CN116492386A - Traditional Chinese medicine composition with lung clearing and throat moistening effects and preparation method and application thereof - Google Patents

Traditional Chinese medicine composition with lung clearing and throat moistening effects and preparation method and application thereof Download PDF

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CN116492386A
CN116492386A CN202310522516.1A CN202310522516A CN116492386A CN 116492386 A CN116492386 A CN 116492386A CN 202310522516 A CN202310522516 A CN 202310522516A CN 116492386 A CN116492386 A CN 116492386A
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traditional chinese
chinese medicine
parts
medicine composition
lung
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陈妹妹
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Yiyuantang Xiamen Pharmaceutical Technology Co ltd
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Yiyuantang Xiamen Pharmaceutical Technology Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/535Perilla (beefsteak plant)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/287Chrysanthemum, e.g. daisy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/484Glycyrrhiza (licorice)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/534Mentha (mint)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/04Drugs for disorders of the respiratory system for throat disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/53Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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Abstract

The invention belongs to the technical field of traditional Chinese medicine compositions, and particularly relates to a traditional Chinese medicine composition with lung clearing and throat wetting effects, and a preparation method and application thereof. The invention provides a traditional Chinese medicine composition with lung-heat clearing and throat-moistening effects, which comprises 1-100 parts of perilla leaf, 1-50 parts of chrysanthemum flower, 1-10 parts of liquorice and 1-10 parts of peppermint, and is obtained by alcohol extraction, concentration and alcohol precipitation. The traditional Chinese medicine composition provided by the invention takes medicinal and edible traditional Chinese medicines such as perilla leaves, chrysanthemum, liquorice and mint as a formula, is based on the traditional Chinese medicine theory guidance of clearing lung and moistening throat, has medicinal and edible dual purposes and no toxic or side effect, and has the obvious effects of resisting inflammation, relieving cough, eliminating phlegm, improving lung functions and the like. The traditional Chinese medicine composition provided by the invention can be used as a medicine and food dual-purpose compound for assisting in clearing lung and moistening throat, and can be applied to diseases such as unsmooth breathing, excessive phlegm, cough, sore throat and the like.

Description

Traditional Chinese medicine composition with lung clearing and throat moistening effects and preparation method and application thereof
Technical Field
The invention belongs to the technical field of traditional Chinese medicine compositions, and particularly relates to a traditional Chinese medicine composition with lung clearing and throat wetting effects, and a preparation method and application thereof.
Background
With the rapid development of industrialization and urbanization, atmospheric environmental pollution has become one of the important risk factors affecting human health. Environmental pollution is harmful to human health, and the respiratory system is necessarily the first place. In the airThe harmful substances can stimulate the lung to cause inflammation, lung function decline and lung pollutant removing capacity reduction, and cause rhinitis, chronic pharyngitis, chronic bronchitis, bronchial asthma, emphysema and other diseases. Epidemiological study data showed that average PM2.5 day concentration was increased by 10. Mu.g/m 3 The incidence and admission rate of respiratory diseases are respectively increased by 2.07 percent and 8.0 percent, wherein the incidence rate of pneumonia and acute bronchitis is increased by 6.3 percent, and the incidence rate of asthma is increased by 9.3 percent. Environmental inhalation pollutants stimulate the production of lung airway inflammation, release a large amount of ROS/RNS and inflammatory factors to enter the blood circulation through pulmonary capillaries, initiate changes in the oxidative stress state and inflammatory level of the circulatory system, and promote the expression of inflammatory factors, chemokines and adhesion molecules. Therefore, it is important to prevent the inhalation of harmful substances, remove the harmful substances in the airway and the lung in time, and protect the airway and the lung function.
The lung is at a key position of the human body system, and people with poor lung have a higher probability of suffering from various diseases of the airway, the lung and the throat, such as tracheitis, pneumonia, sphagitis and the like, and are more prone to catch a cold when changing seasons or when the temperature is greatly changed. Western medicines have definite curative effects on cough relieving, phlegm removing, anti-inflammatory and other treatments of respiratory diseases, but have obvious side effects and adverse reactions, and cannot be taken for a long time as daily preventive medicines. In this regard, the advantages of traditional Chinese medicine are highlighted, and the lung is the core viscera of the respiratory system, and is called "jiao zang-organ" in traditional Chinese medicine. From the aspect of health preservation, the respiratory disease is considered to be due to the heavy consumption of body fluid, and the source of body fluid generation in the five zang organs is the lung, so that lung moistening and body fluid production are the lung clearing and are also the keys for resolving and cleaning harmful substances breathed to the lung. Therefore, development of a medicinal and edible product capable of clearing lung and moistening throat, which has no toxic or side effect and obvious effect, and can be used for a long time, is needed.
Disclosure of Invention
In order to solve the problems, the invention provides a traditional Chinese medicine composition with the effects of clearing lung and moistening throat, and a preparation method and application thereof. The traditional Chinese medicine composition is prepared based on the traditional Chinese medicine theory guidance compatibility of clearing lung and moistening throat, has dual purposes of medicine and food, has no toxic or side effect, and has the effects of obviously resisting inflammation, relieving cough, eliminating phlegm, improving lung functions and the like.
The invention provides a traditional Chinese medicine composition with the effects of clearing lung and moistening throat, which comprises the following raw materials in parts by weight: 1 to 100 parts of perilla leaf, 1 to 50 parts of chrysanthemum, 1 to 10 parts of liquorice and 1 to 10 parts of mint.
Preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 20-100 parts of perilla leaf, 10-50 parts of chrysanthemum, 5-10 parts of liquorice and 5-10 parts of mint.
The invention also provides a preparation method of the traditional Chinese medicine composition with the effects of clearing lung and moistening throat, which comprises the following steps:
extracting the raw materials of the traditional Chinese medicine composition by using a first alcohol solution, filtering, and concentrating the extracting solution to obtain a concentrated solution;
and (3) precipitating the concentrated solution with alcohol by using a second alcohol solution, and collecting precipitate to obtain the traditional Chinese medicine composition.
Preferably, the first alcohol solution and the second alcohol solution are different in concentration.
Preferably, the concentration of the first alcohol solution is lower than that of the second alcohol solution.
Preferably, the method comprises the steps of,the saidThe first alcohol solution comprises 30-50% ethanol water solution by volume percent.
Preferably, the volume ratio of the raw material to the first alcohol solution is 1:5-20.
Preferably, the second solution comprises adding ethanol to the concentrated solution until the final concentration of the ethanol is 80% -95%.
Preferably, the concentration comprises concentrating the mass-to-volume ratio of the raw materials to the concentrated solution to 2kg:1L.
The invention also provides application of the traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the preparation method in preparing medicines for preventing, relieving, improving and/or treating respiratory diseases.
Preferably, the respiratory disease comprises at least one of bronchitis and pharyngitis.
The beneficial effects are that: the invention provides a traditional Chinese medicine composition with the effects of clearing lung and moistening throat, which comprises the following raw materials in parts by weight: 1 to 100 parts of perilla leaf, 1 to 50 parts of chrysanthemum, 1 to 10 parts of liquorice and 1 to 10 parts of mint. The traditional Chinese medicinal materials used in the traditional Chinese medicine compound composition provided by the invention are compatible according to the theory of traditional Chinese medicine, and are organically screened and combined according to the scientific experimental basis of clearing lung and moistening throat, so that the traditional Chinese medicinal compound composition is not simply overlapped by single traditional Chinese medicinal effects. Wherein Perillae herba She Jiebiao has effects of dispelling cold, activating qi-flowing and regulating stomach; can be used for treating common cold due to wind-cold, cough, vomiting of pregnancy, and poisoning of fish and crab. The yellow chrysanthemum has the effects of dispelling wind and heat, clearing liver and improving eyesight; can be used for treating fever, headache, cough, conjunctival congestion, and swelling and pain caused by wind-heat of liver channel or liver fire. Licorice has the effects of invigorating spleen and replenishing qi, clearing heat and detoxicating, eliminating phlegm and relieving cough, and relieving spasm and pain, and has the effects of harmonizing various medicines; it is indicated for weakness of spleen and stomach, lassitude, palpitation, shortness of breath, cough with excessive phlegm, abdominal pain, limb spasm, pain, carbuncle, swelling and sore, and toxicity, and is used for relieving drug toxicity and intensity. Peppermint, herba Menthae, having effects of dispelling wind and heat, clearing head and eyes, relieving sore throat, promoting eruption, soothing liver and promoting qi circulation; can be used for treating wind-heat type common cold, headache, conjunctival congestion, fever, laryngopharynx, and gum swelling and pain. The invention is determined according to various consideration factors such as the characteristics of medicinal materials of each traditional Chinese medicine in the prescription, monarch, minister, assistant and guide compatibility and the like, and is obtained through scientific proportioning optimization. The traditional Chinese medicine composition provided by the invention has no side effect and obvious effect, can be used as a medicine, a dietary supplement or a health food raw material, and is used for treating and/or preventing symptoms such as unsmooth breathing, excessive phlegm, cough, sore throat and the like. The experiment shows that the traditional Chinese medicine composition has good effects in relieving allergic symptoms, prolonging the incubation period of cough, reducing the times of cough, inhibiting ear swelling and reducing inflammatory reaction.
In addition, the preparation method of the traditional Chinese medicine composition provided by the invention is simple and scientific, saves the extraction time and the extraction cost to the maximum extent, and ensures the stability and the effectiveness of the product while conforming to the economic principle.
Detailed Description
The invention provides a traditional Chinese medicine composition with the effects of clearing lung and moistening throat, which comprises the following raw materials in parts by weight: 1 to 100 parts of perilla leaf, 1 to 50 parts of chrysanthemum, 1 to 10 parts of liquorice and 1 to 10 parts of mint.
The invention has no special requirements on the sources of the raw materials of the traditional Chinese medicine composition, and adopts commercial products well known to those skilled in the art.
The traditional Chinese medicine composition provided by the invention comprises 1-100 parts by mass of perilla leaves, preferably 20-100 parts by mass, more preferably 50-100 parts by mass and most preferably 70-100 parts by mass. The perilla leaf has the effects of relieving exterior syndrome, dispelling cold, promoting qi and harmonizing stomach; can be used for treating common cold due to wind-cold, cough, vomiting of pregnancy, and poisoning of fish and crab.
Based on the mass parts of the perilla leaves, the traditional Chinese medicine composition provided by the invention comprises 1-50 parts of chrysanthemum, preferably 10-50 parts, more preferably 20-50 parts and most preferably 40-50 parts. The chrysanthemum has the effects of dispelling wind and heat, clearing liver and improving eyesight; can be used for treating fever, headache, cough, conjunctival congestion, and swelling and pain caused by wind-heat of liver channel or liver fire.
Based on the mass parts of the perilla leaves, the traditional Chinese medicine composition provided by the invention comprises 1-10 parts of liquorice, preferably 5-10 parts, more preferably 7-10 parts and most preferably 8-10 parts. The liquorice has the effects of invigorating spleen and replenishing qi, clearing heat and detoxicating, eliminating phlegm and relieving cough, relieving urgency and pain and harmonizing various medicines; it is indicated for weakness of spleen and stomach, lassitude, palpitation, shortness of breath, cough with excessive phlegm, abdominal pain, limb spasm, pain, carbuncle, swelling and sore, and toxicity, and is used for relieving drug toxicity and intensity.
Based on the mass parts of the perilla leaves, the traditional Chinese medicine composition provided by the invention comprises 1-10 parts of mint, preferably 5-10 parts, more preferably 7-10 parts and most preferably 8-10 parts. The mint has the effects of dispelling wind and heat, clearing head and eyes, relieving sore throat, relieving diagnosis, soothing liver and promoting qi circulation; can be used for treating wind-heat type common cold, headache, conjunctival congestion, fever, laryngopharynx, and gum swelling and pain.
The weight ratio of the raw materials of the traditional Chinese medicine composition provided by the invention is preferably 10:5:1:1.
The perilla leaf is a monarch drug for relieving exterior syndrome and dispelling cold; yellow chrysanthemum is used as a ministerial drug for dispelling wind and heat; licorice is used as an adjuvant drug to regulate the functions of the medicines; peppermint, herba Menthae, as a guiding drug, soothes liver and promote qi circulation.
The invention also provides a preparation method of the traditional Chinese medicine composition with the effects of clearing lung and moistening throat, which comprises the following steps:
extracting the raw materials of the traditional Chinese medicine composition by using a first alcohol solution, filtering, and concentrating the extracting solution to obtain a concentrated solution;
and (3) precipitating the concentrated solution with alcohol by using a second alcohol solution, and collecting precipitate to obtain the traditional Chinese medicine composition.
The concentration of the first alcohol solution is different from that of the second alcohol solution; the concentration of the first alcohol solution is preferably lower than that of the second alcohol solution.
The method comprises the steps of firstly extracting raw medicines by using a first alcohol solution, wherein the first alcohol solution is preferably ethanol water solution with the volume percentage of 30-50%, more preferably ethanol water solution with the volume percentage of 32-50%, and even more preferably ethanol water solution with the volume percentage of 35-50%. The volume ratio of the raw material to the first alcohol solution is 1:5-20, more preferably 1:5-15, and still more preferably 1:10-15. The extraction is preferably heating reflux extraction, and the extraction times are preferably 1-3 times, more preferably 2-3 times; the extraction time is preferably 1 to 3 hours, more preferably 1.5 to 3 hours, and still more preferably 1.5 to 2.5 hours. The extraction of the raw materials in the invention preferably comprises the steps of extracting the raw materials singly or mixing the raw materials and extracting the raw materials together.
After the extraction, the solution obtained by each extraction is combined to obtain an extracting solution, and the extracting solution is concentrated. In the present invention, the concentration preferably comprises concentrating the mass-to-volume ratio of the raw material to the concentrated solution to 2kg:1L based on the mass of the raw material.
The concentration is followed by alcohol precipitation of the concentrate, wherein the alcohol precipitation is preferably carried out by adding ethanol into the concentrate until the final concentration of ethanol is 80% -95%, more preferably until the final concentration of ethanol is 80% -90%, even more preferably until the final concentration of ethanol is 80% -85%, and the alcohol precipitation time is preferably 24 hours.
After the dissolution, the method further comprises the steps of drying and crushing the precipitate, wherein the drying condition is preferably 80 ℃ and reduced pressure drying; the pulverized particle diameter is preferably 80 mesh.
The traditional Chinese medicine composition provided by the invention has obvious effects of clearing lung, moistening throat, resisting allergy, resisting inflammation, relieving cough, eliminating phlegm and relieving asthma, has obvious effects of inhibiting pulmonary inflammation and pharyngitis, has no toxic or side effect, can be used as a dietary auxiliary agent for preparing medicines for preventing, relieving, improving and/or treating respiratory diseases, and can also be used for preparing health-care foods for preventing, relieving and improving respiratory diseases.
The route of administration of the compositions of the present invention is preferably oral. The administration dosage form may be liquid dosage form or solid dosage form. The liquid dosage form can be true solution, colloid, microparticle, emulsion, suspension, etc. Other dosage forms can be tablet, capsule, pill, powder, solution, suspension, emulsion, granule, etc.
The composition of the invention can be prepared into common preparations, slow release preparations, controlled release preparations and various microparticle administration systems. For example, various carriers known in the art can be widely used, such as a unit dosage form of a tablet. For example, diluents and absorbents such as starch, dextrin, calcium sulfate, lactose, mannitol, sucrose, sodium chloride, glucose, urea, calcium carbonate, kaolin, microcrystalline cellulose, aluminum silicate, etc. may be used; wetting agents and binders such as water, gan Bo, polyethylene glycol, ethanol, propanol, starch slurry, dextrin, syrup, honey, dextrose solution, acacia slurry, gelatin slurry, sodium carboxymethyl cellulose, shellac, methyl cellulose, potassium phosphate, polyvinylpyrrolidone, and the like; disintegrants such as dry starch, alginate, agar powder, brown algae starch, sodium bicarbonate and citric acid, calcium carbonate, polyoxyethylene sorbitol fatty acid ester, sodium dodecyl sulfonate, methylcellulose, ethylcellulose, etc.; disintegration inhibitors such as sucrose, glyceryl tristearate, cocoa butter, hydrogenated oils and the like; absorption promoters such as quaternary ammonium salts, sodium dodecyl sulfate, and the like; lubricants such as talc, silica, corn starch, stearate, boric acid, liquid paraffin, polyethylene glycol, and the like. The tablets may be further formulated into coated tablets, such as sugar coated tablets, film coated tablets, enteric coated tablets, or one or more of double and multi-layered tablets.
If the administration unit is formulated as a pill, various carriers well known in the art can be widely used. For example, diluents and absorbents such as glucose, lactose, starch, cocoa butter, hydrogenated vegetable oils, polyvinylpyrrolidone, gelucire, kaolin, talc, etc. may be used; binders such as acacia, tragacanth, gelatin, ethanol, honey, liquid sugar, rice paste or batter, and the like; disintegrating agents, such as one or more of agar powder, dry starch, alginate, sodium dodecyl sulfate, methylcellulose, and ethylcellulose.
If the administration unit is encapsulated, the active ingredient is mixed with the various carriers described above, and the mixture thus obtained is placed in a hard gelatin capsule or a soft capsule. The active ingredients can also be prepared into microcapsules, and the microcapsules are suspended in an aqueous medium to form a suspension for application.
For example, the compositions of the present invention may be formulated as solutions, suspensions, and such formulations may be aqueous or non-aqueous and may contain one or more pharmaceutically acceptable carriers, diluents, binders, lubricants, preservatives, surfactants or dispersants. For example, the diluent may be selected from water, ethanol, polyethylene glycol, 1, 3-propanediol, ethoxylated isostearyl alcohol, polyoxy isostearyl alcohol, polyoxyethylene sorbitol lipase, and the like.
In addition, colorants, preservatives, flavors, flavoring agents, sweeteners, or other materials may be added to the pharmaceutical formulation as desired. Including tablets, capsules or granules.
The invention has no special requirement on the dosage ratio of the traditional Chinese medicine composition and auxiliary materials, and the traditional Chinese medicine composition and auxiliary materials can be prepared by adopting the ratio which is well known to the person skilled in the art.
The invention also provides application of the traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the preparation method in preparing medicines for preventing, relieving, improving and/or treating respiratory diseases.
The invention also provides the application of the traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the preparation method in preparing health-care food for preventing, relieving and improving respiratory diseases.
The respiratory disease comprises at least one of bronchitis and pharyngitis.
In order to further illustrate the present invention, the following examples are provided to describe the present invention in detail with respect to the traditional Chinese medicine composition having lung-heat clearing and throat-moistening effects, and the preparation method and application thereof, but they should not be construed as limiting the scope of the present invention.
Example 1
A preparation method of a traditional Chinese medicine composition with the effects of clearing lung and moistening throat comprises the following steps:
the preparation method comprises the steps of mixing 2000g of perilla leaves, 1000g of chrysanthemum, 200g of liquorice and 200g of mint with 50% (v/v) ethanol, wherein the volume of the 50% (v/v) ethanol is 10 times of the total mass of the perilla leaves, the chrysanthemum, the liquorice and the mint, and obtaining a mixture. Heating and reflux-extracting the mixture for 2 times each for 2 hours, collecting the obtained solution, combining the solutions obtained by the two extractions to obtain an extracting solution, recovering ethanol, concentrating the extracting solution, and ending concentrating when the weight-volume ratio of the raw materials to the concentrated solution is 2kg:1L to obtain 1700ml of concentrated solution;
ethanol is added into the concentrated solution until the alcohol content in the solution is 80%, standing still at room temperature for 24h, filtering is carried out, filter residues are obtained, the filter residues are dried at 80 ℃ under reduced pressure, the dried filter residues are obtained, the dried filter residues are crushed and pass through a 80-mesh sieve, 493g of traditional Chinese medicine composition with the effects of clearing lung and moistening throat is obtained, and the yield is 14.5%.
Example 2:
capsule preparation
100g of the traditional Chinese medicine composition prepared in the example 1 is taken, 50g of pregelatinized starch, 30g of talcum powder and 20g of magnesium stearate are added, uniformly mixed and filled into 0.5g of capsules, and the capsules are obtained.
Example 3:
tablet preparation
100g of the traditional Chinese medicine composition prepared in the example 1 is taken, 60g of starch, 20g of dextrin and 20g of magnesium stearate are added, uniformly mixed, pressed into tablets with the specification of 0.5 g/tablet, and film-coated to obtain tablets.
Example 4:
granule preparation
Taking 100g of the traditional Chinese medicine composition prepared in the example 1, adding 30% ethanol for dissolution and dilution to 1g/mL, adding 100g of sodium lactate monohydrate, uniformly mixing, stirring to form a mass by hand, screening out particles which cannot pass through a 20-mesh sieve and a 80-mesh sieve but can pass through a 10-mesh sieve when the powder is touched, and putting the particles into an oven for drying at 80 ℃ to obtain the dried particles. And (3) drying the dried granules in a vacuum dryer until the water content is 4%, thereby obtaining granules.
Application example 1:
effect of the composition on guinea pig allergic rhinitis
The experimental method comprises the following steps:
40 male cleaning guinea pigs of 180-200g are randomly divided into a blank group, a model group, a composition low-dose group and a composition high-dose group according to the body weight, wherein the total number of the composition low-dose group and the composition high-dose group is 4, and 10 of the composition low-dose group and the composition high-dose group are respectively used. Model group, composition low dose group and composition high dose group guinea pigs were given Ovalbumin (OVA) induced stimulation to prepare rhinitis models: 1mL of 0.03g/mLOVA-0.03g/mL aluminum hydroxide gel suspension is injected intraperitoneally on the 1 st day, 1 time every other day, and total 7 times are carried out for whole body sensitization; on the last 3 days of the experiment, 50. Mu.g of OVA-0.9% sodium chloride solution (i.e., physiological saline solution containing 50. Mu.g of OVA) was instilled at 50. Mu.L per day in nasal cannula solution 1 time per day for 3 consecutive times. The blank group was given an equivalent amount of blank solvent. On the molding day, the drug is administered for gastric lavage administration intervention on the 1 st day of molding, 150mg/kg of the traditional Chinese medicine composition prepared in the example 1 is administered in a composition low dose group, 300mg/kg of the traditional Chinese medicine composition prepared in the example 1 is administered in a composition high dose group, and physiological saline with the same dosage as the administration volume is administered in a blank group and a model group. Each guinea pig was perfused for 21 days continuously 1 time per day. 24h after the last dose, assessed by scoring, 30min after nasal drip challenge, record the number of sneezes, the extent of nasal deflection and nasal secretions. After the recording is completed, the animals are sacrificed by anesthesia, serum and nasal rinse solutions are collected, and the measurement of histamine and IL-4 in serum IgE and rinse solutions is carried out by ELISA method.
Scoring of nasal symptoms:
0 minutes, no sneeze, nasal and nasal secretions are seen;
1 min, sneeze for 1-3 times per 30min, gently scratching nose, and allowing nasal secretion to flow to anterior nares;
2 minutes, sneeze for 4-10 times per 30 minutes, frequent nose scratching and nasal secretion exceeding the anterior nares;
3, sneeze is more than 10 sneezes/30 min, nose is scratched, nasal secretion nasal discharge is full of the face;
experimental results:
(1) Results of action of Compound composition on nasal allergy of guinea pigs
The scoring results are shown in table 1.
Table 1 Effect of Compound composition on evaluation of guinea pig nasal allergy (mean.+ -. Std)
Remarks: in comparison with the blank group, ## p is less than 0.01; p <0.05, p <0.01 compared to model control.
As can be seen from table 1, the guinea pigs showed significant symptoms such as sneeze, nasal grasping, nasal discharge, etc. after OVA nasal drip excitation; the times of nasal grasping and sneezing of the composition administration group are obviously reduced, and the symptom of runny nose is also obviously reduced; the normal control group showed mild nasal grabbing symptoms after physiological salt water drops, and no nasal grabbing and sneezing symptoms.
(2) Influence of compound composition on allergic guinea pig serum and nasal rinse inflammation factors
The collected guinea pig serum and nasal wash were assayed for inflammatory factor levels by ELISA.
The results are shown in Table 2:
table 2 Effect of Compound composition on allergic guinea pig serum and nasal rinse inflammatory factor (mean.+ -. Std)
Remarks: in comparison with the blank group, ## p is less than 0.01; p <0.05, p <0.01 compared to model control.
As can be seen from table 2, the serum IgE of guinea pigs was significantly elevated (the main antibody causing rhinitis) after allergen stimulation, and the composition administration was able to reduce the serum IgE content compared to the model group, the difference was significant (p < 0.05); the nasal rinse inflammatory factor histamine and IL-4 levels were significantly elevated in guinea pigs in the model group compared to the placebo group, whereas the nasal rinse histamine and IL-4 levels were significantly reduced in allergic guinea pigs following treatment with the composition, with a significant difference (p < 0.05) compared to the model group.
Application example 2:
action of the composition on Ammonia-induced cough in mice
The experimental method comprises the following steps:
40 SPF ICR mice with the weight of 18-20 g are randomly divided into a model control group, a positive medicine group (dextromethorphan hydrobromide) and a traditional Chinese medicine composition high-dose group 4 of the traditional Chinese medicine composition low-dose combination, wherein 10 mice are selected from each group. Each group of animals was administered by gavage, 100mg/kg of the traditional Chinese medicine composition prepared in example 1 was administered in the low dose group of the composition, 200mg/kg of the traditional Chinese medicine composition prepared in example 1 was administered in the high dose group of the composition, 20mg/kg of dextromethorphan hydrobromide positive drug was administered in the positive group, 1 time a day for 7 consecutive days, and an equal volume of physiological saline was administered in the model control group. The mice were placed in a 500mL glass container, 0.5mL of concentrated ammonia (25% ammonium hydroxide) was added to the cotton ball (100±5) mg, and immediately taken out after 30 seconds of the last administration, and the time (cough latency) and the number of coughs in 2 minutes when the mice developed cough reflex (abdominal muscle contraction, large mouth, with coughs) were observed and recorded.
The experimental results are shown in table 3:
TABLE 3 influence of Compound composition on ammonia-induced cough in mice (mean.+ -. Std)
Remarks: p <0.05, p <0.01 compared to model control.
As shown in the results of table 3, the low and high dose compound compositions have a significant prolongation effect on the incubation period of cough in mice compared to the model group; the high dose mice had significantly reduced cough counts (P < 0.05) within 2min, while the low dose mice had a tendency to decrease, but no significant differences were seen compared to the model group. The dextromethorphan hydrobromide positive medicine has remarkable inhibition effect on the cough latency and the cough times of mice.
Application example 3:
action of the composition on phenol Red-induced mouse airway sputum production
The experimental method comprises the following steps:
40 SPF ICR mice weighing 18-20 g are randomly divided into a model control group, a positive medicine group and a high-dose group 4 of a composition low-dose composition, wherein 10 ICR mice are selected from each group. Each group of animals was administered by stomach irrigation, 100mg/kg of the traditional Chinese medicine composition prepared in example 1 was administered in the low dose group of the composition, 200mg/kg of the traditional Chinese medicine composition prepared in example 1 was administered in the high dose group of the composition, 1000mg/kg of ammonium chloride positive drug was administered in the positive drug group, 1 time a day for 7 consecutive days, and an equal volume of physiological saline was administered in the model control group. The mice are fasted for 12 hours before the last administration and are not forbidden for water, and after the last administration for 1 hour, the 2.5 percent phenol red physiological saline solution is injected into the abdominal cavity of the mice for 0.2mL/10g; 0.5h after injection, animals were sacrificed under anesthesia and the trachea (thyroid cartilage to tracheal branch) was dissected and removed at 2ml of 5% nahco 3 And (3) carrying out ultrasonic treatment in the solution for 30min, centrifuging for 5min at 1500r/min, taking supernatant, measuring an absorbance OD value at 546nm of the enzyme label instrument, and calculating the phenol red content on a standard curve.
The calculation results are shown in table 4:
table 4 Effect of Compound composition on phenol Red-induced mouse airway sputum production (mean.+ -. Std)
Remarks: p <0.05, p <0.01 compared to model control.
As can be seen from the results in table 4, compared with the model group, the ammonium chloride positive drug, the low dose and the high dose compound composition can significantly increase the tracheal phenol red excretion of mice, and the difference has statistical significance (P <0.05 or P < 0.01).
Application example 4:
asthma relieving effect of compound composition on guinea pig asthma
The experimental method comprises the following steps:
taking male guinea pigs weighing 180-200g, atomizing 1mg/mL histamine phosphate for 30s in a asthma-inducing instrument, observing asthma reaction of the guinea pigs, and recording the time from the start of spraying to the twitch of the animals as falling time, wherein the falling time is the falling time before administration (generally not more than 150s, more than 150s are considered as insensitive and not selected); the next day, 40 guinea pigs were selected and randomly divided into a model control group, a positive drug group, and a composition low-dose composition high-dose group 4 groups of 10 animals each. Each group of animals was administered by gavage, 100mg/kg of the traditional Chinese medicine composition prepared in example 1 was administered in the low dose group of the composition, 200mg/kg of the traditional Chinese medicine composition prepared in example 1 was administered in the high dose group of the composition, 50mg/kg of aminophylline positive drug was administered in the positive group, 1 time a day for 7 consecutive days, and an equal volume of physiological saline was administered in the model control group. After the last dose for 1h, the fall time was measured in the asthma guide, which is the fall time after the dose, recorded for 360s, and the non-falling animals were calculated for 360 s. Calculating the extension rate of the asthma latency of guinea pigs: latency prolongation(s) =post-dose fall time-pre-dose fall time.
The experimental results are shown in table 5:
TABLE 5 Effect of Compound compositions on guinea pig asthma (mean.+ -. Std)
Remarks: p <0.05, p <0.01 compared to model control.
Application example 5:
inhibition effect of compound composition on croton oil induced otitis in mice
The experimental method comprises the following steps:
male Kunming mice weighing 18-20 g were randomly divided into model group, low dose composition group, high dose composition group and dexamethasone group, each group having 10 animals. The preparation was administered by intraperitoneal injection, dexamethasone was administered at 10mg/kg, dexamethasone was administered at 100mg/kg of the traditional Chinese medicine composition prepared in example 1 in the low dose composition group, and 200mg/kg of the traditional Chinese medicine composition prepared in example 1 in the high dose composition group, and an equal volume of physiological saline was administered in the model group. After 30min of administration, 50 μl of 2% croton oil diethyl ether solution was applied to both sides of the left and rear ears of the mice, the mice were sacrificed after dislocation for 4h, both ears were cut off along the auricle baseline, round ears were respectively punched out at the same positions of both ears with a punch with a diameter of 8mm, and the ears were weighed with a precision balance, and ear swelling degree (ear swelling degree=left ear weight-right ear weight) and ear swelling inhibition rate [ ear swelling inhibition rate (%) = (average ear swelling degree of model group-ear swelling degree of administration group)/average ear swelling group of model group×100% ].
The experimental results are shown in table 6:
table 6 Effect of the Compound composition on Croton oil induced otitis in mice (mean+ -SD)
Remarks: p <0.05, p <0.01 compared to model control.
As shown in Table 6, compared with the model group, the compound composition group has remarkable inhibitory activity (P <0.05 or 0.001) on the ear swelling of mice induced by croton oil when being dosed with each dose and the positive control drug, the inhibition rate of 200mg/kg dose can reach 54.6%, and the compound composition group shows obvious dose dependency.
Application example 6:
action of compound composition on LPS-induced acute lung inflammation of mice
The experimental method comprises the following steps:
male Kunming mice weighing 18-22g were randomly assigned to a blank, model, low dose and high dose groups of 10 animals each. The composition was administered by intraperitoneal injection, 150mg/kg of the composition prepared in example 1 was administered to the low dose composition group, 300mg/kg of the composition prepared in example 1 was administered to the high dose composition group, and an equal volume of physiological saline was administered to the blank group and the model group 1 time a day for 7 consecutive days. After 1h of administration on day 7, mice were anesthetized by intraperitoneal injection with 0.6% sodium pentobarbital at a rate of 0.1mL/10g, and 50 μLLPS (2.4 mg/mL) solution was slowly instilled intratracheally, and an equal volume of physiological saline was administered to the blank group. Animals were sacrificed 1h after the last dose, bronchoalveolar lavage fluid (BALF) was taken, and the content of inflammatory factor TNF- α was measured by white blood cell count and ELISA on a five-class blood cell analyzer.
The experimental results are shown in table 7:
table 7 Effect of Compound composition group on acute inflammation of the mouse lung (mean.+ -. SD)
Remarks: compared with the blank control group, the # p is less than 0.01, and the # p is less than 0.01; compared with the model control group, p <0.01
As shown in the results of Table 7, compared with the blank group, the white blood cell and inflammatory factor levels in the BALF of the model mouse are obviously increased, and the white blood cell count and inflammatory factor TNF-alpha levels in the BALF of the model mouse can be obviously reduced by the administration of the compound composition group (150 mg/kg, 300 mg/kg), so that obvious inhibition effects on lung inflammation such as trachea, bronchus and the like are shown.
Application example 7:
action of compound composition on ammonia-induced acute pharyngitis of rats
The experimental method comprises the following steps:
50 Wistar rats weighing 180-220g were randomly divided into a blank group, a model group, a low-dose composition group, a high-dose composition group and a positive control group, each group comprising 10 rats. The compositions were administered by gavage, 150mg/kg of the Chinese medicinal composition prepared in example 1 was administered in the low-dose group, 300mg/kg of the Chinese medicinal composition prepared in example 1 was administered in the high-dose group, 300mg/kg of the clarithromycin positive drug was administered in the positive group, and the same volume of physiological saline was administered in the blank group and the model group 1 time a day for 7 consecutive days. Except for the blank groups, animals of the other groups were sprayed with 15% aqueous ammonia physiological saline solution 2 times daily (1 time in the morning and afternoon) for 10s each time for 3 consecutive days on day 5 after administration. After 2h of last dose, animals of each group were sacrificed under anesthesia, 100mg of pharyngeal tissue was taken, and the ratio of 1:10 adding physiological saline, grinding and homogenizing the tissues, centrifuging at 10000r/min and 4 ℃ for 10min to prepare 10% tissue homogenized supernatant, and measuring the contents of inflammatory factors IL-6 and TNF-alpha by ELISA method.
The experimental results are shown in table 8:
table 8 Effect of Compound composition on Ammonia-induced acute pharyngitis in rats (mean+ -SD)
Remarks: compared with the blank control group, the # p is less than 0.01, and the # p is less than 0.01; compared with the model control group, p <0.01
As can be seen from the results in Table 8, the compound composition administration and the positive control drug have significant inhibitory effects (P <0.05 or 0.001) on inflammatory factors IL-6 and TNF-alpha in the pharyngeal tissues of rats compared with the model group, and the high dose group is close to the positive drug effect.
The comprehensive application examples 1-7 show that the traditional Chinese medicine composition can remarkably inhibit nose anaphylactic reaction of guinea pigs, cough of mice induced by ammonia water, reduce airway sputum generation of mice induced by phenol red, relieve asthma and resist inflammation, and remarkably inhibit acute lung inflammation of mice induced by LPS and acute pharyngitis of rats induced by ammonia water. In addition, no toxic or side effect is found in the animal experiment process, so that the traditional Chinese medicine compound composition has very wide application and development prospect in application of clearing lung and moistening throat.
Although the foregoing embodiments have been described in some, but not all, embodiments of the invention, it should be understood that other embodiments may be devised in accordance with the present embodiments without departing from the spirit and scope of the invention.

Claims (10)

1. The traditional Chinese medicine composition with the effects of clearing lung and moistening throat is characterized by comprising the following raw materials in parts by weight: 1 to 100 parts of perilla leaf, 1 to 50 parts of chrysanthemum, 1 to 10 parts of liquorice and 1 to 10 parts of mint.
2. The traditional Chinese medicine composition according to claim 1, which is characterized by comprising the following raw materials in parts by weight: 20-100 parts of perilla leaf, 10-50 parts of chrysanthemum, 5-10 parts of liquorice and 5-10 parts of mint.
3. The method for preparing the traditional Chinese medicine composition according to claim 1 or 2, which is characterized by comprising the following steps:
extracting the raw materials of the traditional Chinese medicine composition by using a first alcohol solution, and concentrating the extracting solution to obtain a concentrated solution;
precipitating the concentrated solution with alcohol by using a second alcohol solution, and collecting precipitate to obtain the traditional Chinese medicine composition;
the first alcohol solution and the second alcohol solution have different concentrations.
4. A method of preparing as claimed in claim 3, wherein the first alcohol solution is at a lower concentration than the second alcohol solution.
5. The method according to claim 3 or 4, wherein the first alcohol solution comprises 30 to 50% by volume of an aqueous ethanol solution.
6. The method according to claim 3 or 4, wherein the volume ratio of the raw material to the first alcohol solution is 1:5 to 20.
7. The method according to claim 6, wherein the second solution comprises adding ethanol to the concentrate to a final concentration of 80% to 95%.
8. A method of preparation according to claim 3, wherein the mass to volume ratio of the starting material to concentrate is concentrated to 2kg:1l.
9. Use of a traditional Chinese medicine composition according to any one of claims 1 or 2 or a traditional Chinese medicine composition prepared by a preparation method according to any one of claims 3 to 8 in the preparation of a medicament for preventing, alleviating, improving and/or treating respiratory diseases.
10. The use according to claim 9, wherein the respiratory disease comprises at least one of bronchitis, pharyngitis.
CN202310522516.1A 2023-05-10 2023-05-10 Traditional Chinese medicine composition with lung clearing and throat moistening effects and preparation method and application thereof Pending CN116492386A (en)

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