CN109876082A - Nourishiing yin to clear away the lung-heat cream and preparation method thereof - Google Patents
Nourishiing yin to clear away the lung-heat cream and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a kind of nourishiing yin to clear away the lung-heat cream and preparation method thereof, and raw material is mainly grouped as by the group of following parts by weight: 100 parts of glutinous rehmannia, 60 parts of Radix Ophiopogonis, 80 parts of radix scrophulariae, 40 parts of bulbus fritillariae cirrhosae, 40 parts of Radix Paeoniae Alba, 40 parts of cortex moutan, 25 parts of peppermint, 20 parts of Radix Glycyrrhizae.The preparation method production nourishiing yin to clear away the lung-heat cream warp the Pharmacological experiment result shows that its anti-inflammatory, cough-relieving, eliminating the phlegm, in terms of slightly better than current market sold using conventional method prepare nourishiing yin to clear away the lung-heat cream, show that it is above commercially available nourishiing yin to clear away the lung-heat cream (produced in conventional processes) in the total effective rate that treatment chronic bronchitis, acute bronchitis, chronic bronchitis merge pulmonary emphysema through clinical test results.The preparation method shortens the production time, has saved production cost, improves the bioavilability of product, and final product quality is preferable, the nourishiing yin to clear away the lung-heat cream for being relatively superior to conventional method preparation through investigating result.
Description
Technical field
The present invention relates to medicine fields, and in particular to a kind of nourishiing yin to clear away the lung-heat cream and preparation method thereof.
Background technique
Nourishiing yin to clear away the lung-heat preparation is the classics ancient prescription Yangyin Qingfei Tang using the Chinese traditional treatment disease of pulmonary system (first appeared in Qing Dynasty Zheng Mei
" Chonglou Yuyao, Jade Key to the Secluded Chamber " of ravine writing), during the disease for treating lung and throat being prepared in conjunction with Modern preparations technology is common
Medicine preparation goes out good therapeutic effect through many years clinical manifestation.The party mainly includes glutinous rehmannia, radix scrophulariae, Radix Ophiopogonis, bulbus fritillariae cirrhosae, tree peony
Skin, Radix Paeoniae Alba, peppermint, 8 taste medicinal material of Radix Glycyrrhizae have the effect of clearing heat and detoxicating, nourishing lung yin, wherein the effect of each medicinal material are as follows: glutinous rehmannia is supported
Negative heat-clearing;Radix scrophulariae, Radix Ophiopogonis nourishing Yin and promoting production of body fluid, purging fire for removing toxin;Cortex moutan cool blood detumescence;Radix Paeoniae Alba blood-nourishing benefiting yin;Bulbus fritillariae cirrhosae reducing phlegm and resolving masses;
Peppermint dredges table relieving sore-throat;Radix Glycyrrhizae coordinating the drug actions of a prescription.
Paste has absorption fast as treatment lung, the comparatively ideal dosage form of pharyngolaryngitis, and concentration is high, small in size, convenient for protecting
Except many advantages, such as depositing, there is also poor taste, the disadvantages such as bioavilability is low.The present invention is directed to such situation, in conjunction with existing
Generationization extraction and separation technology as often as possible extracts its effective component using above-mentioned medicinal material, at the same remove as far as possible impurity at
Point, to overcome its poor taste, the deficiencies such as bioavilability is low.
Summary of the invention
The purpose of the present invention is to provide a kind of in good taste, high nourishiing yin to clear away the lung-heat cream and preparation method thereof of bioavilability.
The technical solution adopted in the present invention is as follows:
A kind of nourishiing yin to clear away the lung-heat cream, raw material are mainly grouped as by the group of following parts by weight: 100 parts of glutinous rehmannia, 60 parts of Radix Ophiopogonis, radix scrophulariae 80
Part, 40 parts of bulbus fritillariae cirrhosae, 40 parts of Radix Paeoniae Alba, 40 parts of cortex moutan, 25 parts of peppermint, 20 parts of Radix Glycyrrhizae, preparation method includes the following steps:
R1. glutinous rehmannia, Radix Ophiopogonis, radix scrophulariae, bulbus fritillariae cirrhosae, Radix Paeoniae Alba, cortex moutan, peppermint, Radix Glycyrrhizae are taken respectively, are cleaned, it is dry;
R2. weigh component by following parts by weight: 100 parts of glutinous rehmannia, 60 parts of Radix Ophiopogonis, 80 parts of radix scrophulariae, 40 parts of bulbus fritillariae cirrhosae, 40 parts of Radix Paeoniae Alba,
40 parts of cortex moutan, 25 parts of peppermint, 20 parts of Radix Glycyrrhizae;
R3. bulbus fritillariae cirrhosae is taken, hydrochloric acid solution is added to impregnate, ultrasound filters, and filtrate adjusts pH value to neutrality with sodium hydroxide solution, obtains
Bulbus fritillariae cirrhosae extracting solution;
R4. cortex moutan and peppermint use steam distillation respectively, collect distillate, divide and the another device of volatile component is taken to save, the dregs of a decoction wait for
With;
R5. the five tastes such as the dregs of a decoction of step R4 and remaining glutinous rehmannia add 5-15 times to measure water and decoct 2-3 times, 1-3 hours each, merge and decoct
Liquid is stood, and filtration, filtrate merges with bulbus fritillariae cirrhosae extracting solution, is concentrated, through ceramic membrane filter, filtrate is concentrated into right amount, adds refined honey
It 300 parts, mixes, filtration, filtrate is concentrated into defined relative density, lets cool, and obtains thick paste;
R6. take thick paste, the volatile component of cortex moutan and peppermint be added, mix to get.
Further, above-described nourishiing yin to clear away the lung-heat cream, described in step R3 plus hydrochloric acid solution dipping for plus 8-15 times measure salt
Acid solution impregnates 1-3 hours.
Further, above-described nourishiing yin to clear away the lung-heat cream, ultrasonic time described in step R3 are 40-60 minutes.
Further, above-described nourishiing yin to clear away the lung-heat cream, the concentration of hydrochloric acid solution described in step R3 are 0.05mol/L;Institute
The concentration for stating sodium hydroxide solution is 0.1mol/L.
The preparation method of nourishiing yin to clear away the lung-heat cream described in more than one, comprising the following steps:
R1. glutinous rehmannia, Radix Ophiopogonis, radix scrophulariae, bulbus fritillariae cirrhosae, Radix Paeoniae Alba, cortex moutan, peppermint, Radix Glycyrrhizae are taken respectively, are cleaned, it is dry;
R2. weigh component by following parts by weight: 100 parts of glutinous rehmannia, 60 parts of Radix Ophiopogonis, 80 parts of radix scrophulariae, 40 parts of bulbus fritillariae cirrhosae, 40 parts of Radix Paeoniae Alba,
40 parts of cortex moutan, 25 parts of peppermint, 20 parts of Radix Glycyrrhizae;
R3. bulbus fritillariae cirrhosae is taken, hydrochloric acid solution is added to impregnate, ultrasound filters, and filtrate adjusts pH value to neutrality with sodium hydroxide solution, obtains
Bulbus fritillariae cirrhosae extracting solution;
R4. cortex moutan and peppermint use steam distillation respectively, collect distillate, divide and the another device of volatile component is taken to save, the dregs of a decoction wait for
With;
R5. the five tastes such as the dregs of a decoction of step R4 and remaining glutinous rehmannia add 5-15 times to measure water and decoct 2-3 times, 1-3 hours each, merge and decoct
Liquid is stood, and filtration, filtrate merges with bulbus fritillariae cirrhosae extracting solution, is concentrated, through ceramic membrane filter, filtrate is concentrated into right amount, adds refined honey
It 300 parts, mixes, filtration, filtrate is concentrated into defined relative density, lets cool, and obtains thick paste;
R6. take thick paste, the volatile component of cortex moutan and peppermint be added, mix to get.
Further, above-described nourishiing yin to clear away the lung-heat cream is prepared into method, and described in step R3 plus hydrochloric acid solution dipping is
Add 8-15 times to measure hydrochloric acid solution to impregnate 1-3 hours;The ultrasonic time is 40-60 minutes.
Further, above-described nourishiing yin to clear away the lung-heat cream is prepared into method, and the concentration of hydrochloric acid solution described in step R3 is
0.05mol/L;The concentration of the sodium hydroxide solution is 0.1mol/L.
Further, the preparation method of above-described nourishiing yin to clear away the lung-heat cream, ceramics membrane aperture described in step R5 are 0.1-
0.2μm。
Further, the preparation method of above-described nourishiing yin to clear away the lung-heat cream is extracted before ceramic membrane filter described in step R5
Liquid is concentrated into the concentration of " crude drug: medical fluid=1:4~1:10 ".
The application of above-described nourishiing yin to clear away the lung-heat cream lacks band in phlegm or phlegm for treating the lung-dryness syndrome due to yin deficiency, pharyngodynia with dryness, dry cough
Blood.
The beneficial effects of the present invention are:
1. the present invention in addition to paste have absorb fast, concentration is high, small in size, many advantages, such as convenient for saving it
Outside, the disadvantages such as the generally existing poor taste of paste, bioavilability be low are also overcomed, through the Pharmacological experiment result shows that its anti-
The nourishiing yin to clear away the lung-heat cream prepared using conventional method that inflammation, cough-relieving, eliminating the phlegm, antibacterial etc. are slightly sold better than current market, warp
Clinical test results show that it always has in treatment chronic bronchitis, acute bronchitis, chronic bronchitis merging pulmonary emphysema
Efficiency is respectively 93.0%, 100% and 91.2%, is above 78.9%, the 83.3% of commercially available nourishiing yin to clear away the lung-heat cream (produced in conventional processes)
With 79.2%.
2. not only having overcome the disadvantage that Western medicine is palliative and side effect is big, but also Chinese medicine Small side effects are developed, has been not easy to produce
The advantages of raw drug resistance, treating both manifestation and root cause of disease improves the quality of life of patient.
3. preparation method of the present invention is simple to operation, it is compared with the traditional method and shortens the production time, has saved and be produced into
This, improves bioavilability, and final product quality is preferable, the nourishiing yin to clear away the lung-heat for being relatively superior to conventional method preparation through investigating result
Cream.
Specific embodiment
The invention will be further described combined with specific embodiments below, but does not limit the scope of the invention and apply
Range:
One, the research of extraction process
1. the extraction process of bulbus fritillariae cirrhosae
The present invention once compared following extracting method:
(1) method 1(conventional method): bulbus fritillariae cirrhosae medicinal material 40g is taken, 10 times of 70% ethanol as solvent of amount are added, after impregnating 18 hours, with
The speed of 2ml per minute slowly diacolation, makes soluble component filter out completely, and collection is filtered liquid, returns ethyl alcohol, is concentrated into thick paste.
(2) method 2(the method for the present invention): bulbus fritillariae cirrhosae medicinal material 40g is taken, 10 times of amount 0.05mol/L hydrochloric acid solutions, dipping 2 are added
After hour, ultrasound 60 minutes is filtered, and filtrate adjusts pH value to neutrality with 0.1mol/L sodium hydroxide solution, is concentrated into thick paste.
(3) method 3: taking bulbus fritillariae cirrhosae medicinal material 40g, adds 10 times of amount 0.05mol/L hydrochloric acid solutions, dipping is after 18 hours, with every
The speed of minute 2ml slowly diacolation, makes soluble component filter out completely, and collection is filtered liquid, with 0.1mol/L sodium hydroxide solution tune
PH value is saved to neutrality, is concentrated into thick paste.
(4) it method 4: is heated to reflux method: taking bulbus fritillariae cirrhosae medicinal material 40g, add 10 times of amount 0.05mol/L hydrochloric acid solutions, dipping 2
After hour, backheat refluxing extraction 1 hour, filtration, filtrate adjusted pH value to neutrality with 0.1mol/L sodium hydroxide solution, was concentrated into
Thick paste.
Thick paste obtained by above method is taken respectively, measures its rate of extract and total alkaloid therein with imperialine
(C27H43NO3) meter content, the results are shown in Table 1.
1 Different Extraction Method of table extracts result to bulbus fritillariae cirrhosae
Method | The rate of extract (%) | Total alkaloid content (%) |
1 | 17.2 | 0.39 |
2 | 14.3 | 0.51 |
3 | 13.9 | 0.50 |
4 | 18.4 | 0.21 |
As shown in Table 1, method 1(conventional method) the rate of extract it is higher but total alkaloid content is lower, 4 the rate of extract of method is most
Height, but total alkaloid content is minimum, may be due to caused by caustic digestion biological under high temperature, method 2(the method for the present invention) the rate of extract compared with
It is low, but total alkaloid content highest, the rate of extract, total alkaloid content and the method 2 of method 3 quite, illustrate that both methods mention
Take the impurity of object less, active constituent content is higher, due to method 2(the method for the present invention) it is relatively time-consuming, so selection is originally
Invention has selected method 2.
Two, the research of ceramic membrane technological parameter
1. the screening of ceramic membrane aperture
Once to select aperture be 0.1 μm, 0.2 μm, 0.3 μm of ceramic membrane compare research.
Take 12 times of recipe quantities of the present invention, by 5 preparation method step R5 of the embodiment of the present invention preparation gained combined extract,
Be concentrated into crude drug: medical fluid=1:4 obtains 20.4L, is divided into three parts, carries out following tests respectively:
1. taking 6.8 liters of concentrate, filtered by 0.1 μm of ceramic membrane, midway adds 5 liters of purified water, collects filtered solution.
2. taking 6.8 liters of concentrate, filtered by 0.2 μm of ceramic membrane, midway adds 5 liters of purified water, collects filtered solution.
3. taking 6.8 liters of concentrate, filtered by 0.3 μm of ceramic membrane, midway adds 5 liters of purified water, collects filtered solution.
Above three parts of membrane filtration liquid is concentrated into thick paste respectively, is dried to dry cream.Measure total solid, n-butanol extract content,
Ethanol soluble extraction content, the results are shown in Table 2.
The screening of the ceramic membrane aperture of table 2
Number | Ceramic membrane aperture | Total solid (%) | N-butanol extract content (%) | Ethanol soluble extraction content (%) |
1 | 0.1μm | 13.2 | 25.21 | 36.14 |
2 | 0.2μm | 14.4 | 25.03 | 36.07 |
3 | 0.3μm | 15.9 | 23.78 | 35.85 |
It is seen by result above, it is preferable to the retention rate of composition to cross film when 0.1 μm, 0.2 to select aperture, wherein being with aperture especially
It is best to the retention rate of composition that film is crossed at 0.1 μm, but total solid is relatively low, therefore selecting aperture is 0.1 μm -0.2 μm of ceramics
Film is preferably.
2, medical fluid concentration screening excessively before film
20 times of recipe quantities of the present invention are taken, by preparation gained combined extract in 5 preparation method step R5 of the embodiment of the present invention, respectively
Carry out following tests:
1. 35.9 liters of 8 times of recipe quantity filtrates is taken to be concentrated into 3.5 liters (crude drugs: medical fluid=1:2), filtered by 0.1 μm of ceramic membrane, in
Way adds 5 liters of purified water, collects filtered solution, raffinate.
2. 18.0 liters of 4 times of recipe quantity filtrates is taken to be concentrated into 5.2 liters (crude drugs: medical fluid=1:4), pass through 0.1 μm of ceramic membrane filtration
It crosses, midway adds 5 liters of purified water, collects filtered solution, raffinate.
3. 18.0 liters of 4 times of recipe quantity filtrates is taken to be concentrated into 7.0 liters (crude drugs: medical fluid=1:8), pass through 0.1 μm of ceramic membrane filtration
It crosses, midway adds 5 liters of purified water, collects filtered solution, raffinate.
3. 18.0 liters of 4 times of recipe quantity filtrates is taken to be concentrated into 8.8 liters (crude drugs: medical fluid=1:10), pass through 0.1 μm of ceramic membrane filtration
It crosses, midway adds 5 liters of purified water, collects filtered solution, raffinate.
Membrane flux is recorded respectively, and membrane filtration liquid is concentrated into thick paste respectively, is dried to dry cream.Measure total solid, n-butanol leaches
Object content, ethanol soluble extraction content.It the results are shown in Table 3,4.
Table 3 crosses medical fluid concentration screening before film
Number | Liquor strength | Total solid (%) | N-butanol extract content (%) | Ethanol soluble extraction content (%) |
1 | Crude drug: medical fluid=1:2 | 12.6 | 20.35 | 30.72 |
2 | Crude drug: medical fluid=1:4 | 14.2 | 22.75 | 31.31 |
3 | Crude drug: medical fluid=1:8 | 13.6 | 23.12 | 31.40 |
4 | Crude drug: medical fluid=1:10 | 13.2 | 23.33 | 31.48 |
4 membrane flux of table is investigated
Seen by result above, liquor strength is crude drug: it is slower to cross membrane flux when medical fluid=1:2, and hardly possible filtration remains with composition
Declined, and liquor strength is crude drug: it is very fast that medical fluid when medical fluid=1:4 or more crosses membrane flux, retains preferably composition, therefore selects
It selects and extracting solution is concentrated into crude drug: crossing film when medical fluid=1:4~1:10 concentration.
Three, the preparation method of nourishiing yin to clear away the lung-heat cream
Embodiment 1
R1. glutinous rehmannia, Radix Ophiopogonis, radix scrophulariae, bulbus fritillariae cirrhosae, Radix Paeoniae Alba, cortex moutan, peppermint, Radix Glycyrrhizae are taken respectively, are cleaned, it is dry;
R2. component is weighed by following parts by weight: glutinous rehmannia 100g, Radix Ophiopogonis 60g, radix scrophulariae 80g, bulbus fritillariae cirrhosae 40g, Radix Paeoniae Alba 40g, cortex moutan
40g, peppermint 25g, Radix Glycyrrhizae 20g;
R3. load weighted bulbus fritillariae cirrhosae is taken, 0.05 mol/L hydrochloric acid solution of 8 times of amounts is added to impregnate 3 hours, ultrasound 40 minutes, filter
It crosses, filtrate adjusts pH value to neutrality with 0.1mol/L sodium hydroxide solution, obtains bulbus fritillariae cirrhosae extracting solution;
R4. cortex moutan and peppermint use steam distillation respectively, collect distillate, divide and the another device of volatile component is taken to save, the dregs of a decoction wait for
With;
R5. the five tastes such as the dregs of a decoction of step R4 and remaining glutinous rehmannia add water to cook 3 times, and for the first time plus 13 times of amount water decoct 3 hours, the
Secondary plus 10 times of amount water decoct 2 hours, and third time plus 5 times of amount water decoct 1 hour, and collecting decoction is stood, filtration, filtrate and river
Fritillaria extracting solution merges, and is concentrated into crude drug: medical fluid=1:8 concentration, and via hole diameter is 0.1 μm of ceramic membrane filter, and filtrate is concentrated into
In right amount, add refined honey 300g, mix, filtration, filtrate is concentrated into defined relative density, lets cool, and obtains thick paste;
R6. take thick paste, the volatile component of cortex moutan and peppermint be added, mix to get.
Embodiment 2
R1. glutinous rehmannia, Radix Ophiopogonis, radix scrophulariae, bulbus fritillariae cirrhosae, Radix Paeoniae Alba, cortex moutan, peppermint, Radix Glycyrrhizae are taken respectively, are cleaned, it is dry;
R2. component is weighed by following parts by weight: glutinous rehmannia 100g, Radix Ophiopogonis 60g, radix scrophulariae 80g, bulbus fritillariae cirrhosae 40g, Radix Paeoniae Alba 40g, cortex moutan
40g, peppermint 25g, Radix Glycyrrhizae 20g;
R3. load weighted bulbus fritillariae cirrhosae is taken, 0.05 mol/L hydrochloric acid solution of 15 times of amounts is added to impregnate 1 hour, ultrasound 60 minutes, filter
It crosses, filtrate adjusts pH value to neutrality with 0.1mol/L sodium hydroxide solution, obtains bulbus fritillariae cirrhosae extracting solution;
R4. cortex moutan and peppermint use steam distillation respectively, collect distillate, divide and the another device of volatile component is taken to save, the dregs of a decoction wait for
With;
R5. the five tastes such as the dregs of a decoction of step R4 and remaining glutinous rehmannia add water to cook 3 times, and for the first time plus 15 times of amount water decoct 2.5 hours, the
Secondary plus 9 times of amount water decoct 1.5 hours, and third time plus 5 times of amount water decoct 1 hour, and collecting decoction is stood, and filter, filtrate and
Bulbus fritillariae cirrhosae extracting solution merges, and is concentrated into crude drug: medical fluid=1:10 concentration, and via hole diameter is 0.1 μm of ceramic membrane filter, filtrate concentration
To appropriate, add refined honey 300g, mix, filtration, filtrate is concentrated into defined relative density, lets cool, and obtains thick paste;
R6. take thick paste, the volatile component of cortex moutan and peppermint be added, mix to get.
Embodiment 3
R1. glutinous rehmannia, Radix Ophiopogonis, radix scrophulariae, bulbus fritillariae cirrhosae, Radix Paeoniae Alba, cortex moutan, peppermint, Radix Glycyrrhizae are taken respectively, are cleaned, it is dry;
R2. component is weighed by following parts by weight: glutinous rehmannia 100g, Radix Ophiopogonis 60g, radix scrophulariae 80g, bulbus fritillariae cirrhosae 40g, Radix Paeoniae Alba 40g, cortex moutan
40g, peppermint 25g, Radix Glycyrrhizae 20g;
R3. load weighted bulbus fritillariae cirrhosae is taken, 0.05 mol/L hydrochloric acid solution of 12 times of amounts is added to impregnate 2.5 hours, ultrasound 50 minutes, filter
It crosses, filtrate adjusts pH value to neutrality with 0.1mol/L sodium hydroxide solution, obtains bulbus fritillariae cirrhosae extracting solution;
R4. cortex moutan and peppermint use steam distillation respectively, collect distillate, divide and the another device of volatile component is taken to save, the dregs of a decoction wait for
With;
R5. the five tastes such as the dregs of a decoction of step R4 and remaining glutinous rehmannia add water to cook 2 times, for the first time plus the decoctions of 10 times of amount water 2 hours, second
Secondary plus 6 times of amount water decoct 1 hour, and collecting decoction is stood, and filtration, filtrate merges with bulbus fritillariae cirrhosae extracting solution, are concentrated into crude drug: medicine
Liquid=1:4 concentration, via hole diameter are 0.2 μm of ceramic membrane filter, and filtrate is concentrated into right amount, add refined honey 300g, are mixed, and are filtered, filter
Liquid is concentrated into defined relative density, lets cool, and obtains thick paste;
R6. take thick paste, the volatile component of cortex moutan and peppermint be added, mix to get.
Embodiment 4
R1. glutinous rehmannia, Radix Ophiopogonis, radix scrophulariae, bulbus fritillariae cirrhosae, Radix Paeoniae Alba, cortex moutan, peppermint, Radix Glycyrrhizae are taken respectively, are cleaned, it is dry;
R2. component is weighed by following parts by weight: glutinous rehmannia 100g, Radix Ophiopogonis 60g, radix scrophulariae 80g, bulbus fritillariae cirrhosae 40g, Radix Paeoniae Alba 40g, cortex moutan
40g, peppermint 25g, Radix Glycyrrhizae 20g;
R3. load weighted bulbus fritillariae cirrhosae is taken, 0.05 mol/L hydrochloric acid solution of 13 times of amounts is added to impregnate 1.5 hours, ultrasound 60 minutes, filter
It crosses, filtrate adjusts pH value to neutrality with 0.1mol/L sodium hydroxide solution, obtains bulbus fritillariae cirrhosae extracting solution;
R4. cortex moutan and peppermint use steam distillation respectively, collect distillate, divide and the another device of volatile component is taken to save, the dregs of a decoction wait for
With;
R5. the five tastes such as the dregs of a decoction of step R4 and remaining glutinous rehmannia add water to cook 2 times, for the first time plus the decoctions of 12 times of amount water 3 hours, second
Secondary plus 8 times of amount water decoct 2 hours, and collecting decoction is stood, and filtration, filtrate merges with bulbus fritillariae cirrhosae extracting solution, are concentrated into crude drug: medicine
Liquid=1:6 concentration, via hole diameter are 0.1 μm of ceramic membrane filter, and filtrate is concentrated into right amount, add refined honey 300g, are mixed, and are filtered, filter
Liquid is concentrated into defined relative density, lets cool, and obtains thick paste;
R6. take thick paste, the volatile component of cortex moutan and peppermint be added, mix to get.
Embodiment 5
R1. glutinous rehmannia, Radix Ophiopogonis, radix scrophulariae, bulbus fritillariae cirrhosae, Radix Paeoniae Alba, cortex moutan, peppermint, Radix Glycyrrhizae are taken respectively, are cleaned, it is dry;
R2. component is weighed by following parts by weight: glutinous rehmannia 100g, Radix Ophiopogonis 60g, radix scrophulariae 80g, bulbus fritillariae cirrhosae 40g, Radix Paeoniae Alba 40g, cortex moutan
40g, peppermint 25g, Radix Glycyrrhizae 20g;
R3. load weighted bulbus fritillariae cirrhosae is taken, 0.05 mol/L hydrochloric acid solution of 10 times of amounts is added to impregnate 2 hours, ultrasound 60 minutes, filter
It crosses, filtrate adjusts pH value to neutrality with 0.1mol/L sodium hydroxide solution, obtains bulbus fritillariae cirrhosae extracting solution;
R4. cortex moutan and peppermint use steam distillation respectively, collect distillate, divide and the another device of volatile component is taken to save, the dregs of a decoction wait for
With;
R5. the five tastes such as the dregs of a decoction of step R4 and remaining glutinous rehmannia add water to cook 2 times, add 10 times of amount water, second plus 8 times of amounts for the first time
Water decocts 2 hours, collecting decoction every time, stands, and filtration, filtrate merges with bulbus fritillariae cirrhosae extracting solution, is concentrated into crude drug: medical fluid=
The concentration of 1:6, via hole diameter are 0.1 μm of ceramic membrane filter, and filtrate is concentrated into right amount, add refined honey 300g, are mixed, filtration, and filtrate is dense
It is reduced to defined relative density, is let cool, thick paste is obtained;
R6. take thick paste, the volatile component of cortex moutan and peppermint be added, mix to get.
Four, quality investigation
Once final product quality investigation had been carried out to the product of above embodiments 1-5 and commercially available nourishiing yin to clear away the lung-heat cream (conventional method preparation),
The index of investigation mainly includes that appearance, mouthfeel, mobility, viscosity, water solubility compare.As a result 1-5 of the embodiment of the present invention
The appearance of product, mouthfeel, mobility, viscosity, water-soluble preferable, be superior to commercially available nourishiing yin to clear away the lung-heat cream (conventional method system
It is standby).As a result see Table 5 for details.
5 final product quality of table investigates result
Group | Appearance | Mouthfeel | Flowing Property | Viscosity | It is water-soluble |
Embodiment 1 | Uniform color, glossiness are good | Lubrication, sugariness It is suitable for | It is good | It is suitable for stirring, soup ladle with glass rod It is suitable for scooping up | Good water solubility stirs instant, free from admixture Precipitating |
Embodiment 2 | Uniform color, glossiness are good | Lubrication, sugariness It is suitable for | It is good | It is suitable for stirring, soup ladle with glass rod It is suitable for scooping up | Good water solubility stirs instant, free from admixture Precipitating |
Embodiment 3 | Uniform color, glossiness are good | Lubrication, sugariness It is suitable for | It is good | It is suitable for stirring, soup ladle with glass rod It is suitable for scooping up | Good water solubility stirs instant, free from admixture Precipitating |
Embodiment 4 | Uniform color, glossiness are good | Lubrication, sugariness It is suitable for | It is good | It is suitable for stirring, soup ladle with glass rod It is suitable for scooping up | Good water solubility stirs instant, free from admixture Precipitating |
Embodiment 5 | Uniform color, glossiness are good | Lubrication, sugariness It is suitable for | It is good | It is suitable for stirring, soup ladle with glass rod It is suitable for scooping up | Good water solubility stirs instant, free from admixture Precipitating |
Commercially available yin-nourishing Lung-heat clearing plaster | Uniform color, glossiness compared with It is good | Lotion is sticky, Cross sweet tea | Generally | It should not be stirred with glass rod, soup ladle It can scoop up | Water-soluble general, stirring is slightly just molten, There is slight precipitating |
Five, pharmacological testing
(1) animal acute toxicity test
Give the mouse gavaging embodiment of the present invention 5 sample, administration 3 times in 12h, accumulated dose 500ml/kg, BW(are adult (to press 60kg
Meter) taking dose is 1ml/kg.d), it is administered that animal in 7d is strong to deposit, appetite, excrement are normal, and weight is limited to medicine without significant change
Object concentration and volume, fail do not go out LD50, therefore its LD50 must be greater than 500ml/kg, 500 times of BW(adult's taking dose).Table
It is very big that bright 5 sample of the embodiment of the present invention produces oral safety.
(2) long-term toxicity test for animals
To rat by 2 times, 50 times and 100 times of the respectively clinical quasi- daily dose of 2ml/kg, 50ml/kg and 100ml/kg() even
Continuous to gavage 5 sample of the embodiment of the present invention 28 days, as a result animal appearance, behavior, body weight increase are normal, blood routine, blood biochemical, liver
The histological examinations no abnormality seen such as renal function and the heart, lung, liver,spleen,kidney, adrenal gland, testis, ovary.Show by draft dosage,
Approach and the course for the treatment of take 5 secure sample of the embodiment of the present invention and have no toxic side effect.
(3) Pharmacodynamic test of active extract
Purpose: cough-relieving, eliminating the phlegm, anti-inflammatory and bacteriostasis by investigating product of the present invention provide experimental basis for clinical application.
1 test material
Sample: 5 sample of the embodiment of the present invention;Simultaneously using commercially available nourishiing yin to clear away the lung-heat cream (conventional method preparation) as positive control.
Experimental animal: Kunming mouse, cleaning grade, male and female dual-purpose, 20 ± 2g of weight, by animal housing, Guangxi Medical University
It provides.
2 methods and result
The experiment of 2.1 xylene-induced ear swelling in mice
Take Kunming mouse 50, be randomly divided into 5 groups: 5 sample of embodiment high (16 ml/kg), in (8 ml/kg), low (4
Ml/kg) three dosage groups, blank control group (give 0.9% physiological saline of same volume), positive controls (8 ml/kg).Stomach-filling is given
Medicine, 1 time/d, continuous 7d.30min after the last administration, each group mouse uniformly apply 50 μ l of dimethylbenzene in the forward and backward face of mouse right ear and cause
Inflammation, cervical dislocation puts to death mouse after 1h, two ears of left and right is cut along auricle base line, with 9 mm punch of diameter respectively in two ears
Round auricle is laid at same position, weighs in time and ear swelling and swelling inhibiting rate is calculated as follows:
Ear swelling (mg)=auris dextra slice weight-left auricle weight;
Each group mouse right ear after inflammation is caused to occur the red and swollen phenomenon of height, compared with blank control group, 5 sample of the embodiment of the present invention at once
The ear swelling difference of high, medium and low dosage group and positive controls is statistically significant (P < 0.01 or P < 0.05);
The 5 sample administration group swelling of the embodiment of the present invention and swelling inhibiting rate of 3 various doses are in apparent dose-dependence.
The result shows that 5 sample of inventive embodiments can obviously reduce the auricle edema of mice caused by dimethylbenzene xylene within the scope of 4~16 ml/kg,
With anti-inflammatory effect, and acts on and be slightly better than positive control drug.Specifically it is shown in Table 6.
The influence (x ± s) of 6 paraxylene of table cause mouse ear swelling
Group | n | Dosage (ml/kg) | Ear swelling (mg) | Swelling inhibiting rate (%) |
High dose group | 10 | 16 ml/kg | 2.17±1.54** | 31.94 |
Middle dose group | 10 | 8 ml/kg | 3.74±2.24** | 25.07 |
Low dose group | 10 | 4 ml/kg | 4.69±3.04* | 20.30 |
Blank control group | 10 | — | 9.37±3.45 | — |
Positive controls | 10 | 8 ml/kg | 4.26±2.43* | 22.71 |
Note: with blank control group ratio:*P < 0.05,**P < 0.01
2.2 mouse concentrated ammonia liquors cause cough experiment
Take Kunming mouse 50, be randomly divided into 5 groups: 5 sample of embodiment high (16 ml/kg), in (8 ml/kg), low (4
Ml/kg) three dosage groups, blank control group (give 0.9% physiological saline of same volume), positive controls (8 ml/kg).Stomach-filling is given
Medicine, 1 time/d, continuous 7d.Mouse is put into 4L sealed dry container by lh after the last administration one by one, and constant pressure sprays into 25% dense ammonia
Aqueous vapor mist, spraying 5s draw cough, observe its cough latent period and cough number (every 2 min).
Each group mouse after cough is caused different degrees of mouth opening, the cough phenomenon such as contraction of abdominal muscle, with blank control occur
Group is compared, the high agent of 5 sample of the embodiment of the present invention, in, low amounts group and positive controls can significantly extend incubation period of mouse cough
(P < 0.01 or P < 0.05), and reduce cough number (P < 0.01 or P < 0.05).The result shows that with of the invention real
The increase of 5 sample dose of example is applied, the incubation period of each group mouse cough is extended, and cough number is reduced, and the present invention is implemented
5 sample of example has certain antitussive action.Specifically it is shown in Table 7.
Table 7 causes mouse cough reaction to concentrated ammonia liquor
Group | Dosage (ml/kg) | Cough latent period (s) | It coughs number (secondary/2min) |
High dose group | 16 ml/kg | 22.32±1.14** | 13.65±3.46** |
Middle dose group | 8 ml/kg | 16.87±1.33* | 18.41±4.17** |
Low dose group | 4 ml/kg | 9.62±1.29* | 22.52±5.48* |
Blank control group | — | 3.21±0.84 | 31.14±6.16 |
Positive controls | 8 ml/kg | 13.52±1.26** | 19.25±4.33** |
Note: with blank control group ratio:*P < 0.05,**P < 0.01
The experiment of 2.3 mouse tracheae section phenol red excretion
Take Kunming mouse 50, be randomly divided into 5 groups: 5 sample of embodiment high (16 ml/kg), in (8 ml/kg), low (4
Ml/kg) three dosage groups, blank control group (give 0.9% physiological saline of same volume), positive controls (8 ml/kg).Stomach-filling is given
Medicine, 1 time/d, continuous 7d.30 min after the last administration, every mouse peritoneal inject 2.5% phenol red NaHCO30.02 ml/ of solution
G weight, mouse is put to death after 30 min, and each tracheae section is put into and fills 1.5 ml, 5% NaHCO in advance by anatomical isolation tracheae3
In the test tube of solution, ultrasonic cleaning makes the phenol red complete release in tracheae section, and cleaning solution centrifugation takes supernatant in all-wave length
Colorimetric at microplate reader 546nm measures absorbance (A) value, substitutes into phenol red standard curve, calculate phenol red content.
Compared with blank control group, 5 sample of the embodiment of the present invention is high, middle dose group phenol red secretory volume dramatically increases (P
< 0.05 or P < 0.01), although the phenol red secretory volume of 5 sample low dose group of the embodiment of the present invention and positive controls has centainly
The increase of degree, but no significant difference (P > 0.05).The result shows that 5 sample high dose group of the embodiment of the present invention has
Certain phlegm-dispelling functions, and act on and be slightly better than positive control.Specifically it is shown in Table 8.
Influence of the table 8 to the phenol red excretion of mouse tracheae section
Group | n | Dosage (ml/kg) | Phenol red content (μ g/ml) |
High dose group | 10 | 16 ml/kg | 0.676±0.123** |
Middle dose group | 10 | 8 ml/kg | 0.489±0.140* |
Low dose group | 10 | 4 ml/kg | 0.265±0.112 |
Blank control group | 10 | — | 0.221±0.424 |
Positive controls | 10 | 8 ml/kg | 0.298±0.187 |
Note: with blank control group ratio:*P < 0.05
2.4 bacteriostasis
A certain number of small test tubes are taken, are divided into 10 groups, every group 10, respectively at nutrient broth is added in first small test tube of each group
Culture medium 1.5ml, remaining each pipe are separately added into nutrient broth medium 1ml.The present invention, which is added, in first small test tube of 1-5 group implements
Commercial concentration nourishiing yin to clear away the lung-heat cream (original sample) 0.5mL is added in first test tube of 5 sample of example (original sample) 0.5mL, 6-10 group, and each group is mixed
Each 1mL that is sucked out is added in respective second small test tube after even, is repeated in successively decrease and is diluted to the 9th pipe, and the 9th pipe mixes
Afterwards, 1mL mixed liquor is sucked out to discard, medical fluid is not added in the tenth pipe, then draws culture and is diluted to 10 in 24 hours-3Bacteria suspension it is (every
1 hundred million) mL is about that, each group steps up that 0.1mL is added from the first pipe to the 8th pipe point, and bacterium solution is also added in the tenth pipe containing bacterium number
Bacterium is not added as negative control in 0.1mL, the 9th pipe dosing, and the tenth pipe plus bacterium solution not dosing are used as positive control.By above-mentioned preparation
Good small test tube sets 36 DEG C culture 24-48 hours in incubator, and whether there is or not bacterial growths for each pipe that detects by an unaided eye, and as a result see Table 9 for details.
Inhibitory potency of the table 9 to experimental strain
Group | Staphylococcus aureus | Beta hemolytic streptococcus | Pseudomonas aeruginosa | Pneumococcus | Corynebacterium diphtheriae |
5 sample of embodiment | 1:128 | 1:64 | 1:64 | 1:64 | 1:32 |
Commercially available nourishiing yin to clear away the lung-heat cream | 1:64 | 1:32 | 1:64 | 1:32 | 1:32 |
Table 7 the result shows that, 5 sample of the embodiment of the present invention is false single to gold-coloured staphylococci, beta hemolytic streptococcus, verdigris in vitro
Born of the same parents bacterium, pneumococcus and corynebacterium diphtheriae have inhibiting effect, and result is better than comparison medicine (commercially available nourishiing yin to clear away the lung-heat cream).Show this hair
Bright 5 sample of embodiment has stronger bacteriostasis to respiratory tract common pathogen.
The above results of pharmacodynamic test shows 5 sample oral administration of the embodiment of the present invention, mouse caused by paraxylene
Ear swelling has certain inhibiting effect, shows the anti-inflammatory effect for having certain;It is obvious to mouse cough number caused by ammonium hydroxide
It reduces, and imitates relationship in a certain amount, show the antitussive action for having certain;There is increased work to discharge rate phenol red in mouse lung
With showing the phlegm-dispelling functions for having certain;Antibacterial experiment in vitro proves, 5 sample of the embodiment of the present invention is to gold-coloured staphylococci, B-mode
Hemolytic streptococcus, pseudomonas aeruginosa, pneumococcus and corynebacterium diphtheriae have certain inhibiting effect, show have centainly
Bacteriostasis.In summary result thinks, 5 sample of the embodiment of the present invention has cough-relieving, eliminating the phlegm, anti-inflammatory and bacteriostasis, and makees
It is better than the nourishiing yin to clear away the lung-heat cream of produced in conventional processes with effect, illustrates that product of the present invention preparation method effectively increases biological utilisation
Degree.
Six, clinical test
1. general information
Selected observation object is that differential diagnosis in tcm belongs to YIN-deficiency type, the chronic bronchitis of lung heat type and deficiency of Yin lung heat type, urgency
Property bronchitis and patient, totally 222, be divided into: treatment group 128 uses 5 sample of the embodiment of the present invention;Control group 94, make
With commercially available nourishiing yin to clear away the lung-heat cream.Two groups of patient age distributions, the substantially similar (see Table 10)s of various disease proportions.
10 two groups of Genders of table (`x ± SD) compared with age distribution
2. observation method
By 222 cases, 2 groups are randomly divided into, wherein treatment group 128, give 5 sample of the embodiment of the present invention, taken orally, once
10-20ml, 2-3 times on the one.Control group 94, commercially available nourishiing yin to clear away the lung-heat cream is given, is taken orally, a 10-20ml, 2-3 times on the one.
3. result
3.1 adverse reactions and safety evaluatio
During observation, two groups of patients do not have found obvious adverse reaction and toxic side effect.
3.2 Clinical efficacy comparison
Treatment group 128 merges pulmonary emphysema total effective rate point to chronic bronchitis, acute bronchitis, chronic bronchitis
It Wei 93.0%, 100% and 91.2%.Control group 94, chronic bronchitis, acute bronchitis, chronic bronchitis are merged
The total effective rate of pulmonary emphysema is respectively 88.5%, 89.0% and 83.3%.There is certain difference in treatment group compared with the control group, is shown in Table
12.Show that 5 sample treatment chronic bronchitis of the embodiment of the present invention, acute bronchitis, chronic bronchitis merge pulmonary emphysema
Etc. illnesss effect be slightly better than the commercially available nourishiing yin to clear away the lung-heat cream (produced in conventional processes) (being shown in Table 11) of produced in conventional processes.
11 Clinical efficacy comparison of table (example)
4. conclusion
The above clinical test results show 5 sample of embodiment produced through preparation method of the present invention in therapeutic effect better than biography
The nourishiing yin to clear away the lung-heat cream of system method production, illustrates which raises bioavilabilities, and takes safe and reliable, the pair that has no adverse reaction work
With.
Claims (10)
1. a kind of nourishiing yin to clear away the lung-heat cream, raw material are mainly grouped as by the group of following parts by weight: 100 parts of glutinous rehmannia, 60 parts of Radix Ophiopogonis, radix scrophulariae
80 parts, 40 parts of bulbus fritillariae cirrhosae, 40 parts of Radix Paeoniae Alba, 40 parts of cortex moutan, 25 parts of peppermint, 20 parts of Radix Glycyrrhizae, which is characterized in that preparation method packet
Include following steps:
R1. glutinous rehmannia, Radix Ophiopogonis, radix scrophulariae, bulbus fritillariae cirrhosae, Radix Paeoniae Alba, cortex moutan, peppermint, Radix Glycyrrhizae are taken respectively, are cleaned, it is dry;
R2. weigh component by following parts by weight: 100 parts of glutinous rehmannia, 60 parts of Radix Ophiopogonis, 80 parts of radix scrophulariae, 40 parts of bulbus fritillariae cirrhosae, 40 parts of Radix Paeoniae Alba,
40 parts of cortex moutan, 25 parts of peppermint, 20 parts of Radix Glycyrrhizae;
R3. bulbus fritillariae cirrhosae is taken, hydrochloric acid solution is added to impregnate, ultrasound filters, and filtrate adjusts pH value to neutrality with sodium hydroxide solution, obtains
Bulbus fritillariae cirrhosae extracting solution;
R4. cortex moutan and peppermint use steam distillation respectively, collect distillate, divide and the another device of volatile component is taken to save, the dregs of a decoction wait for
With;
R5. the five tastes such as the dregs of a decoction of step R4 and remaining glutinous rehmannia add 5-15 times to measure water and decoct 2-3 times, 1-3 hours each, merge and decoct
Liquid is stood, and filtration, filtrate merges with bulbus fritillariae cirrhosae extracting solution, is concentrated, through ceramic membrane filter, filtrate is concentrated into right amount, adds refined honey
It 300 parts, mixes, filtration, filtrate is concentrated into defined relative density, lets cool, and obtains thick paste;
R6. take thick paste, the volatile component of cortex moutan and peppermint be added, mix to get.
2. nourishiing yin to clear away the lung-heat cream according to claim 1, which is characterized in that described in step R3 plus hydrochloric acid solution dipping is to add 8-
15 times of amount hydrochloric acid solutions impregnate 1-3 hours.
3. nourishiing yin to clear away the lung-heat cream according to claim 1, which is characterized in that ultrasonic time described in step R3 is 40-60 minutes.
4. nourishiing yin to clear away the lung-heat cream according to claim 1, which is characterized in that the concentration of hydrochloric acid solution described in step R3 is
0.05mol/L;The concentration of the sodium hydroxide solution is 0.1mol/L.
5. a kind of preparation method of nourishiing yin to clear away the lung-heat cream as described in claim 1, which comprises the following steps:
R1. glutinous rehmannia, Radix Ophiopogonis, radix scrophulariae, bulbus fritillariae cirrhosae, Radix Paeoniae Alba, cortex moutan, peppermint, Radix Glycyrrhizae are taken respectively, are cleaned, it is dry;
R2. weigh component by following parts by weight: 100 parts of glutinous rehmannia, 60 parts of Radix Ophiopogonis, 80 parts of radix scrophulariae, 40 parts of bulbus fritillariae cirrhosae, 40 parts of Radix Paeoniae Alba,
40 parts of cortex moutan, 25 parts of peppermint, 20 parts of Radix Glycyrrhizae;
R3. bulbus fritillariae cirrhosae is taken, hydrochloric acid solution is added to impregnate, ultrasound filters, and filtrate adjusts pH value to neutrality with sodium hydroxide solution, obtains
Bulbus fritillariae cirrhosae extracting solution;
R4. cortex moutan and peppermint use steam distillation respectively, collect distillate, divide and the another device of volatile component is taken to save, the dregs of a decoction wait for
With;
R5. the five tastes such as the dregs of a decoction of step R4 and remaining glutinous rehmannia add 5-15 times to measure water and decoct 2-3 times, 1-3 hours each, merge and decoct
Liquid is stood, and filtration, filtrate merges with bulbus fritillariae cirrhosae extracting solution, is concentrated, through ceramic membrane filter, filtrate is concentrated into right amount, adds refined honey
It 300 parts, mixes, filtration, filtrate is concentrated into defined relative density, lets cool, and obtains thick paste;
R6. take thick paste, the volatile component of cortex moutan and peppermint be added, mix to get.
6. nourishiing yin to clear away the lung-heat cream according to claim 5 is prepared into method, which is characterized in that described in step R3 plus hydrochloric acid is molten
Liquid dipping impregnates 1-3 hours to add 8-15 times to measure hydrochloric acid solution;The ultrasonic time is 40-60 minutes.
7. nourishiing yin to clear away the lung-heat cream according to claim 5 is prepared into method, which is characterized in that hydrochloric acid solution described in step R3
Concentration be 0.05mol/L;The concentration of the sodium hydroxide solution is 0.1mol/L.
8. the preparation method of nourishiing yin to clear away the lung-heat cream according to claim 5, which is characterized in that ceramics fenestra described in step R5
Diameter is 0.1-0.2 μm.
9. the preparation method of nourishiing yin to clear away the lung-heat cream according to claim 5, which is characterized in that ceramic membrane mistake described in step R5
Extracting solution is concentrated into the concentration of " crude drug: medical fluid=1:4~1:10 " before filtering.
10. the application of nourishiing yin to clear away the lung-heat cream as described in claim 1, which is characterized in that dry for treating the lung-dryness syndrome due to yin deficiency, throat
Bitterly, dry cough lacks phlegm or blood-stained sputum.
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CN115177687A (en) * | 2022-06-30 | 2022-10-14 | 宁波大学 | Yin-nourishing lung-heat-clearing decoction or extract for preventing and treating pneumonia, and preparation and application thereof |
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CN101181513A (en) * | 2007-11-21 | 2008-05-21 | 呼伦贝尔松鹿制药有限公司 | Medicament for curing lung and laryngopharynx disease as well as producing method thereof |
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