CN108553519A - 白芍鲜提冷冻干燥颗粒饮片 - Google Patents
白芍鲜提冷冻干燥颗粒饮片 Download PDFInfo
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- VYQNWZOUAUKGHI-UHFFFAOYSA-N monobenzone Chemical compound C1=CC(O)=CC=C1OCC1=CC=CC=C1 VYQNWZOUAUKGHI-UHFFFAOYSA-N 0.000 title claims abstract description 14
- 238000004108 freeze drying Methods 0.000 title claims abstract description 7
- 239000008187 granular material Substances 0.000 title claims abstract description 5
- 239000006071 cream Substances 0.000 claims abstract description 13
- 235000011389 fruit/vegetable juice Nutrition 0.000 claims abstract description 7
- 238000001035 drying Methods 0.000 claims abstract description 4
- 239000000843 powder Substances 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
- 238000003306 harvesting Methods 0.000 claims abstract description 3
- 239000006187 pill Substances 0.000 claims abstract description 3
- 239000003826 tablet Substances 0.000 claims abstract description 3
- 239000003814 drug Substances 0.000 claims description 13
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 10
- 239000000463 material Substances 0.000 claims description 5
- 239000002245 particle Substances 0.000 claims description 4
- YKRGDOXKVOZESV-WRJNSLSBSA-N Paeoniflorin Chemical compound C([C@]12[C@H]3O[C@]4(O)C[C@](O3)([C@]1(C[C@@H]42)O[C@H]1[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O1)O)C)OC(=O)C1=CC=CC=C1 YKRGDOXKVOZESV-WRJNSLSBSA-N 0.000 claims description 3
- YKRGDOXKVOZESV-UHFFFAOYSA-N paeoniflorin Natural products O1C(C)(C2(CC34)OC5C(C(O)C(O)C(CO)O5)O)CC3(O)OC1C24COC(=O)C1=CC=CC=C1 YKRGDOXKVOZESV-UHFFFAOYSA-N 0.000 claims description 3
- 238000009777 vacuum freeze-drying Methods 0.000 claims description 3
- 244000236658 Paeonia lactiflora Species 0.000 claims description 2
- 235000008598 Paeonia lactiflora Nutrition 0.000 claims description 2
- 238000002156 mixing Methods 0.000 claims description 2
- 239000000047 product Substances 0.000 claims 3
- 210000002615 epidermis Anatomy 0.000 claims 1
- 239000012467 final product Substances 0.000 claims 1
- 238000002386 leaching Methods 0.000 claims 1
- 238000003756 stirring Methods 0.000 claims 1
- 238000004806 packaging method and process Methods 0.000 abstract description 3
- 230000003179 granulation Effects 0.000 abstract 1
- 238000005469 granulation Methods 0.000 abstract 1
- 238000003860 storage Methods 0.000 description 3
- 208000002193 Pain Diseases 0.000 description 2
- 238000001914 filtration Methods 0.000 description 2
- 239000012535 impurity Substances 0.000 description 2
- 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
- 241000205571 Caulophyllum Species 0.000 description 1
- 206010019233 Headaches Diseases 0.000 description 1
- 208000037093 Menstruation Disturbances Diseases 0.000 description 1
- 206010027339 Menstruation irregular Diseases 0.000 description 1
- 210000001015 abdomen Anatomy 0.000 description 1
- 230000000202 analgesic effect Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 238000009835 boiling Methods 0.000 description 1
- 230000008602 contraction Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 208000002173 dizziness Diseases 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 238000000227 grinding Methods 0.000 description 1
- 231100000869 headache Toxicity 0.000 description 1
- 235000008216 herbs Nutrition 0.000 description 1
- 208000006278 hypochromic anemia Diseases 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 230000036565 night sweats Effects 0.000 description 1
- 206010029410 night sweats Diseases 0.000 description 1
- 238000003672 processing method Methods 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 230000002269 spontaneous effect Effects 0.000 description 1
- 230000035900 sweating Effects 0.000 description 1
- 239000008399 tap water Substances 0.000 description 1
- 235000020679 tap water Nutrition 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)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
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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
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
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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
- A61K2236/31—Extraction of the material involving untreated material, e.g. fruit juice or sap obtained from fresh plants
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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
- A61K2236/50—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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- 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
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
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Abstract
本发明公布了一种“白芍鲜提冷冻干燥颗粒饮片”,其主要特征在于:在白芍采收后,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、整粒后包装即可。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,尤其属于白芍饮片的加工领域。
背景技术
中药白芍为毛莨科植物芍药Paeonia lactiflora Pall.的干燥根,具有养血调经,敛阴止汗,柔肝止痛,平抑肝阳的功效。用于血虚萎黄,月经不调,自汗,盗汗,胁痛,腹痛,四肢挛痛,头痛眩晕等的治疗,是中医临床上常见的一味中药。传统白芍的加工方法为:将药材采挖后,洗净,除去头尾和细根,置沸水中煮后除去外皮或去皮后再煮,晒干,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、起效快的新型白芍饮片,势在必行。目前市场白芍饮片,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“白芍鲜提冷冻干燥颗粒”,其主要特征在于:在白芍采收后,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,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。成品饮片含芍药苷(C23H28O11)不得少于3.0%。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。
本发明解决了传统白芍饮片体积庞大、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
将白芍药材采收后,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3%备用,余下清膏-80℃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,再经干燥、整粒后,包装即得成品。成品饮片含芍药苷(C23H28O11)为3.6%。
Claims (2)
1.一种白芍鲜提冷冻干燥颗粒饮片,其主要特征在于:在白芍药材采收后,在药材采收后,及时净选,趁药材表皮湿润时洗净泥沙,切片,加入药材重量1~5倍量的50~70℃的水温浸5~30分钟,并时时搅拌,过滤,药渣压榨取汁;所得药渣中再加入其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,50~80℃条件下减压浓缩至相对密度为1.10~1.25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;成品饮片含芍药苷(C23H28O11)不少于3.0%。
2.根据权利要求1所述的白芍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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CN110007020A (zh) * | 2019-04-03 | 2019-07-12 | 安徽济人药业有限公司 | 一种白芍配方颗粒基准物质的制备及质量控制方法 |
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2018
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN110007020A (zh) * | 2019-04-03 | 2019-07-12 | 安徽济人药业有限公司 | 一种白芍配方颗粒基准物质的制备及质量控制方法 |
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