CN110123907A - A kind of formula granule of fresh Houttuynia cordata and preparation method thereof - Google Patents
A kind of formula granule of fresh Houttuynia cordata and preparation method thereof Download PDFInfo
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- 238000002360 preparation method Methods 0.000 title claims abstract description 23
- 240000000691 Houttuynia cordata Species 0.000 title abstract description 63
- 235000013719 Houttuynia cordata Nutrition 0.000 title abstract description 63
- 239000003814 drug Substances 0.000 claims abstract description 50
- 238000000605 extraction Methods 0.000 claims abstract description 37
- 239000000284 extract Substances 0.000 claims abstract description 34
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- 238000001914 filtration Methods 0.000 claims abstract 2
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- 229920000858 Cyclodextrin Polymers 0.000 claims description 8
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- 239000004375 Dextrin Substances 0.000 claims description 8
- 239000001116 FEMA 4028 Substances 0.000 claims description 8
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 8
- 229920002472 Starch Polymers 0.000 claims description 8
- WHGYBXFWUBPSRW-FOUAGVGXSA-N beta-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO WHGYBXFWUBPSRW-FOUAGVGXSA-N 0.000 claims description 8
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- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 8
- 239000000377 silicon dioxide Substances 0.000 claims description 8
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- 150000001413 amino acids Chemical class 0.000 claims 15
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- 239000004480 active ingredient Substances 0.000 abstract description 12
- REFJWTPEDVJJIY-UHFFFAOYSA-N Quercetin Chemical compound C=1C(O)=CC(O)=C(C(C=2O)=O)C=1OC=2C1=CC=C(O)C(O)=C1 REFJWTPEDVJJIY-UHFFFAOYSA-N 0.000 abstract description 9
- ZVOLCUVKHLEPEV-UHFFFAOYSA-N Quercetagetin Natural products C1=C(O)C(O)=CC=C1C1=C(O)C(=O)C2=C(O)C(O)=C(O)C=C2O1 ZVOLCUVKHLEPEV-UHFFFAOYSA-N 0.000 abstract description 4
- HWTZYBCRDDUBJY-UHFFFAOYSA-N Rhynchosin Natural products C1=C(O)C(O)=CC=C1C1=C(O)C(=O)C2=CC(O)=C(O)C=C2O1 HWTZYBCRDDUBJY-UHFFFAOYSA-N 0.000 abstract description 4
- MWDZOUNAPSSOEL-UHFFFAOYSA-N kaempferol Natural products OC1=C(C(=O)c2cc(O)cc(O)c2O1)c3ccc(O)cc3 MWDZOUNAPSSOEL-UHFFFAOYSA-N 0.000 abstract description 4
- 235000005875 quercetin Nutrition 0.000 abstract description 4
- 229960001285 quercetin Drugs 0.000 abstract description 4
- 238000005520 cutting process Methods 0.000 abstract description 2
- 238000004519 manufacturing process Methods 0.000 abstract description 2
- UAJTZZNRJCKXJN-UHFFFAOYSA-M sodium;2-dodecoxy-2-oxoethanesulfonate Chemical compound [Na+].CCCCCCCCCCCCOC(=O)CS([O-])(=O)=O UAJTZZNRJCKXJN-UHFFFAOYSA-M 0.000 abstract 6
- 239000002245 particle Substances 0.000 abstract 3
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- 239000012530 fluid Substances 0.000 abstract 1
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- 230000000052 comparative effect Effects 0.000 description 17
- 241000758769 Houttuynia Species 0.000 description 15
- 235000013717 Houttuynia Nutrition 0.000 description 15
- 238000005516 engineering process Methods 0.000 description 9
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- 239000004615 ingredient Substances 0.000 description 6
- 235000012239 silicon dioxide Nutrition 0.000 description 6
- 239000007921 spray Substances 0.000 description 6
- LUJAXSNNYBCFEE-UHFFFAOYSA-N Quercetin 3,7-dimethyl ether Natural products C=1C(OC)=CC(O)=C(C(C=2OC)=O)C=1OC=2C1=CC=C(O)C(O)=C1 LUJAXSNNYBCFEE-UHFFFAOYSA-N 0.000 description 5
- PUTDIROJWHRSJW-UHFFFAOYSA-N Quercitrin Natural products CC1OC(Oc2cc(cc(O)c2O)C3=CC(=O)c4c(O)cc(O)cc4O3)C(O)C(O)C1O PUTDIROJWHRSJW-UHFFFAOYSA-N 0.000 description 5
- OXGUCUVFOIWWQJ-XIMSSLRFSA-N acanthophorin B Natural products O[C@H]1[C@H](O)[C@H](O)[C@H](C)O[C@H]1OC1=C(C=2C=C(O)C(O)=CC=2)OC2=CC(O)=CC(O)=C2C1=O OXGUCUVFOIWWQJ-XIMSSLRFSA-N 0.000 description 5
- OEKUVLQNKPXSOY-UHFFFAOYSA-N quercetin 3-O-beta-D-glucopyranosyl(1->3)-alpha-L-rhamnopyranosyl(1->6)-beta-d-galactopyranoside Natural products OC1C(O)C(C(O)C)OC1OC1=C(C=2C=C(O)C(O)=CC=2)OC2=CC(O)=CC(O)=C2C1=O OEKUVLQNKPXSOY-UHFFFAOYSA-N 0.000 description 5
- QPHXPNUXTNHJOF-UHFFFAOYSA-N quercetin-7-O-beta-L-rhamnopyranoside Natural products OC1C(O)C(O)C(C)OC1OC1=CC(O)=C2C(=O)C(O)=C(C=3C=C(O)C(O)=CC=3)OC2=C1 QPHXPNUXTNHJOF-UHFFFAOYSA-N 0.000 description 5
- OXGUCUVFOIWWQJ-HQBVPOQASA-N quercitrin Chemical compound O[C@@H]1[C@H](O)[C@@H](O)[C@H](C)O[C@H]1OC1=C(C=2C=C(O)C(O)=CC=2)OC2=CC(O)=CC(O)=C2C1=O OXGUCUVFOIWWQJ-HQBVPOQASA-N 0.000 description 5
- 230000006837 decompression Effects 0.000 description 4
- 238000009835 boiling Methods 0.000 description 3
- 238000001035 drying Methods 0.000 description 3
- 239000000919 ceramic Substances 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 238000005469 granulation Methods 0.000 description 2
- 230000003179 granulation Effects 0.000 description 2
- 238000003860 storage Methods 0.000 description 2
- 238000003809 water extraction Methods 0.000 description 2
- 238000005550 wet granulation Methods 0.000 description 2
- 206010007247 Carbuncle Diseases 0.000 description 1
- 239000013543 active substance Substances 0.000 description 1
- 230000003110 anti-inflammatory effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 229940126678 chinese medicines Drugs 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 208000001848 dysentery Diseases 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 235000011389 fruit/vegetable juice Nutrition 0.000 description 1
- 239000002674 ointment Substances 0.000 description 1
- 230000001047 pyretic effect Effects 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 229940126680 traditional chinese medicines Drugs 0.000 description 1
- 239000000341 volatile oil Substances 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/78—Saururaceae (Lizard's-tail family)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1611—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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- A61K2236/00—Isolation 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
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation 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
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation 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
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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Abstract
Description
技术领域technical field
本发明涉及中成药生产领域，具体涉及一种鲜鱼腥草配方颗粒及其制备方法。The invention relates to the field of Chinese patent medicine production, in particular to a formula granule of fresh Houttuynia cordata and a preparation method thereof.
背景技术Background technique
鱼腥草为三白草科植物蕺菜Houttuynia cordata Thunb.的新鲜全草或干燥地上部分。鲜品全年均可采割，干品夏季茎叶茂盛花穗多时采割，除去杂质，晒干。本品鲜品和干品均可入药，鲜品用量加倍，水煎或捣汁服，具有清热解毒，消痈排脓，利尿通淋的功效，用于肺痈吐脓，痰热喘咳，热痢，热淋，痈肿疮毒。 Houttuynia cordata Thunb. is the fresh whole herb or dry aerial part of Houttuynia cordata Thunb. The fresh products can be harvested throughout the year, and the dried products can be harvested when the stems and leaves are lush in summer, and the flowers and spikes are long, and the impurities are removed and dried in the sun. Both the fresh and dry products of this product can be used as medicine. The dosage of the fresh product is doubled, and it is decocted or pounded into juice. Dysentery, pyretic stranguria, carbuncle sore.
据相关研究报道，鱼腥草鲜品与干品在成分方面，与相当量鲜品比较，鲜品中挥发油含量、槲皮苷含量均高于干品；在药效学方面，鲜品比干品抗炎作用更强，临床疗效更显著，更具有临床应用价值，但鲜品存在原料采购难、用量大、不易贮藏和保鲜技术难等问题，限制了其在临床上大面积推广应用。因此，亟需加强鲜药制剂技术的开发，以生产质优效显的中药鲜药制剂，保持中药鲜用的特色中医药产业。According to relevant research reports, in terms of composition, the fresh and dry products of Houttuynia cordata have higher volatile oil content and quercetin content than the dry products compared with the equivalent fresh products; Fresh products have stronger anti-inflammatory effect, more significant clinical curative effect, and more clinical application value. However, fresh products have problems such as difficult procurement of raw materials, large dosage, difficult storage and difficult fresh-keeping techniques, which limit their large-scale clinical application. Therefore, it is urgent to strengthen the development of fresh medicine preparation technology to produce high-quality and effective fresh medicine preparations of traditional Chinese medicines and maintain the characteristic Chinese medicine industry of fresh Chinese medicines.
中药配方颗粒是由单味中药饮片经水提、浓缩、干燥、制粒而成，在中医临床配方后，供患者冲服使用。中药配方颗粒的质量水平是以出膏率、指纹图谱或特征图谱、主要活性成分转移率(或含量)三大指标与标准汤剂（以传统中药汤剂的制备方法制备）的一致性进行评价的。Traditional Chinese medicine formula granules are made by extracting, concentrating, drying, and granulating single-flavored Chinese medicine decoction pieces. The quality level of traditional Chinese medicine formula granules is evaluated based on the consistency of the three major indicators of paste yield, fingerprint or characteristic map, and transfer rate (or content) of main active ingredients with standard decoctions (prepared by traditional Chinese medicine decoctions) of.
综上所述，利用现代工业化设备及技术，将鲜药开发成中药配方颗粒，供临床医师开方应用，解决鲜药采购难、用量大、不易贮藏和保鲜技术难等问题。目前，尚未见采用中药多功能提取罐技术制备鲜鱼腥草配方颗粒的报道。To sum up, modern industrial equipment and technology are used to develop fresh medicine into traditional Chinese medicine formula granules for clinicians to prescribe and use, so as to solve the problems of fresh medicine procurement, large dosage, difficult storage and fresh-keeping technology. At present, there is no report on the preparation of fresh Houttuynia formula granules by using the technology of multifunctional extracting tank of traditional Chinese medicine.
发明内容Contents of the invention
本发明解决的技术问题为提供一种便于冲泡的中药颗粒，提供一种鲜鱼腥草配方颗粒。The technical problem to be solved by the invention is to provide a kind of traditional Chinese medicine granule which is convenient for brewing, and provide a kind of formula granule of fresh Houttuynia cordata.
为了解决上述技术问题，本发明提供的技术方案为：In order to solve the problems of the technologies described above, the technical solution provided by the invention is:
一种鲜鱼腥草配方颗粒，包括：A formula granule of fresh Houttuynia cordata, comprising:
将鲜鱼腥草除去杂质，洗净，切段，得鲜鱼腥草饮片；Remove impurities from fresh Houttuynia cordata, wash and cut into sections to obtain fresh Houttuynia cordata decoction pieces;
将鲜鱼腥草饮片投入中药多功能提取罐中，加水煎煮1~3次，每次加水5~20倍量水，加热煎煮0.25~2h，合并提取液；Put the fresh Houttuynia cordata decoction pieces into the Chinese medicine multi-functional extraction tank, add water to decoct 1 to 3 times, add 5 to 20 times the amount of water each time, heat and decoct for 0.25 to 2 hours, and combine the extracts;
提取液过滤，滤液在30~85℃条件下减压浓缩成相对密度为1.01～1.20的清膏；The extract is filtered, and the filtrate is concentrated under reduced pressure at 30-85°C to form a clear paste with a relative density of 1.01-1.20;
取清膏加入第一辅料溶解，喷雾干燥得干浸膏粉；Take the clear paste, add the first auxiliary material to dissolve, and spray dry to obtain dry extract powder;
将干浸膏粉加入第二辅料，干法制粒得鲜鱼腥草配方颗粒。The dry extract powder is added into the second auxiliary material, and dry granulated to obtain formula granules of fresh Houttuynia cordata.
鱼腥草中有效成分之一槲皮苷为热敏性成分，物料湿法制粒烘干过程中成分发生降解，宜适用于干法制粒，为改善物料粘性、流动性以适应干法制粒，同时满足颗粒剂溶化性要求，在清膏配料时即加入相关辅料，并在干法制粒前进一步加入适宜辅料调整其流动性、可压性。Quercitrin, one of the active ingredients in Houttuynia cordata, is a heat-sensitive ingredient. The ingredients degrade during the wet granulation and drying process of the material, so it is suitable for dry granulation. In order to improve the viscosity and fluidity of the material, it can be adapted to dry granulation and meet the granulation requirements. According to the solubility requirements of the agent, the relevant auxiliary materials are added when the clear paste is prepared, and the appropriate auxiliary materials are further added before the dry granulation to adjust its fluidity and compressibility.
采用中药多功能提取罐提取、减压浓缩、瞬时喷雾干燥和干法制粒现代工业化设备及技术，并对各项工艺参数进行研究，从而使鲜鱼腥草配方颗粒槲皮苷含量能持续稳定地达到较高水平，确保了鲜鱼腥草配方颗粒中活性成分转移率与鲜鱼腥草标准汤剂达到一致，提高了鲜鱼腥草配方颗粒的产品质量。同时，将鲜药制成配方颗粒，为临床处方调配新增加鲜鱼腥草配方颗粒品种，生产质优效显的中药鲜药制剂，保持中药鲜用的特色中医药产业，具有重大的临床应用价值及社会效益。The modern industrialized equipment and technology of traditional Chinese medicine multifunctional extraction tank extraction, decompression concentration, instant spray drying and dry granulation are used, and various process parameters are studied, so that the content of quercetin in fresh Houttuynia formula granules can be continuously and stably maintained. Reaching a higher level ensures that the transfer rate of active ingredients in the fresh Houttuynia formula granules is consistent with that of the fresh Houttuynia standard decoction, and improves the product quality of the fresh Houttuynia formula granules. At the same time, the fresh medicine is made into formula granules, and fresh Houttuynia cordata formula granules are newly added for clinical prescriptions, so as to produce high-quality and effective traditional Chinese medicine fresh medicine preparations, and maintain the characteristic Chinese medicine industry of fresh Chinese medicine, which has great clinical application value and social benefits.
优选地，所述煎煮为静态提取。Preferably, the decocting is static extraction.
优选地，所述煎煮为动态提取，所述动态提取为在煎煮过程中进行搅拌。动态提取可以使煎煮过程更加充分，更有利于成分的溶出。Preferably, the decocting is dynamic extraction, and the dynamic extraction is stirring during the decoction. Dynamic extraction can make the decoction process more complete and more conducive to the dissolution of ingredients.
优选地，所述第一辅料为麦芽糊精、糊精、淀粉、乳糖或β-环糊精中的一种或几种。第一辅料可以调整清膏的流动性、可压性。Preferably, the first auxiliary material is one or more of maltodextrin, dextrin, starch, lactose or β-cyclodextrin. The first auxiliary material can adjust the fluidity and compressibility of the clear paste.
优选地，所述第一辅料为麦芽糊精。Preferably, the first auxiliary material is maltodextrin.
优选地，所述喷雾干燥的工艺参数为：控制进风温度160℃～195℃，出风温度80℃～95℃。Preferably, the process parameters of the spray drying are: controlling the inlet air temperature at 160°C-195°C, and the outlet air temperature at 80°C-95°C.
优选地，所述第二辅料为麦芽糊精、糊精、淀粉、乳糖、β-环糊精、二氧化硅或硬脂酸镁中的一种或几种。Preferably, the second auxiliary material is one or more of maltodextrin, dextrin, starch, lactose, β-cyclodextrin, silicon dioxide or magnesium stearate.
优选地，所述第二辅料为麦芽糊精。Preferably, the second auxiliary material is maltodextrin.
优选地，所述第二辅料为麦芽糊精和二氧化硅的混合物。Preferably, the second auxiliary material is a mixture of maltodextrin and silicon dioxide.
一种鲜鱼腥草配方颗粒，根据上述的制备方法制备的鲜鱼腥草配方颗粒。A formula granule of fresh Houttuynia cordata, the formula granule of fresh Houttuynia cordata prepared according to the above-mentioned preparation method.
与现有技术相比，本发明具有的有益效果为：采用中药多功能提取罐提取、减压浓缩、瞬时喷雾干燥和干法制粒现代工业化设备及技术，并对各项工艺参数进行研究，从而使鲜鱼腥草配方颗粒槲皮苷含量能持续稳定地达到较高水平，确保了鲜鱼腥草配方颗粒中活性成分转移率与鲜鱼腥草标准汤剂达到一致，提高了鲜鱼腥草配方颗粒的产品质量。Compared with the prior art, the present invention has the beneficial effects of: adopting the modern industrialized equipment and technology of Chinese medicine multifunctional extraction tank extraction, decompression concentration, instant spray drying and dry granulation, and researching various process parameters, thereby The content of quercetin in the fresh Houttuynia formula granules can reach a higher level continuously and stably, ensuring that the transfer rate of active ingredients in the fresh Houttuynia formula granules is consistent with that of the fresh Houttuynia standard decoction, and improving the fresh Houttuynia Product quality of formulated granules.
同时，将鲜药制成配方颗粒，为临床处方调配新增加鲜鱼腥草配方颗粒品种，生产质优效显的中药鲜药制剂，保持中药鲜用的特色中医药产业，具有重大的临床应用价值及社会效益。At the same time, the fresh medicine is made into formula granules, and fresh Houttuynia cordata formula granules are newly added for clinical prescriptions, so as to produce high-quality and effective traditional Chinese medicine fresh medicine preparations, and maintain the characteristic Chinese medicine industry of fresh Chinese medicine, which has great clinical application value and social benefits.
具体实施方式Detailed ways
以下结合具体实施例来进一步解释本发明，但实施例对本发明不做任何形式的限定。The present invention is further explained below in conjunction with specific examples, but the examples do not limit the present invention in any form.
实施例1Example 1
一种鲜鱼腥草配方颗粒，包括：A formula granule of fresh Houttuynia cordata, comprising:
将鲜鱼腥草除去杂质，洗净，切成0.1~3cm的段，得鲜鱼腥草饮片；Remove impurities from fresh Houttuynia cordata, wash and cut into 0.1-3cm sections to obtain fresh Houttuynia cordata decoction pieces;
将鲜鱼腥草饮片投入中药多功能提取罐中，加水煎煮1次，每次加水20倍量水，加热煎煮1h，合并提取液；Put the fresh Houttuynia cordata decoction pieces into the Chinese medicine multifunctional extraction tank, add water to decoct once, add 20 times the amount of water each time, heat and decoct for 1 hour, and combine the extracts;
提取液过滤，滤液在60℃条件下减压浓缩成相对密度为1.06的清膏；The extract is filtered, and the filtrate is concentrated under reduced pressure at 60°C to form a clear paste with a relative density of 1.06;
取清膏加入麦芽糊精溶解，喷雾干燥得干浸膏粉；Take the clear paste and add maltodextrin to dissolve it, spray dry to obtain dry extract powder;
将干浸膏粉加入麦芽糊精，干法制粒得鲜鱼腥草配方颗粒。所述煎煮为动态提取，所述动态提取为在煎煮过程中进行搅拌。所述喷雾干燥的工艺参数为：控制进风温度170℃～180℃，出风温度80℃～90℃。The dry extract powder is added with maltodextrin, and dry granulated to obtain formula granules of fresh Houttuynia cordata. The decocting is dynamic extraction, and the dynamic extraction is stirring during the decoction process. The process parameters of the spray drying are: controlling the inlet air temperature at 170°C to 180°C, and the outlet air temperature at 80°C to 90°C.
鱼腥草中有效成分之一槲皮苷为热敏性成分，物料湿法制粒烘干过程中成分发生降解，宜适用于干法制粒，为改善物料粘性、流动性以适应干法制粒，同时满足颗粒剂溶化性要求，在清膏配料时即加入相关辅料，并在干法制粒前进一步加入适宜辅料调整其流动性、可压性。Quercitrin, one of the active ingredients in Houttuynia cordata, is a heat-sensitive ingredient. The ingredients degrade during the wet granulation and drying process of the material, so it is suitable for dry granulation. In order to improve the viscosity and fluidity of the material, it can be adapted to dry granulation and meet the granulation requirements. According to the solubility requirements of the agent, the relevant auxiliary materials are added when the clear paste is prepared, and the appropriate auxiliary materials are further added before the dry granulation to adjust its fluidity and compressibility.
采用中药多功能提取罐提取、减压浓缩、瞬时喷雾干燥和干法制粒现代工业化设备及技术，并对各项工艺参数进行研究，从而使鲜鱼腥草配方颗粒槲皮苷含量能持续稳定地达到较高水平，确保了鲜鱼腥草配方颗粒中活性成分转移率与鲜鱼腥草标准汤剂达到一致，提高了鲜鱼腥草配方颗粒的产品质量。同时，将鲜药制成配方颗粒，为临床处方调配新增加鲜鱼腥草配方颗粒品种，生产质优效显的中药鲜药制剂，保持中药鲜用的特色中医药产业，具有重大的临床应用价值及社会效益。动态提取可以使煎煮过程更加充分，更有利于成分的溶出。第一辅料可以调整清膏的流动性、可压性。The modern industrialized equipment and technology of traditional Chinese medicine multifunctional extraction tank extraction, decompression concentration, instant spray drying and dry granulation are used, and various process parameters are studied, so that the content of quercetin in fresh Houttuynia formula granules can be continuously and stably maintained. Reaching a higher level ensures that the transfer rate of active ingredients in the fresh Houttuynia formula granules is consistent with that of the fresh Houttuynia standard decoction, and improves the product quality of the fresh Houttuynia formula granules. At the same time, the fresh medicine is made into formula granules, and fresh Houttuynia cordata formula granules are newly added for clinical prescriptions, so as to produce high-quality and effective traditional Chinese medicine fresh medicine preparations, and maintain the characteristic Chinese medicine industry of fresh Chinese medicine, which has great clinical application value and social benefits. Dynamic extraction can make the decoction process more complete and more conducive to the dissolution of ingredients. The first auxiliary material can adjust the fluidity and compressibility of the clear paste.
实施例2Example 2
一种鲜鱼腥草配方颗粒，包括：A formula granule of fresh Houttuynia cordata, comprising:
将鲜鱼腥草除去杂质，洗净，切成0.1~3cm的段，得鲜鱼腥草饮片；Remove impurities from fresh Houttuynia cordata, wash and cut into 0.1-3cm sections to obtain fresh Houttuynia cordata decoction pieces;
将鲜鱼腥草饮片投入中药多功能提取罐中，加水煎煮2次，每次加水12倍量水，加热煎煮0.5h，合并提取液；Put the fresh Houttuynia cordata decoction pieces into the Chinese medicine multifunctional extraction tank, add water to decoct twice, add 12 times the amount of water each time, heat and decoct for 0.5h, and combine the extracts;
提取液过滤，滤液在60℃条件下减压浓缩成相对密度为1.06的清膏；The extract is filtered, and the filtrate is concentrated under reduced pressure at 60°C to form a clear paste with a relative density of 1.06;
取清膏加入麦芽糊精溶解并搅拌均匀，喷雾干燥得干浸膏粉；Take the clear paste and add maltodextrin to dissolve it, stir evenly, and spray dry to obtain dry extract powder;
将干浸膏粉加入麦芽糊精和二氧化硅，混合均匀，干法制粒得鲜鱼腥草配方颗粒。所述煎煮为动态提取，所述动态提取为在煎煮过程中进行搅拌。所述喷雾干燥的工艺参数为：控制进风温度170℃～180℃，出风温度80℃～90℃。The dry extract powder is added with maltodextrin and silicon dioxide, mixed evenly, and dry granulated to obtain the formula granules of fresh Houttuynia cordata. The decocting is dynamic extraction, and the dynamic extraction is stirring during the decoction process. The process parameters of the spray drying are: controlling the inlet air temperature at 170°C to 180°C, and the outlet air temperature at 80°C to 90°C.
实施例3Example 3
一种鲜鱼腥草配方颗粒，包括：A formula granule of fresh Houttuynia cordata, comprising:
将鲜鱼腥草除去杂质，洗净，切成0.1~3cm的段，得鲜鱼腥草饮片；Remove impurities from fresh Houttuynia cordata, wash and cut into 0.1-3cm sections to obtain fresh Houttuynia cordata decoction pieces;
将鲜鱼腥草饮片投入中药多功能提取罐中，加水煎煮3次，每次加水5倍量水，加热煎煮0.25h，合并提取液；Put the fresh Houttuynia cordata decoction pieces into the Chinese medicine multifunctional extraction tank, add water to decoct 3 times, add 5 times the amount of water each time, heat and decoct for 0.25h, and combine the extracts;
提取液过滤，滤液在50℃条件下减压浓缩成相对密度为1.01的清膏；The extract is filtered, and the filtrate is concentrated under reduced pressure at 50°C to form a clear paste with a relative density of 1.01;
取清膏加入第一辅料溶解，喷雾干燥得干浸膏粉；Take the clear paste, add the first auxiliary material to dissolve, and spray dry to obtain dry extract powder;
将干浸膏粉加入第二辅料，干法制粒得鲜鱼腥草配方颗粒。所述煎煮为动态提取，所述动态提取为在煎煮过程中进行搅拌。所述第一辅料为麦芽糊精、糊精、淀粉、乳糖或β-环糊精中的一种或几种。所述喷雾干燥的工艺参数为：控制进风温度170℃～180℃，出风温度80℃～90℃。所述第二辅料为麦芽糊精、糊精、淀粉、乳糖、β-环糊精、二氧化硅或硬脂酸镁中的一种或几种。The dry extract powder is added into the second auxiliary material, and dry granulated to obtain formula granules of fresh Houttuynia cordata. The decocting is dynamic extraction, and the dynamic extraction is stirring during the decoction process. The first auxiliary material is one or more of maltodextrin, dextrin, starch, lactose or β-cyclodextrin. The process parameters of the spray drying are: controlling the inlet air temperature at 170°C to 180°C, and the outlet air temperature at 80°C to 90°C. The second auxiliary material is one or more of maltodextrin, dextrin, starch, lactose, β-cyclodextrin, silicon dioxide or magnesium stearate.
实施例4Example 4
一种鲜鱼腥草配方颗粒，包括：A formula granule of fresh Houttuynia cordata, comprising:
将鲜鱼腥草除去杂质，洗净，切段，得鲜鱼腥草饮片；Remove impurities from fresh Houttuynia cordata, wash and cut into sections to obtain fresh Houttuynia cordata decoction pieces;
将鲜鱼腥草饮片投入中药多功能提取罐中，加水煎煮1次，每次加水20倍量水，加热煎煮2h，合并提取液；Put the fresh Houttuynia cordata decoction pieces into the Chinese medicine multifunctional extraction tank, add water to decoct once, add 20 times the amount of water each time, heat and decoct for 2 hours, and combine the extracts;
提取液过滤，滤液在80℃条件下减压浓缩成相对密度为1.20的清膏；The extract is filtered, and the filtrate is concentrated under reduced pressure at 80°C to form a clear paste with a relative density of 1.20;
取清膏加入第一辅料溶解，喷雾干燥得干浸膏粉；Take the clear paste, add the first auxiliary material to dissolve, and spray dry to obtain dry extract powder;
将干浸膏粉加入第二辅料，干法制粒得鲜鱼腥草配方颗粒。所述煎煮为动态提取，所述动态提取为在煎煮过程中进行搅拌。所述第一辅料为麦芽糊精、糊精、淀粉、乳糖或β-环糊精中的一种或几种。所述喷雾干燥的工艺参数为：控制进风温度170℃～180℃，出风温度80℃～90℃。所述第二辅料为麦芽糊精、糊精、淀粉、乳糖、β-环糊精、二氧化硅或硬脂酸镁中的一种或几种。The dry extract powder is added into the second auxiliary material, and dry granulated to obtain formula granules of fresh Houttuynia cordata. The decocting is dynamic extraction, and the dynamic extraction is stirring during the decoction process. The first auxiliary material is one or more of maltodextrin, dextrin, starch, lactose or β-cyclodextrin. The process parameters of the spray drying are: controlling the inlet air temperature at 170°C to 180°C, and the outlet air temperature at 80°C to 90°C. The second auxiliary material is one or more of maltodextrin, dextrin, starch, lactose, β-cyclodextrin, silicon dioxide or magnesium stearate.
对比例1Comparative example 1
一种鲜鱼腥草标准汤剂的制备方法，包括如下步骤：A preparation method of fresh Houttuynia cordata standard decoction, comprising the steps of:
将鲜鱼腥草除去杂质，洗净，切段，得鲜鱼腥草饮片；Remove impurities from fresh Houttuynia cordata, wash and cut into sections to obtain fresh Houttuynia cordata decoction pieces;
将鲜鱼腥草饮片投入传统陶瓷煎药壶中，加水煎煮2次，第一次加12倍量水，武火煮沸后，改文火保持微沸煎煮20分钟，第二次加10倍量水，武火煮沸后，改文火保持微沸煎煮15分钟，合并提取液；Put the fresh Houttuynia cordata decoction pieces into a traditional ceramic decoction pot, add water to decoct twice, add 12 times the amount of water for the first time, after boiling with strong fire, change the fire to simmer and keep boiling for 20 minutes, add 10 times the amount for the second time After the water is boiled with strong fire, change the fire to simmer and keep boiling for 15 minutes, then combine the extracts;
提取液过滤，滤液在60℃下减压浓缩至投料量的2倍量的清膏；The extract is filtered, and the filtrate is concentrated under reduced pressure at 60°C to a clear paste that is 2 times the amount of feed;
取清膏进行冷冻干燥，即得鲜鱼腥草标准汤剂（冻干粉）。Take the clear paste and freeze-dry it to obtain the fresh houttuynia standard decoction (freeze-dried powder).
对比例2Comparative example 2
对比例2同实施例2不同之处在于，所述鲜鱼腥草饮片投入传统陶瓷煎药壶中进行煎煮，所述煎煮为静态提取。The difference between Comparative Example 2 and Example 2 is that the decoction pieces of fresh Houttuynia cordata are put into a traditional ceramic decoction pot for decoction, and the decoction is static extraction.
对比例3Comparative example 3
对比例3同实施例2不同之处在于，所述喷雾干燥的工艺参数为：控制进风温度195~200℃，出风温度95~100℃。The difference between Comparative Example 3 and Example 2 is that the process parameters of the spray drying are as follows: the inlet air temperature is controlled at 195-200°C, and the outlet air temperature is 95-100°C.
对比例4Comparative example 4
对比例4同实施例1不同之处在于，所述将鲜鱼腥草饮片投入中药多功能提取罐中，加水煎煮5次，每次加水4倍量水，加热煎煮3h，合并提取液。The difference between Comparative Example 4 and Example 1 is that the fresh Houttuynia cordata decoction pieces are put into the Chinese medicine multi-functional extraction tank, decocted with water 5 times, each time adding 4 times the amount of water, heated and decocted for 3 hours, and combined the extracts .
对比例5Comparative example 5
对比例5同实施例1不同之处在于，所述将鲜鱼腥草饮片投入中药多功能提取罐中，加水煎煮5次，每次加水21倍量水，加热煎煮3h，合并提取液。The difference between Comparative Example 5 and Example 1 is that the fresh Houttuynia cordata decoction pieces are put into the Chinese medicine multifunctional extraction tank, decocted with water 5 times, adding 21 times the amount of water each time, heated and decocted for 3 hours, and combined the extracts .
对比例6Comparative example 6
一种鲜鱼腥草配方颗粒，包括：A formula granule of fresh Houttuynia cordata, comprising:
将鲜鱼腥草除去杂质，洗净，得鲜鱼腥草饮片；Remove impurities from fresh Houttuynia cordata, wash it, and obtain fresh Houttuynia cordata decoction pieces;
将鲜鱼腥草饮片投入中药多功能提取罐中，加水煎煮1次，每次加水12倍量水，加热煎煮2h，合并提取液；Put the fresh Houttuynia cordata decoction pieces into the Chinese medicine multifunctional extraction tank, add water to decoct once, add 12 times the amount of water each time, heat and decoct for 2 hours, and combine the extracts;
提取液过滤，滤液在60℃条件下减压浓缩成相对密度为1.06的清膏；The extract is filtered, and the filtrate is concentrated under reduced pressure at 60°C to form a clear paste with a relative density of 1.06;
取清膏加入麦芽糊精溶解并搅拌均匀，喷雾干燥得干浸膏粉；Take the clear paste and add maltodextrin to dissolve it, stir evenly, and spray dry to obtain dry extract powder;
将干浸膏粉加入麦芽糊精和二氧化硅，混合均匀，干法制粒得鲜鱼腥草配方颗粒。所述煎煮为动态提取，所述动态提取为在煎煮过程中进行搅拌。所述喷雾干燥的工艺参数为：控制进风温度170℃～180℃，出风温度80℃～90℃。The dry extract powder is added with maltodextrin and silicon dioxide, mixed evenly, and dry granulated to obtain the formula granules of fresh Houttuynia cordata. The decocting is dynamic extraction, and the dynamic extraction is stirring during the decoction process. The process parameters of the spray drying are: controlling the inlet air temperature at 170°C to 180°C, and the outlet air temperature at 80°C to 90°C.
实验例Experimental example
将实施例和对比例制备得到的鲜鱼腥草配方颗粒，测定槲皮苷的含量，计算出膏率、转移率情况，结果见表1。The fresh Houttuynia cordata formula granules prepared in Examples and Comparative Examples were used to measure the content of quercitrin, and the ointment rate and transfer rate were calculated. The results are shown in Table 1.
表 1 中药配方颗粒性能指标Table 1 Performance indicators of traditional Chinese medicine formula granules
配方颗粒是否能够替换相应的标准汤剂制品，主要的判断依据为同质量的配方颗粒中的有效成分与标准汤剂中的有效成分含量是否相同。冻干粉不易存储，易受潮，因此不能大面积推广。Whether the formula granules can replace the corresponding standard decoction products is mainly based on whether the active ingredients in the formula granules of the same quality are the same as those in the standard decoction. Freeze-dried powder is not easy to store and is susceptible to moisture, so it cannot be popularized in a large area.
从实施例1、2以及对比例1可以看出本申请中药多功能提取罐提取、减压浓缩、瞬时喷雾干燥和干法制粒现代工业化设备及技术，可确保鲜鱼腥草配方颗粒中活性成分转移率与鲜鱼腥草标准汤剂达到一致，该工艺稳定可行，可为临床处方调配新增加鲜鱼腥草配方颗粒品种。From Examples 1, 2 and Comparative Example 1, it can be seen that the modern industrialized equipment and technology of Chinese medicine multifunctional extraction tank extraction, decompression concentration, instant spray drying and dry granulation can ensure that the active ingredients in the fresh Houttuynia formula granules The transfer rate is consistent with the standard decoction of fresh Houttuynia cordata, the process is stable and feasible, and it can be used for clinical prescriptions to add new varieties of fresh Houttuynia cordata formula granules.
实施例3和4表明在本申请的制备方法的工艺参数范围内，均可以得到同鲜鱼腥草标准汤剂的活性成分一致的鲜鱼腥草配方颗粒。Examples 3 and 4 show that within the range of process parameters of the preparation method of the present application, fresh Houttuynia cordata formula granules consistent with the active ingredients of the fresh Houttuynia cordata standard decoction can be obtained.
对比例2中未采用中药多功能提取罐，而是采用了传统的陶瓷煎药壶进行提取，进而制得的颗粒中的活性成分同实施例或对比例1相比有较大的差别。In Comparative Example 2, a traditional Chinese medicine decoction pot was used instead of a traditional Chinese medicine multifunctional extraction tank, and the active ingredients in the prepared granules were quite different from those in Example or Comparative Example 1.
对比例3中喷雾干燥的温度过高，导致槲皮苷的含量大幅下降。In Comparative Example 3, the spray drying temperature was too high, resulting in a significant drop in the content of quercitrin.
对比例4和5中的鲜鱼腥草的提取方式同实施例中记载的不同，加水量和煎煮时间均不同，导致配方颗粒中槲皮苷的量明显小于实施例1~4。表明采用不同的水提方法或者对鲜鱼腥草的水提参数进行超范围的调整，会导致配方颗粒品质的下降。The extraction methods of fresh Houttuynia cordata in Comparative Examples 4 and 5 are different from those recorded in Examples, and the amount of water added and decocting time are all different, resulting in the amount of quercitrin in the formula granules being significantly smaller than that in Examples 1-4. It shows that adopting different water extraction methods or adjusting the water extraction parameters of fresh Houttuynia cordata beyond the range will lead to the decline of the quality of formula granules.
对比例6中的鱼腥草饮片未切段，直接进行煎煮，煎煮用时较长，同时有效成分的含量也较低，表明鱼腥草切段是提高有效物质含量的重要手段。The decoction pieces of Houttuynia cordata in Comparative Example 6 were not cut into sections and were directly decocted. The decoction took longer and the content of active ingredients was lower, indicating that cutting Houttuynia cordata into sections is an important means to increase the content of active substances.
上列详细说明是针对本发明可行实施例的具体说明，以上实施例并非用以限制本发明的专利范围，凡未脱离本发明所为的等效实施或变更，均应包含于本案的专利范围中。The above detailed description is a specific description of the feasible embodiments of the present invention. The above embodiments are not used to limit the patent scope of the present invention. All equivalent implementations or changes that do not depart from the present invention should be included in the patent scope of this case. middle.
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