CN111973658A - 一种复方金银花微囊的制备工艺 - Google Patents
一种复方金银花微囊的制备工艺 Download PDFInfo
- Publication number
- CN111973658A CN111973658A CN202010760965.6A CN202010760965A CN111973658A CN 111973658 A CN111973658 A CN 111973658A CN 202010760965 A CN202010760965 A CN 202010760965A CN 111973658 A CN111973658 A CN 111973658A
- Authority
- CN
- China
- Prior art keywords
- compound
- honeysuckle
- preparation process
- flos lonicerae
- compound honeysuckle
- 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
- 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)
- A61K36/35—Caprifoliaceae (Honeysuckle family)
- A61K36/355—Lonicera (honeysuckle)
-
- 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)
- A61K36/63—Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
- A61K36/634—Forsythia
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5015—Organic compounds, e.g. fats, sugars
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5052—Proteins, e.g. albumin
- A61K9/5057—Gelatin
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5089—Processes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/04—Drugs for disorders of the respiratory system for throat disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- 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
- A61K2236/19—Preparation or pretreatment of starting material involving fermentation using yeast, bacteria or both; enzymatic treatment
-
- 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, decoction
-
- 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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Mycology (AREA)
- Pulmonology (AREA)
- Microbiology (AREA)
- Alternative & Traditional Medicine (AREA)
- Biotechnology (AREA)
- Botany (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Ophthalmology & Optometry (AREA)
- Neurosurgery (AREA)
- Pain & Pain Management (AREA)
- Rheumatology (AREA)
- Otolaryngology (AREA)
- Biophysics (AREA)
- Dermatology (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
本发明公开了一种复方金银花微囊的制备工艺,将金银花加入水,再加入氯化钠及复合酶,加热浸提,过滤,收集金银花滤液;将连翘、黄芩加入提取罐,再加入水煎煮过滤,合并滤液后再与金银花滤液;浓缩,得浸膏,再经过脉冲气流干燥机干燥,得复方金银花干膏粉;将茶皂素、鼠李糖脂、魔芋胶和明胶加入水中,加热搅拌均匀,得囊材液;将复方金银花干膏粉、增塑剂和囊材液加入均质机进行均质处理,得混合药物;再加入至喷雾流化床进行干燥及制粒,制得复方金银花微囊。本发明提供的复方金银花微囊,不仅能有效实现对药品的高效包封,能够防止药品受潮发霉,提高药物的稳定性,延长贮存期;还能掩盖复方金银花颗粒的不良气味,使得患者更容易接受。
Description
技术领域
本发明涉及中成药制剂技术领域,具体是一种复方金银花微囊的制备工艺。
背景技术
复方金银花颗粒由金银花、连翘、黄芩三味中药经过提取加工制成的中药制剂,市场上已有销售。具有清热解毒、凉血消肿的功效,广泛用于风热感冒、咽炎、扁桃体炎、目痛、牙痛及痈肿疮疖等症。目前市售的复方金银花制剂制剂主要为颗粒制剂,根据市场销售、患者反馈意见及成品留样检验情况,复方金银花颗粒中在贮存过程极易受潮发霉变质,从而影响药效的发挥,也直接影响着治疗的效果。且复方金银花颗粒具有比较重的中药味道,有些消费者无法接受。
微囊化技术系利用天然或合成的高分子包囊材料(统称囊材)作为囊膜壁壳,将固态 药物或液态药物(统称芯材)包在微小、半透性或密封的囊内,从而形成药库型微型胶囊, 因其粒径在1~250μm,属微米级,故名微囊。微囊化技术使内容物在特定条件下以可控的速率释放,使药物具有控释或靶向作用。由于微囊化可以改善被包裹物质的颜色、外观、表观密度、溶解性等物理性质;提高核心物质的稳定性,改善被包裹物质的反应活性、耐久性、热敏性和光敏性,在医院领域已经得到相应的应用。
为了提高复方金银花微囊的稳定性,对复方金银花颗粒的制备工艺进行改进具有必要性。因此,本发明将微囊化技术运用至复方金银花的制备工艺中。
以上背景技术内容的公开仅用于辅助理解本发明的发明构思及技术方案,其并不必然属于本专利申请的现有技术,在没有明确的证据表明上述内容在本专利申请的申请日已经公开的情况下,上述背景技术不应当用于评价本申请的新颖性和创造性。
发明内容
本发明针对现有复方金银花颗粒存在的不足,提供一种复方金银花微囊的制备工艺。本发明提供的复方金银花微囊,可以有效实现对药品的高效包封,能够防止药品受潮发霉,提高药物的稳定性,延长贮存期;还能掩盖复方金银花颗粒的不良气味,使得患者更容易接受。
为了实现以上目的,本发明是通过如下技术方案实现:
一种复方金银花微囊的制备工艺,包括如下步骤:
(1)按照以下重量比称取各原料:金银花750份、连翘750份和黄芩250份;将金银花置于提取罐中,加入其质量8-12倍的水,再加入其质量为0.5-2%的氯化钠及1-2%的复合酶,搅拌均匀,加热至60-80℃,浸提4-6h,过滤,收集金银花滤液;
(2)将连翘、黄芩加入提取罐,再加入药材重量8-10倍的水,煎煮2-3次,每次煎煮1.5-2.5h,过滤,合并滤液后再与金银花滤液;浓缩,得浸膏,再经过脉冲气流干燥机干燥,得复方金银花干膏粉;
(3)将茶皂素、鼠李糖脂、魔芋胶和明胶按照质量比为1-3:1-3:3-5:5-10加入水中,加热搅拌均匀,得囊材液;
(4)将复方金银花干膏粉、增塑剂和囊材液加入均质机进行均质处理,得混合药物;将混合药物再加入至喷雾流化床进行干燥及制粒,制得复方金银花微囊。
进一步地,所述复合酶由质量比为1-3:1的纤维素酶和果胶酶组成。
进一步地,步骤(2)所述浓缩是在压力为-0.05 ~ -0.10Mpa、温度为60-80℃下干燥至固含量为50-60%。
进一步地,步骤(2)所述脉冲气体干燥是在温度为80-100℃,风速为10-15m/s下干燥。
进一步地,所述囊材液的质量分数为20-30%;所述复方金银花干膏粉与囊材液的质量比为1:2-3。
进一步地,所述增塑剂是由蔗糖甘油脂肪酸酯、月桂酸单甘油酯和卵磷脂组成;其加入量为复方金银花微囊质量的3-5%。
进一步地,所述增塑剂中蔗糖甘油脂肪酸酯、月桂酸单甘油酯和卵磷脂的质量比为1-3:1-3:3-5。
进一步地,所述均质处理是在压力为40-60MPa下处理20-30min。
进一步地,步骤(4)是在喷雾进风温度为40-60℃,流化床鼓风温度为60-80℃下进行干燥。
与现有技术相比,本发明的优点及有益效果为:
1、本发明提供的复方金银花微囊,可以有效实现对药品的高效包封,能够防止药品受潮发霉,提高药物的稳定性,延长贮存期;还能掩盖复方金银花颗粒的不良气味,使得患者更容易接受。
2、本发明在金银花提取工艺中加入氯化钠、纤维素酶及果胶酶,有利于细胞壁酶解破裂,促进金银花有效成分的溶出。
3、本制备工艺以茶皂素、鼠李糖脂、魔芋胶和明胶作为壁材材料,能够将复方金银花药剂很好的包封,提高微囊的致密性,使得微囊产品性能更加稳定,且还能掩盖了药品的不良气味。
4、本工艺利用脉冲气流干燥机对复方金银花干膏粉进行干燥,受热均匀,干燥时间段效率提高,干燥过程中有利于复方金银花干膏粉末的分散。
5、本发明工艺还加入蔗糖甘油脂肪酸酯、月桂酸单甘油酯和卵磷脂组成的增塑剂,提高均质过程中的流动性,使复方金银花与壁材能够更好的结合,提高壁材对复方金银花干膏粉的包封效果,制得的微囊表面更加致密光滑,无气孔,药品的稳定性提高。
具体实施方式
下面结合具体实施方式对本发明作进一步详细说明。应该强调的是,下述说明仅仅是示例性的,而不是为了限制本发明的范围及其应用。
实施例1
一种复方金银花微囊的制备工艺,包括如下步骤:
(1)按照以下重量比称取各原料:金银花750份、连翘750份和黄芩250份;将金银花置于提取罐中,加入其质量10倍的水,再加入其质量为1.5%的氯化钠及1.8%的复合酶,所述复合酶由质量比为为2:1的纤维素酶和果胶酶组成,搅拌均匀,加热至70℃,浸提5h,过滤,收集金银花滤液;
(2)将连翘、黄芩加入提取罐,再加入药材重量8倍的水,煎煮3次,每次煎煮2h,过滤,合并滤液后再与金银花滤液;在压力为-0.07Mpa、温度为75℃下浓缩至固含量为55%,得浸膏,再经过脉冲气流干燥机,在温度为90℃、风速为15m/s下干燥,得复方金银花干膏粉;
(3)将茶皂素、鼠李糖脂、魔芋胶和明胶按照质量比为2:1:4:8加入水中,配成质量浓度为27.5%的溶液,加热至60℃搅拌均匀,得囊材液;
(4)将复方金银花干膏粉、增塑剂和囊材液加入均质机,在压力为50Mpa下进行均质处理30min,所述复方金银花干膏粉和囊材液的质量比为1:3,所述增塑剂是由质量比为2:3:4的蔗糖甘油脂肪酸酯、月桂酸单甘油酯和卵磷脂组成,其加入量为复方金银花干膏粉3.6%,得混合药物;将混合药物再加入至喷雾流化床,在喷雾进风温度为50℃,流化床鼓风温度为70℃下进行干燥及制粒,制得粒径为80目的复方金银花微囊。
实施例2
一种复方金银花微囊的制备工艺,包括如下步骤:
(1)按照以下重量比称取各原料:金银花750份、连翘750份和黄芩250份;将金银花置于提取罐中,加入其质量12倍的水,再加入其质量为1%的氯化钠及1.5%的复合酶,所述复合酶由质量比为为1:1的纤维素酶和果胶酶组成,搅拌均匀,加热至65℃,浸提6h,过滤,收集金银花滤液;
(2)将连翘、黄芩加入提取罐,再加入药材重量10倍的水,煎煮2次,每次煎煮2.5h,过滤,合并滤液后再与金银花滤液;在压力为-0.08Mpa、温度为70℃下浓缩至固含量为60%,得浸膏,再经过脉冲气流干燥机,在温度为100℃、风速为12m/s下干燥,得复方金银花干膏粉;
(3)将茶皂素、鼠李糖脂、魔芋胶和明胶按照质量比为1:2:5:7加入水中,配成质量浓度为30%的溶液,加热至70℃搅拌均匀,得囊材液;
(4)将复方金银花干膏粉、增塑剂和囊材液加入均质机,在压力为60Mpa下进行均质处理20min,所述复方金银花干膏粉和囊材液的质量比为1:2,所述增塑剂是由质量比为3:2:5的蔗糖甘油脂肪酸酯、月桂酸单甘油酯和卵磷脂组成,其加入量为复方金银花干膏粉4%,得混合药物;将混合药物再加入至喷雾流化床,在喷雾进风温度为40℃,流化床鼓风温度为65℃下进行干燥及制粒,制得粒径为60目的复方金银花微囊。
实施例3
一种复方金银花微囊的制备工艺,包括如下步骤:
(1)按照以下重量比称取各原料:金银花750份、连翘750份和黄芩250份;将金银花置于提取罐中,加入其质量9倍的水,再加入其质量为0.8%的氯化钠及1.2%的复合酶,所述复合酶由质量比为为2:1的纤维素酶和果胶酶组成,搅拌均匀,加热至70℃,浸提5h,过滤,收集金银花滤液;
(2)将连翘、黄芩加入提取罐,再加入药材重量8倍的水,煎煮3次,每次煎煮2h,过滤,合并滤液后再与金银花滤液;在压力为-0.10Mpa、温度为60℃下浓缩至固含量为55%,得浸膏,再经过脉冲气流干燥机,在温度为90℃、风速为15m/s下干燥,得复方金银花干膏粉;
(3)将茶皂素、鼠李糖脂、魔芋胶和明胶按照质量比为3:2:3:9加入水中,配成质量浓度为22%的溶液,加热至60℃搅拌均匀,得囊材液;
(4)将复方金银花干膏粉、增塑剂和囊材液加入均质机,在压力为40Mpa下进行均质处理30min,所述复方金银花干膏粉和囊材液的质量比为1:3,所述增塑剂是由质量比为2:1:3的蔗糖甘油脂肪酸酯、月桂酸单甘油酯和卵磷脂组成,其加入量为复方金银花干膏粉4.2%,得混合药物;将混合药物再加入至喷雾流化床,在喷雾进风温度为50℃,流化床鼓风温度为70℃下进行干燥及制粒,制得粒径为60目的复方金银花微囊。
实施例4
一种复方金银花微囊的制备工艺,包括如下步骤:
(1)按照以下重量比称取各原料:金银花750份、连翘750份和黄芩250份;将金银花置于提取罐中,加入其质量10倍的水,再加入其质量为1.5%的氯化钠及1.0%的复合酶,所述复合酶由质量比为为2:1的纤维素酶和果胶酶组成,搅拌均匀,加热至80℃,浸提5h,过滤,收集金银花滤液;
(2)将连翘、黄芩加入提取罐,再加入药材重量9倍的水,煎煮3次,每次煎煮2h,过滤,合并滤液后再与金银花滤液;在压力为-0.06Mpa、温度为80℃下浓缩至固含量为50%,得浸膏,再经过脉冲气流干燥机,在温度为80℃、风速为10m/s下干燥,得复方金银花干膏粉;
(3)将茶皂素、鼠李糖脂、魔芋胶和明胶按照质量比为3:2:4:9加入水中,配成质量浓度为27%的溶液,加热至60℃搅拌均匀,得囊材液;
(4)将复方金银花干膏粉、增塑剂和囊材液加入均质机,在压力为50Mpa下进行均质处理30min,所述复方金银花干膏粉和囊材液的质量比为1:2.5,所述增塑剂是由质量比为2:3:5的蔗糖甘油脂肪酸酯、月桂酸单甘油酯和卵磷脂组成,其加入量为复方金银花干膏粉3.8%,得混合药物;将混合药物再加入至喷雾流化床,在喷雾进风温度为50℃,流化床鼓风温度为60℃下进行干燥及制粒,制得粒径为80目的复方金银花微囊。
实施例5
一种复方金银花微囊的制备工艺,包括如下步骤:
(1)按照以下重量比称取各原料:金银花750份、连翘750份和黄芩250份;将金银花置于提取罐中,加入其质量11倍的水,再加入其质量为1.2%的氯化钠及1.8%的复合酶,所述复合酶由质量比为为2:1的纤维素酶和果胶酶组成,搅拌均匀,加热至70℃,浸提5h,过滤,收集金银花滤液;
(2)将连翘、黄芩加入提取罐,再加入药材重量10倍的水,煎煮2次,每次煎煮2.5h,过滤,合并滤液后再与金银花滤液;在压力为-0.07Mpa、温度为75℃下浓缩,得浸膏,再经过脉冲气流干燥机,在温度为80℃、风速为15m/s下干燥,得复方金银花干膏粉;
(3)将茶皂素、鼠李糖脂、魔芋胶和明胶按照质量比为3:2:4:6加入水中,配成质量浓度为25%的溶液,加热至70℃搅拌均匀,得囊材液;
(4)将复方金银花干膏粉、增塑剂和囊材液加入均质机,在压力为50Mpa下进行均质处理25min,所述复方金银花干膏粉和囊材液的质量比为1:3,所述增塑剂是由质量比为2:3:5的蔗糖甘油脂肪酸酯、月桂酸单甘油酯和卵磷脂组成,其加入量为复方金银花干膏粉4.5%,得混合药物;将混合药物再加入至喷雾流化床,在喷雾进风温度为50℃,流化床鼓风温度为60℃下进行干燥及制粒,制得粒径为80目的复方金银花微囊。
将本实施例1-5按照常规方法测定复方金银花微囊包封率及贮存稳定性能,其中包封率=微囊中包封的黄芩苷的质量/微囊中包封与未包封的黄芩苷的总量×100%,产品含量保留率计算条件为:25℃、RH75%下抽样测定,测定结果如表1所示。
表1:本发明提供的复方金银花微囊的包封率及稳定性测定结果
从上述测试结果得知,本发明提供的复方金银花微囊,可以有效实现对药品的高效包封,能够防止药品受潮发霉,提高药物的稳定性,延长贮存期,明显优于市售的复方金银花颗粒。
以上内容是结合具体的/优选的实施方式对本发明所作的进一步详细说明,不能认定本发明的具体实施只局限于这些说明。对于本发明所属技术领域的普通技术人员来说,在不脱离本发明构思的前提下,其还可以对这些已描述的实施例做出若干替代或变型,而这些替代或变型方式都应视为属于本发明的保护范围。
Claims (9)
1.一种复方金银花微囊的制备工艺,其特征在于:包括如下步骤:
(1)按照以下重量比称取各原料:金银花750份、连翘750份和黄芩250份;将金银花置于提取罐中,加入其质量8-12倍的水,再加入其质量为0.5-2%的氯化钠及1-2%的复合酶,搅拌均匀,加热至60-80℃,浸提4-6h,过滤,收集金银花滤液;
(2)将连翘、黄芩加入提取罐,再加入药材重量8-10倍的水,煎煮2-3次,每次煎煮1.5-2.5h,过滤,合并滤液后再与金银花滤液;浓缩,得浸膏,再经过脉冲气流干燥机干燥,得复方金银花干膏粉;
(3)将茶皂素、鼠李糖脂、魔芋胶和明胶按照质量比为1-3:1-3:3-5:5-10加入水中,加热搅拌均匀,得囊材液;
(4)将复方金银花干膏粉、增塑剂和囊材液加入均质机进行均质处理,得混合药物;将混合药物再加入至喷雾流化床进行干燥及制粒,制得复方金银花微囊。
2.根据权利要求1所述复方金银花微囊的制备工艺,其特征在于:所述复合酶由质量比为1-3:1的纤维素酶和果胶酶组成。
3.根据权利要求1所述复方金银花微囊的制备工艺,其特征在于:步骤(2)所述浓缩是在压力为-0.05 ~ -0.10Mpa、温度为60-80℃下干燥至固含量为50-60%。
4.根据权利要求1所述复方金银花微囊的制备工艺,其特征在于:步骤(2)所述脉冲气体干燥是在温度为80-100℃,风速为10-15m/s下干燥。
5.根据权利要求1所述复方金银花微囊的制备工艺,其特征在于:所述囊材液的质量分数为20-30%;所述复方金银花干膏粉与囊材液的质量比为1:2-3。
6.根据权利要求1所述复方金银花微囊的制备工艺,其特征在于:所述增塑剂是由蔗糖甘油脂肪酸酯、月桂酸单甘油酯和卵磷脂组成;其加入量为复方金银花微囊质量的3-5%。
7.根据权利要求6所述复方金银花微囊的制备工艺,其特征在于:所述增塑剂中蔗糖甘油脂肪酸酯、月桂酸单甘油酯和卵磷脂的质量比为1-3:1-3:3-5。
8.根据权利要求1所述复方金银花微囊的制备工艺,其特征在于:所述均质处理是在压力为40-60MPa下处理20-30min。
9.根据权利要求1所述复方金银花微囊的制备工艺,其特征在于:步骤(4)是在喷雾进风温度为40-60℃,流化床鼓风温度为60-80℃下进行干燥。
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN202010760965.6A CN111973658A (zh) | 2020-07-31 | 2020-07-31 | 一种复方金银花微囊的制备工艺 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN202010760965.6A CN111973658A (zh) | 2020-07-31 | 2020-07-31 | 一种复方金银花微囊的制备工艺 |
Publications (1)
Publication Number | Publication Date |
---|---|
CN111973658A true CN111973658A (zh) | 2020-11-24 |
Family
ID=73444948
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN202010760965.6A Pending CN111973658A (zh) | 2020-07-31 | 2020-07-31 | 一种复方金银花微囊的制备工艺 |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN111973658A (zh) |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102001947A (zh) * | 2010-12-08 | 2011-04-06 | 广西金宏昕生物科技有限公司 | 一种金银花绿原酸的制备方法 |
CN106511484A (zh) * | 2016-12-07 | 2017-03-22 | 洛阳君山制药有限公司 | 一种复方金银花颗粒的提取制备工艺 |
CN109985097A (zh) * | 2019-05-21 | 2019-07-09 | 葵花药业集团北京药物研究院有限公司 | 一种复方金银花颗粒的制备方法 |
CN110123862A (zh) * | 2019-06-25 | 2019-08-16 | 江西济民可信药业有限公司 | 一种金银花提取物的制备方法 |
-
2020
- 2020-07-31 CN CN202010760965.6A patent/CN111973658A/zh active Pending
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102001947A (zh) * | 2010-12-08 | 2011-04-06 | 广西金宏昕生物科技有限公司 | 一种金银花绿原酸的制备方法 |
CN106511484A (zh) * | 2016-12-07 | 2017-03-22 | 洛阳君山制药有限公司 | 一种复方金银花颗粒的提取制备工艺 |
CN109985097A (zh) * | 2019-05-21 | 2019-07-09 | 葵花药业集团北京药物研究院有限公司 | 一种复方金银花颗粒的制备方法 |
CN110123862A (zh) * | 2019-06-25 | 2019-08-16 | 江西济民可信药业有限公司 | 一种金银花提取物的制备方法 |
Non-Patent Citations (2)
Title |
---|
本书编委会: "《药学专业知识1》", 31 January 2017, 中国医药科技出版社 * |
顾珂等: "水蒸气蒸馏_盐析法提取金银花挥发油工艺研究", 《亚太传统医药》 * |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US10086032B2 (en) | Method for preparing a Camellia nitidissima Chi lipid-lowering and hypoglycemic agent | |
CN1899361B (zh) | 贞芪药物组合及其制备 | |
CN104739777B (zh) | 一种单味中药粉末的制备方法 | |
CN105342867A (zh) | 一种本草组合物亚微米脂质载体及其制备方法 | |
CN102934710A (zh) | 一种苦荞茶及其制备工艺 | |
Zhang et al. | Preparation and properties of chitosan‐based microspheres by spray drying | |
CN105030561A (zh) | 包载熊果苷和维生素c的丝素蛋白微球及制备方法和应用 | |
CN107137376A (zh) | 一种黑果枸杞提取物微囊及由其制备的枸杞制剂 | |
CN103610659A (zh) | 一种大蒜素药物组合物及其制备方法 | |
CN104224858B (zh) | 蛹虫草微胶囊、制剂及其制备方法 | |
CN102919455A (zh) | 一种苦荞麦芽茶及其制备工艺 | |
CN102919454A (zh) | 一种灵芝苦荞茶及其制备工艺 | |
CN102266452A (zh) | 一种提高缺氧耐受力的中药组合物及其制备方法和应用 | |
CN111973658A (zh) | 一种复方金银花微囊的制备工艺 | |
CN102934717A (zh) | 一种罗布麻苦荞茶及其制备工艺 | |
CN112220859B (zh) | 一种复方中药制剂制备工艺 | |
CN102934719A (zh) | 一种银杏苦荞茶及其制备工艺 | |
CN107625852A (zh) | 一种清热利湿化瘀止带中药组合物及其制备工艺和应用 | |
CN111494334A (zh) | 一种制备蒙花苷微囊颗粒的方法 | |
CN111920894A (zh) | 一种三金微囊制剂的制备方法 | |
CN102934718A (zh) | 一种沙棘苦荞茶及其制备工艺 | |
CN111956696A (zh) | 一种复方金银花薄膜包衣片的制备工艺 | |
CN102940077A (zh) | 一种大麦苦荞茶及其制备工艺 | |
CN102934716A (zh) | 一种红景天苦荞茶及其制备工艺 | |
CN101024060A (zh) | 金嗓散结制剂及其制备方法 |
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 | ||
RJ01 | Rejection of invention patent application after publication |
Application publication date: 20201124 |