CN108992580B - Traditional Chinese medicine composition for eliminating phlegm and relieving cough and preparation method thereof - Google Patents

Traditional Chinese medicine composition for eliminating phlegm and relieving cough and preparation method thereof Download PDF

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CN108992580B
CN108992580B CN201811116208.4A CN201811116208A CN108992580B CN 108992580 B CN108992580 B CN 108992580B CN 201811116208 A CN201811116208 A CN 201811116208A CN 108992580 B CN108992580 B CN 108992580B
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parts
volatile oil
year old
mint
schizonepeta
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CN108992580A (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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Abstract

The invention discloses a traditional Chinese medicine composition for eliminating phlegm and relieving cough, which comprises the following components in parts by weight: 1600-year old platycodon root, 2000-year old loquat leaf, 1600-year old sauropus rostratus, 2000-year old sauropus, 1600-year old swallowwort rhizome, 2000-year blackberry lily, 1000-year old schizonepeta, 1000-year old nervilia, 1500-year old baical skullcap root, 1000-year old mint, and 2000-year old bupleurum root. The invention has the functions of clearing away heat and toxic material, relieving cough and reducing sputum, has obvious curative effect on cough caused by acute and chronic bronchitis, pneumonia and sphagitis and fever, headache and snivel caused by cold, and is safe without toxic and side effect. The invention also discloses a preparation method of the composition, which has the advantages of good product stability, small loss of effective components, low production cost and the like, and overcomes the defects of volatile oil, unstable medicine, large loss of the effective components and the like in the conventional production process of Chinese patent medicines.

Description

Traditional Chinese medicine composition for eliminating phlegm and relieving cough and preparation method thereof
Technical Field
The invention belongs to the field of medicines, relates to a medicine and a preparation method thereof, and particularly relates to a traditional Chinese medicine composition for reducing phlegm and relieving cough and a preparation method thereof.
Background
Cough is a common respiratory symptom, generally caused by inflammation, foreign body, physical or chemical irritation of the trachea, bronchial mucosa or pleura. Cough has a protective effect of removing respiratory tract foreign bodies and secretions. However, if the cough changes from acute to chronic without stop, the patient is often suffered from great pain, such as chest distress, pharynx itch, asthma and the like, and the persistent and acute cough not only affects rest, but also easily consumes physical strength, and can cause the destruction of the alveolar wall elastic tissue to induce emphysema. Cough may be accompanied by expectoration, so generally, it is also necessary to dispel phlegm and resolve phlegm at the same time. At present, most western medicines are treated by antibiotics or western medicines containing anesthetic ingredients, so that cough can not be effectively eradicated, side effects are large, and drug resistance or dependence is easy to produce. The traditional Chinese medicine considers that cough is caused by external infection of six excesses and internal injury of viscera, and the influence on the lung causes the symptoms of sound and phlegm, and the treatment mainly aims at eliminating evil, emphasizes phlegm reduction and qi smoothening, enables the phlegm to be clear and smooth, and enables the lung qi to be smooth. The invention relates to a traditional Chinese medicine composition which is developed by taking Guangxi Zhuang medicine resources as medicinal materials through systematic and rigorous scientific research and has the effects of reducing phlegm, relieving asthma, clearing lung, detoxifying and the like.
(1) Loquat leaves are dried leaves of Eriobotrya japonica (Thunb.) lindl. In Chinese pharmacopoeia 2015 edition: [ PROPERTIES, WESTERN AND GUIJING ] is bitter and slightly cold. It enters lung and stomach meridians. [ FUNCTIONS AND INDICATIONS ] can clear lung-heat, relieve cough, check adverse rise of qi, and arrest vomiting. Can be used for treating cough due to lung heat, asthma, vomiting due to stomach heat, dysphoria with smothery sensation, and thirst. The invention is a main drug-main mother drug.
(2) Sauropus spatulifolius Beille, a dried leaf of Sauropus spatulifolius Beille, a plant of the family euphorbiaceae. In Chinese pharmacopoeia 2015 edition: [ PROPERTIES AND FLAVOUR AND GUIJING ] is sweet, bland and mild. It enters lung and stomach meridians. [ FUNCTIONS AND INDICATIONS ] moisten lung to arrest cough, and relieve constipation. Can be used for treating cough due to lung dryness, pharyngalgia, aphonia, and constipation. The invention is a main drug-main mother drug.
(3) Nerviliae Fordii is leaf or bulb of Orchidaceae plant Thymelaeaceae. The second volume of Guangxi Zhuang nationality autonomous region Zhuang medicinal material quality Standard compilation: [ PROPERTIES AND FLAVOUR ] sweet and cool. [ FUNCTIONS ] can clear away heat, moisten lung, remove blood stasis, and remove toxic substance. It is indicated for pulmonary tuberculosis, phlegm fire, hemoptysis, scrofula, swelling and traumatic injury. The invention is a drug for helping mother-help drug.
(3) Belamcanda chinensis (L.) DC. dried rhizome of Belamcanda chinensis (L.) of Iridaceae. In Chinese pharmacopoeia 2015 edition: [ PROPERTIES, WESTERN AND GUIJING ] is bitter and cold. It enters lung meridian. [ FUNCTIONS AND INDICATIONS ] can clear away heat and toxic materials, eliminate phlegm, and relieve sore throat. Can be used for treating stagnation of heat-toxin and phlegm-fire, sore throat, excessive phlegm and saliva, cough and asthma. The prescription of the invention is a guiding drug-guiding mother drug.
(4) Platycodon grandiflorum, a.dc. dried root of Platycodon grandiflorum Platycodon, grandiflorum (Jacq.) of family Campanulaceae. In Chinese pharmacopoeia 2015 edition: [ PROPERTIES AND WEIGHT-RESERVING GEN ] is bitter, pungent and mild. It enters lung meridian. [ FUNCTIONS AND INDICATIONS ] can ventilate the lung, relieve sore throat, dispel phlegm, and expel pus. Can be used for treating cough with excessive phlegm, chest distress, pharyngalgia, hoarseness, lung carbuncle, and purulent vomiting. The invention is a main drug-main drug.
(5) Cynanchum glaucescens is dried rhizome and root of Cynanchum atratum Bunge (Decne.) Schltr.ex Levl. of Asclepiadaceae or Cynanchum genkwa Bunge (Decne.) hand. In Chinese pharmacopoeia 2015 edition: [ PROPERTIES AND WEIGHT GUIDING GEN ] is pungent, bitter and slightly warm. It enters lung meridian. [ FUNCTIONS AND INDICATIONS ] can direct qi downward, resolve phlegm, and relieve cough. Can be used for treating lung qi stagnation, cough with excessive phlegm, fullness in chest, and dyspnea. The invention is a guiding drug-guiding drug.
(6) Schizonepeta tenuifolia, a dried aerial part of Schizonepeta tenuifolia Briq. In Chinese pharmacopoeia 2015 edition: [ PROPERTIES AND FLAVOUR GUIDING CHANNEL ] is pungent and warm. It enters lung and liver meridians. [ FUNCTIONS AND INDICATIONS ] can relieve exterior syndrome, dispel pathogenic wind, promote eruption and eliminate sore. Can be used for treating common cold, headache, measles, rubella, and initial stage of pyocutaneous disease. The invention is a drug for helping male sex.
(7) Scutellaria baicalensis Georgi is dried root of Scutellaria baicalensis Georgi of Labiatae. In Chinese pharmacopoeia 2015 edition: [ PROPERTIES, WESTERN AND GUIJING ] is bitter and cold. It enters lung, gallbladder, spleen, large intestine and small intestine meridians. [ FUNCTIONS AND INDICATIONS ] can clear away heat and dampness, purge fire and remove toxicity, stop bleeding, and prevent miscarriage. Can be used for treating damp-warm syndrome, summer-heat dampness, chest distress, emesis, dampness-heat distention and fullness, dysentery, jaundice, cough due to lung heat, hyperpyrexia, polydipsia, hematemesis, carbuncle, swelling, sore, and threatened abortion. The invention is a drug for helping mother-help drug.
(8) Mint, a dry aerial part of the mint family, mint Mentha halopthalyx briq. In Chinese pharmacopoeia 2015 edition: [ PROPERTIES AND FLAVOUR GUIDING CHANNELS ] is pungent and cool. It enters lung and liver meridians. [ FUNCTIONS AND INDICATIONS ] can dispel wind-heat. Clearing head and eyes, relieving sore throat, promoting eruption, soothing liver and promoting qi circulation. Can be used for treating wind-heat type common cold, headache, conjunctival congestion, pharyngitis, aphtha, rubella, measles, and chest and hypochondrium swelling. The invention is a drug for helping mother-help drug.
(9) Bupleurum chinense DC or Bupleurum scorzonerifolium Willd is dried root of Bupleurum chinense DC or Bupleurum scorzonerifolium Willd. In Chinese pharmacopoeia 2015 edition: [ PROPERTIES AND WEIGHT GUIDING CHANNEL ] is pungent, bitter and slightly cold. It enters liver, gallbladder and lung meridians. [ FUNCTIONS AND INDICATIONS ] can dispel heat, sooth the liver, relieve depression, and elevate yang qi. Can be used for treating common cold, fever, distending pain of chest and hypochondrium, menoxenia, uterine prolapse, and proctoptosis. The invention is a drug for helping male sex.
The above background disclosure is only for the purpose of assisting understanding of the inventive concept and technical solutions of the present invention, and does not necessarily belong to the prior art of the present patent application, and should not be used for evaluating the novelty and inventive step of the present application in the case that there is no clear evidence that the above content is disclosed at the filing date of the present patent application.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine composition for eliminating phlegm and relieving cough and a preparation method thereof, so as to solve the defects in the prior art.
In order to achieve the purpose, the technical scheme adopted by the invention is as follows:
a traditional Chinese medicine composition for eliminating phlegm and relieving cough comprises the following components in parts by weight: 1600-year old platycodon root, 2000-year old loquat leaf, 1600-year old sauropus rostratus, 2000-year old sauropus, 1600-year old swallowwort rhizome, 2000-year blackberry lily, 1000-year old schizonepeta, 1000-year old nervilia, 1500-year old baical skullcap root, 1000-year old mint, and 2000-year old bupleurum root.
The traditional Chinese medicine composition for eliminating phlegm and relieving cough optimally comprises the following components in parts by weight: 1850 parts of platycodon grandiflorum, 1850 parts of loquat leaves, 1850 parts of sauropus spatholobus stem, 1850 parts of swallowwort rhizome, 1850 parts of blackberry lily, 1233 parts of schizonepeta, 1233 parts of nervilia fordii, 233 parts of scutellaria baicalensis, 1233 parts of mint and 1850 parts of radix bupleuri.
The traditional Chinese medicine composition for eliminating phlegm and relieving cough also comprises the following auxiliary materials: 450 parts of dextrin 350-450 parts and 6-10 parts of steviosin, preferably: 410 parts of dextrin and 8 parts of steviosin.
The traditional Chinese medicine composition for eliminating phlegm and relieving cough can be prepared into any pharmaceutically acceptable oral dosage form, preferably an oral solid preparation, and most preferably a granule.
The preparation method of the granules from the traditional Chinese medicine composition for eliminating phlegm and relieving cough comprises the following steps:
r1, removing impurities from platycodon grandiflorum, loquat leaves, sauropus spatholobus stem, swallowwort rhizome, blackberry lily, schizonepeta, nervilia fordii, scutellaria baicalensis, mint and radix bupleuri respectively, and drying;
and R2, weighing the following components in parts by weight: 1600-2000 parts of platycodon grandiflorum, 1600-2000 parts of loquat leaf, 1600-2000 parts of sauropus, 1600-2000 parts of cynanchum glaucescens, 1600-2000 parts of blackberry lily, 1000-1500 parts of schizonepeta, 1000-1500 parts of nervilia fordii, 1000-1500 parts of scutellaria baicalensis, 1000-1500 parts of mint, 1600-2000 parts of bupleurum chinense, 350-450 parts of dextrin and 6-10 parts of steviosin;
r3, adding 4-8 times of water into the schizonepeta and the mint to extract volatile oil for 1-3 hours to obtain the volatile oil, and collecting the distilled water solution in another container for later use;
r4, preparing the volatile oil obtained in the step R3 into schizonepeta and mint volatile oil inclusion compounds;
r5. decocting radix Platycodonis, folium Eriobotryae, folium sauropus, rhizoma Cynanchi Stauntonii, rhizoma Belamcandae, folium Nerviliae Fordii, radix Scutellariae, and radix bupleuri in 5-12 times of water for 2-3 times (1-2 hr each time), filtering, and mixing filtrates;
r6. concentrating the filtrate to obtain extract with relative density of 1.08-1.12 at 60 deg.C;
r7. mixing above extracts, adding ethanol to ethanol content of 70%, stirring, standing for 24-36 hr, filtering to obtain supernatant, recovering ethanol, and concentrating to obtain soft extract;
r8. mixing above soft extracts with dextrin and steviosin, granulating, and drying;
r9. mixing above dried granules with volatile oil clathrate of herba Schizonepetae and herba Menthae, and packaging.
In the preparation method of the granules from the traditional Chinese medicine composition for eliminating phlegm and relieving cough, the inclusion method of the schizonepeta and mint volatile oil inclusion compound in the step R4 is as follows:
s1, weighing betacyclodextrin;
s2, heating purified water which is 6 times of the amount of the beta-cyclodextrin to 90-100 ℃;
s3, adding beta-cyclodextrin into purified water at the temperature of 90-100 ℃ to prepare a saturated solution;
s4, cooling the saturated solution to 40-50 ℃, slowly adding the volatile oil while stirring, keeping the temperature at 40-50 ℃, stirring for 1 hour, taking out, cooling, sealing, and standing in a cold place (the temperature is 2-10 ℃ specified in the 'Chinese pharmacopoeia' 2015 edition) for more than 4 hours;
s5, removing the supernatant, taking out the inclusion precipitated at the lower layer, filtering, and drying the filtered inclusion at 40-45 ℃ under reduced pressure;
s6, sieving the dried inclusion complex with a 60-mesh sieve to obtain the volatile oil beta-cyclodextrin inclusion complex.
The preparation method of the granules from the traditional Chinese medicine composition for eliminating phlegm and relieving cough comprises the step of S1 of the inclusion method of the schizonepeta and mint volatile oil inclusion compound, wherein betacyclodextrin is weighed according to the proportion of the betacyclodextrin to the volatile oil of 8: 1 (g: ml).
The invention has the beneficial effects that:
1. the traditional Chinese medicine composition for relieving cough and reducing sputum is prepared by modern scientific theory. In the formula, the platycodon root is bitter and pungent, enters lung channels, opens and disperses lung qi, eliminates phlegm and pus, the loquat leaves are sweet and cool, enter lung and stomach channels, clear lung and harmonize stomach, descend qi and reduce phlegm, the sauropus spatholobus stem leaves are used for clearing lung and relieving cough, and the combination of the three medicines is a monarch drug. Radix bupleuri is pungent, bitter and slightly cold, enters the lung channel of liver, gallbladder and lung, is bitter and cold in radix scutellariae, enters the small intestine channel of lung, gallbladder, spleen and large intestine, and is used as a minister, bitter and pungent enter the interior to reduce the dispersion, cold and pungent express to release heat, rise and exit to activate the triple energizer to release interior to release stagnation and qi, disperse stagnated heat, and the nervilia fordii is used for clearing heat and detoxicating, clearing lung and relieving cough, and is used for assisting monarch drugs to clear heat and release exterior, relieving cough and reducing phlegm. Herba schizonepetae is pungent and warm in flavor and warm in nature, mint is pungent and cool in nature, enters lung and liver channels, disperses wind, reduces lung qi, discharges phlegm, relieves cough, blackberrylily rhizome is bitter and cold in nature, enters lung and liver channels, reduces pathogenic fire, detoxifies, eliminates stagnation and diminishes inflammation. The Chinese medicinal materials are used together to play the functions of clearing away heat and toxic material, relieving cough and reducing sputum, and has obvious curative effect on cough caused by acute and chronic bronchitis, pneumonia and sphagitis and fever, headache and snivel caused by cold, and clinical test results show that the total effective rate of treating chronic cough is up to more than 95%.
2. According to the preparation method of the traditional Chinese medicine composition for relieving cough and reducing sputum, disclosed by the invention, the schizonepeta and the mint which are important components in the composition are mixed and extracted, so that the separation of volatile oil and water is facilitated, the yield of the volatile oil is higher than that of the volatile oil which is extracted separately, the production time is saved, and the cost is reduced.
3. The preparation method of the traditional Chinese medicine composition for relieving cough and reducing sputum provided by the invention adopts beta-cyclodextrin to encapsulate volatile components-herba schizonepetae and mint volatile oil, so that the volatile oil is prevented from volatilizing, the stability of the medicine is increased, the loss of the active ingredients is reduced, the utilization rate of the medicine is improved, and the defects that the volatile oil is easy to volatilize, the medicine is unstable, the loss of the active ingredients is large and the like in the conventional production process of Chinese patent medicines are overcome.
The invention is further described with reference to specific examples, without limiting the scope of protection and the scope of application of the invention:
screening preparation process conditions
1. Extraction process of volatile oil of schizonepeta and mint
The invention compares the volatile oil extracted from herba schizonepetae and mint separately with the volatile oil extracted from herba schizonepetae and mint together, and the results are shown in table 1.
TABLE 1 cumulative amount (ml) of volatile oil extracted and mixed respectively
Figure BDA0001810645240000051
From the above results, the volatile oil extracted from the herba schizonepetae and the mint is more than the volatile oil extracted from the herba schizonepetae and the mint respectively, so that the volatile oil extracted from the herba schizonepetae and the mint is mixed.
In addition, the water addition amount for the volatile oil extraction was also examined, and the results are shown in table 2.
TABLE 2 volatile oil extraction (ml) with different water addition
Figure BDA0001810645240000052
Test results show that the oil yield of the volatile oil obtained by extracting the medicinal materials for 2 to 3 hours by adding 6 times of water is large, so the optimal process for extracting the volatile oil is as follows: adding 6 times of water into the medicinal materials, heating and refluxing to extract volatile oil for 2 hours.
2. Water decoction process
By using L9(34) The orthogonal test method is used for researching water addition, extraction times and extraction time, and the result is as follows:
TABLE 3 extraction of Condition factor level tables
Figure BDA0001810645240000053
Table 4 extraction conditions orthogonal test table
Figure BDA0001810645240000061
TABLE 5 analysis of irisflavone variance in extraction test
Figure BDA0001810645240000062
F0.10(2，2)＝9.0F0.05(2，2)＝19.0
Denotes P <0.10
TABLE 6 analysis table for baicalin variance in extraction test
Figure BDA0001810645240000071
F0.10(2，2)＝9.0F0.05(2，2)＝19.0
Denotes P <0.05
TABLE 7 analysis table for variance of ethanol extract in extraction test
Figure BDA0001810645240000072
F0.10(2，2)9.0 denotes P<0.10
The above experimental data analysis of variance shows that the extraction times have significant influence.
Visual analysis shows that the extraction times are main influence factors, and the water addition amount and the extraction time are secondary factors; the optimal condition taking the sub-wild tectorigenin and the baicalin as evaluation indexes is A3B3C3The optimal condition using ethanol extract as evaluation index is B3A3C1Considering the production cost, the optimum extraction condition is selected as A3B3C2Namely: the medicinal materials are extracted by adding water for three times (10 times, 8 times and 8 times of water), and each time, the extraction is carried out for 1.5 hours.
3. Alcohol precipitation process
Because the solubility of the particles prepared by directly extracting the extract with water is unqualified, the conventional alcohol precipitation process is considered for purification, and the impurity removal effect is inspected by taking the dry extract yield, the total content of the sub-wild tectorigenin in the blackberry lily and the baicalin in the scutellaria baicalensis and the solubility as indexes. By using L9(34) The orthogonal test method is used for researching alcohol precipitation concentration, extract relative density and alcohol precipitation time, and the result is as follows:
TABLE 8 factor level table
Figure BDA0001810645240000073
TABLE 9L 9(34) orthogonal design sheet
Figure BDA0001810645240000081
TABLE 10 Ellis lutescens ANOVA TABLE
Figure BDA0001810645240000082
TABLE 11 baicalin ANOVA TABLE
Figure BDA0001810645240000083
F0.10(2，2)＝9.0F0.05(2，2)＝19.0
Denotes P <0.10
Analysis of variance of the experimental data shows that the alcohol precipitation concentration has a significant influence.
Visual analysis shows that the alcohol precipitation concentration is a main influence factor, and the relative density and alcohol precipitation time of the extract are secondary factors; the optimal conditions using sub-wild tectorigenin as evaluation index are A3B1C3The optimal condition taking baicalin as an evaluation index is A1B1C3Selecting the optimal alcohol precipitation condition A to ensure the extraction rate of the sub-wild tectorigenin and consider the production operability and the production cost3B2C2Namely: concentrating the decoction to obtain extract with relative density of 1.10(60 deg.C), adding ethanol to make ethanol content reach 70%, standing for 24 hr, filtering to obtain supernatant, recovering ethanol, and concentrating to obtain soft extract.
Secondly, preparation of a traditional Chinese medicine composition for relieving cough and reducing sputum
Example 1
A method for preparing a Chinese medicinal composition for relieving cough and reducing sputum into granules comprises the following steps:
r1, removing impurities from platycodon grandiflorum, loquat leaves, sauropus spatholobus stem, swallowwort rhizome, blackberry lily, schizonepeta, nervilia fordii, scutellaria baicalensis, mint and radix bupleuri respectively, and drying;
and R2, weighing the following components in parts by weight: 1600g of platycodon grandiflorum, 1600g of loquat leaf, 1600g of sauropus spatholobus stem, 1600g of cynanchum glaucescens, 1600g of blackberry lily, 1000g of schizonepeta, 1000g of nervilia fordii, 1000g of scutellaria baicalensis, 1000g of mint, 1600g of radix bupleuri, 350g of dextrin and 6g of steviosin;
r3, adding 4 times of water into the schizonepeta and the mint to extract volatile oil for 3 hours to obtain the volatile oil, and collecting the distilled water solution in another container for later use;
and R4, preparing the volatile oil obtained in the step R3 into schizonepeta and mint volatile oil inclusion complex: weighing beta-cyclodextrin; heating purified water with the amount of 6 times of that of the beta-cyclodextrin to 90 ℃; adding beta-cyclodextrin into purified water of 90 deg.C to obtain saturated solution; cooling the saturated solution to 40 deg.C, slowly adding the volatile oil while stirring, maintaining at 40 deg.C, stirring for 1 hr, taking out, cooling, sealing, and standing in cold place for 4 hr; discarding the supernatant, taking out the inclusion complex precipitated at the lower layer, filtering, and drying the filtered inclusion complex at 40 deg.C under reduced pressure; sieving the dried inclusion complex with a 60-mesh sieve to obtain a volatile oil BETA-cyclodextrin inclusion complex;
r5. decocting radix Platycodonis, folium Eriobotryae, folium sauropus, rhizoma Cynanchi Stauntonii, rhizoma Belamcandae, folium Nerviliae Fordii, radix Scutellariae, and radix bupleuri in water for 2 times, adding 12 times of water for 2 hr for the first time, adding 9 times of water for 1 hr for the second time, filtering, and mixing filtrates;
r6. concentrating the filtrate to obtain extract with relative density of 1.08 at 60 deg.C;
r7. mixing above extracts, adding ethanol to ethanol content of 70%, stirring, standing for 30 hr, filtering to obtain supernatant, recovering ethanol, and concentrating to obtain soft extract;
r8. mixing above soft extracts with dextrin and steviosin, granulating, and drying;
r9. mixing above dried granules with volatile oil clathrate of herba Schizonepetae and herba Menthae, and packaging.
Example 2
A method for preparing a Chinese medicinal composition for relieving cough and reducing sputum into granules comprises the following steps:
r1, removing impurities from platycodon grandiflorum, loquat leaves, sauropus spatholobus stem, swallowwort rhizome, blackberry lily, schizonepeta, nervilia fordii, scutellaria baicalensis, mint and radix bupleuri respectively, and drying;
and R2, weighing the following components in parts by weight: 2000g of platycodon grandiflorum, 2000g of loquat leaf, 2000g of sauropus rostratus, 2000g of cynanchum glaucescens, 2000g of blackberry lily, 1500g of schizonepeta, 1500g of nervilia fordii, 1500g of scutellaria baicalensis, 1500g of mint, 2000g of radix bupleuri, 450g of dextrin and 10g of steviosin;
r3, adding 8 times of water into the schizonepeta and the mint to extract the volatile oil for 1 hour to obtain the volatile oil, and collecting the distilled water solution in another container for later use;
and R4, preparing the volatile oil obtained in the step R3 into schizonepeta and mint volatile oil inclusion complex: weighing beta-cyclodextrin; heating purified water with the amount of 6 times of that of the beta-cyclodextrin to 100 ℃; adding beta-cyclodextrin into purified water of 100 deg.C to obtain saturated solution; cooling the saturated solution to 50 deg.C, slowly adding the volatile oil while stirring, maintaining at 50 deg.C, stirring for 1 hr, taking out, cooling, sealing, and standing in cold place for 15 hr; discarding the supernatant, taking out the inclusion complex precipitated at the lower layer, filtering, and drying the filtered inclusion complex at 45 ℃ under reduced pressure; sieving the dried inclusion complex with a 60-mesh sieve to obtain a volatile oil BETA-cyclodextrin inclusion complex;
r5. decocting radix Platycodonis, folium Eriobotryae, folium sauropi, rhizoma Cynanchi Stauntonii, rhizoma Belamcandae, folium Nerviliae Fordii, radix Scutellariae, and radix bupleuri with water for 3 times, 10 times of water for the first time, 2 hours for the second time, 7 times of water for the second time, 1.5 hours for the second time, 5 times of water for the third time, 1 hour for the first time, filtering, and mixing filtrates;
r6. concentrating the filtrate to obtain extract with relative density of 1.12 at 60 deg.C;
r7. mixing above extracts, adding ethanol to ethanol content of 70%, stirring, standing for 36 hr, filtering to obtain supernatant, recovering ethanol, and concentrating to obtain soft extract;
r8. mixing above soft extracts with dextrin and steviosin, granulating, and drying;
r9. mixing above dried granules with volatile oil clathrate of herba Schizonepetae and herba Menthae, and packaging.
Example 3
A method for preparing a Chinese medicinal composition for relieving cough and reducing sputum into granules comprises the following steps:
r1, removing impurities from platycodon grandiflorum, loquat leaves, sauropus spatholobus stem, swallowwort rhizome, blackberry lily, schizonepeta, nervilia fordii, scutellaria baicalensis, mint and radix bupleuri respectively, and drying;
and R2, weighing the following components in parts by weight: 1850g of platycodon grandiflorum, 1850g of loquat leaves, 1850g of sauropus, 1850g of swallowwort rhizome, 1850g of blackberry lily, 1233g of schizonepeta, 1233g of nervilia fordii, 1233g of scutellaria baicalensis, 1233g of mint, 1850g of radix bupleuri, 410g of dextrin and 8g of steviosin;
r3, adding 6 times of water into the schizonepeta and the mint to extract volatile oil for 2 hours to obtain the volatile oil, and collecting the distilled water solution in another container for later use;
and R4, preparing the volatile oil obtained in the step R3 into schizonepeta and mint volatile oil inclusion complex: weighing beta-cyclodextrin; heating purified water with the amount of 6 times of that of the beta-cyclodextrin to 95 ℃; adding beta-cyclodextrin into purified water of 95 ℃ to prepare saturated solution; cooling the saturated solution to 45 deg.C, slowly adding the volatile oil while stirring, maintaining at 45 deg.C, stirring for 1 hr, taking out, cooling, sealing, and standing at cold place for 24 hr; discarding the supernatant, taking out the inclusion complex precipitated at the lower layer, filtering, and drying the filtered inclusion complex at 42 deg.C under reduced pressure; sieving the dried inclusion complex with a 60-mesh sieve to obtain a volatile oil BETA-cyclodextrin inclusion complex;
r5. decocting radix Platycodonis, folium Eriobotryae, folium sauropus, rhizoma Cynanchi Stauntonii, rhizoma Belamcandae, folium Nerviliae Fordii, radix Scutellariae, and radix bupleuri with 10 times, 8 times, and 8 times of water for 3 times (1.5 hr each time), filtering, and mixing filtrates;
r6. concentrating the filtrate to obtain extract with relative density of 1.10 at 60 deg.C;
r7. mixing above extracts, adding ethanol to ethanol content of 70%, stirring, standing for 24 hr, filtering to obtain supernatant, recovering ethanol, and concentrating to obtain soft extract;
r8. mixing above soft extracts with dextrin and steviosin, granulating, and drying;
r9. mixing above dried granules with volatile oil clathrate of herba Schizonepetae and herba Menthae, and packaging.
Example 4
A method for preparing a Chinese medicinal composition for relieving cough and reducing sputum into granules comprises the following steps:
r1, removing impurities from platycodon grandiflorum, loquat leaves, sauropus spatholobus stem, swallowwort rhizome, blackberry lily, schizonepeta, nervilia fordii, scutellaria baicalensis, mint and radix bupleuri respectively, and drying;
and R2, weighing the following components in parts by weight: 1850g of platycodon grandiflorum, 1850g of loquat leaves, 1850g of sauropus, 1850g of swallowwort rhizome, 1850g of blackberry lily, 1233g of schizonepeta, 1233g of nervilia fordii, 1233g of scutellaria baicalensis, 1233g of mint, 1850g of radix bupleuri, 410g of dextrin and 8g of steviosin;
r3, adding 6 times of water into the schizonepeta and the mint to extract volatile oil for 2 hours to obtain the volatile oil, and collecting the distilled water solution in another container for later use;
r4, taking platycodon grandiflorum, loquat leaves, sauropus spatholobus stem, swallowwort rhizome, blackberry lily, nervilia fordii, scutellaria baicalensis and radix bupleuri, sequentially adding 10 times, 8 times and 8 times of water, decocting for 3 times, decocting for 1.5 hours each time, filtering, and combining filtrates;
r5. concentrating the filtrate to obtain extract with relative density of 1.10 at 60 deg.C;
r6. mixing above extracts, adding ethanol to ethanol content of 70%, stirring, standing for 24 hr, filtering to obtain supernatant, recovering ethanol, and concentrating to obtain soft extract;
r7. mixing above soft extracts with dextrin and steviosin, granulating, and drying;
r8. mixing above dried granules with volatile oil of herba Schizonepetae and herba Menthae, and packaging.
Third, clinical trial
1 medical record data
1.1 general data
120 patients with chronic cough were selected, 56 men and 64 women, aged 20-63 years, and the average age was 41 years, and the course was 3 months to 2 years. Cough caused by upper respiratory tract infection and acute bronchitis 40 cases, cough caused by chronic bronchitis 45 cases, cough caused by pharyngolaryngitis 25 cases, and cough caused by other diseases 10 cases.
1.2 case selection
The cough is taken as the main symptom in all the cases, the cough time is not improved for more than 2 months, no obvious abnormality is found by chest CT and X-ray film examination, and the cough caused by organic lesion is eliminated.
2 method of treatment
The 120 chronic patients are randomly divided into 5 groups according to various causes, and each group comprises 24 people, namely each group comprises 8 coughs caused by upper respiratory tract infection and acute bronchitis, 9 coughs caused by chronic bronchitis, 5 coughs caused by sphagitis and the like, and 2 coughs caused by other diseases.
2.1 group of examples
The samples of examples 1 to 4 of the present invention were administered orally at a dose of 10g once, 3 times a day for 7 consecutive days.
2.2 control group
The dextromethorphan hydrobromide granules are orally taken, 15-30mg once and 3-4 times a day for 7 days continuously.
3. Evaluation of therapeutic Effect
The treatment effect and adverse reaction of each group of patients are compared. The evaluation criteria of the curative effect are as follows:
(1) and (3) curing: the cough symptom of a patient completely or basically disappears after treatment, and the symptoms are not repeated after the medicine is stopped;
(2) the method has the following advantages: the cough symptom of a patient is obviously relieved after treatment, the frequency and the intensity can be relieved by more than 50 percent, and the symptom is not aggravated after the medicine is stopped;
(3) and (4) invalidation: the cough symptoms of the patients treated have no obvious change, or the cough symptoms are relieved after symptomatic treatment, but the cough is relapsed after the medicine is stopped.
4. Statistical treatment
Data processing and analysis were performed using SPSS 22.0 software, with t-test, indicating that the difference was statistically significant when P < 0.05.
5. Results
5.1 evaluation of adverse reactions and safety
During the treatment, patients in each example group have no adverse reaction. In the control group, 7 patients have different degrees of adverse reactions of dizziness, headache and somnolence, 6 patients have different degrees of adverse reactions of anorexia, nausea and constipation, and 2 patients have adverse reactions of skin allergy, and the treatment is continued under the condition of not influencing the research.
5.2 comparison of clinical efficacy
TABLE 12 comparison of clinical effects of the groups (examples)
Figure BDA0001810645240000131
Note: comparing with control group*P＜0.05
Table 12 the results of the study show that: compared with the control group, the total effective rate of the groups in examples 1 to 3 is obviously higher than that of the control group after treatment, and the difference has statistical significance (P is less than 0.05), while the total effective rate of the group in example 4 is not obviously different from that of the control group, which shows that the volatile oil has certain influence on the curative effect without inclusion.
The clinical test results show that the traditional Chinese medicine composition for relieving cough and reducing sputum can effectively treat chronic cough caused by various causes of disease, and has the advantages of safe use, no obvious adverse reaction and no toxic or side effect. The preparation method of the invention can effectively prevent the volatile oil from volatilizing, increase the stability of the medicine, reduce the loss of effective components and improve the utilization rate of the medicine after the volatile oil is made into the volatile oil beta-cyclodextrin inclusion compound, thereby improving the clinical curative effect.
Fourth, stability test
The samples of the above examples 1 to 4 were respectively packaged in aluminum foil bags and subjected to the stability acceleration test in a test box at the following temperature: 40 ± 2 ℃, relative humidity: 75 +/-5%, and accelerating the test for 3 months, respectively detecting the stability key investigation indexes such as appearance, moisture, qualitative identification of mint and schizonepeta volatile oil, solubility, effective component content and the like, and comparing with the test result of the sample at 0 month, wherein the test result is shown in a table 13.
TABLE 13 stability test results Table
Figure BDA0001810645240000141
As can be seen from the results in Table 13, after accelerated testing for 3 months, the evaluation indexes of the samples in examples 1 to 3 have no obvious change; the indexes of appearance, moisture, solubility and effective component content of the sample in the example 4 are not obviously changed compared with the measurement result of the sample at 0 month, but the volatile oil can not be detected at 3 months of acceleration, which indicates that the sample in the example 4, in which the volatile oil is not included by beta-cyclodextrin, has unstable quality and can not meet the requirements of storage, transportation and use stability. The preparation method of the invention is proved that the quality of the sample in the examples 1-3 is more stable by making the volatile oil into the volatile oil beta-cyclodextrin inclusion complex, and the preparation method can meet the stability requirements of storage, transportation and use.

Claims (2)

1. A traditional Chinese medicine composition for eliminating phlegm and relieving cough is characterized by comprising the following components in parts by weight: 1600-2000 parts of platycodon grandiflorum, 1600-2000 parts of loquat leaf, 1600-2000 parts of sauropus, 1600-2000 parts of cynanchum glaucescens, 1600-2000 parts of blackberry lily, 1000-1500 parts of schizonepeta, 1000-1500 parts of nervilia fordii, 1000-1500 parts of scutellaria baicalensis, 1000-1500 parts of mint, 1600-2000 parts of bupleurum chinense, 350-450 parts of dextrin and 6-10 parts of steviosin; the preparation method of the traditional Chinese medicine composition prepared into granules comprises the following steps:
r1, removing impurities from platycodon grandiflorum, loquat leaves, sauropus spatholobus stem, swallowwort rhizome, blackberry lily, schizonepeta, nervilia fordii, scutellaria baicalensis, mint and radix bupleuri respectively, and drying;
and R2, weighing the following components in parts by weight: 1600-2000 parts of platycodon grandiflorum, 1600-2000 parts of loquat leaf, 1600-2000 parts of sauropus, 1600-2000 parts of cynanchum glaucescens, 1600-2000 parts of blackberry lily, 1000-1500 parts of schizonepeta, 1000-1500 parts of nervilia fordii, 1000-1500 parts of scutellaria baicalensis, 1000-1500 parts of mint, 1600-2000 parts of bupleurum chinense, 350-450 parts of dextrin and 6-10 parts of steviosin;
r3, adding 4-8 times of water into the schizonepeta and the mint to extract volatile oil for 1-3 hours to obtain the volatile oil, and collecting the distilled water solution in another container for later use;
and R4, preparing the volatile oil obtained in the step R3 into schizonepeta and mint volatile oil inclusion complex, wherein the inclusion method comprises the following steps:
s1, weighing betacyclodextrin according to the proportion of betacyclodextrin to volatile oil = 8: 1 (g: ml);
s2, heating purified water which is 6 times of the amount of the beta-cyclodextrin to 90-100 ℃;
s3, adding beta-cyclodextrin into purified water at the temperature of 90-100 ℃ to prepare a saturated solution;
s4, cooling the saturated solution to 40-50 ℃, slowly adding the volatile oil while stirring, keeping the temperature at 40-50 ℃, stirring for 1 hour, taking out, cooling, sealing, and standing in a cold place for more than 4 hours;
s5, removing the supernatant, taking out the inclusion precipitated at the lower layer, filtering, and drying the filtered inclusion at 40-45 ℃ under reduced pressure;
s6, sieving the dried inclusion complex with a 60-mesh sieve to obtain a volatile oil beta-cyclodextrin inclusion complex;
r5. decocting radix Platycodonis, folium Eriobotryae, folium sauropus, rhizoma Cynanchi Stauntonii, rhizoma Belamcandae, folium Nerviliae Fordii, radix Scutellariae, and radix bupleuri in 5-12 times of water for 2-3 times (1-2 hr each time), filtering, and mixing filtrates;
r6. concentrating the filtrate to obtain extract with relative density of 1.08-1.12 at 60 deg.C;
r7. mixing above extracts, adding ethanol to ethanol content of 70%, stirring, standing for 24-36 hr, filtering to obtain supernatant, recovering ethanol, and concentrating to obtain soft extract;
r8. mixing above soft extracts with dextrin and steviosin, granulating, and drying;
r9. mixing above dried granules with volatile oil clathrate of herba Schizonepetae and herba Menthae, and packaging.
2. The traditional Chinese medicine composition for eliminating phlegm and relieving cough according to claim 1, which is characterized by comprising the following components in parts by weight: 1850 parts of platycodon grandiflorum, 1850 parts of loquat leaves, 1850 parts of sauropus spatholobus stem, 1850 parts of swallowwort rhizome, 1850 parts of blackberry lily, 1233 parts of schizonepeta, 1233 parts of nervilia fordii, 233 parts of scutellaria baicalensis, 1233 parts of mint, 1850 parts of radix bupleuri, 410 parts of dextrin and 8 parts of steviosin.
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调畅气机法治疗小儿咳嗽疗效观察;严善福等;《中国中医药信息杂志》;20090615;第16卷(第06期);第67页左栏第1-9段 *

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