers, etc. The main active ingredients of Dendrobium are: Dendrobine, Dendrobium polysaccharide, Dendrobium amine, Dendrobium hydrino. Studies have shown that Dendrobium has antibacterial, antioxidant, antitumor, immune-enhancing and neuroprotective effects.

金银花:含有绿原酸、木犀草素苷等药理活性成分,对溶血性链球菌、金黄葡萄球菌等多种致病菌及上呼吸道感染致病病毒等有较强的抑制力,另外还可增强免疫力、抗早孕、护肝、抗肿瘤、消炎、解热、止血(凝血)、抑制肠道吸收胆固醇等。Honeysuckle: Contains chlorogenic acid, luteolin glycosides and other pharmacologically active ingredients, has strong inhibitory effect on various pathogenic bacteria such as hemolytic streptococcus, Staphylococcus aureus, and upper respiratory tract infection pathogenic viruses, and can also enhance Immunity, anti-early pregnancy, liver protection, anti-tumor, anti-inflammatory, antipyretic, hemostasis (coagulation), inhibition of intestinal absorption of cholesterol, etc.

黄精:具有降血压,降血糖,降血脂,防止动脉粥样硬化,延缓衰老和抗菌等作用,黄精多糖具有免疫激活作用。Polygonatum chinensis: It has the functions of lowering blood pressure, blood sugar, blood lipid, preventing atherosclerosis, delaying aging and antibacterial, etc. Polysaccharide polysaccharide has immune activation effect.

薄荷脑:薄荷脑系由薄荷的叶和茎中所提取,为薄荷和欧薄荷精油中的主要成分。薄荷脑能选择性地刺激人体皮肤或黏膜的冷觉感受器,产生冷觉反射和冷感,引起皮肤黏膜血管收缩(实际上皮肤保持正常);另外对深部组织的血管也可引起收缩,而产生治疗作用。内服可缓解局部炎症(咽喉炎)及治疗感冒,并有健胃,驱风作用。Menthol: Menthol is extracted from the leaves and stems of peppermint and is the main component of peppermint and peppermint essential oils. Menthol can selectively stimulate the cold receptors of human skin or mucous membranes, producing cold reflexes and cold sensations, causing vasoconstriction of skin and mucous membranes (in fact, the skin remains normal); in addition, it can also cause contraction of blood vessels in deep tissues, resulting in Therapeutic effect. Oral administration can relieve local inflammation (pharyngitis) and treat colds, and has the effect of strengthening the stomach and carminative wind.

山梨醇:用作食品或药品的调湿剂、保香剂、抗氧化剂。Sorbitol: used as a moisturizing agent, flavor-preserving agent, and antioxidant for food or medicine.

壳聚糖:壳聚糖有较好的抗菌活性,能抑制真菌、细菌、和病毒的生长繁殖。同时,壳聚糖在食品领域被作为增稠剂、被膜剂。Chitosan: Chitosan has good antibacterial activity and can inhibit the growth and reproduction of fungi, bacteria and viruses. At the same time, chitosan is used as a thickener and coating agent in the food field.

甘油:用作食品或药品的保湿剂、润滑剂。Glycerin: used as a humectant, lubricant for food or medicine.

麦芽糊精:用于增加粘稠度、增强产品分散性和溶解性,麦芽糊精有较好的乳化作用和增稠效果。Maltodextrin: It is used to increase the viscosity, enhance the dispersibility and solubility of the product. Maltodextrin has a good emulsification and thickening effect.

硬脂酸镁:主要用作润滑剂,使制成的药粉具有很好的流动性和可压性。Magnesium stearate: mainly used as a lubricant, so that the prepared powder has good fluidity and compressibility.

与现有技术相比,本发明的有益效果是:本发明产品通过合理的配伍,保持药物适当的甜味、色泽、气味,具有清热解毒、抗菌消炎、生津润喉等作用,在治疗咽喉炎和口腔溃疡等方面具有显著的效果;本发明石斛含片的制备方法能够保存原料中的有效成分,生产工艺合理,适合工业化生产。Compared with the prior art, the beneficial effects of the present invention are: the product of the present invention maintains the appropriate sweetness, color and odor of the medicine through reasonable compatibility, and has the functions of clearing away heat and detoxifying, antibacterial and anti-inflammatory, promoting body fluid and moistening the throat, etc. It has remarkable effects on the treatment of oral ulcers and the like; the preparation method of the dendrobium buccal tablet of the present invention can preserve the effective components in the raw materials, and the production process is reasonable and suitable for industrial production.

具体实施方式Detailed ways

下面结合具体实施例来进一步描述本发明,本发明的优点和特点将会随着描述而更为清楚,但本发明的保护范围不限于以下实施例。The present invention will be further described below with reference to specific embodiments, and the advantages and characteristics of the present invention will become clearer with the description, but the protection scope of the present invention is not limited to the following embodiments.

实施例1:Example 1:

一种石斛含片,由以下组份组成(重量份):铁皮石斛200份、薄荷脑26份、黄精20份、金银花22份、山梨醇5份、壳聚糖15份、甘油6份、麦芽糊精8份、硬脂酸镁30份。A dendrobium buccal tablet, comprising the following components (in parts by weight): 200 parts of Dendrobium officinale, 26 parts of menthol, 20 parts of Polygonatum chinensis, 22 parts of honeysuckle, 5 parts of sorbitol, 15 parts of chitosan, 6 parts of glycerin, and malt 8 parts of dextrin, 30 parts of magnesium stearate.

制备方法如下:The preparation method is as follows:

(1)a、称取处方量的石斛、黄精和金银花,粉碎,过400目筛,得超微粉末,采用40%乙醇水溶液提取,提取液减压蒸去乙醇,得提取液和提取后的药渣;b、将a步骤的提取液上大孔树脂柱,依次用蒸馏水、碱液洗脱;其中,蒸馏水洗脱液为流出液A;碱液洗脱得流出液B;流出液B用酸中和至中性,用40%乙醇水溶液浸提3h,减压蒸干得粉末①;按质量比1:5将a步骤所述的药渣与水混合,保持60℃水浴6h,冷却后与b步骤所述的流出液A合并,浓缩,加入无水乙醇产生沉淀,过滤,干燥,得粉末②;将粉末①与粉末②混合均匀,得中药混合物,备用;(1) a, take by weighing the dendrobium, Rhizoma Polygonatidis and honeysuckle of recipe quantity, pulverize, cross 400 mesh sieves, obtain ultrafine powder, adopt 40% ethanol aqueous solution extraction, extracting solution is decompressed and evaporate ethanol, obtain extracting solution and after extraction dregs; b. the extract of step a is placed on a macroporous resin column, and eluted with distilled water and alkali solution successively; wherein, the distilled water eluent is effluent A; the alkali solution is eluted to obtain effluent B; The acid was neutralized to neutral, leached with 40% ethanol aqueous solution for 3 hours, and evaporated to dryness under reduced pressure to obtain powder ①; the medicinal residues described in step a were mixed with water at a mass ratio of 1:5, kept in a 60°C water bath for 6 hours, and after cooling Combine with the effluent A described in step b, concentrate, add absolute ethanol to produce precipitation, filter, and dry to obtain powder 2; Mix powder 1 and powder 2 to obtain a Chinese medicine mixture, for subsequent use;

(2)将步骤(1)的中药混合物与处方量的薄荷脑、山梨醇、壳聚糖、甘油混合均匀,备用;(2) the traditional Chinese medicine mixture of step (1) and the menthol, sorbitol, chitosan, glycerol of recipe quantity are mixed, for subsequent use;

(3)在步骤(2)的混合料中添加处方量的硬脂酸镁、麦芽糊精,混合均匀、干燥、过筛,得到组合物,压片,得石斛含片。(3) adding the magnesium stearate and maltodextrin of the recipe quantity to the mixture in step (2), mixing uniformly, drying, and sieving to obtain the composition, and tableting to obtain dendrobium buccal tablets.

实施例2:Example 2:

一种石斛含片,由以下组份组成(重量份):金钗石斛180份、薄荷脑12份、黄精18份、金银花17份、山梨醇5份、壳聚糖12份、甘油2份、麦芽糊精8份、硬脂酸镁23份。A dendrobium buccal tablet is composed of the following components (in parts by weight): 180 parts of Dendrobium officinale, 12 parts of menthol, 18 parts of Polygonatum chinensis, 17 parts of honeysuckle, 5 parts of sorbitol, 12 parts of chitosan, 2 parts of glycerin, 8 parts of maltodextrin, 23 parts of magnesium stearate.

制备方法如下:The preparation method is as follows:

(1)a、称取处方量的石斛、黄精和金银花,粉碎,过500目筛,得超微粉末,采用45%乙醇水溶液提取,提取液减压蒸去乙醇,得提取液和提取后的药渣;b、将a步骤的提取液上大孔树脂柱,依次用蒸馏水、碱液洗脱;其中,蒸馏水洗脱液为流出液A;碱液洗脱得流出液B;流出液B用酸中和至中性,用50%乙醇水溶液浸提1.5h,减压蒸干得粉末①;按质量比1:5将a步骤所述的药渣与水混合,保持50℃水浴4h,冷却后与b步骤所述的流出液A合并,浓缩,加入无水乙醇产生沉淀,过滤,干燥,得粉末②;将粉末①与粉末②混合均匀,得中药混合物,备用;(1) a, take by weighing the dendrobium, Rhizoma Polygonatidis and honeysuckle of recipe quantity, pulverize, cross 500 mesh sieves, obtain ultrafine powder, adopt 45% ethanol aqueous solution extraction, extracting solution decompression steams ethanol, obtains extracting solution and after extraction dregs; b. the extract of step a is placed on a macroporous resin column, and eluted with distilled water and alkali solution successively; wherein, the distilled water eluent is effluent A; the alkali solution is eluted to obtain effluent B; The acid was neutralized to neutrality, extracted with 50% ethanol aqueous solution for 1.5 hours, and evaporated to dryness under reduced pressure to obtain powder ①; the medicinal residues described in step a were mixed with water at a mass ratio of 1:5, kept in a 50°C water bath for 4 hours, and cooled. Then combine with the effluent A described in step b, concentrate, add absolute ethanol to produce precipitation, filter, and dry to obtain powder ②; Mix powder ① and powder ② uniformly to obtain a traditional Chinese medicine mixture for subsequent use;

(2)将步骤(1)的中药混合物与处方量的薄荷脑、山梨醇、壳聚糖、甘油混合均匀,备用;(2) the traditional Chinese medicine mixture of step (1) and the menthol, sorbitol, chitosan, glycerol of recipe quantity are mixed, for subsequent use;

(3)在步骤(2)的混合料中添加处方量的硬脂酸镁、麦芽糊精,混合均匀、干燥、过筛,得到组合物,压片,得石斛含片。(3) adding the magnesium stearate and maltodextrin of the recipe quantity to the mixture in step (2), mixing uniformly, drying, and sieving to obtain the composition, and tableting to obtain dendrobium buccal tablets.

实施例3:Example 3:

一种石斛含片,由以下组份组成(重量份):霍山石斛235份、薄荷脑26份、黄精28份、金银花22份、山梨醇7份、壳聚糖15份、甘油6份、麦芽糊精12份、硬脂酸镁40份。A dendrobium buccal tablet, comprising the following components (parts by weight): 235 parts of Dendrobium Huoshan, 26 parts of menthol, 28 parts of Polygonatum chinensis, 22 parts of honeysuckle, 7 parts of sorbitol, 15 parts of chitosan, 6 parts of glycerin, and malt 12 parts of dextrin, 40 parts of magnesium stearate.

制备方法如下:The preparation method is as follows:

(1)a、称取处方量的石斛、黄精和金银花,粉碎,过450目筛,得超微粉末,采用45%乙醇水溶液提取,提取液减压蒸去乙醇,得提取液和提取后的药渣;b、将a步骤的提取液上大孔树脂柱,依次用蒸馏水、碱液洗脱;其中,蒸馏水洗脱液为流出液A;碱液洗脱得流出液B;流出液B用酸中和至中性,用45%乙醇水溶液浸提2h,减压蒸干得粉末①;c、按质量比1:5将a步骤所述的药渣与水混合,保持40℃℃水浴5h,冷却后与b步骤所述的流出液A合并,浓缩,加入无水乙醇产生沉淀,过滤,干燥,得粉末②;将粉末①与粉末②混合均匀,得中药混合物,备用;(1) a, take by weighing the dendrobium, Rhizoma Polygonatidis and honeysuckle of the recipe quantity, pulverize, cross 450 mesh sieves, obtain ultrafine powder, adopt 45% ethanol aqueous solution extraction, the extracting solution is decompressed and evaporated ethanol, obtains extracting solution and after the extraction dregs; b. the extract of step a is placed on a macroporous resin column, and eluted with distilled water and alkali solution successively; wherein, the distilled water eluent is effluent A; the alkali solution is eluted to obtain effluent B; The acid was neutralized to neutral, leached with 45% ethanol aqueous solution for 2 hours, and evaporated to dryness under reduced pressure to obtain powder①; c. Mix the medicinal residues described in step a with water in a mass ratio of 1:5, and keep in a water bath at 40°C for 5 hours , after cooling, merge with the effluent A described in step b, concentrate, add absolute ethanol to produce precipitation, filter, and dry to obtain powder 2; Mix powder 1 and powder 2 homogeneously to obtain a traditional Chinese medicine mixture, for subsequent use;

(2)将步骤(1)的中药混合物与处方量的薄荷脑、山梨醇、壳聚糖、甘油混合均匀,备用;(2) the traditional Chinese medicine mixture of step (1) and the menthol, sorbitol, chitosan, glycerol of recipe quantity are mixed, for subsequent use;

(3)在步骤(2)的混合料中添加处方量的硬脂酸镁、麦芽糊精,混合均匀、干燥、过筛,得到组合物,压片,得石斛含片。(3) adding the magnesium stearate and maltodextrin of the recipe quantity to the mixture in step (2), mixing uniformly, drying, and sieving to obtain the composition, and tableting to obtain dendrobium buccal tablets.

实施例4:Example 4:

一种石斛含片,由以下组份组成(重量份):霍山石斛200份、薄荷脑20份、黄精20份、金银花20份、山梨醇5份、壳聚糖12份、甘油6份、麦芽糊精10份、硬脂酸镁30份。A dendrobium lozenge, comprising the following components (in parts by weight): 200 parts of Dendrobium Huoshan, 20 parts of menthol, 20 parts of Polygonatum chinensis, 20 parts of honeysuckle, 5 parts of sorbitol, 12 parts of chitosan, 6 parts of glycerin, and malt 10 parts of dextrin and 30 parts of magnesium stearate.

制备方法:Preparation:

(1)a、称取处方量的石斛、黄精和金银花,粉碎,过500目筛,得超微粉末,采用40%乙醇水溶液提取,提取液减压蒸去乙醇,得提取液和提取后的药渣;b、将a步骤的提取液上大孔树脂柱,依次用蒸馏水、碱液洗脱;其中,蒸馏水洗脱液为流出液A;碱液洗脱得流出液B;流出液B用酸中和至中性,用45%乙醇水溶液浸提2h,减压蒸干得粉末①;c、按质量比1:5将a步骤所述的药渣与水混合,保持40℃水浴6h,冷却后与b步骤所述的流出液A合并,浓缩,加入无水乙醇产生沉淀,过滤,干燥,得粉末②;将粉末①与粉末②混合均匀,得中药混合物,备用;(1) a, take by weighing the dendrobium, Rhizoma Polygonatidis and honeysuckle flower of recipe quantity, pulverize, cross 500 mesh sieves, obtain ultrafine powder, adopt 40% ethanol aqueous solution extraction, extracting solution is decompressed and evaporate ethanol, obtain extracting solution and after extraction dregs; b. the extract of step a is placed on a macroporous resin column, and eluted with distilled water and alkali solution successively; wherein, the distilled water eluent is effluent A; the alkali solution is eluted to obtain effluent B; The acid is neutralized to neutrality, extracted with 45% ethanol aqueous solution for 2 hours, and evaporated to dryness under reduced pressure to obtain powder ①; c. Mix the medicinal residues described in step a with water at a mass ratio of 1:5, and keep in a 40°C water bath for 6 hours, After cooling, it is combined with the effluent A described in step b, concentrated, added with absolute ethanol to produce precipitation, filtered, and dried to obtain powder ②; powder ① and powder ② are mixed uniformly to obtain a traditional Chinese medicine mixture, which is for subsequent use;

(2)将步骤(1)的中药混合物与处方量的薄荷脑、山梨醇、壳聚糖、甘油混合均匀,备用;(2) the traditional Chinese medicine mixture of step (1) and the menthol, sorbitol, chitosan, glycerol of recipe quantity are mixed, for subsequent use;

(3)在步骤(2)的混合料中添加处方量的硬脂酸镁、麦芽糊精,混合均匀、干燥、过筛,得到组合物,压片,得石斛含片。(3) adding the magnesium stearate and maltodextrin of the recipe quantity to the mixture in step (2), mixing uniformly, drying, and sieving to obtain the composition, and tableting to obtain dendrobium buccal tablets.

对比例1:Comparative Example 1:

一种石斛含片,由以下组份组成(重量份):铁皮石斛100份、薄荷脑5份、黄精7份、金银花10份、山梨醇1份、壳聚糖4份、甘油1份、麦芽糊精3份、硬脂酸镁10份。A dendrobium buccal tablet, comprising the following components (parts by weight): 100 parts of Dendrobium officinale, 5 parts of menthol, 7 parts of Polygoni Radix, 10 parts of honeysuckle, 1 part of sorbitol, 4 parts of chitosan, 1 part of glycerin, and malt 3 parts of dextrin, 10 parts of magnesium stearate.

制备方法:与实施例1相同。Preparation method: same as Example 1.

对比例2:Comparative Example 2:

一种石斛含片,由以下组份组成(重量份):铁皮石斛400份、薄荷脑30份、黄精35份、金银花40份、山梨醇20份、壳聚糖20份、甘油15份、麦芽糊精40份、硬脂酸镁70份。A dendrobium buccal tablet, comprising the following components (in parts by weight): 400 parts of Dendrobium officinale, 30 parts of menthol, 35 parts of Polygonatum chinensis, 40 parts of honeysuckle, 20 parts of sorbitol, 20 parts of chitosan, 15 parts of glycerin, and malt 40 parts of dextrin, 70 parts of magnesium stearate.

制备方法:与实施例1相同。Preparation method: same as Example 1.

对比例3:Comparative Example 3:

一种石斛含片,由以下组份组成(重量份):与实施例1相同。A dendrobium buccal tablet is composed of the following components (parts by weight): the same as in Example 1.

制备方法:Preparation:

(1)取处方量的铁皮石斛、黄精、金银花充分干燥后粉粹,过75目筛备用;(1) get the Dendrobium officinale, Polygonatum chinensis, Honeysuckle flower of the recipe quantity after fully drying and pulverize, cross 75 mesh sieves for subsequent use;

(2)将步骤(1)所得粉粹的粉末充分搅拌混合,得混合料备用;(2) the powder of step (1) gained pulverization is fully stirred and mixed to obtain mixture for subsequent use;

(3)在步骤(2)所得混合料中添加处方量的薄荷脑、山梨醇、壳聚糖、甘油、麦芽糊精、硬脂酸镁,混合,过筛得到组合物,在压片机上加工成石斛含片。(3) add the menthol, sorbitol, chitosan, glycerol, maltodextrin, magnesium stearate of recipe quantity in the compound obtained in step (2), mix, sieve to obtain the composition, and process on the tablet machine Into dendrobium lozenges.

对比例4:Comparative Example 4:

一种石斛含片,由以下组份组成(重量份):A dendrobium lozenge, consisting of the following components (parts by weight):

(鱼腥草替换黄精、蔗糖替换壳聚糖和山梨醇、)金钗石斛200份、薄荷脑26份、鱼腥草20份、金银花22份、蔗糖15份、甘油6份、麦芽糊精8份、硬脂酸镁30份(Houttuynia cordata replaces Polygonatum, sucrose replaces chitosan and sorbitol,) 200 parts of Dendrobium officinale, 26 parts of menthol, 20 parts of Houttuynia cordata, 22 parts of honeysuckle, 15 parts of sucrose, 6 parts of glycerin, 8 parts of maltodextrin 30 parts magnesium stearate

制备方法:与实施例1相同。Preparation method: same as Example 1.

实验例1:感官指标测定Experimental Example 1: Measurement of Sensory Indexes

实验方法:取上述实施例1至实施例4、对比例1至对比例4的样品,分别考察其外观、口感、崩解度。实验结果见表1:Experimental method: Take the samples from the above-mentioned Examples 1 to 4 and Comparative Examples 1 to 4, and investigate their appearance, taste and disintegration degree respectively. The experimental results are shown in Table 1:

表1:感官指标测定结果Table 1: Measurement results of sensory indicators

Figure BDA0001320352070000071
Figure BDA0001320352070000071

实验结果表明:实施例1至实施例4样品均表现出优良的感官指标;对比例1的样品在口感上不清爽且略有苦味,对比例2的样品在口感上略清爽且略甜,可能是因为二者的处方用量配比不合理所致;对比例3的样品表面略粗糙,这是由于其加工工艺较为简单,组份加工过程不够精制;对比例4的样品中添加了大量的甜味剂,导致甜味重。The experimental results show that: the samples from Example 1 to Example 4 all show excellent sensory indicators; the sample of Comparative Example 1 is not refreshing and slightly bitter in taste, and the sample of Comparative Example 2 is slightly refreshing and slightly sweet in taste, which may be It is due to the unreasonable ratio of the prescription and dosage of the two; the surface of the sample of Comparative Example 3 is slightly rough, because its processing technology is relatively simple, and the component processing process is not refined enough; the sample of Comparative Example 4 is added with a large amount of sweetener. Flavoring agent, resulting in heavy sweetness.

实验例2:体外抑菌实验Experimental example 2: In vitro antibacterial experiment

MIC测定:分别取实施例1至实施例4、对比例1至对比例4的样品以营养肉汤稀释(二倍稀释法)配置成各浓度的实验液,分别置于试管中(1.0ml/管),每管加入1.0ml的菌液(1.5×106CFU/ml),混匀,同时设计空白对照(只含肉汤)、阳性对照(不加实验液)、阴性对照(不加菌液),置于35±1℃的生化培养箱中培养24h,肉眼观察细菌生长情况。上层液澄清为无菌生长,上层液浑浊为有菌生长,以试管中无细菌生长的最小药物浓度为MIC。实验结果见表2。MIC determination: respectively take the samples from Example 1 to Example 4 and Comparative Example 1 to Comparative Example 4 and dilute them with nutrient broth (double dilution method) to configure the experimental solution of each concentration, and place them in test tubes (1.0ml/ tube), add 1.0ml of bacterial solution (1.5×10 6 CFU/ml) to each tube, mix well, and design blank control (only broth), positive control (without adding experimental solution), negative control (without adding bacteria) solution), placed in a biochemical incubator at 35 ± 1 °C for 24 h, and observed the growth of bacteria with the naked eye. The clear upper liquid is aseptic growth, the turbid upper liquid is bacterial growth, and the minimum drug concentration without bacterial growth in the test tube is the MIC. The experimental results are shown in Table 2.

MBC测定:在测定的MIC的基础上,将各管内容物用0.01ml的接种环接种于培养皿中,置于35±1℃的生化培养箱中培养24h,观察细菌生长情况,能将99.9%加入原始的细菌杀死的最低药物浓度为MBC。实验结果见表3。MBC determination: On the basis of the measured MIC, inoculate the contents of each tube into a petri dish with a 0.01ml inoculation loop, and place it in a biochemical incubator at 35±1°C for 24h to observe the growth of bacteria. % The lowest drug concentration at which the original bacteria were added was MBC. The experimental results are shown in Table 3.

表2:体外抑菌实验结果(MIC) 单位mg/mlTable 2: In vitro bacteriostatic test results (MIC) unit mg/ml

Figure BDA0001320352070000081
Figure BDA0001320352070000081

表2:体外抑菌实验结果(MBC) 单位mg/mlTable 2: In vitro bacteriostatic test results (MBC) unit mg/ml

Figure BDA0001320352070000082
Figure BDA0001320352070000082

Figure BDA0001320352070000091
Figure BDA0001320352070000091

实验结果表明:对比例1~4的实验结果与实施例1~4相比均较差。实施例1至实施例4样品对金黄色葡萄球菌、肺炎链球菌、绿脓杆菌和大肠杆菌菌具有很好的抑菌和杀菌效果,最低抑菌浓度(MIC)在0.0625-0.125mg/ml之间,最低杀菌浓度(MBC)在0.125-0.25mg/ml之间,说明本发明产品具有很好的抑菌效果。The experimental results show that the experimental results of Comparative Examples 1 to 4 are inferior to those of Examples 1 to 4. The samples from Example 1 to Example 4 have good bacteriostatic and bactericidal effects on Staphylococcus aureus, Streptococcus pneumoniae, Pseudomonas aeruginosa and Escherichia coli, and the minimum inhibitory concentration (MIC) is between 0.0625-0.125mg/ml The minimum bactericidal concentration (MBC) is between 0.125-0.25 mg/ml, indicating that the product of the present invention has a good bacteriostatic effect.

通过本发明的处方配伍及制备工艺获得一种石斛含片,该含片为圆形片状、表面光洁、紧实,口感清爽不甜腻,保持药物适当的甜味、色泽、气味,具有清热解毒、抗菌消炎、生津润喉等作用,针对金黄色葡萄球菌、肺炎链球菌、绿脓杆菌、α-溶血性链球菌、β-溶血性链球菌、流感嗜血杆菌、大肠杆菌等具有很好的抑制和杀灭作用,在治疗咽喉炎和口腔溃疡等方面具有显著的效果。本发明石斛含片采用精制的制备工艺,能够充分提取中药组份的有效成分,各组份有效成分形成协同增效的作用,发挥药物最大的治疗功效,生产工艺合理,适合工业化生产。A kind of dendrobium buccal tablet is obtained through the prescription compatibility and preparation process of the present invention. The buccal tablet is in the shape of a round sheet, has a smooth and firm surface, has a refreshing taste and is not sweet and greasy, maintains the appropriate sweetness, color and smell of the medicine, and has the properties of clearing heat. It has the functions of detoxification, antibacterial and anti-inflammatory, invigorating body fluid and moisturizing throat. It has a significant effect in the treatment of pharyngitis and oral ulcers. The dendrobium buccal tablet of the invention adopts a refined preparation process, can fully extract the effective components of the traditional Chinese medicine components, the effective components of each component form a synergistic effect, exert the maximum therapeutic effect of the drug, and the production process is reasonable and suitable for industrial production.

以上所述仅为本发明的较佳实施例而已,并不用以限制本发明,凡在本发明的精神和原则之内,所做的任何修改、等同替换、改进等,均应包含在本发明保护的范围之内。The above descriptions are only preferred embodiments of the present invention, and are not intended to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present invention shall be included in the present invention. within the scope of protection.

Claims (3)

1. The dendrobe buccal tablet is characterized by being prepared from the following components in parts by weight: 180-235 parts of dendrobium, 12-26 parts of menthol, 18-28 parts of rhizoma polygonati, 17-22 parts of honeysuckle, 5-7 parts of sorbitol, 12-15 parts of chitosan, 2-6 parts of glycerol, 8-12 parts of maltodextrin and 23-40 parts of magnesium stearate;
the preparation method of the dendrobium nobile buccal tablet comprises the following steps:
(1) weighing dendrobium, polygonatum and honeysuckle according to the prescription amount, crushing, sieving with a 400-mesh sieve and a 500-mesh sieve to obtain superfine powder, extracting by adopting 40-45% ethanol water solution, and distilling the extracting solution under reduced pressure to remove ethanol to obtain extracting solution and extracted dregs; b. b, putting the extracting solution obtained in the step a on a macroporous resin column, and sequentially eluting with distilled water and alkali liquor; wherein the distilled water eluent is an effluent A; eluting with alkali solution to obtain effluent B; neutralizing the effluent B with acid to neutrality, leaching with 40-50% ethanol water solution for 1.5-3 hr, and vacuum evaporating to obtain powder I; c. mixing the medicine residues obtained in the step a with water according to the mass ratio of 1:5, keeping the mixture in a water bath at the temperature of 40-60 ℃ for 4-6h, cooling the mixture, combining the cooled mixture with the effluent liquid A obtained in the step b, concentrating the mixture, adding absolute ethyl alcohol to generate a precipitate, filtering the precipitate, and drying the precipitate to obtain powder II; uniformly mixing the powder I and the powder II to obtain a traditional Chinese medicine mixture for later use;
(2) uniformly mixing the traditional Chinese medicine mixture obtained in the step (1) with the menthol, sorbitol, chitosan and glycerol according to the prescription amount for later use;
(3) adding magnesium stearate and maltodextrin in the formula amount into the mixture obtained in the step (2), uniformly mixing, drying, sieving to obtain a composition, and tabletting to obtain the dendrobium buccal tablet.
2. The dendrobe buccal tablet according to claim 1, which is prepared from the following components in parts by weight: 200 parts of dendrobium, 26 parts of menthol, 20 parts of rhizoma polygonati, 22 parts of honeysuckle, 5 parts of sorbitol, 15 parts of chitosan, 6 parts of glycerol, 8 parts of maltodextrin and 30 parts of magnesium stearate.
3. The dendrobium nobile buccal tablet according to any one of claims 1 to 2, wherein the dendrobium nobile is one or more of dendrobium nobile, dendrobium officinale, dendrobium huoshanense and dendrobium verbena.
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