CN109223844A - CAULIS SCHEFFLERAE KWANGSIENSIS piece and preparation method thereof - Google Patents

CAULIS SCHEFFLERAE KWANGSIENSIS piece and preparation method thereof Download PDF

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CN109223844A
CN109223844A CN201811162923.1A CN201811162923A CN109223844A CN 109223844 A CN109223844 A CN 109223844A CN 201811162923 A CN201811162923 A CN 201811162923A CN 109223844 A CN109223844 A CN 109223844A
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caulis schefflerae
schefflerae kwangsiensis
parts
preparation
kwangsiensis
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韦天宝
黄智波
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Laibin City Weiwei Medicine Extraction Co Ltd
Guangxi Weiwei Pharmaceutical Co Ltd
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Laibin City Weiwei Medicine Extraction Co Ltd
Guangxi Weiwei Pharmaceutical Co Ltd
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Publication of CN109223844A publication Critical patent/CN109223844A/en
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    • 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)
    • A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K9/00—Medicinal preparations characterised by special physical form
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    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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    • 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
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • 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]
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    • 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
    • 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
    • A61K2236/55—Liquid-liquid separation; Phase separation

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Abstract

The invention discloses CAULIS SCHEFFLERAE KWANGSIENSIS pieces and preparation method thereof.CAULIS SCHEFFLERAE KWANGSIENSIS medicinal material is taken, after crushed, is infiltrated with 5% sodium bicarbonate solution, 30-40% ethyl alcohol heating and refluxing extraction, filtration are used again, and filtrate stands 24-48 hours in 0-4 DEG C of freezer, it filters, medicinal extract is obtained after decompression filtrate recycling ethanol, adds water, it mixes, being adjusted with acid solution ph is 3-4, then the butanol solution extraction being saturated with water, n-butanol is recovered under reduced pressure in extract liquor, and auxiliary material is added, and mixes, granulation, tabletting to get.The CAULIS SCHEFFLERAE KWANGSIENSIS active component with the pain effect that relieves the pain provided by the invention is prepared into sustained-release tablet, and the long-acting slow release of effective component persistently relieves the pain, and can continue to improve patient pain's state, facilitate clinical application.

Description

CAULIS SCHEFFLERAE KWANGSIENSIS piece and preparation method thereof
Technical field
Extraction separation and applied technical field the present invention relates to Chinese medicine, and in particular to Chinese peach piece and preparation method thereof.
Background technique
Pain is clinical common sympton, and the complication of many diseases all with pain, is brought great pain to patients.Mesh Preceding clinically common anodyne refer to can partially or completely medicine for relieving pain, have non-steroidal anti-inflammatory drugs and central analgesic Two class of medicine.Common anodyne has aspirin, somedon, paracetamol, phenylbutazone, rofecoxib etc..But it is used for a long time, stomach and intestine Road reaction and renal toxicity increase, erious adverse reaction, are unfavorable for the treatment and recovery of patient disease, and some anesthesia classes have habituation Property, therefore it is unable to prolonged application.And Chinese Traditional Medicine significantly improves clinical symptoms and sign treating pain or have when complication, Such as rhizoma corydalis, Radix Notoginseng, with adverse reaction is few and the advantages such as light.CAULIS SCHEFFLERAE KWANGSIENSIS is in treatment sciatica, trigeminal neuralgia etc. The special efficacy of stubborn and stupid pain causes people and more and more pays close attention to.
CAULIS SCHEFFLERAE KWANGSIENSIS is Chinese medicine simply with Guangxi national characters, records in " Guangxi Chinese herbal medicine ", is Araliaceae The drying stem and branch with leaf or stem branch of Radix Schfflerae kwangisensis Schefllera kwangsiensis Merr.ex Li.Its nature and flavor slight bitter, Puckery, temperature has wind-expelling pain-stopping, relaxing tendons and activating collaterals and other effects.It is mainly used for treating rheumatic arthritis, sciatica, trigeminal neuralgia Pain and kidney, biliary tract pains and other diseases.CAULIS SCHEFFLERAE KWANGSIENSIS main product is distributed mainly on the counties such as Wuming, the Fusui in Guangxi in Guangxi." the Guangxi people Race's medicine short course " in CAULIS SCHEFFLERAE KWANGSIENSIS the effect of and common method be described: root, stem are decocted in water for oral dose, treating rheumatic heart disease, premenstrual abdomen Bitterly, it catches a cold；Wine clothes are rushed in decocting, control lumbago due to wind-wetness evil；Be decocted in water for oral dose simultaneous ablution, harnesses the river swollen；Deposited affected part is mashed, fracture is controlled；Mash deposited wound Around mouthful, venomous snake bite is controlled.The research to CAULIS SCHEFFLERAE KWANGSIENSIS domestic at present is reported few, and Liu Xian etc. publishes thesis " the anti-inflammatory town of CAULIS SCHEFFLERAE KWANGSIENSIS Pain acts on the screening of active component " in, preliminary screening is carried out to the petroleum ether, ethyl acetate, n-butanol portion of CAULIS SCHEFFLERAE KWANGSIENSIS, as a result Show that ethyl acetate extract has more significant antalgic and inflammation relieving effect, but there are no further mentioning suitable for large-scale production Take the report of purification process and application.Hu book equality develops CAULIS SCHEFFLERAE KWANGSIENSIS organic acid composition Study and ointment, using ion Exchange chromatography and modern separation technology determine the optimum extraction process of total organic acids, and carry out pharmacological research, but extracting method Complicated, high production cost, is not suitable for industrialized production.The present invention further study CAULIS SCHEFFLERAE KWANGSIENSIS relieve the pain pain effective active at Point, the pain active component and suitable for the extraction of large-scale production of more effectively relieving the pain has been filtered out by optimizing method for extraction and purification Method, and it is prepared into the tablet with slow releasing function, currently, there is not yet relevant report.
The disclosure of background above technology contents is only used for auxiliary and understands inventive concept and technical solution of the invention, not The prior art for necessarily belonging to present patent application shows above content in the applying date of present patent application in no tangible proof In the case where having disclosed, above-mentioned background technique should not be taken to the novelty and creativeness of evaluation the application.
Summary of the invention
The purpose of the present invention is to provide it is a kind of extracted from CAULIS SCHEFFLERAE KWANGSIENSIS have relieve the pain pain effect active component and its Preparation method, and it is prepared into long-acting slow-release tablet, long-acting lasting remission patient is ailing.
A kind of CAULIS SCHEFFLERAE KWANGSIENSIS piece, the CAULIS SCHEFFLERAE KWANGSIENSIS piece the preparation method comprises the following steps: CAULIS SCHEFFLERAE KWANGSIENSIS medicinal material, after crushed, with 5% bicarbonate Sodium solution infiltration, then 30-40% ethyl alcohol heating and refluxing extraction is used, filtration, filtrate stands 24-48 hours in 0-4 DEG C of freezer, filter It crosses, medicinal extract is obtained after decompression filtrate recycling ethanol, adds water, mix, being adjusted with acid solution ph is 3-4, then the positive fourth being saturated with water Alcoholic solution extraction, extract liquor are recovered under reduced pressure n-butanol, and auxiliary material is added, and mix, granulation, tabletting to get.
Above-described CAULIS SCHEFFLERAE KWANGSIENSIS piece, is made of the supplementary material of following parts by weight: 3000 parts of CAULIS SCHEFFLERAE KWANGSIENSIS medicinal material, solubility 1-5 parts of starch, 3-8 parts of carboxymethyl cellulose, 1-2 parts of polyvinylpyrrolidone, 5-10 parts of microcrystalline cellulose, magnesium stearate 0.5- 1.0 part.
The preparation method of CAULIS SCHEFFLERAE KWANGSIENSIS piece described in more than one, comprising the following steps:
S1. 3000 parts of CAULIS SCHEFFLERAE KWANGSIENSIS medicinal material are taken, is crushed, is infiltrated with 5% sodium bicarbonate solution, then added with 30-40% ethyl alcohol Circumfluence distillation, filtration, obtains primary filtrate；
S2. primary filtrate is stood 24-48 hours in 0-4 DEG C of freezer, filtered, medicinal extract is obtained after decompression filtrate recycling ethanol；
S3. water is added in medicinal extract, mixes, being adjusted with acid solution ph is 3-4；
S4. n-butanol is recovered under reduced pressure in the butanol solution extraction being saturated with water, extract liquor, and dry, obtained extract is i.e. For CAULIS SCHEFFLERAE KWANGSIENSIS active component；
S5. soluble starch 1-5 parts, 3-8 parts of carboxymethyl cellulose, polyvinyl pyrrole are added in CAULIS SCHEFFLERAE KWANGSIENSIS active component 1-2 parts of alkanone, 5-10 parts of microcrystalline cellulose, 0.5-1.0 parts of magnesium stearate, mix, tabletting to get.
The preparation method of above-described CAULIS SCHEFFLERAE KWANGSIENSIS piece crushes CAULIS SCHEFFLERAE KWANGSIENSIS medicinal material in the step S1 and is preferably ground into slightly Powder.
The preparation method of above-described CAULIS SCHEFFLERAE KWANGSIENSIS piece, the dosage of 5% sodium bicarbonate solution is medicine in the step S1 Material weight is preferably measured for 1-1.2 times, and infiltrating time is preferably 20-30 minutes.
The preparation method of above-described CAULIS SCHEFFLERAE KWANGSIENSIS piece, heating and refluxing extraction number is preferably 2-3 times in the step S1.
The preparation method of above-described CAULIS SCHEFFLERAE KWANGSIENSIS piece, it is preferably Chinese peach that 30-40% amount of alcohol is added in the step S1 6-8 times of leaf medicinal material weight is measured.
The preparation method of above-described CAULIS SCHEFFLERAE KWANGSIENSIS piece, amount of water is preferably 4-6 times of medicinal extract weight in the step S3 Amount, the acid are preferably hydrochloric acid or sulfuric acid.
The preparation method of above-described CAULIS SCHEFFLERAE KWANGSIENSIS piece, the butanol solution being saturated with water in the step S4 preferably extract 2-3 times.
The application of above-described CAULIS SCHEFFLERAE KWANGSIENSIS piece, the CAULIS SCHEFFLERAE KWANGSIENSIS piece is in the health care product or medicine for preventing or treating pain symptom The application in object space face.The especially pain such as rheumatic arthritis, sciatica, trigeminal neuralgia and kidney, biliary tract.
The beneficial effects of the present invention are:
1, the present invention is screened by modernization extraction separation method in conjunction with pharmacological evaluation, preferably obtains making with the pain that relieves the pain With significant CAULIS SCHEFFLERAE KWANGSIENSIS active component, fumaric extract yield is up to 82% or more in the active component；Internal and body Outer pharmacodynamic test shows to all have significant analgesia, anti-inflammatory effect, and CAULIS SCHEFFLERAE KWANGSIENSIS active component more reported in the literature activity it is strong, Good drug efficacy.
2, the CAULIS SCHEFFLERAE KWANGSIENSIS active component with the pain effect that relieves the pain provided by the invention is prepared into sustained-release tablet, and effective component is long Slow release is imitated, is persistently relieved the pain, can continue to improve patient pain's state, facilitate clinical application.Chinese peach provided by the invention simultaneously The preparation method of leaf effective-part, operation is simple, and the active component high income of extraction, strong operability, production cost is low, It is suitble to industrial scale mass production.
Specific embodiment
The invention will be further described combined with specific embodiments below, but does not limit the scope of the invention and apply Range.CAULIS SCHEFFLERAE KWANGSIENSIS medicinal material used in the embodiment of the present invention is bought from Yulin medicinal material market, lot number 20171105, each embodiment Medicinal material used is same batch.
One, the preparation of CAULIS SCHEFFLERAE KWANGSIENSIS active component and CAULIS SCHEFFLERAE KWANGSIENSIS piece of the present invention
Embodiment 1
The preparation method of CAULIS SCHEFFLERAE KWANGSIENSIS active component, comprising the following steps:
S1. CAULIS SCHEFFLERAE KWANGSIENSIS medicinal material 5kg is taken, coarse powder is ground into, is infiltrated 20 minutes with 5% sodium bicarbonate solution 5kg, then with 6 Amount 30 ethyl alcohol heating and refluxing extraction 2 times again, 1 hour every time, filtration obtained primary filtrate；
S2. primary filtrate is stood 24 hours in 0-4 DEG C of freezer, filtered, medicinal extract is obtained after decompression filtrate recycling ethanol；
S3. 4 times of amount water are added in medicinal extract, mix, adjusting solution ph with hydrochloric acid solution is 3；
S4. the butanol solution being saturated with water extracts 2 times, and n-butanol is recovered under reduced pressure in extract liquor, dry, obtained extract As CAULIS SCHEFFLERAE KWANGSIENSIS active component.
The preparation method of 1 CAULIS SCHEFFLERAE KWANGSIENSIS piece of embodiment:
With the preparation method of the above CAULIS SCHEFFLERAE KWANGSIENSIS active component, the dosage of CAULIS SCHEFFLERAE KWANGSIENSIS medicinal material is 30kg, and being prepared into CAULIS SCHEFFLERAE KWANGSIENSIS has Position is imitated, soluble starch 10g, carboxymethyl cellulose 30g, polyvinylpyrrolidone 10g, microcrystalline cellulose 50g, tristearin is added Sour magnesium 5g, mix, tabletting to get.
Embodiment 2
The preparation method of CAULIS SCHEFFLERAE KWANGSIENSIS active component, comprising the following steps:
S1. CAULIS SCHEFFLERAE KWANGSIENSIS medicinal material 30kg is taken, coarse powder is ground into, is infiltrated 30 minutes with 5% sodium bicarbonate solution 6kg, then with 8 Amount 40% ethyl alcohol heating and refluxing extraction 3 times again, 2 hours every time, filtration obtained primary filtrate；
S2. primary filtrate is stood 48 hours in 0-4 DEG C of freezer, filtered, medicinal extract is obtained after decompression filtrate recycling ethanol；
S3. 6 times of amount water are added in medicinal extract, mix, adjusting solution ph with sulfuric acid solution is 4；
S4. the butanol solution being saturated with water extracts 3 times, and n-butanol is recovered under reduced pressure in extract liquor, dry, obtained extract As CAULIS SCHEFFLERAE KWANGSIENSIS active component.
The preparation method of 2 CAULIS SCHEFFLERAE KWANGSIENSIS piece of embodiment:
With the preparation method of the above CAULIS SCHEFFLERAE KWANGSIENSIS active component, the dosage of CAULIS SCHEFFLERAE KWANGSIENSIS medicinal material is 30kg, and being prepared into CAULIS SCHEFFLERAE KWANGSIENSIS has Position is imitated, soluble starch 50g, carboxymethyl cellulose 80g, polyvinylpyrrolidone 20g, microcrystalline cellulose 100g, hard is added Fatty acid magnesium 10g, mix, tabletting to get.
Embodiment 3
The preparation method of CAULIS SCHEFFLERAE KWANGSIENSIS active component, comprising the following steps:
S1. CAULIS SCHEFFLERAE KWANGSIENSIS medicinal material 5kg is taken, coarse powder is ground into, is infiltrated 25 minutes with 5% sodium bicarbonate solution 5.5kg, then use 7 times amount 35% ethyl alcohol heating and refluxing extraction 2 times, 1.5 hours every time, filtration, obtain primary filtrate；
S2. primary filtrate is stood 32 hours in 0-4 DEG C of freezer, filtered, medicinal extract is obtained after decompression filtrate recycling ethanol；
S3. 5 times of amount water are added in medicinal extract, mix, adjusting solution ph with hydrochloric acid solution is 3.5；
S4. the butanol solution being saturated with water extracts 3 times, and n-butanol is recovered under reduced pressure in extract liquor, dry, obtained extract As CAULIS SCHEFFLERAE KWANGSIENSIS active component.
The preparation method of 3 CAULIS SCHEFFLERAE KWANGSIENSIS piece of embodiment:
With the preparation method of the above CAULIS SCHEFFLERAE KWANGSIENSIS active component, the dosage of CAULIS SCHEFFLERAE KWANGSIENSIS medicinal material is 30kg, and being prepared into CAULIS SCHEFFLERAE KWANGSIENSIS has Position is imitated, soluble starch 30g, carboxymethyl cellulose 50g, polyvinylpyrrolidone 15g, microcrystalline cellulose 80g, tristearin is added Sour magnesium 7g, mix, tabletting to get.
Embodiment 4
The preparation method of CAULIS SCHEFFLERAE KWANGSIENSIS active component, comprising the following steps:
S1. CAULIS SCHEFFLERAE KWANGSIENSIS medicinal material 5kg is taken, coarse powder is ground into, is infiltrated 20 minutes with 5% sodium bicarbonate solution 4kg, then with 8 Amount 40% ethyl alcohol heating and refluxing extraction 3 times again, 1 hour every time, filtration obtained primary filtrate；
S2. primary filtrate is stood 24 hours in 0-4 DEG C of freezer, filtered, medicinal extract is obtained after decompression filtrate recycling ethanol；
S3. 4 times of amount water are added in medicinal extract, mix, adjusting solution ph with sulfuric acid solution is 4；
S4. the butanol solution being saturated with water extracts 3 times, and n-butanol is recovered under reduced pressure in extract liquor, dry, obtained extract As CAULIS SCHEFFLERAE KWANGSIENSIS active component.
The preparation method of 4 CAULIS SCHEFFLERAE KWANGSIENSIS piece of embodiment:
With the preparation method of the above CAULIS SCHEFFLERAE KWANGSIENSIS active component, the dosage of CAULIS SCHEFFLERAE KWANGSIENSIS medicinal material is 30kg, and being prepared into CAULIS SCHEFFLERAE KWANGSIENSIS has Position is imitated, soluble starch 20g, carboxymethyl cellulose 60g, polyvinylpyrrolidone 18g, microcrystalline cellulose 60g, tristearin is added Sour magnesium 6g, mix, tabletting to get.
Two, the preparation of documents CAULIS SCHEFFLERAE KWANGSIENSIS anti-inflammatory and analgesic effect active component
Comparative example
CAULIS SCHEFFLERAE KWANGSIENSIS medicinal material 0.5kg is taken, coarse powder is ground into, is heated to reflux 3 times with 75% ethyl alcohol, 1 hour every time, is filtered, close And extracting solution, ethyl alcohol is recycled, the powder that gets dry extract is dried in vacuo.With petroleum ether (60-90 DEG C) heating and refluxing extraction 3 times, 1 is small every time When, petroleum ether extract is discarded, takes extraction residue, then with ethyl acetate heating and refluxing extraction 3 times, every time 1 hour, is filtered, is closed And extracting solution, filtration, filtrate recycles ethyl acetate, and it is dry, obtain anti-inflammatory and analgesic effect active component comparative example sample.
Three, embodiment sample assay
1. chromatographic condition
Chromatographic column is Shimadzu VP-ODS column (250mm x 4.6mm): mobile phase is -0.2% phosphoric acid solution of methanol (5:95)； Flow velocity is 1.OmL/min, and column temperature is room temperature；Detector is Japanese Shimadzu SPD-M10Avp UV detector, and the detection wave people are 210nm。
2. the configuration of solution
The preparation of reference substance solution: precision weighs that fumaric acid reference substance is appropriate, adds methanol that every 1mL is made containing 10 μ g's Solution to get.
The preparation of sample solution: taking above-mentioned the present embodiment 1-4 active component, comparative example sample each 1g, accurately weighed, It is set in 100mL conical flask respectively, adds 50% ethanol solution 50mL, weighed weight, heating water bath reflux 2h lets cool, adds 50% second Alcohol supplies the weight of less loss, shakes up, 0.45 μ L miillpore filter filtration to get.
3. test result
The sample solution for taking above-described embodiment 1-4 active component, comparative example sample preparation to obtain, with fumaric acid For the performance assessment criteria of assay, measurement result is shown in Table 1, and calculates extract yield.
1 embodiment sample assay result table of table
Above-mentioned test result shows that the fumaric acid content in 1-4 sample of the embodiment of the present invention is all larger than comparison and implements Example group, extract yield height is 82% or more, high by 30% or more compared with comparative example group content, illustrates that the present invention is excellent through inventor Change the extracting method of screening, the extraction of organic acid is more complete in CAULIS SCHEFFLERAE KWANGSIENSIS medicinal material, and extraction efficiency is high, and effective active composition contains Amount is high.
Four, internal pharmacodynamics test
1. material
1.1 experiment reagents
Sample: respectively 3 active component of Example, prepare resulting CAULIS SCHEFFLERAE KWANGSIENSIS active component in comparative example, face use The grinding of preceding plus water is configured to the suspension of various concentration, as test solution；Positive control: acetylsalicylic acid tablet is matched before use It is spare at solution.
Reagent: rat, mouse, rabbit maintain feed (multifarious Jia Xing Biotechnology Co., Ltd of Wuhan City)；95% is edible Grade alcohol is that chemistry is pure, remaining reagent is that analysis is pure.
1.2 laboratory apparatus
Electronic balance (0.1g-1000g, Zhejiang Kai Feng group company)；Digital display thermostat water bath (HH-6, the general day instrument in Changzhou Device Manufacturing Co., Ltd)；Centrifuge (5430R, eppendorf desk type multifunctional refrigerated centrifuge)；Electrothermostat (DNP- 9052A, Xingtai Run Lian Science and Technology Development Co., Ltd.).
1.3 experimental animal
Cleaning grade Kunming mouse, 19~21g of weight；Cleaning grade Wistar rat, weight 150-200g；Regular grade is newly western Blue rabbit, 2.0~2.5kg of weight；Animal male and female dual-purpose requires selection Animal Sex according to different tests.Animal origin is in Guangxi Medical university.Rearing conditions: 25 ± 5 DEG C of room temperature, humidity 60 ± 20%.Feed is provided, freely ingests, drink water.
2. experimental method
2.1 analgesic test
2.1.1 hot plate method will first be vented beaker in water bath, and amount of water is not floated in water bath with beaker falls partially to spend, if Determining water bath temperature is 55 DEG C, and after temperature rises to 55 DEG C and stablizes, taking 100 weight is that 19~21g female mice is placed in sky In beaker, the incubation period (second) for licking metapedes reaction with mouse, for pain indicator, it is small between 5 seconds and 30 seconds to select the response latency Mouse (mouse of jump is rejected) measures and records the pain sensation response latency of every mouse (as pain threshold before medicine).It will Qualified mice is randomly divided into 3 high dose group of blank control group, positive drug control group (acetylsalicylic acid tablet) and embodiment, low dose Amount group, comparative example high dose group, every group 12.Start stomach-filling after grouping and give corresponding test medicine, 1 time a day, even It is 3 days continuous, the pain sensation response latency (person was in terms of 60 seconds in greater than 60 seconds) of each group mouse is measured after 1 hour, after the last administration with medicine Medicine analgesic effect is evaluated with the pain threshold difference before medicine afterwards (if being negative value with the pain threshold difference before medicine after medicine in terms of 0).
2.2.2 writhing method takes mouse 60,19~21g of weight, be randomly divided into blank control group, positive drug control group (Ah Take charge of a forest tract) and 3 high dose group of embodiment, low dose group, comparative example group high dose group, every group 12.It is filled after grouping Stomach gives corresponding test medicine, and 1 time a day, for three days on end, every mouse difference 0.6% acetic acid of ip is molten after last dose 1 hour Liquid 0.5ml, there is writhing response number in each every group of every mouse in 15 minutes from after injection acetum for observation, evaluates drug town Pain effect.
2.2 anti-inflammatory effect
2.2.1 the influence of Carrageenan rat podarthrum swelling
50 rats are taken, it is high to be randomly divided into blank control group, positive drug control group (acetylsalicylic acid tablet) and embodiment 3 Dosage group, low dose group, comparative example high dose group, every group 10.After animal packet, by method with rat start stomach-filling to Corresponding test drug is given, 1 time a day, for three days on end.Administration in 3rd day is thick with every rat right hind leg vola pedis of vernier caliper measurement simultaneously It spends (mm), as control value before medicine.1% carrageenan is subcutaneously injected in 30 minutes every group of every rat right hind leg vola pedis after administration 0.1ml/ only causes inflammation, cause it is scorching after 2,4,6h measure every rat right hind leg vola pedis thickness (mm) again so that right hind foot after inflammation Right hind vola pedis calculates swelling rate with a thickness of swelling before plantar thickness-cause is scorching.
3. the influence pair rabbit kneecap joint
2.0~2.5kg of weight new zealand rabbit 30 is selected, half male and half female is randomly divided into Normal group, model by gender Control group, positive controls (acetylsalicylic acid tablet), 3 high dose group of embodiment, low dose group, comparative example high dose group, often Group 6.It is in addition to Normal group, remaining 1.6% papain physiology salt of each group rabbit right Injection in knuckle articular cavity is water-soluble Liquid 0.5ml was injected once, co-injection 2 times again every 3 days.Modeling simultaneously, rabbit gives relative medicine by a group stomach-filling, daily 1 It is secondary, continuous 4 weeks.The 2nd day after the last administration, rabbit is put to death, kneecap joint tissue is taken, first substantially visually observes cartilage, then put Enter and impregnated in the formalin solution that volume fraction is 10%, row Hematoxylin-eosin (HE) dyes, and light is related under the microscope Morphological change, and carry out histological scores.
3 experimental results
3.1 analgesic activity
Hot plate method test result shows that 3 high dose group of embodiment has apparent analgesic activity, compared with positive controls, right The mouse hot-plate reaction time can be extended than embodiment high dose group, it is statistically significant compared with blank control group, it is shown in Table 2. Writhing method test result shows that 3 high dose group of embodiment has apparent analgesic activity, can significantly reduce mouse acetic acid injection and draw The writhing number risen, it is statistically significant compared with blank control group, it is shown in Table 3.
The analgesic activity result table of 2 hot plate method of table
Compared with blank control group: P < 0.01 * P < 0.05, * *
The analgesic activity result table of 3 writhing method of table
Compared with blank control group: P < 0.01 * P < 0.05, * *
3.2 anti-inflammatory effect
Test result shows that 3 high dose group of the embodiment of the present invention, low dose group and comparative example high dose group are diagonally pitched Dish glue causes the swelling of rat toes to have obvious anti-inflammatory effect, is shown in Table 4.
The influence result table of 4 Carrageenan of table cause rat toes swelling
Compared with blank control group: P < 0.01 * P < 0.05, * *
3.2.1 to the influence in rabbit kneecap joint
The embodiment of the present invention 3,5, which can reduce rabbit knee Osteoarthritis, to be shown to rabbit kneecap joint test result Pathological change, can reduce Papain enzymic rabbit knee osteoarthritis model articular cartilage pathology scoring score value, see Table 5.
The influence result table that table 5 scores to rabbit articular cartilage pathology
Compared with Normal group:▲▲P<0.01；Compared with model control group: P < 0.01 * P < 0.05, * *
Three, clinical application is tested
1. case selection
Selection is because of the functions of joint such as sciatica, affected nerves of patients with trigeminal neuralgia or rheumatism, arthritis, urarthritis Impaired patients.
2. therapeutic scheme
Therapeutic scheme one: taking commercially available acetylsalicylic acid tablet, each taking 1 (0.5g/ piece), 4 times a day.
Therapeutic scheme two: taking 3 CAULIS SCHEFFLERAE KWANGSIENSIS piece of the embodiment of the present invention, each taking 1 (0.5g/ piece), 2 times a day.
3. clinical efficacy
105 patients for meeting above-mentioned case selection condition are selected, male: 55, female: 50, the age: 15-65 years old.Using Above-mentioned therapeutic scheme treatment, is as a result detailed in following table.
Clinical efficacy investigation result table
Clinical test results show: treating above-mentioned case using the traditional chinese medicine composition of the invention, cure rate 70% is efficient 98%, this forest tract good effect of more conventional antalgica Ah does not have the adverse reactions such as gastrointestinal tract, can be obviously improved rheumatism, close The joint function disturbances patients such as inflammation, urarthritis are saved, the also stubborn and stupid pain such as sciatica, trigeminal neuralgia has good Curative effect.
4. typical case
(1) Jiang, male, 45 years old, because of the bad life habits such as long-term heavy drinking and the intake of high-fat, protein food, Cause with urarthritis, the raising of certain blood uric acid makes urarthritis break out, and knee joint red and swollen heat pain unbearably, uses 3 CAULIS SCHEFFLERAE KWANGSIENSIS piece of the embodiment of the present invention, each taking 1 (0.5g/ piece), 2 times a day.Red and swollen, pain relief, two stars after 7 days Red and swollen, pain disappears after phase, and joint motion is normal.
(2) poplar, female, 66 years old, left facial part recurrent exerbation paroxysmal shocks by electricity sample shouting pain 5 years, especially after wind and washes It is easy to send out when face listlessly, oral card aspirin can be relieved pain, but the drowsiness equal toxicities of dizziness and tinnitus are serious after medicine, are diagnosed as Trigeminal neuralgia.Using 3 CAULIS SCHEFFLERAE KWANGSIENSIS piece of the embodiment of the present invention, each taking 1 (0.5g/ piece), 2 times a day.After 1 week, Duration of seizure reduction, pain relief, do not reaccess after 1 month, fully recover.
(3) face, male, 62 years old, sciatica.Using 3 CAULIS SCHEFFLERAE KWANGSIENSIS piece of the embodiment of the present invention, each taking 1 (0.5g/ piece), 2 times a day.Pain relief after 5 days, pain disappears after 10 days, fully recovers after 15 days, can normal walking and movement.
The above content is combine it is specific/further detailed description of the invention for preferred embodiment, cannot Assert that specific implementation of the invention is only limited to these instructions.General technical staff of the technical field of the invention is come It says, without departing from the inventive concept of the premise, some replacements or modifications can also be made to the embodiment that these have been described, And these substitutions or variant all shall be regarded as belonging to protection scope of the present invention.

Claims (10)

1. a kind of CAULIS SCHEFFLERAE KWANGSIENSIS piece, which is characterized in that the CAULIS SCHEFFLERAE KWANGSIENSIS piece the preparation method comprises the following steps: CAULIS SCHEFFLERAE KWANGSIENSIS medicinal material, after crushed, use 5% sodium bicarbonate solution infiltration, then 30-40% ethyl alcohol heating and refluxing extraction is used, it filters, filtrate stands in 0-4 DEG C of freezer It 24-48 hours, filters, medicinal extract is obtained after decompression filtrate recycling ethanol, adds water, mix, being adjusted with acid solution ph is 3-4, then is used N-butanol is recovered under reduced pressure in the extraction of water saturated butanol solution, extract liquor, and auxiliary material is added, and mixes, granulation, tabletting to get.
2. CAULIS SCHEFFLERAE KWANGSIENSIS piece according to claim 1, which is characterized in that be made of the supplementary material of following parts by weight: Chinese peach 3000 parts of leaf medicinal material, 1-5 parts of soluble starch, 3-8 parts of carboxymethyl cellulose, 1-2 parts of polyvinylpyrrolidone, microcrystalline cellulose 5-10 parts, 0.5-1.0 parts of magnesium stearate.
3. a kind of preparation method of CAULIS SCHEFFLERAE KWANGSIENSIS piece as described in claim 1, which comprises the following steps:
S1. 3000 parts of CAULIS SCHEFFLERAE KWANGSIENSIS medicinal material are taken, is crushed, is infiltrated with 5% sodium bicarbonate solution, then heated back with 30-40% ethyl alcohol Stream extracts, and filtration obtains primary filtrate；
S2. primary filtrate is stood 24-48 hours in 0-4 DEG C of freezer, filtered, medicinal extract is obtained after decompression filtrate recycling ethanol；
S3. water is added in medicinal extract, mixes, being adjusted with acid solution ph is 3-4；
S4. n-butanol is recovered under reduced pressure in the butanol solution extraction being saturated with water, extract liquor, and dry, obtained extract is the Chinese Peach leaf active component；
S5. soluble starch 1-5 parts, 3-8 parts of carboxymethyl cellulose, polyvinylpyrrolidone are added in CAULIS SCHEFFLERAE KWANGSIENSIS active component 1-2 parts, 5-10 parts of microcrystalline cellulose, 0.5-1.0 parts of magnesium stearate, mix, tabletting to get.
4. the preparation method of CAULIS SCHEFFLERAE KWANGSIENSIS piece according to claim 3, which is characterized in that crush CAULIS SCHEFFLERAE KWANGSIENSIS in the step S1 Medicinal material is at coarse powder.
5. the preparation method of CAULIS SCHEFFLERAE KWANGSIENSIS piece according to claim 3, which is characterized in that 5% carbonic acid in the step S1 The dosage of hydrogen sodium solution is that 1-1.2 times of medicinal material weight is measured, and infiltrating time is 20-30 minutes.
6. the preparation method of CAULIS SCHEFFLERAE KWANGSIENSIS piece according to claim 3, which is characterized in that be heated to reflux and mention in the step S1 Taking number is 2-3 times.
7. the preparation method of CAULIS SCHEFFLERAE KWANGSIENSIS piece according to claim 3, which is characterized in that 30- is added in the step S1 40% amount of alcohol is that 6-8 times of CAULIS SCHEFFLERAE KWANGSIENSIS medicinal material weight is measured.
8. the preparation method of CAULIS SCHEFFLERAE KWANGSIENSIS piece according to claim 3, which is characterized in that amount of water is leaching in the step S3 4-6 times of cream weight is measured, and the acid is hydrochloric acid or sulfuric acid.
9. the preparation method of CAULIS SCHEFFLERAE KWANGSIENSIS piece according to claim 3, which is characterized in that be saturated with water in the step S4 Butanol solution extracts 2-3 times.
10. the application of CAULIS SCHEFFLERAE KWANGSIENSIS piece as described in claim 1, it is characterised in that: the CAULIS SCHEFFLERAE KWANGSIENSIS piece is preventing or treating pain The health care product of pain symptom or the application in terms of drug.
CN201811162923.1A 2018-09-30 2018-09-30 CAULIS SCHEFFLERAE KWANGSIENSIS piece and preparation method thereof Pending CN109223844A (en)

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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106727796A (en) * 2015-11-19 2017-05-31 哈尔滨圣吉药业股份有限公司 A kind of CAULIS SCHEFFLERAE KWANGSIENSIS dispersible tablet and preparation method thereof

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106727796A (en) * 2015-11-19 2017-05-31 哈尔滨圣吉药业股份有限公司 A kind of CAULIS SCHEFFLERAE KWANGSIENSIS dispersible tablet and preparation method thereof

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
刘娴，等: "汉桃叶抗炎镇痛作用有效部位的筛选", 《安徽医药》 *

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