CN108619305A - 地黄鲜提冷冻干燥颗粒饮片 - Google Patents
地黄鲜提冷冻干燥颗粒饮片 Download PDFInfo
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- CN108619305A CN108619305A CN201810733204.4A CN201810733204A CN108619305A CN 108619305 A CN108619305 A CN 108619305A CN 201810733204 A CN201810733204 A CN 201810733204A CN 108619305 A CN108619305 A CN 108619305A
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- 241000405414 Rehmannia Species 0.000 title claims abstract description 14
- 239000008187 granular material Substances 0.000 title claims abstract description 7
- 238000004108 freeze drying Methods 0.000 title claims abstract description 6
- 239000006071 cream Substances 0.000 claims abstract description 13
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 11
- 235000011389 fruit/vegetable juice Nutrition 0.000 claims abstract description 7
- 238000001035 drying Methods 0.000 claims abstract description 4
- 235000020985 whole grains Nutrition 0.000 claims abstract description 4
- 239000002775 capsule Substances 0.000 claims abstract description 3
- 239000006187 pill Substances 0.000 claims abstract description 3
- 239000000843 powder Substances 0.000 claims abstract description 3
- 239000003826 tablet Substances 0.000 claims abstract description 3
- 238000003306 harvesting Methods 0.000 claims abstract 2
- 239000003814 drug Substances 0.000 claims description 14
- 239000000463 material Substances 0.000 claims description 4
- 238000001914 filtration Methods 0.000 claims description 3
- 239000012535 impurity Substances 0.000 claims description 3
- 239000002245 particle Substances 0.000 claims description 3
- 238000009777 vacuum freeze-drying Methods 0.000 claims description 3
- 229930185474 acteoside Natural products 0.000 claims description 2
- FBSKJMQYURKNSU-ZLSOWSIRSA-N acteoside Chemical compound O[C@@H]1[C@H](O)[C@@H](O)[C@H](C)O[C@H]1O[C@H]1[C@H](OC(=O)\C=C\C=2C=C(O)C(O)=CC=2)[C@@H](CO)O[C@@H](OCCC=2C=C(O)C(O)=CC=2)[C@@H]1O FBSKJMQYURKNSU-ZLSOWSIRSA-N 0.000 claims description 2
- FBSKJMQYURKNSU-UKQWSTALSA-N acteoside I Natural products C[C@@H]1O[C@H](O[C@@H]2[C@@H](O)[C@H](OCCc3ccc(O)c(O)c3)O[C@H](CO)[C@H]2OC(=O)C=Cc4ccc(O)c(O)c4)[C@H](O)[C@H](O)[C@H]1O FBSKJMQYURKNSU-UKQWSTALSA-N 0.000 claims description 2
- 238000002156 mixing Methods 0.000 claims description 2
- 238000004806 packaging method and process Methods 0.000 claims description 2
- 239000008399 tap water Substances 0.000 claims description 2
- 235000020679 tap water Nutrition 0.000 claims description 2
- QFRYQWYZSQDFOS-UHFFFAOYSA-N verbascoside Natural products CC1OC(COC2C(O)C(COC3OC(C(O)C(O)C3O)C(=O)O)OC(Oc4cc(O)cc5OC(=CC(=O)c45)c6ccc(O)c(O)c6)C2O)C(O)C(O)C1O QFRYQWYZSQDFOS-UHFFFAOYSA-N 0.000 claims description 2
- -1 clean in time Substances 0.000 claims 1
- 238000003756 stirring Methods 0.000 claims 1
- 230000003179 granulation Effects 0.000 abstract 1
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- 239000008280 blood Substances 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 238000000227 grinding Methods 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- MCSXGCZMEPXKIW-UHFFFAOYSA-N 3-hydroxy-4-[(4-methyl-2-nitrophenyl)diazenyl]-N-(3-nitrophenyl)naphthalene-2-carboxamide Chemical compound Cc1ccc(N=Nc2c(O)c(cc3ccccc23)C(=O)Nc2cccc(c2)[N+]([O-])=O)c(c1)[N+]([O-])=O MCSXGCZMEPXKIW-UHFFFAOYSA-N 0.000 description 1
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 description 1
- 208000030090 Acute Disease Diseases 0.000 description 1
- 206010010774 Constipation Diseases 0.000 description 1
- 208000015220 Febrile disease Diseases 0.000 description 1
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 1
- 208000034507 Haematemesis Diseases 0.000 description 1
- 241000013557 Plantaginaceae Species 0.000 description 1
- 206010037660 Pyrexia Diseases 0.000 description 1
- 210000001124 body fluid Anatomy 0.000 description 1
- 239000010839 body fluid Substances 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 206010012601 diabetes mellitus Diseases 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 208000001780 epistaxis Diseases 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 229930182478 glucoside Natural products 0.000 description 1
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Classifications
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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)
- A61K36/80—Scrophulariaceae (Figwort family)
- A61K36/804—Rehmannia
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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
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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
- A61K2236/10—Preparation or pretreatment of starting material
- A61K2236/13—Preparation or pretreatment of starting material involving cleaning, e.g. washing or peeling
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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
- A61K2236/10—Preparation or pretreatment of starting material
- A61K2236/15—Preparation or pretreatment of starting material involving mechanical treatment, e.g. chopping up, cutting or grinding
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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
- A61K2236/33—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
本发明公布了一种“地黄鲜提冷冻干燥颗粒饮片”,其主要特征在于:在地黄采收后,趁鲜洗涤、切片、榨汁、提取,提取液浓缩成清膏后冷冻干燥,再经粉碎、制粒、干燥、整粒后真空包装。颗粒饮片的含水量少于10%。本饮片质量稳定,既可以入汤剂煎煮,也可以直接入丸剂、散剂、片剂、胶囊剂,利于携带,临床使用方便。
Description
技术领域
本发明属于中药饮片技术领域,尤其属于地黄饮片的加工领域。
背景技术
中药地黄为玄参科植物地黄的新鲜或干燥块根。地黄具有清热凉血,养阴生津的功效。本品主要用于治疗热入营血,温毒发斑,吐血衄血,热病伤阴,舌绛烦渴,津伤便秘,阴虚发热,骨蒸劳热,内热消渴等,是中医临床上常见的一味中药。传统地黄的加工方法为:秋季采挖,除去芦头、须根及泥沙,鲜用;或将地黄缓缓烘焙至约八成干,打包,储运。到饮片厂后,再洗涤、润软、切片、干燥、包装。此类饮片体积大,卫生学标准差,易于受潮、长霉、生虫,不利于保管,储存和运输成本高。此外,这样的饮片质量稳定性差,临床疗效难以保障,病人服用不方便,起效慢。因此,开发一种质量稳定可靠、储存/运输成本低、利于保管、携带和使用方便、起效快的新型地黄饮片,势在必行。目前市场地黄饮片,除了传统饮片之外,还有超微粉饮片和浓缩颗粒饮片两种形式,但两者都是以传统饮片为原料,其质量决定于传统饮片的质量,且超微饮片不能解决药材污染的问题;浓缩颗粒只能提取出水溶性成分。
发明内容
本发明公布了一种“地黄鲜提冷冻干燥颗粒饮片”,其主要特征在于:在地黄采收后,及时净选,去除泥沙等杂质和非药用部位,于24小时内趁鲜用自来水洗净并切成2~5mm厚的片。将此切好的片加入1~5倍重量50~70℃的水中,浸泡并时时搅拌5~30分钟,过滤,药渣压榨取汁。所得药渣中再加入5~10倍重量的水,煮沸10~30分钟,趁热过滤,药渣再次榨汁,收集药汁。合并上述药汁,过60~100目筛,减压浓缩,温度为50~75℃,浓缩至相对密度为1.15~1.25的清膏。将此清膏留取0.5%~3%备用,余下清膏-80℃冻结后再真空冷冻干燥。收集冻干物,粉碎后与上述备用的清膏混合制备颗粒,再经干燥、整粒后,包装即得成品。成品饮片含毛蕊花糖苷不少于0.040%。本饮片临床一般使用量为1~5g,既可入汤剂煎服、冲服,也可直接入丸剂、散剂、胶囊剂及片剂中,从而大大提高了临床使用的便捷性和顺应性,有利于临床急症的治疗。
本发明解决了传统地黄饮片体积庞大、储运成本高、不利于保管、易生霉生虫、卫生学条件差、质量不稳定等诸多缺点,由于是趁鲜提取,质量比超微粉碎饮片和浓缩颗粒饮片更好。
具体实施例
将地黄药材采收后,净选,除去泥沙等杂质和非药用部位,在6小时内趁鲜用自来水洗净,并切成3mm厚的片。将此片加入5倍重量的70℃的纯净水,搅拌30分钟,过滤,药渣压榨取汁。 再往上述药渣中再加入8倍重量的纯净水,煮沸20分钟提取,趁热过滤,药渣再次榨汁,收集药汁。合并上述药汁,减压浓缩,温度为设定为70℃,浓缩至相对密度为1.20的清膏。将此清膏留取0.5%备用,余下清膏-80℃冻结后再真空冷冻干燥。收集冻干物,低温粉碎后与上述备用的清膏混合制备颗粒,再经干燥、整粒后,真空包装,即得成品。成品饮片含毛蕊花糖苷为0.045%。
Claims (2)
1.一种地黄鲜提冷冻干燥颗粒饮片,其主要特征在于:在地黄药材采收后,及时净选,去除泥沙等杂质和非药用部位,保持药材表面湿润,于24小时内趁鲜用自来水洗净并切成2~5mm厚的片,加入1~5倍重量50~70℃的水,浸泡并时时搅拌5~30分钟,过滤,药渣压榨取汁;所得药渣中再加入5~10倍重量的水,煮沸10~30分钟,趁热过滤,药渣再次榨汁,收集药汁;合并上述药汁,过60~100目筛,减压浓缩,温度为50~75℃,浓缩至相对密度为1.15~1.25的清膏;将此清膏留取0.5%~3%备用,余下清膏冻结后真空冷冻干燥;收集冻干物,与上述备用的清膏混合制备颗粒,经干燥、整粒后,包装即得成品;成品饮片含毛蕊花糖苷不得少于0.040%。
2.根据权利要求1所述的地黄鲜提冷冻干燥颗粒饮片,其主要特征在于:临床一般使用量为1~5g,既可入汤剂煎服、冲服,也可直接入丸剂、散剂、胶囊剂及片剂中。
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN112007087A (zh) * | 2019-09-11 | 2020-12-01 | 广东一方制药有限公司 | 鲜地黄提取方法、鲜地黄提取液、鲜地黄颗粒及组合物 |
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2018
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN112007087A (zh) * | 2019-09-11 | 2020-12-01 | 广东一方制药有限公司 | 鲜地黄提取方法、鲜地黄提取液、鲜地黄颗粒及组合物 |
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