CN112891429A - Mulberry and chrysanthemum granules capable of ventilating lung and relieving cough and preparation method of mulberry and chrysanthemum granules - Google Patents

Mulberry and chrysanthemum granules capable of ventilating lung and relieving cough and preparation method of mulberry and chrysanthemum granules Download PDF

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CN112891429A
CN112891429A CN202110250522.7A CN202110250522A CN112891429A CN 112891429 A CN112891429 A CN 112891429A CN 202110250522 A CN202110250522 A CN 202110250522A CN 112891429 A CN112891429 A CN 112891429A
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mulberry
chrysanthemum
lung
cough
ventilating
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张君利
吕剑涛
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Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a mulberry and chrysanthemum lung-ventilating and cough-relieving granule and a preparation method thereof. The mulberry and chrysanthemum lung-ventilating and cough-relieving granules are prepared from mulberry leaves, chrysanthemum, platycodon grandiflorum, radix peucedani, scutellaria baicalensis, mint, uncaria, houttuynia cordata, cynanchum glaucescens, pummelo peel, aster honey and liquorice; the mulberry and chrysanthemum lung-ventilating and cough-relieving granules can obviously improve the clinical symptoms of patients with acute bronchitis wind-heat invading lung syndrome, shorten the course of disease and improve the life quality of the patients, and meanwhile, the granules have the characteristics of quick dispersion, good absorption and the like and are easily accepted by the patients. The invention takes alcohol-soluble extract as an index, and adopts an orthogonal test to research the extraction process; the dosage, the relative density, the granulation conditions and the like of the flavoring agent are further researched, the forming process parameters are determined, the production efficiency is effectively improved, the production cost is reduced, and the produced product can completely meet the quality standard requirement.

Description

Mulberry and chrysanthemum granules capable of ventilating lung and relieving cough and preparation method of mulberry and chrysanthemum granules
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a mulberry and chrysanthemum lung-ventilating and cough-relieving granule and a preparation method thereof.
Background
Acute bronchitis is a common clinical disease and frequently encountered disease, is inflammation of bronchial mucosa caused by infection of pathogens such as viruses or bacteria and is often secondary to upper respiratory tract infection. The disease usually affects both trachea and bronchi, and is clinically characterized by cough with (or without) increased bronchial secretions. The traditional Chinese medicine considers that the lung is a delicate organ, is easy to be affected by exogenous pathogenic factors, is wind as yang pathogenic factors, is good at moving and changing, is the long of a hundred diseases, and if the lung is attacked by heat, the lung fails to disperse and disperse, the lung is disordered and the lung qi is reversely coughed, so that the syndrome of wind-heat invading the lung is formed. The clinical manifestations of this syndrome are frequent and severe cough, hoarseness, sore throat, sticky or yellow sputum, fever, aversion to wind, headache, sore limbs, yellow nasal discharge, thirst and other exterior heat syndromes, thin and yellow tongue coating, and floating and rapid or superficial and slippery pulse. The symptoms are both exterior syndrome of exogenous pathogenic factors and heat syndrome. On the basis, the treatment principles of dispelling wind and clearing heat, ventilating lung and relieving cough are taken. At present, decoction is mostly adopted for treating the disease in the traditional Chinese medicine, the problem of time and energy consumption during decoction is caused, and the decoction is difficult to store, poor in taste and inconvenient to carry, so that the use of a patient is influenced.
Disclosure of Invention
Aiming at the problems, the invention provides the mulberry and chrysanthemum lung-ventilating and cough-relieving granule for treating the acute bronchitis and the preparation method thereof, the mulberry and chrysanthemum lung-ventilating and cough-relieving granule can obviously improve the clinical symptoms of patients with acute bronchitis wind-heat affecting lung syndrome, shorten the course of disease and improve the life quality of the patients, and meanwhile, the granule has the characteristics of quick dispersion, good absorption and the like and is easy to be accepted by the patients.
The invention relates to a mulberry and chrysanthemum lung-ventilating and cough-relieving granule which is prepared from mulberry leaves, chrysanthemum, platycodon grandiflorum, radix peucedani, scutellaria baicalensis, mint, uncaria, houttuynia cordata, cynanchum glaucescens, exocarpium citri grandiflorum, aster honey and liquorice; every 1000g of mulberry and chrysanthemum lung-ventilating and cough-relieving granules are prepared from 200g of mulberry leaves, 200g of chrysanthemum, 200g of platycodon grandiflorum, 160g of radix peucedani, 160g of scutellaria baicalensis, 120g of mint, 160g of uncaria, 240g of houttuynia cordata, 120g of cynanchum glaucescens, 120g of pummelo peel, 200g of aster honey and 120g of liquorice.
The auxiliary material is dextrin or steviosin or a mixture thereof.
The preparation method of the mulberry and chrysanthemum lung-ventilating and cough-relieving granule comprises the following specific steps:
(1) extracting, weighing the raw materials in proportion, adding 10 times of water, heating to boil, decocting for 1 hour, and filtering; adding 8 times of water into the filter residue, heating to boil, decocting for 1 hr, and filtering; merging the filtrates;
(2) concentrating under the control of steam pressure less than 0.30Mpa, concentration temperature of 65-85 deg.C, vacuum degree less than-0.10 Mpa, concentrating the filtrate to relative density of 1.25-1.30, and stopping concentrating to obtain fluid extract;
(3) drying, adding dextrin into the clear paste, uniformly mixing, spreading into a baking pan, and drying at 70-75 ℃ to obtain dry paste;
(4) pulverizing the dry extract into fine powder, and sieving to obtain extract powder;
(5) granulating, namely placing the paste powder into a granulator, adding steviosin, mixing, adding ethanol, uniformly stirring to prepare a soft material, sieving to prepare wet granules, and flatly paving in a baking pan; drying the wet granules at 70 +/-3 ℃ until the moisture of the granules is controlled to be not more than 6.0%, and finishing granules to obtain the mulberry and chrysanthemum granules for ventilating the lung and relieving cough.
The relative density of the concentrated filtrate in the step (2) is the relative density at 50 ℃.
The water content of the dry paste in the step (3) is not more than 6.0 percent.
The ethanol in the step (5) is 75-80% ethanol
In the invention, the mulberry leaves are bitter and sweet in taste and slightly cold in nature, enter lung meridian, are light in nature, clear and disperse, and are good at dispelling wind heat in upper jiao, clearing lung and moistening dryness to stop cough. Chrysanthemum is sweet, bitter and slightly cold, enters lung meridian, and is good at dispelling wind-heat and clearing away heat and toxic material. Platycodon grandiflorum is bitter and pungent in flavor and neutral in nature, enters lung meridian, and is good at dispersing lung qi and eliminating phlegm, relieving cough and relieving sore throat. The three ingredients are combined together to clear the wind-heat in the upper energizer, ventilate the lung and relieve cough, clear and relieve headache and eyes, so the traditional Chinese medicine is a monarch drug. The peucedanum root, radix Peucedani is bitter, pungent and slightly cold, enters lung meridian, and is good at descending qi and eliminating phlegm, and dispersing wind-heat. Huang Qin is bitter in taste and cold in nature, enters lung meridian and excels in clearing heat in lung meridian. Peppermint, pungent and cool, light in weight and floating upward, can disperse wind-heat in upper energizer to clear head, eyes and throat. Uncaria rhynchophylla is sweet and cool, and can clear liver heat and disperse pathogenic wind-heat, so it is good at treating wind-heat affection by exogenous wind-heat, headache and conjunctival congestion. Yu xing Cao is pungent and cold in property, has the actions of clearing heat and removing toxicity. The five medicines are combined to help the monarch medicine to disperse wind-heat in upper jiao, recover the functions of lung and disperse descending, relieve cough and clear head, eyes and throat, so the traditional Chinese medicine is a ministerial medicine. Bai Qian is bitter and pungent with mild warm property, good at directing qi downward, eliminating phlegm and relieving cough. Hua Ju hong is pungent, bitter and warm in property, and has the actions of relieving exterior syndrome, dispelling cold, promoting qi circulation, relieving epigastric distention, drying dampness and resolving phlegm. Honey aster is pungent, bitter and warm, enters lung meridian, and is good at moistening lung and descending qi, resolving phlegm and relieving cough. The three medicines are combined to help the monarch and ministerial medicines clear away the heat evil in the upper jiao, ventilate the lung, reduce phlegm and relieve cough, and prevent the monarch and ministerial medicines from being bitter and cold, so the traditional Chinese medicine is an adjuvant medicine. Licorice root, radix Glycyrrhizae is sweet and neutral in nature and cool in nature, Wu Jie Geng can disperse lung qi, dispel phlegm, relieve cough, and harmonize the other drugs, so it is used as a guiding drug. The whole formula is compatible, and has the effects of dispelling wind, clearing heat, ventilating lung and relieving cough.
The mulberry and chrysanthemum lung-ventilating and cough-relieving granules can obviously improve the clinical symptoms of patients with acute bronchitis wind-heat invading lung syndrome, shorten the course of disease and improve the life quality of the patients, and meanwhile, the granules have the characteristics of quick dispersion, good absorption and the like and are easily accepted by the patients. The invention takes alcohol-soluble extract as an index, and adopts an orthogonal test to research the extraction process; the dosage, the relative density, the granulation conditions and the like of the flavoring agent are further researched, the forming process parameters are determined, the production efficiency is effectively improved, the production cost is reduced, and the produced product can completely meet the quality standard requirement.
Detailed Description
Example 1
A granule, SANGJUXUEFENGZHIKE granule, is prepared from folium Mori, flos Chrysanthemi, radix Platycodi, radix Peucedani, Scutellariae radix, herba Menthae, ramulus Uncariae cum uncis, herba Houttuyniae, rhizoma Cynanchi Stauntonii, exocarpium Citri Grandis, radix Asteris, and Glycyrrhrizae radix; every 1000g of mulberry and chrysanthemum lung-ventilating and cough-relieving granules are prepared from 200g of mulberry leaves, 200g of chrysanthemum, 200g of platycodon grandiflorum, 160g of radix peucedani, 160g of scutellaria baicalensis, 120g of mint, 160g of uncaria, 240g of houttuynia cordata, 120g of cynanchum glaucescens, 120g of pummelo peel, 200g of aster honey and 120g of liquorice.
The mulberry and chrysanthemum lung-ventilating and cough-relieving granules also comprise auxiliary materials, wherein the auxiliary materials are dextrin or stevioside or a mixture thereof.
The preparation method of the mulberry and chrysanthemum lung-ventilating and cough-relieving granule comprises the following specific steps:
(1) extracting, weighing the raw materials in proportion, adding 10 times of water, heating to boil, decocting for 1 hour, and filtering; adding 8 times of water into the filter residue, heating to boil, decocting for 1 hr, and filtering; merging the filtrates;
(2) concentrating under the control of steam pressure less than 0.30Mpa, concentration temperature of 65-85 deg.C, vacuum degree less than-0.10 Mpa, concentrating the filtrate to relative density of 1.25-1.30, and stopping concentrating to obtain fluid extract;
(3) drying, adding dextrin into the clear paste, uniformly mixing, spreading into a baking pan, and drying at 70-75 ℃ to obtain dry paste;
(4) pulverizing the dry extract into fine powder, and sieving to obtain extract powder;
(5) granulating, namely placing the paste powder into a granulator, adding steviosin, mixing, adding ethanol, uniformly stirring to prepare a soft material, sieving to prepare wet granules, and flatly paving in a baking pan; drying the wet granules at 70 +/-3 ℃ until the moisture of the granules is controlled to be not more than 6.0%, and finishing granules to obtain 1000g of the mulberry and chrysanthemum granules for ventilating the lung and relieving cough.
The relative density of the concentrated filtrate in the step (2) is the relative density at 50 ℃.
The water content of the dry paste in the step (3) is not more than 6.0 percent.
The ethanol in the step (5) is 75-80% ethanol.
The product is 10 g/bag, and is administered orally 1 bag at a time and 2 times a day; or following the medical advice.
Example 2 Water extraction Process study
In order to determine the better extraction parameters, the conditions related to the extraction process are optimized by adopting an orthogonal test, 3 levels are respectively selected by taking the water adding amount, the extraction time and the extraction times as influence factors, the test is arranged according to an L9(34), and the better extraction process is screened. The factor levels are shown in table 1.
TABLE 1 orthogonal test factor horizon
Figure BDA0002965850630000031
The extraction process index is determined by alcohol soluble extract index, 18 parts of decoction pieces are weighed according to the prescription proportion respectively, and the test is carried out according to the orthogonal test scheme. The results are shown in tables 2 and 3.
TABLE 2 results of orthogonal experiments
Figure BDA0002965850630000032
Figure BDA0002965850630000041
TABLE 3 ANOVA TABLE
Figure BDA0002965850630000042
Note: denotes P <0.05
As can be seen from the visual analysis of Table 2, the best process is A3B3C2Namely, the water adding amount is 10 multiplied by 8 times, the extraction times are 2 times, and the extraction time is 2 hours each time. The influence of each factor on the alcohol-soluble extract is C in turn by the range analysis>A>B, combined with the analysis of variance in Table 3, factor A, C, i.e., the amount of water added and the number of extractions, had a significant effect on the extract, and factor B, i.e., the extraction time, had no significant effect on the extract. Comprehensively considering economic factors of energy saving, time saving, cost reduction and the like and the requirement of large production, for A3B3C2And A3B2C2And (5) comparing the processes. The results are shown in Table 4.
TABLE 4 best Process vs. improved Process
Figure BDA0002965850630000043
Figure BDA0002965850630000051
Verified, Process A3B2C2The alcohol-soluble extract content of the process A is about the optimum3B2C298.0% of the total extract, the extraction rate is the best process A3B2C294.3% of the total weight. Comprehensively considering economic factors such as energy conservation, time conservation and cost reduction and the like and the requirement of large-scale production, selecting the process A3B2C2The preparation method comprises decocting in water twice, adding 10 times of water for the first time, adding 8 times of water for the second time, and decocting for 1 hr。
Process verification
According to the determined extraction process parameters, 3 parts of medicinal materials are respectively taken according to the prescription proportion, extracted, concentrated, dried and the alcohol-soluble extract and the extraction rate are calculated, and the data are shown in table 5.
Table 5 process verification results
Figure BDA0002965850630000052
The test result shows that: the water addition amount is respectively 10 times and 8 times of the medicinal materials, the extraction time is respectively 1 hour and 1 hour, the alcohol-soluble extracts are respectively 34.84%, 34.57% and 34.65%, and the extraction rates are respectively 25.97%, 26.21% and 26.17%. The process is stable and feasible.
Example 3 inspection of Molding Process
Determination of the amount of auxiliary materials
200g of mulberry leaf, 200g of chrysanthemum, 200g of platycodon grandiflorum, 200g of radix peucedani, 160g of radix scutellariae and 160g of radix scutellariae
120g of uncaria stem with hooks 160g of houttuynia cordata and 240g of cynanchum glaucescens 120g of pummelo peel
Honey aster 200g licorice root 120g
Making into 1000g
The average extraction rate obtained by the water extraction process is 26.1 percent, the dry paste amount after extraction is 522.0g, and the dosage of the auxiliary materials is 478.0g, which meets the requirement of the addition of the auxiliary materials in Chinese pharmacopoeia granules. Considering the difference of the quality of the medicinal materials of different batches, the preparation is prepared into 1000 preparation units by adjusting the dosage of the auxiliary materials and stabilizing the preparation. The process adopts dextrin and steviosin as auxiliary materials.
Selection of flavouring Agents
The preparation adopts steviosin as flavoring agent, and is added according to the proportion of 0.5%, 1.0% and 1.5%, and the result is as follows.
TABLE 6 determination of stevia addition
Figure BDA0002965850630000061
The test result shows that: when the steviosin accounts for 0.5% of the medicinal powder, the taste is bitter; when the steviosin accounts for 1.0% of the medicinal powder, the taste is proper; when the steviosin accounts for 1.5% of the medicinal powder, the taste is sweet, so that 1.0% of the medicinal powder is selected as the steviosin.
Investigation of relative Density
By combining the literature and the technical characteristics of granules, the optimum relative density of the concentrated clear paste is examined by taking the drying time and the dry paste amount as indexes. Weighing 5 parts of decoction pieces (each part is weighed according to 1/2 of the prescription decoction piece) according to the prescription proportion respectively, adding water and decocting twice, adding 10 times of water for the first time, and decocting for 1 hour; adding 8 times of water for the second time, and decocting for 1 hour. Filtering the decoction, mixing the filtrates, concentrating into fluid extract with different relative densities, adding adjuvants, and drying. The results are shown in Table 7.
Table 7 relative density investigation
Figure BDA0002965850630000062
The test result shows that: when the relative density is low, the clear paste amount is large, the clear paste and dextrin are easy to mix, but the drying time is long, and the energy consumption and the time consumption are long; when the relative density is high, the clear paste and the dextrin are difficult to mix, and the clear paste is easy to stick to the wall, so that the loss amount is large; when the relative density (measured at 50 ℃) is 1.25-1.30, the clear paste and the dextrin are easy to mix, the drying time is short, the loss is less, and the method is suitable for production operation, so that the relative density (measured at 50 ℃) of the clear paste is 1.25-1.30.
Example 4 drying Process investigation
Weighing 3 parts of decoction pieces (1/2 parts of the prescription) according to the prescription proportion, extracting according to the extraction process, concentrating to obtain clear paste with the relative density of 1.25 (measured at 50 ℃), adding a certain amount of dextrin, and fully mixing. Drying at 65 deg.C, 70 deg.C and 75 deg.C for 16 hr, and measuring water content of the dried extract. The results are shown in the following table.
TABLE 8 examination results of different drying temperatures
Figure BDA0002965850630000071
As can be seen from the above table, the moisture after drying at 65 ℃ is higher; the water content after drying at 70-75 deg.C is suitable. The drying temperature is set to 70-75 ℃ by comprehensively considering economic factors such as energy conservation, time conservation, cost reduction and the like and the requirement of large-scale production.
EXAMPLE 5 granulation Process investigation
The dry extract No. 3 of example 3 was pulverized and weighed 4 parts, 100g each, and granulated with 70%, 75%, 80%, 85% ethanol, respectively, to obtain the results shown in the following table:
TABLE 9 granulation Effect of ethanol of different concentrations
Figure BDA0002965850630000072
The test result shows that: when the concentration of the ethanol is 70%, the soft material is sticky, granulation is difficult, and loss is large; when the concentration of the ethanol is 75% and 80%, the soft material has proper viscosity, easy granulation and less loss; when the concentration of the ethanol is 85%, the soft material is loose, difficult to granulate and large in loss. Therefore, 75-80% ethanol is selected for granulation.
EXAMPLE 6 preparation of three batches of pilot samples
1 production facility information
The extraction workshop is provided with all equipment and conditions required for extraction, filtration, concentration and the like; all equipment and conditions required for crushing, mixing, granulating, drying and packaging for producing granules are arranged in a preparation workshop, and all production sites and equipment laboratories have qualified inspection conditions. The equipment used for the production is shown in Table 10.
TABLE 10 granule production facility
Figure BDA0002965850630000073
Figure BDA0002965850630000081
2 Pilot production
Taking 50 times of prescription amount of medicinal materials, carrying out three batches of pilot scale production, adding 10 times of water for the first time and 8 times of water for the second time, decocting for 1 hour respectively, filtering decoction, combining filtrates, concentrating to obtain fluid extract with relative density of 1.25-1.30(50 ℃), adding appropriate amount of dextrin, mixing, drying, pulverizing, sieving with 80 mesh sieve, adding appropriate amount of steviosin, mixing, granulating, drying, and packaging. The test data are shown in Table 11.
TABLE 11 data of three pilot samples
Figure BDA0002965850630000082
Figure BDA0002965850630000091
Test results show that the production process is simple, scientific and reasonable, the production efficiency can be effectively improved, the production cost is reduced, and the produced product can completely meet the quality standard requirements, which indicates that the process is feasible.
Example 7 quality control standard of intermediate of granule prepared from folium Mori and flos Chrysanthemi for releasing the Lung and relieving cough
[ PROPERTIES ] the product is brown to brownish black granules; light smell, bitter taste.
[ IDENTIFICATION ] A sample solution is prepared by collecting 5g of this product, adding 30ml of petroleum ether (60-90 deg.C), heating and refluxing for 30 min, discarding the petroleum ether solution, volatilizing the residue, adding 30ml of ethanol, performing ultrasonic treatment for 20 min, filtering, evaporating the filtrate to dryness, adding 10ml of hot water to the residue, stirring in a water bath at 60 deg.C to dissolve, filtering, evaporating the filtrate to dryness, and adding 1ml of methanol to the residue to dissolve. Taking 2g of folium Mori as reference material, and making into reference material solution by the same method. Performing thin layer chromatography (general rule 0502) test, sucking 5 μ l of the above solutions, respectively dropping on the same silica gel G thin layer plate, pre-saturating with developing agent for 10 min with the upper layer solution of toluene-ethyl acetate-formic acid (5: 2: 1) as developing agent in developing cylinder, developing to about 8cm, taking out, air drying, and inspecting under ultraviolet lamp (365 nm). The test chromatogram shows fluorescent spots of the same color at the positions corresponding to those of the control chromatogram.
(2) Taking 5g of the product, adding 10ml of methanol, carrying out ultrasonic treatment for 15 minutes, filtering, and taking the filtrate as a test solution. Taking naringin reference substance, adding methanol to obtain solution containing 1mg per 1ml, and making into reference substance solution. Performing thin layer chromatography (0502 of the four ministry of the national pharmacopoeia 2015), collecting 2 μ l of the above solutions, respectively dropping on the same high performance silica gel G thin layer plate, developing with ethyl acetate-acetone-glacial acetic acid-water (8: 4: 0.3: 1) as developing agent, taking out, air drying, spraying with 5% aluminum trichloride ethanol solution, heating at 105 deg.C for 1 min, and inspecting under ultraviolet lamp (365 nm). The test chromatogram shows fluorescent spots of the same color at the positions corresponding to those of the control chromatogram.
(3) Collecting 5g of the product, adding diethyl ether 40ml, heating and refluxing for 1 hr, filtering, removing ether solution, adding methanol 30ml into the residue, heating and refluxing for 1 hr, filtering, evaporating the filtrate to dryness, dissolving the residue with water 40ml, extracting with n-butanol for 3 times (20 ml each time), mixing n-butanol solutions, washing with water for 3 times, removing water solution, evaporating n-butanol solution to dryness, dissolving the residue with methanol 5ml to obtain sample solution. Taking another 1g of Glycyrrhrizae radix as reference material, and making into reference material solution by the same method. Performing thin layer chromatography (0502 of the four ministry of the national pharmacopoeia 2015), sucking 2 μ l of the above solutions, respectively dropping on a silica gel G thin layer plate prepared from 1% sodium hydroxide solution, developing with ethyl acetate-formic acid-glacial acetic acid-water (15: 1: 1: 2) as developing agent, taking out, air drying, spraying 10% sulphuric acid ethanol solution, heating at 105 deg.C until the spots are clearly developed, and inspecting under ultraviolet lamp (365 nm). In the chromatogram of the test solution, fluorescent spots with the same color appear at the corresponding positions of the chromatogram of the reference solution.
[ water ], [ granularity ], [ solubility ], [ limit of microorganism ] should comply with the regulations of granule (0104 in the rules of the four ministry of the United states of America pharmacopoeia of China 2015).
[ Total Mixed particle content measurement ] was measured by high performance liquid chromatography (0512 in the four Ministry of pharmacopoeia 2015).
Octadecylsilane chemically bonded silica is used as a filler in chromatographic conditions and system applicability tests; methanol-water-phosphoric acid (47: 53: 0.2) is used as a mobile phase; the detection wavelength was 280 nm. The number of theoretical plates is not less than 2500 calculated by baicalin peak.
Preparation of reference solution A proper amount of baicalin reference substance dried at 60 deg.C under reduced pressure for 4 hr is precisely weighed, and added with methanol to obtain a solution containing 20 μ g per 1 ml.
Preparing a test solution, taking a proper amount of the test solution, grinding, taking about 2g, precisely weighing, adding 40ml of 70% ethanol, carrying out ultrasonic treatment for 15 minutes, cooling, filtering, putting a filtrate into a 100ml measuring flask, washing a container and residues with a small amount of 70% ethanol in turn, filtering the washing solution into the same measuring flask, adding 70% ethanol to the scale, and shaking uniformly. Precisely measuring 1ml, placing into a 10ml measuring flask, adding methanol to scale, and shaking.
The determination method comprises precisely sucking 10 μ l of each of the reference solution and the sample solution, injecting into high performance liquid chromatograph, and determining.
One gram of the product contains baicalin (C) in addition to Scutellariae radix21H28O11) Calculated, the content of the active ingredients should not be less than 6.0 mg.
Example 8 investigation of the efficacy and safety of SANGJU Lung-ventilating and cough-relieving granule
The diagnosis standard of acute bronchitis is formulated by referring to the 'cough diagnosis and treatment guide' of the respiratory disease institute of China medical society in 2009, and the wind-heat affecting lung syndrome diagnosis standard is formulated by referring to the 'internal medicine of traditional Chinese medicine' (seventh edition of Chinese traditional medicine publishing house), the curative effect and the safety of the mulberry and chrysanthemum Xuanhua granule are investigated, and the curative effect and the safety are summarized, and the summary is as follows:
1 clinical data and methods
1.1 study object
100 patients with acute bronchitis and wind-heat affecting lung syndrome, who were selected randomly from outpatients of clinics affiliated to cigarette stands of Binzhou medical college in 2013, were treated with the mulberry chrysanthemum lung-ventilating and cough-relieving granules or the mulberry orange lung-ventilating and cough-relieving decoction, and the gender and age of the patients were shown in the following tables (table 12 and table 13).
TABLE 12 age distribution of treatment groups
Figure BDA0002965850630000111
TABLE 13 treatment group gender distribution
Figure BDA0002965850630000112
1.2 diagnostic criteria
1.2.1 Western medicine diagnosis Standard (refer to 2009 department of respiratory disease of Chinese medical society, "guidelines for diagnosis and treatment of cough" (1) to formulate the diagnosis Standard of acute bronchitis.)
First, the upper respiratory tract infection symptoms often appear in the early stage of onset.
② cough can be aggravated with or without expectoration; if accompanied by bacterial infection, yellow purulent sputum is often produced.
③ the general symptoms can disappear in several days, but the cough and expectoration generally last for 2-3 weeks.
X-ray examination shows no obvious abnormality or only increased lung texture. The respiratory sounds of the lung and both lung of the examinee are coarse, sometimes with the effect of moisture or dry rale.
Fifthly, diseases such as influenza, pneumonia, tuberculosis, pertussis, acute tonsillitis and the like are eliminated.
1.2.2 Chinese medicine diagnostic standards
Traditional Chinese medicine syndrome classification: referring to the internal medicine of traditional Chinese medicine (seventh edition of Chinese medicine publishing house), the diagnosis standard of the syndrome of traditional Chinese medicine is formulated as follows:
the main symptoms are: frequent cough, hoarseness, sore throat, sticky or yellow expectoration.
The secondary symptoms are as follows: fever, aversion to wind, headache, limp limbs, yellow nasal discharge, thirst, thin and yellow coating of the tongue, and superficial, rapid or slippery pulse.
1.2.4 symptom grading quantization Table
Refer to the clinical guidelines of new drugs (see Table 14 for details).
TABLE 14 hierarchical quantization table of symptoms
Figure BDA0002965850630000121
Note: the tongue coating and pulse are described in detail and not scored.
1.3 inclusion criteria
(1) Meets the above Western diagnosis standard and Chinese medicine syndrome diagnosis standard.
(2) The nature is not limited.
(3) The age is 18-65 years.
(4) The patient signs an informed consent.
1.4 exclusion criteria
(1) Cough and expectoration caused by pulmonary tuberculosis, pulmonary abscess, bronchial asthma, bronchiectasis, heart disease, and cardiac insufficiency.
(2) Patients with heart, liver and kidney diseases and serious diseases of hematopoietic system are combined. .
(3) Pregnant and lactating women.
(4) Others have used other therapeutic drugs.
(5) Allergic constitution or those allergic to various drugs.
2. The treatment scheme comprises the following steps:
2.1 therapeutic dosage and treatment course
Administering granule or decoction of SANGJU for dispersing lung qi and relieving cough, orally, 2 times per day, 1 bag each time, and continuously taking for 5 days.
2.2 Observation of therapeutic Effect
2.2.1 background data Observation
1. Demographic data: gender, age, height, weight, etc.
2. General clinical data: course of disease, history of treatment, complications and medication.
2.2.2 safety indices
1. Vital signs: such as blood pressure, respiration, heart rate, etc. (before and after the test).
2. Adverse events (detailed record over time).
2.2.3 therapeutic index
1. The main curative effect indexes are as follows: the curative effect of the syndrome of traditional Chinese medicine
2. Secondary efficacy index: single symptom curative effect
2.2.4 Main Observation indicators
Cough, expectoration, hoarseness, pharyngalgia, aversion to wind, fever, headache, soreness of limbs, watery nasal discharge, thirst, etc., and comprehensive evaluation of the change of physical signs.
3. Criteria for therapeutic effect
The comprehensive evaluation is carried out according to the main symptoms and physical sign changes of cough, expectoration, hoarseness, pharyngalgia, aversion to wind, fever and the like of the patients before and after the treatment.
Note: the calculation formula (nimodipine method) is:
treatment (%) - (pre-treatment integral-post-treatment integral) ÷ pre-treatment integral ] × 100%.
(1) The main symptoms and physical signs disappear or basically disappear in clinical recovery, and the syndrome integral value is reduced by more than or equal to 95 percent.
(2) The significant main symptoms and physical signs are obviously improved, and the syndrome integral value is reduced by more than or equal to 70 percent.
(3) The effective main symptoms and physical signs are also improved, and the syndrome integral value is reduced by more than or equal to 30 percent.
(4) The main symptoms and physical signs are not obviously improved or even aggravated, and the syndrome integral value is reduced by less than 30%.
Statistical treatment
The data analysis was performed using SPSS13.0, with P <0.05 as the difference being statistically significant.
4. Results
4.1 comparison of Total efficacy after treatment
TABLE 15 comparison of therapeutic Effect
Figure BDA0002965850630000141
Clinical test results show that the mulberry and chrysanthemum lung-ventilating and cough-relieving granules have definite curative effect on acute bronchitis wind-heat invading lung syndrome, and the total effective rate reaches 92.0%.
4.2 Single treatment Effect of post-treatment symptoms
TABLE 16 therapeutic effect on cough
Figure BDA0002965850630000142
TABLE 17 therapeutic effect on expectoration
Figure BDA0002965850630000143
TABLE 18 therapeutic effect on hoarseness and pharyngalgia
Figure BDA0002965850630000144
TABLE 19 therapeutic effect on aversion to wind
Figure BDA0002965850630000145
TABLE 20 therapeutic effects on fever
Figure BDA0002965850630000146
TABLE 21 therapeutic effect on headache
Figure BDA0002965850630000151
TABLE 22 therapeutic effects on soreness of limbs
Figure BDA0002965850630000152
TABLE 23 therapeutic effect on runny nose
Figure BDA0002965850630000153
TABLE 24 therapeutic effect on thirst
Figure BDA0002965850630000154
Clinical test results show that the mulberry and chrysanthemum lung-ventilating and cough-relieving granules can obviously improve clinical symptoms and physical signs of patients such as cough, expectoration, hoarseness, pharyngalgia, fever, aversion to wind, headache, limb soreness, watery nasal discharge, thirst and the like; the traditional Chinese medicine syndrome of the patients before and after treatment is obviously improved.
5. Security check
In the treatment process, 2 patients have nausea symptoms, and the symptoms are slight, so that the administration is not influenced, and other obvious adverse reaction events do not occur.
6. Discussion of the related Art
The mulberry and chrysanthemum lung-ventilating and cough-relieving granules are clinical proved formulas for treating acute bronchitis wind-heat affecting lung syndrome, and have good clinical effects in clinical application. Modern pharmacological research of a single medicinal material in the prescription shows that: folium Mori water extract can reduce IL-1 beta-induced Nitric Oxide (NO) and prostaglandin E2(PGE2) The generation of the compound and the reduction of the expression of nitric oxide synthase (iNOS) and COX-2 show that the mulberry leaves have certain curative effect on the inflammation treatment; the chrysanthemum has certain inhibition effect on staphylococcus albus and staphylococcus aureus and has obvious anti-inflammatory effect; the platycodon grandiflorum aqueous extract can obviously prolong the cough incubation period of rats and obviously reduce cough frequency; the radix peucedani extract has a certain cough relieving effect on experimental cough of mice and has the effect of eliminating phlegm; the scutellaria has stronger antibacterial and antiviral effects, can improve the pneumonia diseases of mice, and can effectively inhibit staphylococcus aureus and escherichia coli; the mint can stimulate organs to generate new secretion, so that thick mucus is easy to be discharged out of the body, and the mint has the effects of resisting inflammation and easing pain; the uncaria ethanol extract can reduce capillary permeability, can reduce auricle swelling of an auricle swelling model mouse, and has certain anti-inflammatory effect; herba Houttuyniae can inhibit Staphylococcus aureus, Bacillus influenzae, Diplococcus pneumoniae, Escherichia coli, Bacillus dysenteriae, and Salmonella typhi, and has antiinflammatory, analgesic, antitussive, and antiasthmatic effects; rhizoma Cynanchi Stauntonii has remarkable effects of relieving cough, eliminating phlegm, resisting inflammation, etc.; exocarpium Citri Grandis has effects of eliminating phlegm and relieving asthma, and relieving coughActing; the water decoction of the aster has obvious effects of eliminating phlegm and relieving cough; the Glycyrrhrizae radix has expectorant, antitussive, antiinflammatory, and antiviral effects.
The research result shows that the mulberry and chrysanthemum lung-ventilating and cough-relieving granules can obviously improve the clinical symptoms of patients with acute bronchitis wind-heat affecting lung syndrome, shorten the course of disease, improve the life quality of the patients, have high safety, do not have serious adverse reaction time during treatment, and are worthy of clinical popularization and application.

Claims (6)

1. A mulberry and chrysanthemum lung-ventilating and cough-relieving granule is characterized by being prepared from mulberry leaves, chrysanthemum, platycodon grandiflorum, radix peucedani, scutellaria baicalensis, mint, uncaria, houttuynia cordata, cynanchum glaucescens, exocarpium citri grandis, aster honey and liquorice; every 1000g of mulberry and chrysanthemum lung-ventilating and cough-relieving granules are prepared from 200g of mulberry leaves, 200g of chrysanthemum, 200g of platycodon grandiflorum, 160g of radix peucedani, 160g of scutellaria baicalensis, 120g of mint, 160g of uncaria, 240g of houttuynia cordata, 120g of cynanchum glaucescens, 120g of pummelo peel, 200g of aster honey and 120g of liquorice.
2. The mulberry and chrysanthemum lung ventilating and cough relieving granule as claimed in claim 1, further comprising an auxiliary material, wherein the auxiliary material is dextrin or stevioside or a mixture thereof.
3. The method for preparing the mulberry-chrysanthemum lung-ventilating and cough-relieving granule as claimed in any one of claims 1 or 2, is characterized by comprising the following specific steps:
(1) extracting, weighing the raw materials in proportion, adding 10 times of water, heating to boil, decocting for 1 hour, and filtering; adding 8 times of water into the filter residue, heating to boil, decocting for 1 hr, and filtering; merging the filtrates;
(2) concentrating under the control of steam pressure less than 0.30Mpa, concentration temperature of 65-85 deg.C, vacuum degree less than-0.10 Mpa, concentrating the filtrate to relative density of 1.25-1.30, and stopping concentrating to obtain fluid extract;
(3) drying, adding dextrin into the clear paste, uniformly mixing, spreading into a baking pan, and drying at 70-75 ℃ to obtain dry paste;
(4) pulverizing the dry extract into fine powder, and sieving to obtain extract powder;
(5) granulating, namely placing the paste powder into a granulator, adding steviosin, mixing, adding ethanol, uniformly stirring to prepare a soft material, sieving to prepare wet granules, and flatly paving in a baking pan; drying the wet granules at 70 +/-3 ℃ until the moisture of the granules is controlled to be not more than 6.0%, and finishing granules to obtain the mulberry and chrysanthemum granules for ventilating the lung and relieving cough.
4. The method for preparing mulberry and chrysanthemum lung ventilating and cough relieving granules according to claim 3, wherein the relative density of the concentrated filtrate in the step (2) is the relative density at 50 ℃.
5. The method for preparing mulberry and chrysanthemum lung-ventilating and cough-relieving granules according to claim 3, wherein the moisture of the dry paste in the step (3) is not more than 6.0%.
6. The method for preparing mulberry and chrysanthemum lung ventilating and cough relieving granules according to claim 3, wherein the ethanol in the step (5) is 75-80% ethanol.
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