CN106729406A - The preparation method of premenstrual peace preparation - Google Patents

The preparation method of premenstrual peace preparation Download PDF

Info

Publication number
CN106729406A
CN106729406A CN201611228007.4A CN201611228007A CN106729406A CN 106729406 A CN106729406 A CN 106729406A CN 201611228007 A CN201611228007 A CN 201611228007A CN 106729406 A CN106729406 A CN 106729406A
Authority
CN
China
Prior art keywords
preparation
fructus aurantii
decoction
radix bupleuri
ethanol
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.)
Granted
Application number
CN201611228007.4A
Other languages
Chinese (zh)
Other versions
CN106729406B (en
Inventor
林凡儒
王世礼
薛颖
高聪杰
刘超
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Xiang Yu Pharmaceutical Ltd Co
Original Assignee
Xiang Yu Pharmaceutical Ltd Co
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Xiang Yu Pharmaceutical Ltd Co filed Critical Xiang Yu Pharmaceutical Ltd Co
Priority to CN201611228007.4A priority Critical patent/CN106729406B/en
Publication of CN106729406A publication Critical patent/CN106729406A/en
Application granted granted Critical
Publication of CN106729406B publication Critical patent/CN106729406B/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
    • A61K36/9066—Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
    • 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
    • A61K36/18—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)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/233—Bupleurum
    • 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
    • A61K36/236—Ligusticum (licorice-root)
    • 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
    • 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
    • A61K36/484—Glycyrrhiza (licorice)
    • 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)
    • A61K36/75—Rutaceae (Rue family)
    • A61K36/752—Citrus, e.g. lime, orange or lemon
    • 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)
    • A61K36/889—Arecaceae, Palmae or Palmaceae (Palm family), e.g. date or coconut palm or palmetto
    • 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)
    • A61K36/89—Cyperaceae (Sedge family)
    • A61K36/8905—Cyperus (flatsedge)
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • 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
    • A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH

Landscapes

  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Mycology (AREA)
  • Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Medical Informatics (AREA)
  • Botany (AREA)
  • Biotechnology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Medicines Containing Plant Substances (AREA)

Abstract

The invention belongs to medicine extractive technique field, the preparation method of premenstrual peace preparation is disclosed, it comprises the following steps：Step 1）Take raw material, step 2）Prepare radix bupleuri Fructus Aurantii extract, step 3）Distillation, decoction and alcohol extracting, step 4）Granulation, compressing tablet and coating.Premenstrual peace preparation effect prepared by the present invention is better than prior art, non-toxic, can carry out further clinical experimental study.

Description

The preparation method of premenstrual peace preparation
Technical field
The invention belongs to medicine extractive technique field, and in particular to the preparation method of premenstrual peace preparation.
Background technology
Premenstrual peace is main have radix bupleuri, Fructus Aurantii, cortex albiziae, root tuber of aromatic turmeric, rhizoma cyperi, rascal, play both sides of the street, tangerine seed, Radix Angelicae Sinensis, the root of herbaceous peony, river The raw materials such as rhizome of chuanxiong, Poria cocos, the shell of areca nut, Radix Glycyrrhizae are prepared from, and are the active drugs for treating pre-menstrual period nercousness；Product is film-coating Piece, removes and is coated aobvious sepia；Gas fragrance, bitter, micro-pungent.Indication：Liver-smoothing, qi-regulating is promoting blood circulation and removing obstruction in channels.It is mainly used in women Pre-menstrual period nercousness, Chinese medical discrimination belong to stagnation of QI due to depression of the liver person, symptoms include premenstrual excited, fidgety irritability, it is depressed, it is melancholy, Swollen breasts, distending pain in the chest and hypochondrium, hypogastric pain or headache, or have different degrees of oedema, more or less mensis in amount, color is dark, dark tongue quality, arteries and veins String.The approved date of premenstrual peace piece is 2010-3-26, and production unit is Shandong Xiang space health pharmaceutical Co. Ltd, is the present invention Applicant.The premenstrual peace related invention patent " premenstrual peace piece preparation technology and its detection method " of applicant's early stage, by adding Plus bulk drug, improve drug effect, but have that prescription is complicated, the defect such as cost of material is higher.
Applicant has found that the medicine material extracting method is relatively single in pharmacy procedure, to plurality of raw materials using identical Extraction process, the defect that there is effective ingredients from lossing；And known drug is improved, the research and development of enterprise's early stage can be saved Cost, is the focus of business research in recent years.
The content of the invention
In order to overcome the defect of prior art, the present invention to propose the preparation method of premenstrual peace preparation, the preparation method is simple Active ingredient that is feasible, being extracted raw material to greatest extent, improves drug effect, reduces drug administration amount.
The present invention is achieved by the following technical solution：
The preparation method of premenstrual peace preparation, it comprises the following steps：Step 1）Take raw material, step 2）Prepare the extraction of radix bupleuri Fructus Aurantii Thing, step 3）Distillation, decoction and alcohol extracting, step 4）Granulation, compressing tablet and coating.
Specifically, the step 1）Take raw material：
Radix bupleuri 400g Fructus Aurantii 400g cortex albiziae 320g root tubers of aromatic turmeric 320g
Rhizoma cyperi 320g rascal 240g plays both sides of the street 280g tangerine seeds 240g
Radix Angelicae Sinensis 320g root of herbaceous peony 320g Ligusticum wallichii 240g Poria cocos 240g
Shell of areca nut 240g Radix Glycyrrhizaes 120g；
Specifically, the step 2）Prepare radix bupleuri Fructus Aurantii extract：Radix bupleuri and Fructus Aurantii are crushed in pulverizer, 200 mesh sieves are crossed, Then the flat bed of 3mm thickness is paved into, intensity is placed in for 3000uW/cm2Ultraviolet under irradiate 30min, collect powder and be placed in appearance In device, then add double weight 70%（v/v）Ethanol, be heated to 40 DEG C, then 300rpm stirring extract, in extraction process Control microwave power for 500W, extraction time is 60min；12 hours are stood, filtrate is collected in filtering, then low-temperature rotary evaporation Ethanol, then freeze-drying are reclaimed, radix bupleuri Fructus Aurantii extract is obtained final product.
Specifically, the step 3）Distillation, decoction and alcohol extracting：Root tuber of aromatic turmeric, rhizoma cyperi, rascal, Radix Angelicae Sinensis and Ligusticum wallichii are mixed, Volatile oil is extracted with the way of distillation, the dregs of a decoction are standby, and volatile oil is made Benexate Hydrochloride of beta-schardinger dextrin, standby；By above-mentioned medicine Slag adds 8 times of weight waters to decoct 2 times, 1 hour for the first time, second 0.5 hour, and filtrate A is collected in collecting decoction, filtration；By residue Raw material mixes, and adds water to cook 2 times, adds 10 times of weight waters decoctions, 2 hours, second plus 8 times weight waters to decoct for the first time 1 hour, Merge decoction liquor, liquor B is collected in filtration；Merging filtrate A and liquor B, are concentrated under reduced pressure into the leaching that density is 1.20-1.25g/mL Cream, lets cool, and adds ethanol, makes alcohol content be 55%（v/v）, 24 hours are stood, filtration, precipitation uses 55%（v/v）Ethanol is washed, filter Cross, merging filtrate, reclaim ethanol and be concentrated under reduced pressure into the medicinal extract that density is 1.20-1.25g/mL, spray drying obtains dried powder.
Specifically, the step 4）Granulation, compressing tablet and coating：Toward step 3）Step 3 is added in gained dried powder）Institute Obtain Benexate Hydrochloride and step 2）Gained radix bupleuri Fructus Aurantii extract, mixes, and is made particle, dries, plus auxiliary material carboxymethyl forms sediment Powder, Magnesium Stearate proper quantity is mixed, and is pressed into 1000, and film coating is obtained final product.
The characteristics of present invention is relative to prior art mainly includes but is not limited to the following aspects：
Premenstrual peace preparation effect prepared by the present invention is better than existing preparation, and dosage is also accordingly reduced；It is prepared by the present invention Different traditional Chinese medicine ingredients are processed by method simple possible using different technologies, improve the active ingredient of each raw material, are increased Drug effect, reduces wastage of material；Saikoside and Bupleurum chinense polysaccharide are the principle active components in radix bupleuri, and extraction generally uses water Alcohol deposition method is carried, saikoside when separating is extracted and chemical change is easily occurred, and cause Bupleurum chinense polysaccharide composition leaching rate low；Fructus Aurantii carries When taking, by the way of decocting, the decomposition of letones is easily caused；The present invention can improve effective group using less particle diameter Point leaching rate, recovery rate higher can be obtained by the way of ultraviolet irradiation coordinates microwave alcohol extracting, it is to avoid the loss of composition And wastage of material；Tablet effect prepared by the animal experiment prompting present invention is better than prior art, non-toxic, can further be faced Bed experimental study.
Specific embodiment
In order that those skilled in the art more fully understand the technical scheme in the application, below in conjunction with the application tool Body embodiment, is more clearly and completely described to the present invention, it is clear that described embodiment is only the application one Divide embodiment, rather than whole embodiments.Based on the embodiment in the application, those of ordinary skill in the art are not making The every other embodiment obtained under the premise of creative work, should all belong to the scope of protection of the invention.
Embodiment 1
The preparation method of premenstrual peace preparation, it comprises the following steps：
Weigh following raw material for standby：
Radix bupleuri 400g Fructus Aurantii 400g cortex albiziae 320g root tubers of aromatic turmeric 320g
Rhizoma cyperi 320g rascal 240g plays both sides of the street 280g tangerine seeds 240g
Radix Angelicae Sinensis 320g root of herbaceous peony 320g Ligusticum wallichii 240g Poria cocos 240g
Shell of areca nut 240g Radix Glycyrrhizaes 120g；
Radix bupleuri and Fructus Aurantii are crushed in pulverizer, 200 mesh sieves are crossed, the flat bed of 3mm thickness is then paved into, being placed in intensity is 3000uW/cm2Ultraviolet under irradiate 30min, collect powder and be placed in container, then add double weight 70%（v/v）Second Alcohol, is heated to 40 DEG C, and then 300rpm stirrings are extracted, and it is 500W that microwave power control in extraction process, and extraction time is 60min；12 hours are stood, filtrate is collected in filtering, ethanol, then freeze-drying are reclaimed in then low-temperature rotary evaporation, obtain final product radix bupleuri trifoliate orange Shell extract；Absorbance method detects that Bupleurum chinense polysaccharide total yield is 5.62%, trifoliate orange for 6.73%, HPLC methods measure saikoside total yield The total yield of shell neohesperidin and aurantiin is 12.6%；
Root tuber of aromatic turmeric, rhizoma cyperi, rascal, Radix Angelicae Sinensis and Ligusticum wallichii are mixed, volatile oil is extracted with the way of distillation, the dregs of a decoction are standby, volatile oil β- Cyclodextrin is made inclusion compound, standby；8 times of weight waters are added to decoct 2 times the above-mentioned dregs of a decoction, 1 hour for the first time, second 0.5 hour, Filtrate A is collected in collecting decoction, filtration；By surplus stock（Cortex albiziae, play both sides of the street, tangerine seed, the root of herbaceous peony, Poria cocos, the shell of areca nut, Radix Glycyrrhizae） Mixing, adds water to cook 2 times, adds 10 times of weight waters decoctions, 2 hours, second plus 8 times weight waters to decoct for the first time 1 hour, merging Liquor B is collected in decoction liquor, filtration；Merging filtrate A and liquor B, are concentrated under reduced pressure into the medicinal extract that density is 1.20-1.25g/mL, put It is cold, ethanol is added, make alcohol content be 55%（v/v）, 24 hours are stood, filtration, precipitation uses 55%（v/v）Ethanol is washed, filtration, is closed And filtrate, to reclaim ethanol and be concentrated under reduced pressure into the medicinal extract that density is 1.20-1.25g/mL, spray drying adds volatile oil beta-ring paste Inclusion compounds and radix bupleuri Fructus Aurantii extract, are mixed, and are made particle, dry, plus auxiliary material CMS, and Magnesium Stearate proper quantity is mixed It is even, 1000 are pressed into, film coating is obtained final product.
Tablet prepared by above-mentioned preparation method is Film coated tablets, removes and is coated aobvious sepia；Gas fragrance, bitter, micro-pungent.
【Specification】Every weight 0.37g（Film coated tablets）
【Storage】It is closed, put at shady and cool drying.
Comparative example 1
Premenstrual peace piece：
Radix bupleuri 400g Fructus Aurantii 400g cortex albiziae 320g root tubers of aromatic turmeric 320g
Rhizoma cyperi 320g rascal 240g plays both sides of the street 280g tangerine seeds 240g
Radix Angelicae Sinensis 320g root of herbaceous peony 320g Ligusticum wallichii 240g Poria cocos 240g
Shell of areca nut 240g Radix Glycyrrhizaes 120g
Seven tastes such as the taste of the above 14, radix bupleuri, Fructus Aurantii, root tuber of aromatic turmeric, rhizoma cyperi, rascal, Radix Angelicae Sinensis, Ligusticum wallichii extract volatile oil with the way of distillation, wave Hair oil is made inclusion compound of beta-schardinger dextrin, standby；The dregs of a decoction add the decocting of 8 times of amounts to boil 2 times, 1 hour for the first time, second 0.5 hour, Collecting decoction, filtration；The taste of remaining cortex albiziae etc. seven is added water to cook 2 times, adds the decocting of 10 times of amounts to boil for the first time 2 hours, Jia 8 for the second time Amount decocting again is boiled 1 hour, collecting decoction, filtration；Merge above-mentioned filtrate, be concentrated under reduced pressure into the leaching that density is 1.20-1.25g/mL Cream, is let cool, and adds ethanol, makes alcohol content be 55%, stands 24 hours, and filtration, precipitation is washed with 55% ethanol, is filtered, and merges filter Liquid, reclaims ethanol and is concentrated under reduced pressure into the medicinal extract that density is 1.20-1.25g/mL, and spray drying adds volatile oil beta-cyclodextrin bag Compound, is mixed, and is made particle, dries, plus auxiliary material CMS, and Magnesium Stearate proper quantity is mixed, and is pressed into 1000, bag film Clothing, obtains final product.
Absorbance method detects that Bupleurum chinense polysaccharide total yield is 4.03%, trifoliate orange for 3.98%, HPLC methods measure saikoside total yield The total yield of shell neohesperidin and aurantiin is 8.2%.
This product is Film coated tablets, removes and is coated aobvious sepia；Gas fragrance, bitter, micro-pungent.
【Usage and consumption】Orally.One time 5,2 times a day.Each menstruation to start for first 14 days medication, and clothes to menstruation come Tide is discontinued, and 3 menstrual cycles of continuous medication are a course for the treatment of.
【Specification】Every weight 0.37g（Film coated tablets）
【Storage】It is closed, put at shady and cool drying.
Embodiment 2
Animal toxicity test
Healthy Kunming Strains of Mouse 60, male and female half and half, body weight is 19.5 ± 1.7g, 60 mouse is randomly divided into two groups, often Group male and female half and half, wherein 30 is control group, fill with ordinary water；Other 30 mouse give the preparation of the preparation of embodiment 1, and dosage is 200mg/kg, three times a day, Application mouse carries out toxicity test and shows：Compare with control group, mouse has no substantially poor after administration It is different, experiment Continuous Observation three weeks, mouse systemic situation, ingest, drink water, body weight increase it is normal.Three after the administration same day and administration In all, animal dead is had no, point out the medicine toxicity low, clinical application safety.
Embodiment 3
First, analgesic test：
Selection female KM mouse 90, weight range is 21 ± 2g, and health is disease-free, and our company's Experimental Animal Center is raised.With Machine is divided into 3 groups, respectively 1 group of physiological saline group, embodiment（Preparation prepared by embodiment 1）, 1 group of reference examples（It is prepared by reference examples 1 Preparation）；It is taken twice daily, each dosage is that (1 group of 1 group of embodiment and reference examples give medicine, physiology to 200mg/kg respectively Salt solution group gives the physiological saline of equivalent weight), continuous gavage is administered 3 days, in after last gastric infusion 1 hour, intraperitoneal injection Only, mouse writhing number of times in observation 30min the results are shown in Table 1 to 0.6% glacial acetic acid 0.2ml/.
Table 1
Group Mouse number Writhing number of times in 30min
Physiological saline group 30 33.9±11.8
1 group of reference examples 30 8.2±2.9
1 group of embodiment 30 6.1±2.1
2nd, calm experiment：
Selection female KM mouse 60, weight range is 21 ± 2g, and health is disease-free, and our company's Experimental Animal Center is raised.With Machine is divided into 3 groups, respectively 1 group of physiological saline group, embodiment（Preparation prepared by embodiment 1）, 1 group of reference examples；Administration two daily Secondary, each dosage is that (1 group of 1 group of embodiment and reference examples give medicine to 200mg/kg respectively, and physiological saline group gives equivalent weight Physiological saline), continuous gavage be administered 3 days, in after last gastric infusion 30min, respectively to mouse peritoneal injection amobarbital Sodium 50mg/kg.To overturn areflexia and revert to sleep index, the length of one's sleep after record mouse injection.Concrete outcome is shown in Table 2：
Table 2
Group Mouse number The length of one's sleep（min）
Physiological saline group 20 51.8±20.4
1 group of reference examples 20 73.6±29.6
1 group of embodiment 20 82.3±21.8
Conclusion：Zoopery is pointed out, and medicine analgesic sedation effect prepared by the embodiment of the present invention 1 is good, better than existing preparation.
Listed above is only optimal specific embodiment of the invention.It is clear that the invention is not restricted to above example, may be used also To there is many deformations.All changes that one of ordinary skill in the art can directly derive from present disclosure or associate Shape, is considered as protection scope of the present invention.

Claims (5)

1. it is premenstrual peace preparation preparation method, it comprises the following steps：Step 1）Take raw material, step 2）Prepare the extraction of radix bupleuri Fructus Aurantii Thing, step 3）Distillation, decoction and alcohol extracting, step 4）Granulation, compressing tablet and coating.
2. preparation method according to claim 1, it is characterised in that the step 1）Take raw material：
Radix bupleuri 400g Fructus Aurantii 400g cortex albiziae 320g root tubers of aromatic turmeric 320g
Rhizoma cyperi 320g rascal 240g plays both sides of the street 280g tangerine seeds 240g
Radix Angelicae Sinensis 320g root of herbaceous peony 320g Ligusticum wallichii 240g Poria cocos 240g
Shell of areca nut 240g Radix Glycyrrhizaes 120g.
3. the preparation method according to claim 1-2, it is characterised in that the step 2）Prepare radix bupleuri Fructus Aurantii extract： Radix bupleuri and Fructus Aurantii are crushed in pulverizer, 200 mesh sieves are crossed, the flat bed of 3mm thickness is then paved into, intensity is placed in for 3000uW/ cm2Ultraviolet under irradiate 30min, collect powder and be placed in container, then add double weight 70%（v/v）Ethanol, heating To 40 DEG C, then 300rpm stirrings are extracted, and control microwave power for 500W in extraction process, and extraction time is 60min；Stand 12 Hour, filtrate is collected in filtering, and ethanol, then freeze-drying are reclaimed in then low-temperature rotary evaporation, obtain final product radix bupleuri Fructus Aurantii extract.
4. the preparation method according to claim 1-3, it is characterised in that the step 3）Distillation, decoction and alcohol extracting：Will The mixing of root tuber of aromatic turmeric, rhizoma cyperi, rascal, Radix Angelicae Sinensis and Ligusticum wallichii, volatile oil is extracted with the way of distillation, and the dregs of a decoction are standby, volatile oil beta-schardinger dextrin Benexate Hydrochloride is made, it is standby；8 times of weight waters are added to decoct 2 times the above-mentioned dregs of a decoction, 1 hour for the first time, 0.5 is small for the second time When, merging decoction liquor, filtrate A is collected in filtration；Surplus stock is mixed, is added water to cook 2 times, 10 times of weight decoctings are added for the first time Boil 2 hours, add 8 times of weight waters to decoct for the second time 1 hour, merge decoction liquor, filtration, collection liquor B；Merging filtrate A and filtrate B, is concentrated under reduced pressure into the medicinal extract that density is 1.20-1.25g/mL, lets cool, and adds ethanol, makes alcohol content be 55%（v/v）, stand 24 Hour, filtration, precipitation uses 55%（v/v）Ethanol is washed, filtration, and merging filtrate reclaims ethanol, is concentrated under reduced pressure into density for 1.20- The medicinal extract of 1.25g/mL, spray drying obtains dried powder.
5. the preparation method according to claim 1-4, it is characterised in that the step 4）Granulation, compressing tablet and coating：It is past Step 3）Step 3 is added in gained dried powder）Gained Benexate Hydrochloride and step 2）Gained radix bupleuri Fructus Aurantii extract, mixes It is even, particle is made, dry, plus auxiliary material CMS, Magnesium Stearate proper quantity, mix, 1000 are pressed into, film coating is obtained final product.
CN201611228007.4A 2016-12-27 2016-12-27 Preparation method of premenstrual ease preparation Active CN106729406B (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201611228007.4A CN106729406B (en) 2016-12-27 2016-12-27 Preparation method of premenstrual ease preparation

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201611228007.4A CN106729406B (en) 2016-12-27 2016-12-27 Preparation method of premenstrual ease preparation

Publications (2)

Publication Number Publication Date
CN106729406A true CN106729406A (en) 2017-05-31
CN106729406B CN106729406B (en) 2020-06-02

Family

ID=58922756

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201611228007.4A Active CN106729406B (en) 2016-12-27 2016-12-27 Preparation method of premenstrual ease preparation

Country Status (1)

Country Link
CN (1) CN106729406B (en)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110314214A (en) * 2019-08-12 2019-10-11 翔宇药业股份有限公司 A kind of peace piece and its quality determining method before menstruation
CN110339177A (en) * 2019-08-20 2019-10-18 广西万寿堂药业有限公司 Puerperal blood clot dispersing tablet and preparation method thereof
CN110368473A (en) * 2019-08-12 2019-10-25 翔宇药业股份有限公司 The preparation process of premenstrual peace piece

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1220163A (en) * 1998-11-12 1999-06-23 东莞市亚洲制药有限公司 Drug for curing premenstrual tension
CN103446567A (en) * 2013-08-30 2013-12-18 林凡友 Premenstrual ease pharmaceutical composition and preparation technique thereof
CN105213973A (en) * 2015-10-19 2016-01-06 翔宇药业股份有限公司 For alleviating the pharmaceutical composition of symptom before feminine menstrual

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1220163A (en) * 1998-11-12 1999-06-23 东莞市亚洲制药有限公司 Drug for curing premenstrual tension
CN103446567A (en) * 2013-08-30 2013-12-18 林凡友 Premenstrual ease pharmaceutical composition and preparation technique thereof
CN105213973A (en) * 2015-10-19 2016-01-06 翔宇药业股份有限公司 For alleviating the pharmaceutical composition of symptom before feminine menstrual

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
卫强: "《天然药物化学实验指导》", 31 December 2014, 安徽大学出版社 *

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110314214A (en) * 2019-08-12 2019-10-11 翔宇药业股份有限公司 A kind of peace piece and its quality determining method before menstruation
CN110368473A (en) * 2019-08-12 2019-10-25 翔宇药业股份有限公司 The preparation process of premenstrual peace piece
CN110339177A (en) * 2019-08-20 2019-10-18 广西万寿堂药业有限公司 Puerperal blood clot dispersing tablet and preparation method thereof

Also Published As

Publication number Publication date
CN106729406B (en) 2020-06-02

Similar Documents

Publication Publication Date Title
CN102416139B (en) Chinese medicine composition for treating breast diseases
CN106729406A (en) The preparation method of premenstrual peace preparation
CN101670068B (en) Medicament for treating gonarthromeningitis and preparation technology thereof
CN102319357B (en) Lipid-lowering dispersible tablets and preparation technology thereof
CN101584807A (en) Application of traditional Chinese medicine composition in preparing medicament of insulin sensitizer
CN108126026A (en) The preparation method of cordyceps sinensis QISHEN CAPSULE
CN101088546A (en) Heart-benefiting Yixinshu micropill and its prepn process
CN101347605B (en) Chinese medicinal composition for treating gout and preparation method and application thereof
CN106729405B (en) Pharmaceutical preparation for treating premenstrual syndrome and preparation method thereof
CN102846879A (en) Composition for depressing blood fat
CN1943756B (en) A Chinese traditional medicinal composition used for treatment of hypertension and its preparation method
CN105250427A (en) Pharmaceutical composition for treating heart diseases
CN104474195A (en) Traditional Chinese medicine compound preparation for treating leucoderma and preparation method of traditional Chinese medicine compound preparation
CN107890528A (en) A kind of Chinese medicine composition for treating hyperuricemia and preparation method thereof
CN105998697A (en) Medicine composition for treating esophagus cancer
CN100522238C (en) Pain-relieving and abdominal mass-eliminatnig bolus and its preparation
CN112656866A (en) Peach red four-ingredient particle and preparation method thereof
CN110314214A (en) A kind of peace piece and its quality determining method before menstruation
CN108371656A (en) The preparation method of six ingredients containing rehmanniae drop pill
CN110368473A (en) The preparation process of premenstrual peace piece
CN106728081A (en) The preparation of pure and impure kidney-tonifying capsule and the quality standard method of inspection
CN107970401A (en) A kind of medicine for treating constipation and preparation method thereof
CN1899428B (en) Chinese medicine preparation for treating pain and its preparing method
CN106728079B (en) Method for producing capsule preparation of Chinese caterpillar fungus, astragalus and ginseng
CN105213537A (en) A kind of pharmaceutical composition for the treatment of congestive heart failure

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
GR01 Patent grant
GR01 Patent grant