CN104258259A - 孕康胶囊的制备方法 - Google Patents
孕康胶囊的制备方法 Download PDFInfo
- Publication number
- CN104258259A CN104258259A CN201410538185.1A CN201410538185A CN104258259A CN 104258259 A CN104258259 A CN 104258259A CN 201410538185 A CN201410538185 A CN 201410538185A CN 104258259 A CN104258259 A CN 104258259A
- Authority
- CN
- China
- Prior art keywords
- parts
- radix
- filtrate
- thick paste
- preparation
- 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
- 239000002775 capsule Substances 0.000 title claims abstract description 28
- 238000002360 preparation method Methods 0.000 title claims abstract description 23
- 239000003814 drug Substances 0.000 claims abstract description 33
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 25
- 239000000706 filtrate Substances 0.000 claims abstract description 20
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 18
- 239000000843 powder Substances 0.000 claims abstract description 15
- 229940079593 drug Drugs 0.000 claims abstract description 14
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 11
- 229920002472 Starch Polymers 0.000 claims abstract description 9
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 9
- 239000002002 slurry Substances 0.000 claims abstract description 9
- 239000008107 starch Substances 0.000 claims abstract description 9
- 235000019698 starch Nutrition 0.000 claims abstract description 9
- 238000011049 filling Methods 0.000 claims abstract description 3
- 239000000203 mixture Substances 0.000 claims abstract description 3
- 108010052008 colla corii asini Proteins 0.000 claims description 17
- 239000006071 cream Substances 0.000 claims description 12
- 239000002994 raw material Substances 0.000 claims description 11
- 238000002791 soaking Methods 0.000 claims description 11
- 238000007670 refining Methods 0.000 claims description 9
- 239000012141 concentrate Substances 0.000 claims description 8
- 241000756943 Codonopsis Species 0.000 claims description 5
- 239000009636 Huang Qi Substances 0.000 claims description 5
- 241001619461 Poria <basidiomycete fungus> Species 0.000 claims description 5
- 238000001035 drying Methods 0.000 claims description 5
- 238000002156 mixing Methods 0.000 claims description 5
- VYQNWZOUAUKGHI-UHFFFAOYSA-N monobenzone Chemical compound C1=CC(O)=CC=C1OCC1=CC=CC=C1 VYQNWZOUAUKGHI-UHFFFAOYSA-N 0.000 claims description 5
- 239000002244 precipitate Substances 0.000 claims description 5
- 210000000582 semen Anatomy 0.000 claims description 5
- 239000006228 supernatant Substances 0.000 claims description 4
- 238000001914 filtration Methods 0.000 claims description 2
- 239000012467 final product Substances 0.000 claims description 2
- 230000000694 effects Effects 0.000 abstract description 13
- 239000006188 syrup Substances 0.000 abstract description 12
- 235000020357 syrup Nutrition 0.000 abstract description 12
- 238000004519 manufacturing process Methods 0.000 abstract description 5
- 239000002552 dosage form Substances 0.000 abstract description 3
- 241001061264 Astragalus Species 0.000 abstract 1
- 235000010110 Astragalus glycyphyllos Nutrition 0.000 abstract 1
- 241000123589 Dipsacus Species 0.000 abstract 1
- 235000006533 astragalus Nutrition 0.000 abstract 1
- 235000004879 dioscorea Nutrition 0.000 abstract 1
- 239000003292 glue Substances 0.000 abstract 1
- 239000000463 material Substances 0.000 abstract 1
- 238000001556 precipitation Methods 0.000 abstract 1
- 230000000052 comparative effect Effects 0.000 description 8
- 238000000034 method Methods 0.000 description 7
- 235000008504 concentrate Nutrition 0.000 description 6
- 241000699666 Mus <mouse, genus> Species 0.000 description 4
- 206010000210 abortion Diseases 0.000 description 3
- 231100000176 abortion Toxicity 0.000 description 3
- RGLYKWWBQGJZGM-ISLYRVAYSA-N diethylstilbestrol Chemical compound C=1C=C(O)C=CC=1C(/CC)=C(\CC)C1=CC=C(O)C=C1 RGLYKWWBQGJZGM-ISLYRVAYSA-N 0.000 description 3
- 229960000452 diethylstilbestrol Drugs 0.000 description 3
- 241000699670 Mus sp. Species 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 230000037396 body weight Effects 0.000 description 2
- 230000007812 deficiency Effects 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 230000035935 pregnancy Effects 0.000 description 2
- 239000000047 product Substances 0.000 description 2
- 230000006641 stabilisation Effects 0.000 description 2
- 238000011105 stabilization Methods 0.000 description 2
- 238000010254 subcutaneous injection Methods 0.000 description 2
- 239000007929 subcutaneous injection Substances 0.000 description 2
- 206010000242 Abortion threatened Diseases 0.000 description 1
- 208000008899 Habitual abortion Diseases 0.000 description 1
- 238000012449 Kunming mouse Methods 0.000 description 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- 208000005985 Threatened Abortion Diseases 0.000 description 1
- 230000002421 anti-septic effect Effects 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 230000027326 copulation Effects 0.000 description 1
- 230000003203 everyday effect Effects 0.000 description 1
- 210000003754 fetus Anatomy 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 210000003734 kidney Anatomy 0.000 description 1
- 238000002372 labelling Methods 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 229940127554 medical product Drugs 0.000 description 1
- 230000000813 microbial effect Effects 0.000 description 1
- 244000005700 microbiome Species 0.000 description 1
- 235000016709 nutrition Nutrition 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 210000000952 spleen Anatomy 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 238000003809 water extraction Methods 0.000 description 1
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)
- A61K36/88—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
- 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)
-
- 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)
- A61K36/46—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)
- A61K36/906—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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
-
- 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
-
- 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
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
Landscapes
- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Mycology (AREA)
- Biotechnology (AREA)
- Alternative & Traditional Medicine (AREA)
- Microbiology (AREA)
- Medical Informatics (AREA)
- Botany (AREA)
- Cell Biology (AREA)
- Dermatology (AREA)
- Biomedical Technology (AREA)
- Developmental Biology & Embryology (AREA)
- Immunology (AREA)
- Virology (AREA)
- Zoology (AREA)
- Neurosurgery (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
本发明公开了一种孕康胶囊的制备方法,将山药、续断、黄芪等二十二味中药材按下述步骤加工:步骤一、将上述原料药用50~60℃温水浸泡后过滤,滤液备用;步骤二、将步骤一过滤后的药渣加水煎煮后过滤,滤液备用;步骤三、合并步骤一和步骤二获得的滤液,加入原料药阿胶,浓缩制成稠膏;步骤四、醇沉步骤三获得的稠膏,取上清液并浓缩制成精制稠膏;步骤五、将步骤四获得的精制稠膏减压干燥制成干膏粉;步骤六、向步骤五获得的干膏粉中加入硬脂酸镁、淀粉浆,混匀后填充即得。本发明所述的孕康胶囊的制备方法能够保证新剂型可以实现原有孕康糖浆的功效,满足实际生产要求和消费需求。
Description
技术领域
本发明涉及一种孕康胶囊的制备方法,属于医药产品生产制造技术领域。
背景技术
孕康糖浆是一种公知的健脾固肾、养血安胎的药物,主要用于治疗肾虚型和气血虚弱型先兆流产和习惯性流产。众所周知,中药糖浆制剂因含糖等营养成分,在制备和贮藏过程中极易被微生物污染,导致糖浆霉败变质;为防止霉败现象的发生,生产中除需要采取防止污染措施外,常加入适宜的防腐剂以阻止或延缓微生物的增殖,使糖浆质量符合卫生学要求。由此可知,孕康糖浆其制剂形式导致其保质期较短,且发生霉败变质的风险较高。
胶囊制剂是一种非常常见的药物制剂形式,其具有提高药物的稳定性的效果,因药物装在胶囊壳中与外界隔离,避开了水分、空气、光线的影响,对具有不良嗅味、不稳定的药物有一定程度的遮蔽、保护与稳定作用。由于传统的孕康糖浆其制剂中含有水份,会使胶囊壁溶解的液体药剂,因此无法直接制成胶囊制剂,而对于孕康糖浆中的原料改变加工工艺则难以保证新剂型可以实现原有孕康糖浆的功效。
发明内容
本发明正是针对现有技术存在的不足,提供一种孕康胶囊的制备方法,可以实现原有孕康糖浆的功效,满足实际生产要求和消费需求。
为解决上述问题,本发明所采取的技术方案如下:
一种孕康胶囊的制备方法,由以下各质量份的原料药按下述方法制成:山药150份,续断90份,黄芪120份,当归90份,狗脊120份,菟丝子90份,桑寄生60份,杜仲90份,补骨脂90份,党参90份,茯苓120份,白术90份,阿胶30份,地黄120份,山茱萸90份,枸杞子120份,乌梅60份,白芍90份,砂仁60份,益智60份,苎麻根90份,黄芩60份,艾叶10份;
步骤一、将上述原料药除阿胶外,其余均用50~60℃温水浸泡后过滤,滤液备用;
步骤二、将步骤一过滤后的药渣加水煎煮后过滤,滤液备用;
步骤三、合并步骤一和步骤二获得的滤液,加入上述原料药阿胶,浓缩制成稠膏;
步骤四、醇沉步骤三获得的稠膏,取上清液并浓缩制成精制稠膏;
步骤五、将步骤四获得的精制稠膏减压干燥制成干膏粉;
步骤六、向步骤五获得的干膏粉中加入硬脂酸镁、淀粉浆,混匀后填充即得。
作为上述技术方案的改进,在上述步骤一中,除阿胶外的原料药用50~60℃温水浸泡4小时,且水量为用于浸泡的原料药总质量的5倍。
作为上述技术方案的改进,在上述步骤二中,将步骤一过滤后的药渣加水煎煮3次,每次加水量为用于煎煮的药渣质量的4倍,3次煎煮时间分别为2小时、1小时和0.5小时,过滤并合并滤液。
作为上述技术方案的改进,所述步骤六中,用于混合的干膏粉、淀粉浆和硬脂酸镁的质量份数依次为:100份、5~10份和0.05~0.5份。
本发明与现有技术相比较,本发明的实施效果如下:
本发明所述的孕康胶囊的制备方法,为孕康糖浆提供了新的应用剂型,使药物在胶囊壳中与外界隔离,避开了水分、空气、光线的影响,对具有不良嗅味、不稳定的药物有一定程度的遮蔽、保护与稳定作用;且本发明提供的胶囊制备方法能够保证新剂型可以实现原有孕康糖浆的功效,满足实际生产要求和消费需求。
具体实施方式
下面将结合具体的实施例来说明本发明的内容。
具体实施例1
本具体实施所提供的孕康胶囊的制备方法,由以下各质量份的原料药按下述方法制成:山药150份,续断90份,黄芪120份,当归90份,狗脊120份,菟丝子90份,桑寄生60份,杜仲90份,补骨脂90份,党参90份,茯苓120份,白术90份,阿胶30份,地黄120份,山茱萸90份,枸杞子120份,乌梅60份,白芍90份,砂仁60份,益智60份,苎麻根90份,黄芩60份,艾叶10份;
步骤一、将上述原料药除阿胶外,其余均用50~60℃温水浸泡4小时,且水量为用于浸泡的原料药总质量的5倍,浸泡后过滤,滤液备用;
步骤二、将步骤一过滤后的药渣加水煎煮并过滤3次,每次加水量为用于煎煮的药渣质量的4倍,3次煎煮时间分别为2小时、1小时和0.5小时,合并滤液备用;
步骤三、合并步骤一和步骤二获得的滤液,加入上述原料药阿胶,浓缩制成稠膏;
步骤四、醇沉步骤三获得的稠膏,取上清液并浓缩制成精制稠膏;
步骤五、将步骤四获得的精制稠膏减压干燥制成干膏粉;
步骤六、取步骤五获得的干膏粉100克,加入淀粉浆8克、硬脂酸镁0.2克,混匀后填充制得胶囊。
对照实施例1
本具体实施所提供的孕康胶囊的制备方法,由以下各质量份的原料药按下述方法制成:山药150份,续断90份,黄芪120份,当归90份,狗脊120份,菟丝子90份,桑寄生60份,杜仲90份,补骨脂90份,党参90份,茯苓120份,白术90份,阿胶30份,地黄120份,山茱萸90份,枸杞子120份,乌梅60份,白芍90份,砂仁60份,益智60份,苎麻根90份,黄芩60份,艾叶10份;
步骤一、将上述原料药除阿胶外,其余均用50~60℃温水浸泡4小时,且水量为用于浸泡的原料药总质量的5倍,浸泡后过滤,滤液备用;
步骤二、将步骤一过滤后的药渣加水煎煮并过滤3次,每次加水量为用于煎煮的药渣质量的4倍,3次煎煮时间分别为2小时、1小时和0.5小时,合并滤液备用;
步骤三、合并步骤一和步骤二获得的滤液,加入上述原料药阿胶,浓缩制成稠膏;
步骤四、将步骤三获得的稠膏减压干燥制成干膏粉;
步骤五、取步骤四获得的干膏粉100克,加入淀粉浆8克、硬脂酸镁0.2克,混匀后填充制得胶囊。
对照实施例2
本具体实施所提供的孕康胶囊的制备方法,由以下各质量份的原料药按下述方法制成:山药150份,续断90份,黄芪120份,当归90份,狗脊120份,菟丝子90份,桑寄生60份,杜仲90份,补骨脂90份,党参90份,茯苓120份,白术90份,阿胶30份,地黄120份,山茱萸90份,枸杞子120份,乌梅60份,白芍90份,砂仁60份,益智60份,苎麻根90份,黄芩60份,艾叶10份;
步骤一、将上述原料药除阿胶外,加水煎煮并过滤3次,每次加水量为用于煎煮的药渣质量的4倍,3次煎煮时间分别为2小时、2小时和1小时,合并滤液备用;
步骤二、向步骤一获得的滤液中加入上述原料药阿胶,浓缩制成稠膏;
步骤三、醇沉步骤二获得的稠膏,取上清液并浓缩制成精制稠膏;
步骤四、将步骤三获得的精制稠膏减压干燥制成干膏粉;
步骤五、取步骤四获得的干膏粉100克,加入淀粉浆8克、硬脂酸镁0.2克,混匀后填充制得胶囊。
试验实施例
实验对象为昆明种小鼠;雌鼠体重为28~30克;雄鼠体重为35~40克;小鼠按2︰1的雌雄比例合笼交配,检出阴栓之日为妊娠第1天,将受孕的雌鼠随机分成7个试验组。
除空白组和模型组外,其余试验组连续给药10天,每天早、晚各一次;与此同时除空白组外,其余试验组于妊娠7~8日连续皮下注射己烯雌酚2天,空白组皮下注射等体积的生理盐水2天。
各试验组小鼠于妊娠第18日处死,解剖,观察各组活胎数。对己烯雌酚所致流产的保胎作用效果见下表1:
表1、己烯雌酚所致流产的保胎作用效果
分组 | 雌鼠数 | 剂量 | 活胎数 | 活胎率 |
空白组 | 20只 | -- | 16只 | 100% |
模型组 | 20只 | -- | 3只 | 21% |
具体实施例1 | 20只 | 2g/kg | 12只 | 71% |
对照实施例1 | 20只 | 2g/kg | 7只 | 47% |
对照实施例1 | 20只 | 4g/kg | 10只 | 63% |
对照实施例2 | 20只 | 2g/kg | 5只 | 33% |
对照实施例2 | 20只 | 4g/kg | 6只 | 35% |
由上述表1可知:具体实施例1所提供的孕康胶囊的制备方法所制得的药物具有较好的保胎效果;对照实施例1中由于未经过醇沉精制工艺处理,所制得的孕康胶囊产品效果有所下降,在增加一倍用量后效果能够接近具体实施例1;对照实施例2中原料药未经过温水浸泡,直接采用煎煮方式水提原料药中的有效成分,尽管延长了煎煮的时间,但所制得的孕康胶囊产品效果仍不理想。
以上内容是结合具体的实施例对本发明所作的详细说明,不能认定本发明具体实施仅限于这些说明。对于本发明所属技术领域的技术人员来说,在不脱离本发明构思的前提下,还可以做出若干简单推演或替换,都应当视为属于本发明保护的范围。
Claims (4)
1.一种孕康胶囊的制备方法,其特征是由以下各质量份的原料药按下述方法制成:山药150份,续断90份,黄芪120份,当归90份,狗脊120份,菟丝子90份,桑寄生60份,杜仲90份,补骨脂90份,党参90份,茯苓120份,白术90份,阿胶30份,地黄120份,山茱萸90份,枸杞子120份,乌梅60份,白芍90份,砂仁60份,益智60份,苎麻根90份,黄芩60份,艾叶10份;
步骤一、将上述原料药除阿胶外,其余均用50~60℃温水浸泡后过滤,滤液备用;
步骤二、将步骤一过滤后的药渣加水煎煮后过滤,滤液备用;
步骤三、合并步骤一和步骤二获得的滤液,加入上述原料药阿胶,浓缩制成稠膏;
步骤四、醇沉步骤三获得的稠膏,取上清液并浓缩制成精制稠膏;
步骤五、将步骤四获得的精制稠膏减压干燥制成干膏粉;
步骤六、向步骤五获得的干膏粉中加入硬脂酸镁、淀粉浆,混匀后填充即得。
2.如权利要求1所述的孕康胶囊的制备方法,其特征是,在上述步骤一中,除阿胶外的原料药用50~60℃温水浸泡4小时,且水量为用于浸泡的原料药总质量的5倍。
3.如权利要求2所述的孕康胶囊的制备方法,其特征是,在上述步骤二中,将步骤一过滤后的药渣加水煎煮3次,每次加水量为用于煎煮的药渣质量的4倍,3次煎煮时间分别为2小时、1小时和0.5小时,过滤并合并滤液。
4.如权利要求1至3中任一所述的孕康胶囊的制备方法,其特征是,所述步骤六中,用于混合的干膏粉、淀粉浆和硬脂酸镁的质量份数依次为:100份、5~10份和0.05~0.5份。
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201410538185.1A CN104258259A (zh) | 2014-10-13 | 2014-10-13 | 孕康胶囊的制备方法 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201410538185.1A CN104258259A (zh) | 2014-10-13 | 2014-10-13 | 孕康胶囊的制备方法 |
Publications (1)
Publication Number | Publication Date |
---|---|
CN104258259A true CN104258259A (zh) | 2015-01-07 |
Family
ID=52149916
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN201410538185.1A Pending CN104258259A (zh) | 2014-10-13 | 2014-10-13 | 孕康胶囊的制备方法 |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN104258259A (zh) |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN106075276A (zh) * | 2016-08-29 | 2016-11-09 | 岳贵霞 | 一种用于治疗先兆流产的中药制剂及其制备方法 |
CN110917311A (zh) * | 2018-09-20 | 2020-03-27 | 江西济民可信药业有限公司 | 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 |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101066417A (zh) * | 2007-03-06 | 2007-11-07 | 回音必集团浙江亚东制药有限公司 | 孕康口服液在制备治疗妇女月经不调药物中的用途 |
CN101380440A (zh) * | 2008-09-02 | 2009-03-11 | 回音必集团浙江亚东制药有限公司 | 孕康口服液在制备治疗肾虚型不孕症药物中的用途 |
CN102512621A (zh) * | 2011-12-21 | 2012-06-27 | 江西济民可信药业有限公司 | 一种孕康胶囊的制备的方法 |
-
2014
- 2014-10-13 CN CN201410538185.1A patent/CN104258259A/zh active Pending
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101066417A (zh) * | 2007-03-06 | 2007-11-07 | 回音必集团浙江亚东制药有限公司 | 孕康口服液在制备治疗妇女月经不调药物中的用途 |
CN101380440A (zh) * | 2008-09-02 | 2009-03-11 | 回音必集团浙江亚东制药有限公司 | 孕康口服液在制备治疗肾虚型不孕症药物中的用途 |
CN102512621A (zh) * | 2011-12-21 | 2012-06-27 | 江西济民可信药业有限公司 | 一种孕康胶囊的制备的方法 |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN106075276A (zh) * | 2016-08-29 | 2016-11-09 | 岳贵霞 | 一种用于治疗先兆流产的中药制剂及其制备方法 |
CN110917311A (zh) * | 2018-09-20 | 2020-03-27 | 江西济民可信药业有限公司 | 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 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
CN103519043A (zh) | 一种营养保健蜂蜜及其制备方法 | |
CN103535735B (zh) | 灵芝解酒组合物、膏剂及其制作方法和用途 | |
CN103421640A (zh) | 一种药酒曲 | |
CN103191332A (zh) | 具有健胃消食作用的组合物及保健品 | |
CN101983702A (zh) | 一种治疗胃虚的中药组合物及其制备方法 | |
CN104524424A (zh) | 一种美容排毒祛斑口服液及其制备方法 | |
CN101601440A (zh) | 反刍动物饲料添加剂 | |
CN103071103B (zh) | 一种治疗流产的孕康口服液及其制备方法 | |
CN105902927A (zh) | 一种多功能保健中药配方 | |
CN104161889A (zh) | 一种治疗母猪无乳综合症的中药口服液及其制备方法 | |
CN104258259A (zh) | 孕康胶囊的制备方法 | |
CN105327238A (zh) | 一种健脾养胃的中药组合物及其制备方法和用途 | |
CN101766707A (zh) | 一种治疗口腔疾病的中药制剂 | |
CN103462167A (zh) | 植物饮料以及植物饮料的制作方法 | |
CN104258258A (zh) | 孕康滴丸的制备方法 | |
CN105878712A (zh) | 一种补心安神的中药组合物及其制备方法 | |
CN101317951A (zh) | 一种滋阴清热补心安神胶囊的制作方法 | |
CN105613667A (zh) | 一种雪莲果保健糕点及其制备方法 | |
CN110651858A (zh) | 一种降尿酸、缓解痛风的袋泡茶及其制备方法 | |
CN105878710A (zh) | 一种滋养阴血安神补心的中药组合物及其制备方法 | |
CN104042885A (zh) | 新小儿肺热咳喘口服制剂 | |
CN104721528A (zh) | 一种滋阴养血补心安神的中药组合物及其制备方法 | |
CN103141844A (zh) | 一种用于增强免疫力的食品及其制备方法 | |
CN103169811A (zh) | 一种改善睡眠的保健药品及制造方法 | |
CN101606964A (zh) | 一种兽用中药复方制剂 |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
C06 | Publication | ||
PB01 | Publication | ||
C10 | Entry into substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
WD01 | Invention patent application deemed withdrawn after publication | ||
WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20150107 |