CN108992580A - Chinese medicine composition and preparation method thereof for preventing phlegm from forming and stopping coughing - Google Patents

Chinese medicine composition and preparation method thereof for preventing phlegm from forming and stopping coughing Download PDF

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CN108992580A
CN108992580A CN201811116208.4A CN201811116208A CN108992580A CN 108992580 A CN108992580 A CN 108992580A CN 201811116208 A CN201811116208 A CN 201811116208A CN 108992580 A CN108992580 A CN 108992580A
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parts
medicine composition
volatile oil
chinese medicine
schizonepeta
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CN108992580B (en
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黄敏
黄国东
韦瑀龙
谢广源
黄燕琼
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RUIKANG HOSPITAL AFFILIATED TO GUANGXI UNIVERSITY OF CHINESE MEDICINE
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RUIKANG HOSPITAL AFFILIATED TO GUANGXI UNIVERSITY OF CHINESE MEDICINE
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    • A61K36/185—Magnoliopsida (dicotyledons)
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Abstract

The invention discloses a kind of Chinese medicine compositions for preventing phlegm from forming and stopping coughing, comprise the following components in parts by weight: 1600-2000 parts of campanulaceae, 1600-2000 parts of loguat leaf, 1600-2000 parts of Folium Sauropi, 1600-2000 parts of Cynanchum glaucescens, 1600-2000 parts of blackberry lily, 1000-1500 parts of schizonepeta, 1000-1500 parts of ford nervilia leaf, 1000-1500 parts of radix scutellariae, 1000-1500 parts of peppermint, 1600-2000 parts of radix bupleuri.The present invention has clearing heat and detoxicating, relieving cough and reducing sputum function, and to cough caused by acute/chronic bronchitis, pneumonia, sphagitis and fever caused by catching a cold, headache, spray tears have significant curative effect, and safe without toxic side effect.The invention also discloses the preparation method of the composition, which has product stability good, and effective component loss is small, and the advantages such as production cost is low, the disadvantages of volatile oil is volatile, and drug is unstable, and effective component loss is big is overcome in Chinese patent drug conventional production process.

Description

Chinese medicine composition and preparation method thereof for preventing phlegm from forming and stopping coughing
Technical field
The invention belongs to medicine field, it is related to a kind of drug and preparation method thereof, and in particular to one kind is used for preventing phlegm from forming and stopping coughing Chinese medicine composition and preparation method thereof.
Background technique
Cough is a kind of common respiratory symptom, normally due to trachea-bronchial epithelial cell mucous membrane or pleura by inflammation, foreign matter, Physically or chemically sexual stimulus causes.Coughing has the protective effect for removing respiratory tract foreign body and secretion.But if cough is not Stop, switch to chronic by acute, often bring great pain to patients, such as uncomfortable in chest, pharynx itches, breathes, and persistently violent cough Rest is not only influenced, goes back easy consumption physical strength, and the destruction of alveolar wall elastic fibrous tissue can be caused, induces pulmonary emphysema.Cough can be adjoint Expectoration, therefore eliminating the phlegm, resolving sputum are also needed while general cough-relieving.Currently, doctor trained in Western medicine mostly with antibiotic or contains the Western medicine of anesthetic composition Treatment, can neither effectively eradicate cough, and side effect is also big, be easy production drug resistance or dependence.Chinese medicine thinks that cough is because outer Feel the six external factors which cause diseases, internal organs internal injury influences the sound disease for having phlegm caused by lung, and based on eliminating evil, attention resolving sputum is pleasant for treatment, keeps phlegm clear Gas is suitable, and lung qi a surname is smooth.The present invention is that inventor passes through system, rigorous scientific research, using Guangxi Zhuang medicine resource as medicinal raw material The Chinese medicine composition with expectorant and asthma-curing, lung-heat clearing and detoxification and other effects developed.
(1) loguat leaf is the dried leaf of rosaceous plant loquat Eriobotrya japonica (Thunb.) Lindl.. Record in " Chinese Pharmacopoeia " version in 2015: [nature and flavor and channel tropism] is bitter, slightly cold.It attaches to the lung and stomach meridians.[function and cure mainly] clearing lung and relieving cough, Stopping nausea and vomiting by lowering the adverse flow of QI.For cough with lung heat, circulation of vital energy in the wrong direction asthma is anxious, and stomach energy is vomitted inverse, dysphoria and thirsty.It is main ingredient --- main mother in side of the present invention Medicine.
(2) Folium Sauropi is the dried leaf of euphorbia plant Folium Sauropi Sauropus spatulifolius Beille.It receives Be loaded in " Chinese Pharmacopoeia " version in 2015: [nature and flavor and channel tropism] is sweet, light, puts down.It attaches to the lung and stomach meridians.[function and cure mainly] moistening lung to arrest cough is led to Just.For xeropulmonary cough, pharyngalgia aphonia, constipation.It is main ingredient in side of the present invention --- main mother's medicine.
(3) ford nervilia leaf is the leaf of orchid taro orchid or the leaf with bulb." strengthen quality of medicinal material mark in Guangxi Zhuang Autonomous Region Quasi- compilation " volume Two: [nature and flavor] are sweet, cool.[major function] heat-clearing, moistening lung dissipate the stasis of blood, removing toxic substances.Control tuberculosis, convulsive seizure due to phlegm-fire hemoptysis, scrofula, Pyogenic infections, traumatic injury.Medicine is helped in Fang Zhongwei of the present invention --- help female medicine.
(3) blackberry lily is the dry rhizome of irides blackberry lily Belamcanda chinensis (L.) DC..Record in " Chinese Pharmacopoeia " version in 2015: [nature and flavor and channel tropism] is bitter, trembles with fear.It is distributed in lung channel.[function with cure mainly] clearing heat and detoxicating, dissolving phlegm, relieving sore-throat.With In heat toxin convulsive seizure due to phlegm-fire pent-up, abscess of throat, accumulation and obstruction of sputum, cough and asthma.It is priming in side of the present invention --- draw female medicine.
(4) campanulaceae is Campanulaceae campanulaceae Platycodon, grandiflorum (Jacq.) A.DC. dry root.It receives Be loaded in " Chinese Pharmacopoeia " version in 2015: [nature and flavor and channel tropism] is bitter, pungent, puts down.It is distributed in lung channel.[function and cure mainly] promoting the dispersing function of the lung, relieving sore-throat are dispelled Phlegm, apocenosis.For coughing with a lot of sputum, chest distress, pharyngalgia hoarse voice, lung carbuncle pyemesis.It is main ingredient --- Your Majesty's medicine in side of the present invention.
(5) Cynanchum glaucescens is Asclepiadaceae plant rhizoma et radix cynanchi stauntoni Cynanchum stauntonii (Decne.) Schltr.ex Or the dry rhizome and root of leaves of Daphne genkwa Cynanchum glaucescens Cynanchum glaucescens (Decne.) Hand.-M azz. Levl..It records In " Chinese Pharmacopoeia " version in 2015: [nature and flavor and channel tropism] is pungent, bitter, tepor.It is distributed in lung channel.[function and cure mainly] sending down abnormally ascending, dissolving phlegm, only Cough.Stop up real, coughing with a lot of sputum for lung qi, fullness sensation in chest asthma is anxious.It is priming in side of the present invention --- draw public medicine.
(6) schizonepeta is the dry aerial parts of Lamiaceae plant schizonepeta Schizonepeta tenuifolia Briq.. It records in " Chinese Pharmacopoeia " version in 2015: [nature and flavor and channel tropism] pungent, tepor.Return lung, Liver Channel.[function and cure mainly] inducing diaphoresis relieve heat, Promoting eruption, disappear sore.For catching a cold, have a headache, morbilli, rubeola, sore from the beginning of.Medicine is helped in Fang Zhongwei of the present invention --- help public medicine.
(7) radix scutellariae is the dry root of Lamiaceae plant radix scutellariae Scutellaria baicalensis Georgi.Record in " Chinese Pharmacopoeia " version in 2015: [nature and flavor and channel tropism] is bitter, trembles with fear.Return lung, gallbladder, spleen, large intestine, small intestinl channel.[function and cure mainly] heat-clearing Eliminating dampness, purging fire for removing toxin, hemostasis, miscarriage prevention.For damp-warm syndrome, summer-heat and damp, chest tightness and emesis, damp and hot feeling of fullness, dysentery, jaundice, cough with lung heat, height Hot polydipsia blood-head tells nosebleed, carbuncle sore tumefacting virus, threatened abortion.Medicine is helped in Fang Zhongwei of the present invention --- help female medicine.
(8) peppermint is the dry aerial parts of Lamiaceae plant peppermint Mentha haplocalyx Briq..Record in " Chinese Pharmacopoeia " version in 2015: [nature and flavor and channel tropism] is pungent, cool.Return lung, Liver Channel.[function and cure mainly] dispelling wind and heat from the body.Head clearing, Relieving sore-throat, promoting eruption, soothing the liver promoting the circulation of qi.For anemopyretic cold, wind-warm syndrome is from the beginning of headache, hot eyes, sore throat, aphtha, rubeola, morbilli, chest side of body is swollen It is bored.Medicine is helped in Fang Zhongwei of the present invention --- help female medicine.
(9) radix bupleuri is umbelliferae bupleurum Bupleurum chinense DC. or radix bupleuri scorzoneraefolii Bupleurum The dry root of scorzonerifolium Willd..Record in " Chinese Pharmacopoeia " version in 2015: [nature and flavor and channel tropism] is pungent, bitter, micro- It is cold.Return liver, gallbladder, lung channel.[function with cure mainly] evacuation is brought down a fever, soothing liver-qi stagnation, lifting disease.For cold, fever, fevers and chills alternate, Sternal rib pain, irregular menstruation, uterine prolapse, rectal prolapse.Medicine is helped in Fang Zhongwei of the present invention --- help public medicine.
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 Chinese medicine composition and preparation method thereof that the purpose of the present invention is to provide a kind of for preventing phlegm from forming and stopping coughing, with solve with Upper the deficiencies in the prior art.
To achieve the above object, the technical solution adopted in the present invention is as follows:
A kind of Chinese medicine composition for preventing phlegm from forming and stopping coughing, comprises the following components in parts by weight: 1600-2000 parts of campanulaceae, Pi 1600-2000 parts of rake leaf, 1600-2000 parts of Folium Sauropi, 1600-2000 parts of Cynanchum glaucescens, 1600-2000 parts of blackberry lily, schizonepeta 1000- 1500 parts, 1000-1500 parts of ford nervilia leaf, 1000-1500 parts of radix scutellariae, 1000-1500 parts of peppermint, 1600-2000 parts of radix bupleuri.
The above-described Chinese medicine composition for preventing phlegm from forming and stopping coughing, most preferably comprises the following components in parts by weight: campanulaceae 1850 Part, 1850 parts of loguat leaf, 1850 parts of Folium Sauropi, 1850 parts of Cynanchum glaucescens, 1850 parts of blackberry lily, 1233 parts of schizonepeta, 1233 parts of ford nervilia leaf, Huang 233 parts of a kind of reed mentioned in ancient books, 1233 parts of peppermint, 1850 parts of radix bupleuri.
The above-described Chinese medicine composition for preventing phlegm from forming and stopping coughing further includes following auxiliary material: 350-450 parts of dextrin, stevia rebaudianum It is 6-10 parts plain, it is best preferred are as follows: 410 parts of dextrin, 8 parts of Steviosin.
The above-described Chinese medicine composition for preventing phlegm from forming and stopping coughing can be prepared into pharmaceutically acceptable any oral agents Type is preferably prepared to oral solid formulation, is most preferably preferably prepared to granule.
The Chinese medicine composition for preventing phlegm from forming and stopping coughing described in more than one is prepared into the preparation method of granule, including following Step:
R1. campanulaceae, loguat leaf, Folium Sauropi, Cynanchum glaucescens, blackberry lily, schizonepeta, ford nervilia leaf, radix scutellariae, peppermint, radix bupleuri are taken respectively, are carried out Removal of impurities, it is dry；
R2. it is weighed by following parts by weight: 1600-2000 parts of campanulaceae, 1600-2000 parts of loguat leaf, Folium Sauropi 1600-2000 Part, 1600-2000 parts of Cynanchum glaucescens, 1600-2000 parts of blackberry lily, 1000-1500 parts of schizonepeta, 1000-1500 parts of ford nervilia leaf, radix scutellariae 1000-1500 parts, 1000-1500 parts of peppermint, 1600-2000 parts of radix bupleuri, 350-450 parts of dextrin, 6-10 parts of Steviosin；
R3. it takes schizonepeta, peppermint that 4-8 times of amount of water is added to extract volatile oil 1-3 hours, obtains volatile oil, the aqueous solution after distillation is another Device harvesting is spare；
R4. volatile oil obtained by step R3 preparation schizonepeta, Herba Menthae Haplocalycis volatile oil inclusion complex are taken；
R5. campanulaceae, loguat leaf, Folium Sauropi, Cynanchum glaucescens, blackberry lily, ford nervilia leaf, radix scutellariae, radix bupleuri are taken, 5-12 times of amount of water is added to decoct 2- It is 3 times, 1-2 hours each, filtering, merging filtrate；
Relative density is the medicinal extract of 1.08-1.12 when above-mentioned filtrate being R6. concentrated into 60 DEG C；
R7. above-mentioned medicinal extract is taken, ethyl alcohol, which is added, makes alcohol content up to 70%, stirs evenly, and stands 24-36 hours, and leaching supernatant returns Ethyl alcohol is received, thick paste is concentrated into；
R8. above-mentioned thick paste is taken, dextrin and Steviosin is added, is mixed, is made pellet, it is dry；
R9. take above-mentioned dry particle, add schizonepeta, Herba Menthae Haplocalycis volatile oil inclusion complex, mix, packing to get.
The above-described Chinese medicine composition for preventing phlegm from forming and stopping coughing is prepared into the preparation method of granule, chaste tree in step R4 Mustard, Herba Menthae Haplocalycis volatile oil inclusion complex inclusion method are as follows:
S1. betadex is weighed；
S2. the purified water for being equivalent to 6 times of betadex amounts is taken to be heated to 90 DEG C~100 DEG C；
S3. betadex is added in 90 DEG C~100 DEG C of purified water and saturated solution is made；
S4. saturated solution is let cool to 40 DEG C~50 DEG C, is slowly added to volatile oil while stirring, be maintained at 40 DEG C~50 DEG C Stirring 1 hour is taken out, is let cool, and seals, and cold place's (" Chinese Pharmacopoeia " version predetermined temperature in 2015 is 2 DEG C~10 DEG C) is placed 4 hours More than；
S5. liquid is discarded supernatant, the inclusion complex that lower layer is precipitated is taken out, filtering takes filtered inclusion complex in 40 DEG C~45 DEG C It is dried under reduced pressure；
S6. dry inclusion complex crosses 60 meshes, obtains volatile oil betadex inclusion complex.
The above-described Chinese medicine composition for preventing phlegm from forming and stopping coughing is prepared into the preparation method of granule, and schizonepeta, peppermint are waved In betadex in the inclusion method and step S1 of hair oil inclusion complex: volatile oil=8: the ratio of 1 (g: ml) weighs times his ring and pastes Essence.
The beneficial effects of the present invention are:
1, the present invention is used for relieving cough and reducing sputum Chinese medicine composition, is formulated by modern scientific theory.Campanulaceae is bitter in side Xin Ping, enters lung channel, open the inhibited lung-energy, eliminating the phlegm apocenosis, and loguat leaf sweet and cool-natured enters lung stomach meridian, clearing lung-heat stomach function regulating, lowering the adverse-rising QI to resolve phlegm, Folium Sauropi clearing lung-heat Cough-relieving, resolving sputum and relieving asthma, three medicines share as monarch.Radix bupleuri is worked hard slightly cold, enters liver and gallbladder lung channel, radix scutellariae bitter cold enters lung gallbladder splenomegaly intestines small intestine Through, two medicines to for minister, toil enters inner drop and dissipates, and the Xin Dabiao that trembles with fear is antipyretic, and lifting enters and leaves the gas that unhitches in logical three Jiao Dabiao go out, dissipate it is hot and suffocating, Ford nervilia leaf is clearing heat and detoxicating, clearing lung and relieving cough, and principal drug assistance relieving superficies by cooling, relieving cough and reducing sputum altogether.Schizonepeta pungent-warm, peppermint is pungent cool, enters lung Liver Channel, Dispelling wind and heat inducing diaphoresis, Cynanchum glaucescens Xin Ganwen enter lung channel, drop-down lung qi, lower phlegm and relieving cough, blackberry lily bitter cold, enter lung Liver Channel, fall fire removing toxic substances, Dissipating bind, anti-inflammatory, four medicines share to make, outer to dissipate its chill heat, keep channels and collaterals unobstructed, then lining is not compeled, and interior drop is rushed inverse, keep throat clear Void, then table gas is not stopped up, the evil outer solution of table and in yin assign, stop phlegm Su Shui, all under water channel.All medicines share play altogether it is clearing heat and detoxicating, Relieving cough and reducing sputum function generates heat, headache, spray tears to cough caused by acute/chronic bronchitis, pneumonia, sphagitis and caused by catching a cold There is significant curative effect, shows to treat chronic cough total effective rate up to 95% or more through clinical test results.
2, provided by the present invention for the preparation method of relieving cough and reducing sputum Chinese medicine composition, by composition it is important at Point --- schizonepeta, peppermint mixing are extracted, and are conducive to volatile oil and are separated from water, and volatile oil yield, which is higher than, individually to be extracted, and are saved It production time, reduces costs.
3, it provided by the present invention for the preparation method of relieving cough and reducing sputum Chinese medicine composition, is easily waved using beta-cyclodextrin inclusion Ingredient --- schizonepeta, Herba Menthae Haplocalycis volatile oil prevent volatile oils to hair, increase the stability of drug, reduce effective component Loss, improves the utilization rate of drug, overcomes in Chinese patent drug conventional production process that volatile oil is volatile, and drug is unstable, has Imitate the disadvantages of ingredient loss is big.
The invention will be further described combined with specific embodiments below, but does not limit the scope of the invention and apply Range:
One, preparation process conditional filtering
1, schizonepeta, Herba Menthae Haplocalycis volatile oil extraction process
The present invention compared schizonepeta, peppermint individually extract volatile oil with mix extract volatile oil, the results are shown in Table 1.
Table 1 extracts respectively and mixes extraction volatile oil cumulative amount (ml)
It can be seen from the above result that the oil mass that schizonepeta, peppermint mixing obtain when extracting volatile oil than individually extracting volatile oil It is more, therefore the present invention extracts volatile oil using schizonepeta, peppermint mixing.
In addition, also being investigated to the amount of water of volatile oil extracting, it the results are shown in Table 2.
The different amount of water volatile oil extracting amounts (ml) of table 2
Test result shows that it is larger that medicinal material adds 6 times of amounts 2-3 hours volatile oil of extraction of water to obtain oil mass, therefore volatile oil extracting is most Good technique are as follows: medicinal material adds 6 times of water amounts, and heating and refluxing extraction volatile oil 2 hours.
2, water decocting process
Using L9(34) orthogonal experiment, amount of water, extraction time, extraction time are studied, as a result as follows:
3 extraction conditions factor level table of table
4 extraction conditions orthogonal test table of table
Table 5 extracts test irisflorentin analysis of variance table
F0.10 (2,2)=9.0F0.05 (2,2)=19.0
* P < 0.10 is indicated
Table 6 extracts test scutelloside analysis of variance table
F0.10 (2,2)=9.0F0.05 (2,2)=19.0
* indicates P < 0.05
Table 7 extracts Experiment on Ethanol extract analysis of variance table
F0.10 (2,2)=9.0* indicates P < 0.10
The above experimental data variance analysis shows that extraction time has a significant impact.
Intuitively analysis shows, extraction time is major influence factors, and amount of water, extraction time are secondary cause；With secondary open country Tectorigenin and scutelloside are that the optimal conditions of evaluation index is A3B3C3, using ethanol soluble extraction as the optimal conditions of evaluation index For B3A3C1, consider production cost, therefore selected optimum extraction condition is A3B3C2, it may be assumed that medicinal material extracting in water (amount of water 10 three times Again, 8 times, 8 times), it extracts 1.5 hours every time.
3, alcohol precipitation process
Since to prepare particle melting unqualified for direct the water extracted immersing paste, therefore consider that conventional alcohol precipitation process is purified, and It is that index investigates removal of impurities effect by scutelloside total content, the melting in irisflorentin and radix scutellariae in dried cream yield, blackberry lily Fruit.Using L9(34) orthogonal experiment, alcohol precipitation concentration, medicinal extract relative density, alcohol precipitation time are studied, as a result as follows:
8 factor level table of table
Table 9 L9 (34) orthogonal array
10 irisflorentin analysis of variance table of table
11 scutelloside analysis of variance table of table
F0.10 (2,2)=9.0F0.05 (2,2)=19.0
* P < 0.10 is indicated
The above experimental data variance analysis shows that alcohol precipitation concentration has a significant impact.
Intuitively analysis shows, alcohol precipitation concentration is major influence factors, and medicinal extract relative density, alcohol precipitation time are secondary cause； It is A by the optimal conditions of evaluation index of irisflorentin3B1C3, it is by the optimal conditions of evaluation index of scutelloside A1B1C3, to guarantee irisflorentin recovery rate, and consider to produce operability and production cost, select best alcohol precipitation condition For A3B2C2, it may be assumed that decocting liquid is concentrated into the medicinal extract that relative density is 1.10 (60 DEG C), and ethyl alcohol, which is added, makes alcohol content up to 70%, stands 24 Hour, leaching supernatant recycles ethyl alcohol, continues to be concentrated into thick paste.
Two, a kind of preparation for relieving cough and reducing sputum Chinese medicine composition
Embodiment 1
A kind of preparation method being prepared into granule for relieving cough and reducing sputum Chinese medicine composition, comprising the following steps:
R1. campanulaceae, loguat leaf, Folium Sauropi, Cynanchum glaucescens, blackberry lily, schizonepeta, ford nervilia leaf, radix scutellariae, peppermint, radix bupleuri are taken respectively, are carried out Removal of impurities, it is dry；
R2. it is weighed by following parts by weight: campanulaceae 1600g, loguat leaf 1600g, Folium Sauropi 1600g, Cynanchum glaucescens 1600g, blackberry lily 1600g, schizonepeta 1000g, ford nervilia leaf 1000g, radix scutellariae 1000g, peppermint 1000g, radix bupleuri 1600g, dextrin 350g, Steviosin 6g；
R3. it takes schizonepeta, peppermint that 4 times of amounts of water is added to extract volatile oil 3 hours, obtains volatile oil, the another device of the aqueous solution after distillation is received It deposits spare；
R4. volatile oil obtained by step R3 preparation schizonepeta, Herba Menthae Haplocalycis volatile oil inclusion complex are taken: weighing betadex；It takes quite 90 DEG C are heated in the purified water that 6 times of betadex are measured；It is molten by saturation is made in 90 DEG C of betadex addition of purified water Liquid；Saturated solution is let cool to 40 DEG C, is slowly added to volatile oil while stirring, 40 DEG C is maintained at and stirs 1 hour, take out, let cool, Sealing, cold place are placed 4 hours；Liquid is discarded supernatant, the inclusion complex that lower layer is precipitated is taken out, filtering takes filtered inclusion complex in 40 It DEG C is dried under reduced pressure；Dry inclusion complex crosses 60 meshes, obtains volatile oil betadex inclusion complex；
R5. campanulaceae, loguat leaf, Folium Sauropi, Cynanchum glaucescens, blackberry lily, ford nervilia leaf, radix scutellariae, radix bupleuri are taken, is added water to cook 2 times, for the first time 12 times of amount water are added to decoct 2 hours, for the second time plus 9 times of amount water decoct 1 hour, filtering, merging filtrate；
The medicinal extract that relative density is 1.08 when above-mentioned filtrate being R6. concentrated into 60 DEG C；
R7. above-mentioned medicinal extract is taken, ethyl alcohol, which is added, makes alcohol content up to 70%, stirs evenly, 30 hours are stood, leaching supernatant, recycling Ethyl alcohol is concentrated into thick paste；
R8. above-mentioned thick paste is taken, dextrin and Steviosin is added, is mixed, is made pellet, it is dry；
R9. take above-mentioned dry particle, add schizonepeta, Herba Menthae Haplocalycis volatile oil inclusion complex, mix, packing to get.
Embodiment 2
A kind of preparation method being prepared into granule for relieving cough and reducing sputum Chinese medicine composition, comprising the following steps:
R1. campanulaceae, loguat leaf, Folium Sauropi, Cynanchum glaucescens, blackberry lily, schizonepeta, ford nervilia leaf, radix scutellariae, peppermint, radix bupleuri are taken respectively, are carried out Removal of impurities, it is dry；
R2. it is weighed by following parts by weight: campanulaceae 2000g, loguat leaf 2000g, Folium Sauropi 2000g, Cynanchum glaucescens 2000g, blackberry lily 2000g, schizonepeta 1500g, ford nervilia leaf 1500g, radix scutellariae 1500g, peppermint 1500g, radix bupleuri 2000g, dextrin 450g, Steviosin 10g；
R3. it takes schizonepeta, peppermint that 8 times of amounts of water is added to extract volatile oil 1 hour, obtains volatile oil, the another device of the aqueous solution after distillation is received It deposits spare；
R4. volatile oil obtained by step R3 preparation schizonepeta, Herba Menthae Haplocalycis volatile oil inclusion complex are taken: weighing betadex；It takes quite 100 DEG C are heated in the purified water that 6 times of betadex are measured；Betadex is added in 100 DEG C of purified water and saturation is made Solution；Saturated solution is let cool to 50 DEG C, is slowly added to volatile oil while stirring, 50 DEG C is maintained at and stirs 1 hour, take out, put Cold, sealing, cold place is placed 15 hours；Liquid is discarded supernatant, the inclusion complex that lower layer is precipitated is taken out, filtering takes filtered inclusion complex It is dried under reduced pressure in 45 DEG C；Dry inclusion complex crosses 60 meshes, obtains volatile oil betadex inclusion complex；
R5. campanulaceae, loguat leaf, Folium Sauropi, Cynanchum glaucescens, blackberry lily, ford nervilia leaf, radix scutellariae, radix bupleuri are taken, is added water to cook 3 times, for the first time Add 10 times of amount water, decoct 2 hours, second plus 7 times of amount water decoct 1.5 hours, and third time plus 5 times of amount water decoct 1 hour, mistake Filter, merging filtrate；
The medicinal extract that relative density is 1.12 when above-mentioned filtrate being R6. concentrated into 60 DEG C；
R7. above-mentioned medicinal extract is taken, ethyl alcohol, which is added, makes alcohol content up to 70%, stirs evenly, 36 hours are stood, leaching supernatant, recycling Ethyl alcohol is concentrated into thick paste；
R8. above-mentioned thick paste is taken, dextrin and Steviosin is added, is mixed, is made pellet, it is dry；
R9. take above-mentioned dry particle, add schizonepeta, Herba Menthae Haplocalycis volatile oil inclusion complex, mix, packing to get.
Embodiment 3
A kind of preparation method being prepared into granule for relieving cough and reducing sputum Chinese medicine composition, comprising the following steps:
R1. campanulaceae, loguat leaf, Folium Sauropi, Cynanchum glaucescens, blackberry lily, schizonepeta, ford nervilia leaf, radix scutellariae, peppermint, radix bupleuri are taken respectively, are carried out Removal of impurities, it is dry；
R2. it is weighed by following parts by weight: campanulaceae 1850g, loguat leaf 1850g, Folium Sauropi 1850g, Cynanchum glaucescens 1850g, blackberry lily 1850g, schizonepeta 1233g, ford nervilia leaf 1233g, radix scutellariae 1233g, peppermint 1233g, radix bupleuri 1850g, dextrin 410g, Steviosin 8g；
R3. it takes schizonepeta, peppermint that 6 times of amounts of water is added to extract volatile oil 2 hours, obtains volatile oil, the another device of the aqueous solution after distillation is received It deposits spare；
R4. volatile oil obtained by step R3 preparation schizonepeta, Herba Menthae Haplocalycis volatile oil inclusion complex are taken: weighing betadex；It takes quite 95 DEG C are heated in the purified water that 6 times of betadex are measured；It is molten by saturation is made in 95 DEG C of betadex addition of purified water Liquid；Saturated solution is let cool to 45 DEG C, is slowly added to volatile oil while stirring, 45 DEG C is maintained at and stirs 1 hour, take out, let cool, Sealing, cold place are placed 24 hours；Liquid is discarded supernatant, the inclusion complex that lower layer is precipitated is taken out, filtering takes filtered inclusion complex in 42 It DEG C is dried under reduced pressure；Dry inclusion complex crosses 60 meshes, obtains volatile oil betadex inclusion complex；
R5. campanulaceae, loguat leaf, Folium Sauropi, Cynanchum glaucescens, blackberry lily, ford nervilia leaf, radix scutellariae, radix bupleuri are taken, successively plus 10 times of water, 8 times, 8 It measures again, decocts 3 times, 1.5 hours every time, filter, merging filtrate；
The medicinal extract that relative density is 1.10 when above-mentioned filtrate being R6. concentrated into 60 DEG C；
R7. above-mentioned medicinal extract is taken, ethyl alcohol, which is added, makes alcohol content up to 70%, stirs evenly, 24 hours are stood, leaching supernatant, recycling Ethyl alcohol is concentrated into thick paste；
R8. above-mentioned thick paste is taken, dextrin and Steviosin is added, is mixed, is made pellet, it is dry；
R9. take above-mentioned dry particle, add schizonepeta, Herba Menthae Haplocalycis volatile oil inclusion complex, mix, packing to get.
Embodiment 4
A kind of preparation method being prepared into granule for relieving cough and reducing sputum Chinese medicine composition, comprising the following steps:
R1. campanulaceae, loguat leaf, Folium Sauropi, Cynanchum glaucescens, blackberry lily, schizonepeta, ford nervilia leaf, radix scutellariae, peppermint, radix bupleuri are taken respectively, are carried out Removal of impurities, it is dry；
R2. it is weighed by following parts by weight: campanulaceae 1850g, loguat leaf 1850g, Folium Sauropi 1850g, Cynanchum glaucescens 1850g, blackberry lily 1850g, schizonepeta 1233g, ford nervilia leaf 1233g, radix scutellariae 1233g, peppermint 1233g, radix bupleuri 1850g, dextrin 410g, Steviosin 8g；
R3. it takes schizonepeta, peppermint that 6 times of amounts of water is added to extract volatile oil 2 hours, obtains volatile oil, the another device of the aqueous solution after distillation is received It deposits spare；
R4. campanulaceae, loguat leaf, Folium Sauropi, Cynanchum glaucescens, blackberry lily, ford nervilia leaf, radix scutellariae, radix bupleuri are taken, successively plus 10 times of water, 8 times, 8 It measures again, decocts 3 times, 1.5 hours every time, filter, merging filtrate；
The medicinal extract that relative density is 1.10 when above-mentioned filtrate being R5. concentrated into 60 DEG C；
R6. above-mentioned medicinal extract is taken, ethyl alcohol, which is added, makes alcohol content up to 70%, stirs evenly, 24 hours are stood, leaching supernatant, recycling Ethyl alcohol is concentrated into thick paste；
R7. above-mentioned thick paste is taken, dextrin and Steviosin is added, is mixed, is made pellet, it is dry；
R8. take above-mentioned dry particle, add schizonepeta, Herba Menthae Haplocalycis volatile oil, mix, packing to get.
Three, clinical test
1 medical history information
1.1 general information
120 Chronic Cough Patients are chosen, wherein male 56, female 64, the age 20-63 years old, 41 years old, the course of disease 3 average The moon was to 2 years.Cough 40 caused by the infection of the upper respiratory tract and acute bronchitis, the caused cough 45 of chronic bronchitis, It coughs 25 caused by sphagitis etc., cough 10 caused by other diseases.
1.2 case selection
Above-mentioned case is to cough as cardinal symptom, and Cough length has been more than not improve centainly for 2 months, through chest CT And X-ray film is checked, does not find significant exception, eliminates cough caused by organic disease.
2 treatment methods
Above-mentioned 120 chronic patients are randomly divided into 5 groups by the various causes of disease, every group of 24 people, i.e., every group includes upper breathing Cough 8 caused by road infection and acute bronchitis, chronic bronchitis is caused to cough 9, cough caused by sphagitis etc. It coughs 5, cough 2 caused by other diseases.
2.1 embodiment groups
1-4 sample of the embodiment of the present invention is given, is taken orally, a 10g 3 times a day continuously takes 7 days.
2.2 control group
Dextromethorphan hydrobromide particle is given, is taken orally, a 15-30mg 3-4 times on the one, continuously takes 7 days.
3. therapeutic evaluation
By the therapeutic effect of each group patient and adverse reaction expansion comparison.The standard of curative effect evaluation are as follows:
(1) it cures: being treated patient's cough symptom and wholly or substantially disappeared, symptom is without repeatedly after drug withdrawal；
(2) effectively: substantially reduced through treatment patient's cough symptom, frequency and intensity mitigate up to 50% or more, Er Qieting Symptom is without exacerbation after medicine；
(3) invalid: alleviated through treatment patient's cough symptom without cough symptom after significant change or symptomatic treatment, but It coughs and recurs after drug withdrawal.
4. statistical procedures
Data processing and analysis are carried out using 22.0 software of SPSS, while being examined using t, as P < 0.05, shows difference It is statistically significant.
5. result
5.1 adverse reactions and safety evaluatio
In therapeutic process, each embodiment group patient does not occur adverse reaction.It is different degrees of that control group has 7 patients to occur Dizziness, headache, drowsiness adverse reaction, there is different degrees of anorexia, nausea, constipation adverse reaction in 6 patients, 2 There is skin allergy adverse reaction in patient, continues to treat in the case where not influencing research conditions.
5.2 Clinical efficacy comparison
12 each group Clinical efficacy comparison (example) of table
Note: compared with the control group*P < 0.05
12 result of study of table shows: after treatment compared with the control group, the total effective rate of embodiment 1-3 group is obviously higher than right According to the total effective rate of group, difference is statistically significant (P < 0.05), and 4 groups of embodiment of total effective rate and control group always has The difference of efficiency is unobvious, illustrates that volatile oil has a certain impact to curative effect without inclusion.
The above clinical test results show that the present invention can effectively treat various diseases for relieving cough and reducing sputum Chinese medicine composition The chronic cough because caused by, and use is safe, and no obvious adverse reaction has no toxic side effect.Preparation method of the present invention passes through handle After volatile oil is made into volatile oil betadex inclusion complex, volatile oils can be effectively prevented, increase the stability of drug, The loss for reducing effective component, improves the utilization rate of drug, to improve clinical efficacy.
Four, stability test
Above-described embodiment 1-4 sample is good with packaging of aluminium foil bag respectively, set Accelerated stability test tank test: temperature: 40 ± 2 DEG C, relative humidity: 75 ± 5%, it is accelerated test 3 months, fixed to appearance character, moisture, peppermint and Herba Schizonepetae volatile oil respectively Property identification, melting, active constituent content equistability high spot reviews index are detected, and with sample measurement result at 0 month Compare, test result is shown in Table 13.
13 stability test result table of table
By accelerated test 3 months it can be seen from 13 result of table, the equal nothing of every performance assessment criteria of embodiment 1-3 sample Significant change；Index and sample measurement at 0 month of the appearance character, moisture, melting, active constituent content of 4 sample of embodiment As a result compare, no significant change, but volatile oil has failed to detect when accelerating 3 months, prompt volatile oil without his ring again 4 sample quality of embodiment of dextrin inclusion is unstable, is not able to satisfy storage, transport, the stability requirement used.Illustrate the present invention After volatile oil by being made into volatile oil betadex inclusion complex by preparation method, embodiment 1-3 sample quality is relatively stable, can Meet the stability requirement storing, transport, using.

Claims (10)

1. a kind of Chinese medicine composition for preventing phlegm from forming and stopping coughing, which is characterized in that comprise the following components in parts by weight: campanulaceae 1600- 2000 parts, 1600-2000 parts of loguat leaf, 1600-2000 parts of Folium Sauropi, 1600-2000 parts of Cynanchum glaucescens, 1600-2000 parts of blackberry lily, chaste tree 1000-1500 parts of mustard, 1000-1500 parts of ford nervilia leaf, 1000-1500 parts of radix scutellariae, 1000-1500 parts of peppermint, radix bupleuri 1600-2000 Part.
2. the Chinese medicine composition according to claim 1 for preventing phlegm from forming and stopping coughing, which is characterized in that including following parts by weight Component: 1850 parts of campanulaceae, 1850 parts of loguat leaf, 1850 parts of Folium Sauropi, 1850 parts of Cynanchum glaucescens, 1850 parts of blackberry lily, 1233 parts of schizonepeta, blueness 1233 parts of semiaquilegia adoxoides, 233 parts of radix scutellariae, 1233 parts of peppermint, 1850 parts of radix bupleuri.
3. the Chinese medicine composition according to claim 1 or 2 for preventing phlegm from forming and stopping coughing, which is characterized in that the Chinese traditional medicine composition Object further includes following auxiliary material: 350-450 parts of dextrin, 6-10 parts of Steviosin.
4. the Chinese medicine composition according to claim 1 or 2 for preventing phlegm from forming and stopping coughing, which is characterized in that the Chinese traditional medicine composition Object further includes following auxiliary material: 410 parts of dextrin, 8 parts of Steviosin.
5. the Chinese medicine composition according to claim 1 or 2 for preventing phlegm from forming and stopping coughing, which is characterized in that the Chinese traditional medicine composition Object is prepared into pharmaceutically acceptable any peroral dosage form.
6. the Chinese medicine composition according to claim 3 for preventing phlegm from forming and stopping coughing, which is characterized in that the peroral dosage form is mouth Oral solid preparation.
7. the Chinese medicine composition according to claim 4 for preventing phlegm from forming and stopping coughing, which is characterized in that the oral solid formulation For granule.
8. a kind of preparation method for being prepared into granule for the Chinese medicine composition of preventing phlegm from forming and stopping coughing as claimed in claim 5, It is characterized in that, comprising the following steps:
R1. campanulaceae, loguat leaf, Folium Sauropi, Cynanchum glaucescens, blackberry lily, schizonepeta, ford nervilia leaf, radix scutellariae, peppermint, radix bupleuri are taken respectively, are removed It is miscellaneous, it is dry；
R2. weighed by following parts by weight: 1600-2000 parts of campanulaceae, 1600-2000 parts of loguat leaf, 1600-2000 parts of Folium Sauropi, 1600-2000 parts of Cynanchum glaucescens, 1600-2000 parts of blackberry lily, 1000-1500 parts of schizonepeta, 1000-1500 parts of ford nervilia leaf, radix scutellariae 1000- 1500 parts, 1000-1500 parts of peppermint, 1600-2000 parts of radix bupleuri, 350-450 parts of dextrin, 6-10 parts of Steviosin；
R3. it takes schizonepeta, peppermint that 4-8 times of amount of water is added to extract volatile oil 1-3 hours, obtains volatile oil, the another device of the aqueous solution after distillation is received It deposits spare；
R4. volatile oil obtained by step R3 preparation schizonepeta, Herba Menthae Haplocalycis volatile oil inclusion complex are taken；
R5. campanulaceae, loguat leaf, Folium Sauropi, Cynanchum glaucescens, blackberry lily, ford nervilia leaf, radix scutellariae, radix bupleuri are taken, 5-12 times of amount of water is added to decoct 2-3 times, 1-2 hours every time, filtering, merging filtrate；
Relative density is the medicinal extract of 1.08-1.12 when above-mentioned filtrate being R6. concentrated into 60 DEG C；
R7. above-mentioned medicinal extract is taken, ethyl alcohol, which is added, makes alcohol content up to 70%, stirs evenly, and stands 24-36 hours, and leaching supernatant recycles second Alcohol is concentrated into thick paste；
R8. above-mentioned thick paste is taken, dextrin and Steviosin is added, is mixed, is made pellet, it is dry；
R9. take above-mentioned dry particle, add schizonepeta, Herba Menthae Haplocalycis volatile oil inclusion complex, mix, packing to get.
9. the Chinese medicine composition according to claim 8 for preventing phlegm from forming and stopping coughing is prepared into the preparation method of granule, special Sign is: schizonepeta in the step R4, Herba Menthae Haplocalycis volatile oil inclusion complex inclusion method are as follows:
S1. betadex is weighed；
S2. the purified water for being equivalent to 6 times of betadex amounts is taken to be heated to 90 DEG C~100 DEG C；
S3. betadex is added in 90 DEG C~100 DEG C of purified water and saturated solution is made；
S4. saturated solution is let cool to 40 DEG C~50 DEG C, is slowly added to volatile oil while stirring, be maintained at 40 DEG C~50 DEG C stirrings It 1 hour, takes out, lets cool, seal, cold place is placed 4 hours or more；
S5. liquid is discarded supernatant, the inclusion complex that lower layer is precipitated is taken out, filtering takes filtered inclusion complex to depressurize in 40 DEG C~45 DEG C It is dry；
S6. dry inclusion complex crosses 60 meshes, obtains volatile oil betadex inclusion complex.
10. the Chinese medicine composition according to claim 9 for preventing phlegm from forming and stopping coughing is prepared into the preparation method of granule, special Sign is: in betadex in the step S1: volatile oil=8: the ratio of 1 (g: ml) weighs betadex.
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