CN108815446A - 一种养血安胎孕康口服液的制备方法 - Google Patents
一种养血安胎孕康口服液的制备方法 Download PDFInfo
- Publication number
- CN108815446A CN108815446A CN201810693307.2A CN201810693307A CN108815446A CN 108815446 A CN108815446 A CN 108815446A CN 201810693307 A CN201810693307 A CN 201810693307A CN 108815446 A CN108815446 A CN 108815446A
- Authority
- CN
- China
- Prior art keywords
- added
- preparation
- water
- flocculate
- circumfluence distillation
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/36—Skin; Hair; Nails; Sebaceous glands; Cerumen; Epidermis; Epithelial cells; Keratinocytes; Langerhans cells; Ectodermal cells
-
- 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
- A61K36/06—Fungi, e.g. yeasts
- A61K36/07—Basidiomycota, e.g. Cryptococcus
- A61K36/076—Poria
-
- 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
- A61K36/11—Pteridophyta or Filicophyta (ferns)
- A61K36/12—Filicopsida or Pteridopsida
-
- 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)
-
- 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)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/232—Angelica
-
- 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)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/282—Artemisia, e.g. wormwood or sagebrush
-
- 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)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/284—Atractylodes
-
- 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)
- A61K36/34—Campanulaceae (Bellflower family)
- A61K36/344—Codonopsis
-
- 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)
- A61K36/39—Convolvulaceae (Morning-glory family), e.g. bindweed
-
- 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)
- A61K36/40—Cornaceae (Dogwood family)
-
- 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)
- A61K36/43—Cuscutaceae (Dodder family), e.g. Cuscuta epithymum or greater dodder
-
- 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)
- A61K36/46—Eucommiaceae (Eucommia family), e.g. hardy rubber tree
-
- 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)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/481—Astragalus (milkvetch)
-
- 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)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/487—Psoralea
-
- 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)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/539—Scutellaria (skullcap)
-
- 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)
- A61K36/65—Paeoniaceae (Peony family), e.g. Chinese peony
-
- 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
-
- 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)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
- A61K36/736—Prunus, e.g. plum, cherry, peach, apricot or almond
-
- 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
-
- 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)
- A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
- A61K36/815—Lycium (desert-thorn)
-
- 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)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/894—Dioscoreaceae (Yam family)
- A61K36/8945—Dioscorea, e.g. yam, Chinese yam or water yam
-
- 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)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/906—Zingiberaceae (Ginger family)
- A61K36/9062—Alpinia, e.g. red ginger or galangal
-
- 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)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/906—Zingiberaceae (Ginger family)
- A61K36/9064—Amomum, e.g. round cardamom
-
- 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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/06—Antiabortive agents; Labour repressants
Landscapes
- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Biotechnology (AREA)
- Botany (AREA)
- Mycology (AREA)
- Alternative & Traditional Medicine (AREA)
- Medical Informatics (AREA)
- Microbiology (AREA)
- Cell Biology (AREA)
- Pregnancy & Childbirth (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Endocrinology (AREA)
- Reproductive Health (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Gynecology & Obstetrics (AREA)
- Dermatology (AREA)
- Biomedical Technology (AREA)
- Developmental Biology & Embryology (AREA)
- Immunology (AREA)
- Virology (AREA)
- Zoology (AREA)
- Neurosurgery (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
本发明涉及一种养血安胎孕康口服液的制备方法,所述方法步骤如下:采用热回流提取技术,将(阿胶除外)山药等二十味药材按上述重量份比例,投入热回流装置中,加热煮至微沸,再加入黄芩药材,启动热回流提取器进行热回流提取。采用热回流提取技术,用8倍量水提取时间为1小时,回流开始时间为2小时,热回流速度控制在1L/h,得到提取物后,进一步加入0.1‰‑0.25‰澄清剂壳聚糖除杂。
Description
技术领域
本发明属于药学领域,特别涉及一种养血安胎中药口服液制剂孕康口服液的新的制备方法。
背景技术
孕康口服液是目前已经上市的中药制剂产品,由山药、续断、黄芪、当归、白芍、补骨脂、黄芩等多种中药材经加工制成。具有健脾固肾,养血安胎。等功效。主要用于肾虚型和气血虚弱型先兆流产和习惯性流产等疾病,临床疗效显著,应用广泛。
孕康口服液由以下重量份的中药原料药经过加工制备而成:
阿胶25g 山药125g 续断5g 黄芪100g 当归75g 狗脊100g
菟丝子75g 桑寄生50g 杜仲75g 补骨脂75g 党参75g 茯苓100g
白术75g 地黄100g 山茱萸75g 枸杞子100g 乌梅50g 白芍75g
砂仁50g 益智50g 苎麻根75g 艾叶8.3g 黄芩50g
一种养血安胎孕康口服液的制备方法如下:
以上二十三味,除阿胶外,其余山药等二十二味用温水浸泡4小时,滤过,滤液备用,药渣加水煎煮三次,第一次2小时,第二次1小时,第三次0.5小时,滤过,合并上述滤液,加入阿胶溶化后,浓缩成每1ml含生药1g的清膏;清膏加乙醇使含醇量达70%,静置,滤过,滤液回收乙醇,加入蜂蜜83g、蔗糖88g、苯甲酸钠3.0g及水适量,混匀,加氢氧化钠试液调pH值至5~6,加水至1000ml,滤过,灌封,灭菌,即得。
现有制备孕康口服液的方法通常都是通过将药材进行前期处理和后期煎煮制作而成。在制备过程中,药材经过温浸、煎煮三次,累计煎煮时间近7.5小时,提取液中除含有有效成分外,提取出了大量鞣质、色素等成份,这些成份造成后续药液的过滤困难。最终口服液在有效期内储存过程中,大量的鞣质、色素等成份析出,使得药液混浊,并有沉淀产生。此种提取方法黄芩苷的提取转移率仅有20%-30%左右,不能将有效成份最大限度的提取出来。孕康口服液的适用人群比较特殊,为待产的孕妇,孕妇对药物的敏感性和安全性要求更高,因此,本发明对现有技术进行了改进,提供一种新的孕康口服液的制备方法。
孕康口服液作为有中国特色的药品,代表着我国药物研究和应用的新成果,但随着科技的飞速发展和人民的物质文化需求的不断提升,传统工艺的口服液就显得美中不足,运用高科技的制剂技术,可生产一种新的孕康口服液的制剂。
发明内容
本发明目的在于提供一种养血安胎孕康口服液新的制备方法,以解决上述问题。
本发明的血安胎孕康口服液配方如下:
阿胶25g 山药125g 续断5g 黄芪100g 当归75g 狗脊100g
菟丝子75g 桑寄生50g 杜仲75g 补骨脂75g 党参75g 茯苓100g
白术75g 地黄100g 山茱萸75g 枸杞子100g 乌梅50g 白芍75g
砂仁50g 益智50g 苎麻根75g 艾叶8.3g 黄芩50g
本发明的血安胎孕康口服液,制备方法如下:
采用热回流提取技术,将(阿胶除外)山药等二十味药材按上述重量份比例,投入热回流装置中,加热煮至微沸,再加入黄芩药材,启动热回流提取器进行热回流提取。采用热回流提取技术,用8倍量水提取时间为1小时,回流开始时间为2小时,热回流速度控制在1L/h;得到提取物,加水后加入絮凝物除杂,再制备成口服液。
其中所述絮凝物,制备方法如下:量取纯化水,加热至50-60℃,加入冰醋酸,搅匀,再加入壳聚糖,全部溶解,再加入碱性溶液使壳聚糖和碱充分反应得白色絮凝物,再用清水洗涤白色絮凝物至中性得到絮凝物。
优选的,本发明的制备方法包括以下步骤:
除阿胶外,山药等二十味药材置热回流装置中,加热煮至微沸,再加入黄芩,启动热回流提取器进行热回流采热回流提取,滤过,滤液加入阿胶溶化后,浓缩成每1ml含生药1g的清膏;清膏加乙醇使含醇量达70%,静置,滤过,滤液回收乙醇,滤液加入适当的水,加入絮凝物,搅拌,静置,过滤,滤液加入蜂蜜83g、蔗糖88g、加入苯甲酸钠及水,加氢氧化钠调pH值至5~6,加水至1000mL,过滤,灌装即得。
其中所述絮凝物,制备方法如下:
1)量取22.4ml纯化水,加热至50-60℃,加入0.22ml冰醋酸,搅匀,再加入0.224g壳聚糖,全部溶解;
2)再把1g氢氧化钠和1g碳酸钠分别加入到200毫升水中搅拌溶解,配成碱液。
3)将碱液缓慢滴入0.5%壳聚糖溶液中,使壳聚糖溶液和碱充分反应得白色絮凝物,过滤后,再用清水洗涤絮凝物至中性。
本发明发现,黄芩苷为药物的制药活性成分,其对于疗效的影响至关重要,本发明通过对工艺的不断优化,采用热回流提取技术,通过优化提取参数,使黄芩苷提取更充分。得到的浸膏再用辅料和合适的絮凝剂进行配制,得到适当的口服液。
本发明采用的技术包括:
1、将药材置热回流装置中,加热煮至微沸,再加入黄芩,启动热回流提取器进行热回流,针对关键参数加水量、提取时间、热回流速度、煎煮次数等因素,设置3个水平,采用L934正交实验设计表,以黄芩苷为评价指标,进行工艺研究,按上述参数进行工艺筛选,确定最佳提取工艺。
2.处方量的阿胶加4倍量的水烊化后,药液备用;
3.配料后的过滤采用帆布、过滤纸板及微孔滤膜,或钛棒过滤器加助滤剂等方法进行过滤。对上述过滤方法进行工艺筛选,确定最佳过滤技术。
3.灌装;用全自动灌装机进行灌装。
4.包装;
下述实验例和实施例用于进一步说明但不限于本发明。
热回流提取技术简介:
传统的煎煮工艺容易使药材局部温度过高,不能很好完成解吸、溶解、扩散。采用热回流技术,提取溶剂能不断地与药材进行解吸、溶解、扩散,进而达到充分提取的效果。该技术为溶剂连续加到药面上,由上至下通过药材层,药材中的溶质含量与溶剂中溶质含量保持了较高梯度,药材中的溶质高速溶出,直至完全溶出,具有提取效率高的特点。提取液停止抽入浓缩器,浓缩的二次蒸汽转送冷却器,浓缩继续进行,直至浓缩成浸膏,放出备用,由于溶质高速溶出,提取时间短,浓缩与提取同时进行,浓缩采取双效浓缩,该技术能快速浓缩提取液,有效地节约能源。故药材到浓缩药膏比传统的时间短,设备利用率高。
该技术操作为将药材投入提取罐内,加药材一定数量水,开启提取罐直通和夹套蒸汽阀门,使药材提取一定时间后,提取液抽入浓缩器进行浓缩。热的溶剂落到药材的表面进行提取,完成一个连续提取和浓缩。
为了提高孕康口服液药材中的有效物质的溶出,根据实验参数,优化相应的提取参数。
其优选过程如下:
山药:125g,续断:75g,黄芪:100g,当归:75g,狗脊:100g,菟丝子:75g,桑寄生:50g,杜仲:75g,补骨脂:75g,党参:75g,茯苓:100g,白术:75g,地黄:100g,山茱萸:75g,枸杞子:100g,乌梅:50g,白芍:75g,砂仁:50g,益智:50g,苎麻根:75g,艾叶:8.3g等二十味药材置热回流装置中,加热煮至微沸,再加入黄芩:50g,启动热回流提取器进行热回流采热回流提取技术根据检测结果(参照中国药典2015版一部孕康口服液的检测方法),进行实验筛选。见表1
步骤1的提取进行工艺优化,采用热回流提取技术。以黄芩苷转移率为考察指标按4因素3水平进行正交实验,实验结果及方差分析见表1、表2、表3.
表1黄芩等药材提取工艺因素水平表
表2关于提取因素筛选的正交实验表
表3影响提取转移率的因素的方差分析
经分析可见,执回流速度、热回流开始时间对处方有显著性影响,根据均值可以得出提取工艺参数组合以执回流速度为1L/h,热回流开始时间为2小时为最佳搭配,按此方案对配方进行工艺优化。由于采用了热回流技术,大幅度提高了黄芩药材的含量转移率,缩短了工艺路线,避免了原工艺前煮次数,前煮时间过长对产品品质带来的潜在问题。因此最佳工艺为:采用热回流技术提取,用8倍量水提取时间为1小时,回流开始时间为2小时,热回流速度控制在1L/h。
本发明的优点:相对于传统工艺,提取浓缩时间缩短了大约3小时,因为传统工艺中提取浓缩时间至少需要7.5小时,而本工艺中提取浓缩时间4小时足够,减少了药液中鞣质及色素等无效成分的析出,解决了药液过滤困难的工艺问题;该产品全年产量可达到6万件,销售连年递增,取得了巨大的市场份额。现我公司拟将该产品作为市场重点推广产品,预计明年销售额会有一个更大的增长,将会节约大量的人力、物力成本,而且采用本发明后,针对有效成份黄芩苷含量的检测,比较传统提取方式黄芩苷的提取转移率可以提高至70%-75%,说明通过本工艺在同等服用量上能够在很大程度上提高药效。
为了改善一种养血安胎孕康口服液的澄明度,本发明加入了澄清剂,所述澄清剂选自:ZTC1+1天然澄清剂、壳聚糖、蛋清、101果汁澄清剂、明胶,经过筛选,本发明采用壳聚糖制备的絮凝物作为澄清剂。
其筛选的过程如下,按照一定的比例,加入以下不同的澄清剂。
除阿胶外,山药等二十味药材置热回流装置中,加热煮至微沸,再加入黄芩,启动热回流提取器进行热回流采热回流提取,滤过,滤液加入阿胶溶化后,浓缩成每1ml含生药1g的清膏;清膏加乙醇使含醇量达70%,静置,滤过,滤液回收乙醇,滤液加入适当的水,加入同样浓度和剂量的澄清剂,搅拌,过滤,滤液加入蜂蜜83g、蔗糖88g、加入适当的苯甲酸钠及水适量,混匀,加氢氧化钠调pH值至5~6,加水至1000mL,过滤,灌装即得。其结果见表4
表4澄清剂的筛选
加入名称 | 0个月沉淀 | 加速3个月沉淀 | 加速6个月沉淀 |
ZTC1+1天然澄清剂 | 0.001% | 0.039% | 0.066% |
101果汁澄清剂 | 0.003% | 0.038% | 0.0760% |
蛋清 | 0.003% | 0.032% | 0.060% |
明胶 | 0.006% | 0.041% | 0.065% |
壳聚糖 | 0.001% | 0.003% | 0.006% |
通过上述实验表明,采用壳聚糖作为澄清剂的样品稳定性最好,样品加速六个月基本无沉淀产生,因此我们优选壳聚糖作为澄清剂。
表5壳聚糖用量的筛选
从上表的结果可以看出加入,极微量的壳聚糖对孕康口服液澄明度具有非常明显澄清效果,随着量的增大,颜色变浅。
本发明还包括用壳聚糖制备的絮凝物的制备方法,所述方法,步骤如下:
0.5%壳聚糖的配制:量取3600ml纯化水,加热至50-60℃,加入36ml冰醋酸,搅匀,再加入18g壳聚糖,边加边搅拌至全部溶解。
上述溶液中加入一定的碱水,并不断的搅拌,析出白色絮凝物,将白色絮凝物过滤后用水洗为中性。
将孕康517g浸膏加入纯化水400g中搅匀,再加入20g的絮凝物,过滤,再加蜂蜜83g、蔗糖88g、加入适当的苯甲酸钠及水适量,混匀,加氢氧化钠调pH值至5~6,加水至1000mL,过滤,灌装即得。
其中所述的碱水可以氢氧化钠和碳酸钠的任何比例,优选1:1,不局限此2种碱,还包括可以食用氨水之类弱碱和或其他氢氧化钾等强碱。
以上絮凝物的制备方法是本发明经过筛选获得的,筛选过程如下:
通过上述实验表明,采用壳聚糖+冰醋酸+氢氧化钠+碳酸钠絮凝物作为澄清剂的样品稳定性最好,样品加速六个月基本无沉淀产生,因此我们优选壳聚糖+冰醋酸+氢氧化钠+碳酸钠絮凝物作为澄清剂。
经过本发明的制备方法的改进,本发明的口服液,在疗效上优于用现有技术制备的口服液,以下为疗效对比实验:
具体实施方式
实施例1:
按下述配比称取原料:
阿胶25g 山药125g 续断5g 黄芪100g 当归75g 狗脊100g
菟丝子75g 桑寄生50g 杜仲75g 补骨脂75g 党参75g 茯苓100g
白术75g 地黄100g 山茱萸75g 枸杞子100g 乌梅50g 白芍75g
砂仁50g 益智50g 苎麻根75g 艾叶8.3g 黄芩50g
将上述各组份制成本发明药物的生产方法是:
【制法】除阿胶外,山药等二十味药材置热回流装置中,加热煮至微沸,再加入黄芩,启动热回流提取器进行热回流采热回流提取,滤过,滤液加入阿胶溶化后,浓缩成每1ml含生药1g的清膏;清膏加乙醇使含醇量达70%,静置,滤过,滤液回收乙醇,滤液加入适当的水,加入20g的絮凝物,搅拌,过滤,滤液加入蜂蜜83g、蔗糖88g、加入适当的苯甲酸钠及水适量,混匀,加氢氧化钠调pH值至5~6,加水至1000mL,过滤,灌装即得。
实施例2:
按下述配比称取原料:
阿胶25g 山药125g 续断5g 黄芪100g 当归75g 狗脊100g
菟丝子75g 桑寄生50g 杜仲75g 补骨脂75g 党参75g 茯苓100g
白术75g 地黄100g 山茱萸75g 枸杞子100g 乌梅50g 白芍75g
砂仁50g 益智50g 苎麻根75g 艾叶8.3g 黄芩50g
将上述各组份制成本发明药物的生产方法是:
【制法】除阿胶外,山药等二十味药材置热回流装置中,加热煮至微沸,再加入黄芩,启动热回流提取器进行热回流采热回流提取,滤过,滤液加入阿胶溶化后,浓缩成每1ml含生药1g的清膏;清膏加乙醇使含醇量达70%,静置,滤过,滤液回收乙醇,浓缩后得清膏。
1)0.5%澄清剂的配制:量取22.4ml纯化水,加热至50-60℃,加入0.22ml冰醋酸,搅匀,再加入0.224g壳聚糖,全部溶解。
2)再把1克氢氧化钠和1克碳酸钠分别加入到200毫升水中搅拌溶解(配成碱液)。
3)将碱液缓慢滴入0.5%澄清剂中,使壳聚糖溶液和碱充分反应得白色絮凝物,再用清水洗涤至近中性备用。
4)清膏加热倒入1倍量的加苯甲酸钠的纯化水中,加入20g的絮凝物,搅拌,静置48h,过滤,滤液备用。滤液再加鲜竹沥及淀粉糖浆,加热煮沸20分钟,趁热滤过,滤液放冷,滤液加入蜂蜜83g、蔗糖88g、加入适当的苯甲酸钠及水适量,混匀,加氢氧化钠调pH值至5~6,加水至1000mL,过滤,灌装即得。
Claims (4)
1.一种养血安胎孕康口服液的制备方法,其特征在于,由以下重量配比的原料药制备而成:
制备方法如下:
采用热回流提取技术,将(阿胶除外)山药等二十味药材按上述重量份比例,投入热回流装置中,加热煮至微沸,再加入黄芩药材,启动热回流提取器进行热回流提取。采用热回流提取技术,用8倍量水提取时间为1小时,回流开始时间为2小时,热回流速度控制在1L/h;得到提取物,加水后加入絮凝物除杂,再制备成口服液。
2.根据权利要求1所述的制备方法,其特征在于,其中所述絮凝物,制备方法如下:量取纯化水,加热至50-60℃,加入冰醋酸,搅匀,再加入壳聚糖,全部溶解,再加入碱性溶液使壳聚糖和碱充分反应得白色絮凝物,再用清水洗涤白色絮凝物至中性得到絮凝物。
3.根据权利要求1所述的制备方法,其特征在于,包括以下步骤:
除阿胶外,山药等二十味药材置热回流装置中,加热煮至微沸,再加入黄芩,启动热回流提取器进行热回流采热回流提取,滤过,滤液加入阿胶溶化后,浓缩成每1ml含生药1g的清膏;清膏加乙醇使含醇量达70%,静置,滤过,滤液回收乙醇,滤液加入适当的水,加入絮凝物,搅拌,静置,过滤,滤液加入蜂蜜83g、蔗糖88g、加入苯甲酸钠及水,加氢氧化钠调pH值至5~6,加水至1000mL,过滤,灌装即得。
4.根据权利要求3所述的制备方法,其特征在于,所述絮凝物,制备方法如下:
1)量取22.4ml纯化水,加热至50-60℃,加入0.22ml冰醋酸,搅匀,再加入0.224g壳聚糖,全部溶解;
2)再把1g氢氧化钠和1g碳酸钠分别加入到200毫升水中搅拌溶解,配成碱液。
3)将碱液缓慢滴入0.5%壳聚糖溶液中,使壳聚糖溶液和碱充分反应得白色絮凝物,过滤后,再用清水洗涤絮凝物至中性。
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201810693307.2A CN108815446A (zh) | 2018-06-29 | 2018-06-29 | 一种养血安胎孕康口服液的制备方法 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201810693307.2A CN108815446A (zh) | 2018-06-29 | 2018-06-29 | 一种养血安胎孕康口服液的制备方法 |
Publications (1)
Publication Number | Publication Date |
---|---|
CN108815446A true CN108815446A (zh) | 2018-11-16 |
Family
ID=64134865
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN201810693307.2A Pending CN108815446A (zh) | 2018-06-29 | 2018-06-29 | 一种养血安胎孕康口服液的制备方法 |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN108815446A (zh) |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN103638484A (zh) * | 2013-11-22 | 2014-03-19 | 江西济民可信药业有限公司 | 一种复方鲜竹沥液的制备方法 |
CN104173893A (zh) * | 2014-07-28 | 2014-12-03 | 江西济民可信药业有限公司 | 一种孕康口服液的制备方法 |
-
2018
- 2018-06-29 CN CN201810693307.2A patent/CN108815446A/zh active Pending
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN103638484A (zh) * | 2013-11-22 | 2014-03-19 | 江西济民可信药业有限公司 | 一种复方鲜竹沥液的制备方法 |
CN104173893A (zh) * | 2014-07-28 | 2014-12-03 | 江西济民可信药业有限公司 | 一种孕康口服液的制备方法 |
Non-Patent Citations (1)
Title |
---|
张伯礼等: "《中药现代化二十年 1996-2015》", 31 October 2016, 上海科学技术出版社 * |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
CN1586544A (zh) | 一种药酒及其制造方法 | |
CN1732916A (zh) | 含原花青素和其它功能成分的复方医疗保健制剂 | |
CN103933220B (zh) | 一种治疗更年期综合症的药物 | |
CN103356801A (zh) | 低温连续提取结合膜分离技术制备八珍颗粒的方法 | |
CN101670068B (zh) | 一种治疗膝关节滑膜炎的药物及其制备工艺 | |
CN102488798A (zh) | 一种治疗非酒精性脂肪肝的药物 | |
CN101601440A (zh) | 反刍动物饲料添加剂 | |
CN108042766A (zh) | 一种补肾通络养脑膏及其制备方法 | |
CN102319357A (zh) | 一种降脂灵分散片及其制备工艺 | |
CN108815391A (zh) | 一种肝损伤保护功能的双石斛提取物的制备工艺 | |
CN108815446A (zh) | 一种养血安胎孕康口服液的制备方法 | |
CN102048841A (zh) | 一种具有催乳作用的中药组合物及其制备工艺 | |
CN110917311A (zh) | 一种用于保胎、调理经期及妇女更年期的中药口服液及其生产工艺 | |
CN104771595B (zh) | 一种增强免疫力的中药组合物及其制备方法 | |
CN107335009A (zh) | 一种散结养血膏方及其制备方法 | |
CN106177416B (zh) | 一种降血糖的中药组合物及其制备方法 | |
CN102293923A (zh) | 一种藏药组合物在制备预防和治疗骨质疏松药物中的应用 | |
CN110522875A (zh) | 一种养血安胎孕康口服液的制备方法 | |
CN106668431B (zh) | 一种具有温肾、益气等疗效的中药组合物及其制备方法和应用 | |
CN102233089B (zh) | 一种用于更年期综合症的中药组合物及其制备方法 | |
CN101112610A (zh) | 一种中药凝胶剂及其制备方法 | |
CN100353971C (zh) | 消风止痒颗粒及其制备方法 | |
CN114432410B (zh) | 一种活血祛瘀膏方及其应用 | |
CN109820982A (zh) | 一种孕康口服液的制备工艺 | |
CN109939188A (zh) | 具有解酒护肝功效的组合物及其制备方法和应用 |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
PB01 | Publication | ||
PB01 | Publication | ||
SE01 | Entry into force of request for substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
RJ01 | Rejection of invention patent application after publication |
Application publication date: 20181116 |
|
RJ01 | Rejection of invention patent application after publication |