KR101416453B1 - A medicine composition for treating bronchial asthma and preparative method thereof - Google Patents

Abstract

The present invention provides a medicinal pharmaceutical composition for treating bronchial asthma and a method for producing the same. The herbal composition is prepared from pure botanical raw materials including horse mackerel, white mackerel, white mackerel, golden mackerel, passenger mackerel, barbed wire, The herbal composition is effective for treating bronchial asthma.

Description

TECHNICAL FIELD [0001] The present invention relates to a medicinal composition for treating bronchial asthma,

The present invention relates to a traditional Chinese medicine composition for treating bronchial asthma and a method for producing the same. The present invention belongs to the field of Chinese herbal medicine technology.

Bronchial asthma (hereinafter "asthma") is a common chronic lung disease. There are currently about 200 million people worldwide suffering from asthma, and there are about 20 million people with asthma in China. According to data from five major Chinese cities, the incidence of asthma among students ages 3 to 14 is between 3% and 5%. In general, the incidence is higher in younger children than adults, and adult males and females appear to be approximately the same. About 40% of patients have family history. Survey results indicated that 33% of asthmatic patients required hospitalization or first aid due to asthma, 58% of patients lost working hours due to asthma, and 79% of asthmatic patients had normal exercise and leisure activities 63% of asthmatic patients had to change their original lifestyle, 68% of asthmatic patients suffered from sleep disorders due to asthma, and 74% of asthmatic patients could not perform normal physical labor Giving. Asthma is a modern disease. The incidence will not decrease with improvements in people's health and living standards. Instead, the incidence of asthma continues to increase.

Over the past two decades, humankind has been actively studying effective asthma prevention and treatment, which is the subject of tireless research by medical professionals. Not only in foreign countries but also in China, the commonly used medicines for treating this disease include the following categories: inhaled corticosteroids, β2 agonists, inhaled anticholinergic drugs, theophyllines, Leukotriene antagonists, other inflammatory mediator antagonists and cytokine antagonists, bone marrow eosinophil progenitor cell inhibitors, and allergen-specific immunotherapy and gene therapy. In recent years, these drugs, which are primarily aimed at alleviating a series of bronchial inflammatory manifestations and symptoms, have achieved several clinical effects. Concerns about the frequency of clinical symptoms and the long-term (long-term) control of respiratory therapists remain a concern. In addition, in the treatment of asthmatic patients, the duration of treatment, when to reduce the dose, how to reduce the dose, when the patient will stop the drug, and to achieve the purpose of asthma control by any method or program And whether it is more efficient and safe for asthmatic patients. These problems are not only challenging for clinicians, but also adding a lot of difficulty to the continuous treatment of patients. On the other hand, some harmful side effects of the medicines have seriously affected the patient's continued treatment. Nearly half of all asthmatic patients in China are not ideally under their asthma control, and most asthmatics at baseline and rural areas are not able to effectively control their disease. There is a long way to go to achieve the goals of generally preventing and treating asthma and improving the efficacy of medicines.

In the prevention and treatment of bronchial asthma, traditional medicinal herbs have a history of thousands of years, and ancient doctors have been constantly studying the principles, methods, prescriptions and medicines for asthma, and have found many effective prescriptions. Pharmacological studies have shown that traditional medicinal treatments for asthma have a wide range of potent effects, including modulation of the immune system, anti-allergy, asthma relief, cough prevention, genomics, and inflammation. Traditional medicine can relieve airway inflammation and airway hyperresponsiveness. Clinical studies have shown that treatment with the herbal medicines has fewer side effects than the medicines and can greatly alleviate symptoms such as wheezing, chest compressions, coughs and sputum. Most patients are able to enter the lunar phase of asthma during treatment or reduce their hormone dose and improve their quality of life.

Dingchuan decoction, recorded in She Sheng Zhong Miao Fang, a Chinese medicinal herbal medicine recipe, is a honey-baking herbal Ephedrae , stir-fry Semen Ginkgo ), Cortex Mori , Golden ( Radix Scutellariae , Semen Armeniacae Amarum , Rhizoma Pinelliae ), a device ( Fructus Perillae ), Radix Paeoniae Rubra , Lumbricus , Periostracum Cicadae ), celadon ( Radix Trichosanthis ) Associated Fructus Forsythiae ). This is a popular prescription for asthma treatment. Experiments have shown that Chungcheon Ganghwa has antagonistic effects against histamine-induced asthma induced by histamine and acetylcholine chloride spray, and antagonism to histamine-induced contraction of isolated tracheal smooth muscle of guinea pigs [Li , zhengmu et al., Pharmacology research of Dingchuan decoction in treating bronchial asthma. Traditional Chinese Medicinal Materials. 1999, 22 (8): 411]. Jungcheon hot spring can accelerate secretion of phenol red in mouse airway. From the pharmacological point of view, these results demonstrate that Chungcheon Ganghwa has satisfactory effects on asthma relief and dementia.

SUMMARY OF THE INVENTION

Traditional Chinese Medicine composition of the invention is manufactured from pure natural herbal substances, including ephedra, Morus golden row, contrary, the elements, such as gwandonghwa (Flos Farfarae). The composition significantly alleviates symptoms of bronchial asthma such as wheezing, chest compressions, coughs, and sputum, and the effect is clearly better than that of Zhengcheng.

Composition of invention

One aspect of the invention is to provide a pesticide composition for treating bronchial asthma.

Another aspect of the present invention is to provide a method for preparing a traditional medicine composition for treating bronchial asthma.

The herbal composition of the present invention is prepared from the following herbal raw materials.

40 to 90 parts by weight of mahogany, 136 to 300 parts by weight of corn syrup, 146 to 300 parts by weight of corn syrup,

46 to 151 parts by weight, 46 to 151 parts by weight of Ganoderma lucidum, 46 to 151 parts by weight,

46 to 151 parts by weight of the element, 146 to 300 parts by weight of the base, 46 to 151 parts by weight of the binder,

46 to 151 parts by weight of gold, 46 to 151 parts by weight of silver,

146 to 300 parts by weight of Herba Houttuyniae,

146 to 300 parts by weight of silkworm, 46 to 151 parts by weight of silkworm.

Another herbal composition of the present invention is prepared from the following herbal raw materials.

77 to 88 parts by weight of maize, 136 to 165 parts by weight of corn syrup, 255 to 300 parts by weight of sake,

46 to 65 parts by weight of bagasse, 110 to 151 parts by weight of Ganoderma glutinosa, 46 to 65 parts by weight of glutaraldehyde,

105 to 151 parts by weight of the device, 146 to 165 parts by weight of the raw material, 46 to 65 parts by weight of the carrier,

103 to 151 parts by weight of gold, 46 to 65 parts by weight,

255 to 300 parts by weight of silkworm, 103 to 151 parts by weight of silkworm.

Preferably, the inventive herbal medicine composition is prepared from the following herbal medicine raw materials.

50 to 76 parts by weight of mahwang, 166 to 253 parts by weight of corn syrup, 166 to 253 parts by weight of sake,

66 to 101 parts by weight, 66 to 101 parts by weight of Ganoderma lucidum, 66 to 101 parts by weight,

66 to 101 parts by weight of the element, 166 to 253 parts by weight of the base, 66 to 101 parts by weight of the binder,

66 to 101 parts by weight of gold, 66 to 101 parts by weight, 166 to 253 parts by weight,

166 to 253 parts by weight of silkworm, 66 to 101 parts by weight of silicate.

Preferably, the inventive herbal medicine composition is prepared from the following herbal medicine raw materials.

50 parts by weight of mahwah, 253 parts by weight of corn syrup, 166 parts by weight of sake,

66 parts by weight of bagasse, 101 parts by weight of Ganoderma lucidum, 101 parts by weight of anti-

66 parts by weight of the element, 166 parts by weight of the novolak, 101 parts by weight of passerby,

66 parts by weight of gold, 66 parts by weight, 253 parts by weight,

25 parts by weight of silkworm, 66 parts by weight of tie.

Preferably, the inventive herbal medicine composition is prepared from the following herbal medicine raw materials.

76 parts by weight of mahwah, 166 parts by weight of corn syrup, 253 parts by weight of sake,

101 parts by weight of bagasse, 66 parts by weight of Ganoderma glutinosa, 66 parts by weight of glutaraldehyde,

101 parts by weight of the element, 253 parts by weight of norbornene, 66 parts by weight of propylene glycol,

101 parts by weight of gold, 101 parts by weight,

166 parts by weight of silkworm, 101 parts by weight of silicate.

Preferably, the inventive herbal medicine composition is prepared from the following herbal medicine raw materials.

70 parts by weight of mahwang, 241 parts by weight of corn syrup, 245 parts by weight of jujube,

98 parts by weight of bagasse, 94 parts by weight of Ganoderma lucidum, 95 parts by weight of aspartame,

94 parts by weight of the element, 230 parts by weight of norbornene, 92 parts by weight of propylene glycol,

91 parts by weight of gold, 97 parts by weight of Seetae, 237 parts by weight of Seeds,

231 parts by weight of silkworm, 91 parts by weight of tie.

Preferably, the inventive herbal medicine composition is prepared from the following herbal medicine raw materials.

63 parts by weight of mahwah, 210 parts by weight of corn syrup, 210 parts by weight of sake,

84 parts by weight of bagasse, 84 parts by weight of Ganoderma glutinosa, 84 parts by weight of glutaraldehyde,

84 parts by weight of element, 210 parts by weight of radix, 84 parts by weight of runner,

84 parts by weight of gold, 84 parts by weight of persimmon, 210 parts by weight of cordierite,

210 parts by weight of silkworm, 84 parts by weight of bridged.

Preferably, the inventive herbal medicine composition is prepared from the following herbal medicine raw materials.

61 parts by weight of mahwah, 198 parts by weight of corn syrup, 223 parts by weight of sake,

78 parts by weight of bagasse, 92 parts by weight of Ganoderma glutinosa, 73 parts by weight of glutaraldehyde,

85 parts by weight of the device, 188 parts by weight of the novolak, 87 parts by weight of the passenger,

88 parts by weight of gold, 79 parts by weight, 221 parts by weight,

218 parts by weight of silkworm, and 81 parts by weight of tie.

Preferably, the crude drug raw material of the Chinese medicine composition of the present invention is as follows. In other words, mahwang is honey-baking safflower, baguette is roasted baguette, alum processed Rhizoma Pinelliae, element is roasted element and passenger is roasted passenger.

The herbal medicine raw materials of the present invention can be replaced by the same or similar functional ingredients of the Chinese traditional medicine such as "National Standard of Traditional Chinese Medicine Processing" or "Great Dictionary of Traditional Chinese Medicine" . ≪ / RTI >

The Chinese medicine composition of the present invention is prepared from a crude drug raw material. "Prepared" can be understood as any conventional method used in the preparation of Chinese herbal medicine, such as preparation of a Chinese medicine composition by directly pulverizing and concentrating the extract extracted by a conventional solvent extraction method. In addition, this includes further purification methods such as purification through conventional solvent extraction and large pore resin column.

In addition, the composition of the present invention may be prepared in various dosage forms such as capsules, tablets, powders, oral solutions, soft capsules, pills, tinctures, syrups, suppositories, gels and spray.

Preferably, in the present invention,

a) taking in the gold and 1/3 to 3/4 inversions according to the preparation rate and pulverizing them into fine powder for use in the subsequent step,

b) In order to use in the next step, 6 to 10 times of 50 to 80% ethanol was added to the flask, and the flask was filled with the relative amount of the flour, whitening agent, Heating and refluxing the extract twice for 1 to 3 hours each time, recovering ethanol from the extract solution under reduced pressure, and concentrating the solution to obtain an extract having a relative density of 1.05 to 1.10 at 60 ° C,

c) In order to use in the next step, water is added in a ratio of 7 to 10 times with respect to the preparation ratio, nadir, nadir, pickle, Mixing the bath liquids and concentrating the solution to obtain an extract having a relative density of 1.05 to 1.10 at 60 DEG C and combining the extract with the extract of step b)

d) mixing the micropowder of step a) with the combined extract of step c) to obtain a herbal medicine composition

≪ / RTI >

The composition may also be formulated into a clinically acceptable dosage form such as capsules, tablets, powders, oral dosage solutions, soft capsules, pills, tinctures, syrups, suppositories, gels and sprays through conventional processes .

  As used herein, "add X amount of solvent" refers to weight / volume ratio. For example, "6 to 8 times the amount of solvent added to the drug substance" Of a solvent.

In order to obtain the desired dosage formulations, it is necessary to add pharmaceutically acceptable additives such as fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives and the like in the preparation of these dosage forms. Examples of fillers include starch, pregelatinized starch, lactose, mannitol, chitosan, microcrystalline cellulose, and sucrose. Examples of the disintegrant include starch, pregelatinized starch, microcrystalline cellulose, carboxymethyl sodium starch, crosslinked polyvinylpyrrolidone, low-substituted hydroxypropylcellulose, crosslinked carboxymethyl sodium cellulose and the like. Examples of the lubricant include magnesium stearate, sodium lauryl sulfate, talc, and silica. Examples of the suspending agent include polyvinylpyrrolidone, microcrystalline cellulose, sucrose, agar, hydroxypropyl methylcellulose and the like. Examples of sweeteners include saccharin, aspartame, sucrose, sodium cyclic acid and glycyrrhetinic acid. Examples of the flavoring agent include sweeteners and various flavors. Preservatives include nipagin, benzoic acid, sodium benzoate, sorbic acid and salts thereof, benzalkonium bromide, chlorhexidine acetate, and eucalyptus oil.

Yet another embodiment of the present invention provides a process for producing a tablet dosage form of the above herbal composition. In this method,

a) taking the inverse of gold and 1/2 amount according to the preparation ratio and pulverizing them into fine powder for use in the subsequent step,

b) In order to use in the next step, 6 to 10 times of 50 to 80% ethanol was added to the flask, and the flask was filled with the relative amount of the flour, whitening agent, Heating and refluxing the extracted solution three times for 1 to 3 hours each time, recovering ethanol from the extract solution under reduced pressure, and concentrating the solution to obtain an extract having a relative density of 1.05 to 1.10 at 60 ° C,

c) In order to use in the next step, take 7-10 times the amount of water by taking the relative amount of syrup, nadir, pickle, silkworm, and allium according to the preparation ratio, and rinse twice for 1 to 4 hours each time, Mixing the bath liquids and concentrating the solution to obtain an extract having a relative density of 1.05 to 1.10 at 60 DEG C and combining the extract with the extract of step b)

d) mixing the fine powder of step a) with the combined extract of step c), adding an appropriate amount of adjuvant to the mixture to obtain granules by spray granulation, drying and then filtering out the granules with a mesh sieve and waiting ,

e) preparing the granules of step d) through a conventional process into a tablet dosage form

.

Preferably, the method for preparing a tablet dosage form of the above-

a) taking the inverse of gold and 1/2 amount according to the preparation ratio and pulverizing them into fine powder for use in the subsequent step,

b) In order to use in the next step, 8 parts by volume of 60% ethanol is added, and the mixture is stirred for 1.5 hours each time Heating and refluxing three times, recovering ethanol from the extract solution under reduced pressure, and concentrating the solution to obtain an extract having a relative density of 1.05 to 1.10 at 60 ° C,

c) In order to use in the next step, the relative amounts of nuclides, nuclides, starch, silkworms and ligaments are taken according to the preparation ratio, 9 times water is added and the mixture is stirred for 2 hours each time for 2 hours. And concentrating the solution to obtain an extract having a relative density of 1.05 to 1.10 at 60 DEG C and combining the extract with the extract of step b)

d) mixing the fine powder of step a) with the combined extract of step c), adding an appropriate amount of adjuvant to the mixture to obtain granules by spray granulation, drying and then filtering out the granules with a mesh sieve and waiting ,

e) preparing the granules of step d) through a conventional process into a tablet dosage form

.

Depending on the total weight of the herbal composition, the composition may be administered at a dose of 15 to 30 g / day, once or twice to four times daily. Preferably, the dose is 22 g / day, and may be administered three times a day.

In order to confirm the activity of the inventive herbal medicine composition (hereinafter referred to as "composition of the present invention"), tablet preparation formulations of the present invention prepared using the method described in Example 1 were pulverized into powders and pharmacological tests The effectiveness of the composition of the present invention in the treatment of bronchial asthma has been demonstrated. In addition, the therapeutic effect of the basic pharmacokinetic part of the tablet was evaluated by the disclosed method (each of 9 g of mahwang, kwandong, passerby and undergarment, 12 g of bagasse (roasted until yellow), 6 g of each 3 g licorice ( Radix Glycyrrhizae ) is added to the water, and the above ingredients are added to obtain a Jungchun hot pot (Ha, xiaobo and Xiao, xian. (2001) (11): 21.]} And compared with the treatment effect of Jungcheon hot pot. In this experiment, it was confirmed that the composition of the present invention is more effective in treating asthma than Jungcheon Supangkan.

It has been confirmed that the composition of the present invention has an excellent therapeutic effect in treating bronchial asthma by alleviation of asthma and cough, gonadal, and anti-inflammatory action. Bronchial asthma is a common chronic lung disease. The composition of the present invention has a wide safety range, has a suppressive action in several aspects, and treats both the cause and symptoms of the disease. This composition not only avoids the side effects associated with single-purpose medicines, but also treats chronic diseases for a long period of time. The acute toxicity test results show that the composition of the present invention did not show any significant toxicity in the mice administered three times per day, with a maximum concentration of 254.4 g of herbal medicine / kg in the stomach, followed by 14 days of observation. This dose is equivalent to 687.57 times the clinical dose for humans. The results of the long-term toxicity studies on rats also show that the compositions of the present invention exhibit no significant toxicity in rats dosed at doses of 22 g, 11 g and 5.5 g herb / kg over a long period of (26 weeks) .

The following experiments and Examples include  Are used for further illustrating the present invention, and the present invention is not limited thereto.

Experiment 1: Anti-asthma  Experiment

I. Effect of the composition of the present invention on the early stage reaction of bronchial asthma

1. Experimental material

1.1 Animals: Acquired a healthy white Hartley species guinea pig, male half and female half of a pure white body with a body mass of 200 ± 25 g from the Experimental Animal Center of the National Institute of Pharmacy and Biological Products Respectively. The warranty number is SCXK (BJ) 2002-0010.

1.2 Drugs and reagents:

(1) Test Drug: The drug of the composition of the present invention of batch number 20060801 was provided by Shijiazhuang Yiling Pharmaceutical Co., Ltd. 1 g of the drug of the final composition corresponds to 4.5 g of crude drug. The human clinical dose of the drug is 22 g of herbal medicine per day. The drug was combined with 0.5% CMC-Na (carboxymethyl sodium cellulose) to prepare a solution of the required concentration before use.

(2) Positive counterpart: Aminophylline tablets of batch number 20061103, suitable for the treatment of bronchial asthma and obstructive emphysema, were provided from Peking Zizhu Pharmaceutical Co., Ltd.

(3) Chungcheong medicine: Supplied from Shijiazhuang Eing Pharmaceutical Co. The dosage for human use is 69 g of herbal medicine per day. The drug was combined with 0.5% CMC-Na (carboxymethyl sodium cellulose) to prepare a solution of the required concentration before use. As used herein, "... g herbal medicine / day" refers to the daily dose of the drug substance.

(4) of albumin: manufactured by Sigma Company.

(5) Acecolex: manufactured by Sigma.

1.3 Apparatus: Yadu Medicinal Evaporator, Model YC-Y800B, Beijing Yadu Technology Co., Ltd. products.

2. Methods and results

1. Animals and drug administration:

After grouping the animals, 80 guinea pigs were placed in a sealed organic glass cover (4 L) in a batch. The asthma induction solution (an equal mixture of 2% acacolex and 0.1% histamine phosphate) was sprayed into the glass cover using an ultrasonic atomizer at a rate of 15 seconds / hour, with a spray volume of 4 ml / The particle size was 1 to 5 μm. After spraying, incubation period of guinea pig spontaneous seizure was observed within 6 minutes. Guinea pigs with a latency period of more than 120 seconds were excluded from the follow-up experiment. Sixty six eligible guinea pigs were selected and randomly divided into six groups: asthma model group, aminophylline group, Jungcheon supernatant group, high dose group, heavy dose group, and low dose group of the composition of the present invention. In the asthma model group, the same volume of solvent was administered to the gastrointestinal tract, and the aminophylline group was administered aminophylline to the gastrointestinal tract at 0.06 g / kg (corresponding to seven times the human clinical dose) g / kg (corresponding to 7 times the human clinical dose) was administered to the gastrointestinal tract. In the high dose group, the combined dose group and the low dose group of the composition of the present invention, 5.1 g / kg, 2.6 g / kg and 1.3 g / kg, corresponding to 14, 7 and 3.5 times the clinical dose for humans, respectively, were administered into the gastrointestinal tract. For each group, each drug was administered for 4 consecutive days. The experiment was started one hour after the last administration.

2. Anti-asthmatic effects of drug-induced asthma in guinea pigs

The animals in each group were placed in a closed organic cover and asthma was induced by the method described above. After spraying, the incubation period of asthma in guinea pigs was observed at 6 minutes. If asthma cramps were not observed, the incubation period was considered to be 6 minutes. Statistical analysis of variance and T-test was performed by SPSS 10.0. The results show that significant prolongation of latency of asthma induced by acycloax and histamine phosphate in guinea pigs was observed in the high dose group and the heavy dose group of the composition of the present invention. In the low dose group of the composition of the present invention, asthma latency period of guinea pig was slightly prolonged, but statistically no difference was observed compared to the asthma model group. See Table 1-1.

)Table 1-1: Anti-asthmatic effect of the composition of the present invention on drug-induced asthma in guinea pigs

)

Note: Comparison with asthma model group, * p <0.05, ** p <0.01.

Breathing in a liquid mixture of histamine and acacolax induces asthma in normal guinea pigs. High throughput and moderate doses of the compositions of the present invention (5.1 g / kg and 2.6 g / kg, respectively) can significantly prolong the appearance of asthma and vomiting in asthmatic guinea pigs (p <0.05 and p < 0.01). After sensitization with ovalbumin (OVA), guinea pigs produce anti-OVA IgE antibodies that bind to mast cells. Inhaling the OVA antigen leads to degranulation by binding of OVA and IgE on the cell surface and induces an asthma attack by the secretion of the inflammatory mediator. Administration of the composition of the present invention at high dosages and at moderate doses (5.1 g / kg and 2.6 g / kg, respectively) significantly prolongs asthma latency of guinea pigs. In addition, the composition of the present invention showed a better anti-asthmatic effect than that of Jung-Chun Sang-In.

II . Effect of the composition of the present invention on the late phase response of bronchial asthma

1. Animals and Drug Administration: 60 healthy white Hartley guinea pigs were randomly divided into six groups, asthma model group, high dose group, heavy dose group and low dose group (5.1 g / kg, 2.6 g / kg and 1.3 g / kg), a sedimentation group (8.1 g / kg) and an aminophylline positive control group (0.06 g / kg of aminophylline administered as gastrointestinal tract). Animals in the asthma model group received the same volume of solvent. In guinea pigs, each drug was administered to the gastrointestinal tract for 3 days before induction of asthma, followed by 4 consecutive days.

2. Anti-asthmatic effect of the composition of the present invention on guinea pig induced asthma by OVA: Each group of guinea pigs was sensitized by intramuscular injection of 0.2 ml of 4% OVA salt solution in the hind leg and 0.2 ml of 4% aluminum hydroxide latex was intraperitoneally Lt; / RTI &gt; On day 7, guinea pigs were sensitized again in the same manner. One hour after the last injection, asthma was induced by spraying the animals with an asthma inducing solution that was ultrasonically sprayed for 6 minutes. The asthma induction solution was a 2% OVA saline solution and the spray volume was less than 4 ml / min. The incubation period of asthmatic convulsions of guinea pigs was observed at 6 minutes. If asthma cramps were not observed, the incubation period was considered to be 6 minutes. The results were analyzed using the dispersion method and the T test method. All analyzes were performed using SPSS 10.0. The results showed that the incubation period of guinea pig-induced asthma sensitized with OVA was significantly prolonged in the high-dose group and the high-dose group of the composition of the present invention. The asthma latency of guinea pigs was also slightly prolonged in the group administered with the composition of the present invention, but the difference was not statistically significant as compared with the asthma model group. See Table 1-2.

)Table 1-2: Effects of OVA-sensitized guinea pigs on induced asthma incubation period

)

Note: Compared with the asthma model group, * p <0.05, ** p <0.01.

An experimental model of airway inflammation, which is predominantly caused by eosinophils (EOS) infiltration, can be established by sensitizing guinea pigs with OVA and inhaling the animal with sprayed OVA multiple times. This is known as an allergic bronchial asthma guinea pig model. This experiment showed that the incubation period of the OVA induced asthma of the guinea pigs was significantly prolonged and the EOS number in the whole blood of the two groups of animals was reduced in the high dose group and the moderate dose group (5.1 g / kg and 2.6 g / kg, respectively) (P < 0.05, p < 0.01, respectively). This suggests that administration of the composition of the present invention at a high throughput and at a moderate dose has a better effect in delaying bronchial asthma in guinea pigs than in the case of Jungcheon hot pot.

Experiment 2: Cough relief, gonad and Inflammation  Action experiment

I. Experimental Study on Cough Relief Effect of the Composition of the Present Invention

One. Experimental material

1.1 Experimental animals

72 healthy KM mice weighing 18-20 g were divided into male half and female half in Beijing Vital River Experimental Animal Technical Co. Was purchased from Beijing Vital River Experimental animal Technical Co. Ltd. The warranty number is SCXK (BJ) 2002-0003. The mice were marked with 5% picric acid, and 5 mice were confined in each case. These mice were housed in a pharmacy laboratory of the Hebei Medical University Pharmacy Research Laboratory in an environment of 12 hours light / day, 20 ~ 23 ℃ temperature and relative humidity of 40 ~ 60%. The mice were housed in whole-value grain feedstuffs from the Hebei Experimental Animal Center and water was ingested indefinitely. Mice were placed in a dietary environment for 3 days.

1.2 Experimental Drugs

The composition of the present invention: 1 g of dry powder corresponds to 4.5 g of crude drug. The clinical drug dosage for humans is 22 g of herbal medicine / day, i.e., 0.37 g of herbal medicine / kg of weight (standard weight of 60 kg). The drug was provided by Shijiazhuang Eing Pharmaceuticals as batch no. 20060801. Prior to use, the drug was combined with 0.5% CMC-Na to prepare the required concentration of suspension.

Chungcheon Sangmang: Provided by Shijiazhuang Eing Pharmaceutical Company. The human clinical dose of this drug is 69 g of herbal medicine per day. Prior to use, the above medicament was formulated with 0.5% CMC-Na to prepare the required concentration of suspension.

0.9 mg / ml of a solution of the phosphate codeine compound, Hong Kong Aomei Pharmaceutical Plant, Batch No. 060115.

1.3 Experimental reagent

Concentrated sulfuric acid: Analytical purity, Beijing Chemical Plant, Batch number: 20020809.

2. Experimental Method

2.1 Dose setting principle

The maximum clinical dose of the composition of the present invention is 22 g of herbal medicine / day, i.e., 0.37 g of herbal medicine / kg (standard weight of 60 kg). The doses administered to the mice were 5, 10 and 20 times the above clinical doses, i.e. 1.85 g, 3.7 g and 7.4 g of herbal medicine / kg / day (high dose group, low dose group, low dose group, respectively) &Lt; / RTI &gt; 11.5 g of herbal medicine / kg / day was administered to the Jungcheon hot spring group, which is 10 times the clinical dose. The control and positive drug groups were set separately.

2.2 Routes of Administration and Dose

Each day, from 9:00 am to 10:00 am, the mice in each group were given the drug in the gastrointestinal tract, consistent with clinically recommended oral dosing regimens. The drug was administered at 0.1 ml / 10 g body weight for 5 consecutive days.

2.3 Dose and Grouping

According to the dose setting principle, mice were divided into the following five groups. See Table 2-1.

Table 2-1: Experiments for relieving the cough of mice with the composition of the present invention Animals group and dose

2.4. Experimental course

2.4.1. Preparation of sulfur dioxide: A 250 ml flask with a side opening was connected to the bladder with a rubber tube. Sodium hydrogensulfate was added to the flask. The burette was fixed to the bottle cap, and the burette was filled with concentrated sulfuric acid. The burette piston was opened and concentrated sulfuric acid was added dropwise. Sulfur dioxide gas was generated to fill the pouch. The pouch was fixed with a haemostat. 4 to 10 ml of the above gas was taken with a syringe before use.

2.4.2. KM mice were randomly divided into six groups, with 12 mice per group being male and half female. The animal groups were the control group, the Jungcheon fortified group, the phosphorylated cordine group, the high dose group, the heavy dose group, and the low dose group of the composition of the present invention. All animals received 0.1 ml / 10 g of the drug in the gastrointestinal tract for five consecutive days. The control group received 0.5% CMC-Na. After 0.5 hours from the final administration, mice in each group were placed in a 250 ml jar filled with sulfur dioxide. The incubation period (time from sulfur dioxide injection to cough occurrence) and frequency of cough were observed 2 minutes later. A typical cough of the mouse is accompanied by abdominal contractions and wide mouth opening, sometimes accompanied by coughing. The cough reduction rate was calculated using the following equation.

3. Statistical Method

). 군들간의 차이는 일원 분산 분석법 (one-factor analysis of variance)으로 수행하였다.Experimental data were analyzed with SPSS 11.5. Statistical results were expressed as normal ± standard deviation (

). Differences between groups were analyzed by one-factor analysis of variance.

4. Experimental results

The effects of the composition of the present invention on cough induced by sulfur dioxide were observed and shown in Table 2.2. The results showed that latency of the cough induced in the control mice was 19.58 ± 8.17 seconds and cough frequency after 2 minutes was 69.25 ± 26.93 times. The latency of coughing in the mice administered with the composition of the present invention at a low dose, a heavy dose, and a high dose was 54.58 ± 35.57 seconds, 57.67 ± 30.53 seconds and 73.50 ± 37.81 seconds, respectively. The incubation period of these animals was significantly longer than that of the control group (P <0.05 or P <0.01), and the cough frequency after 2 minutes was 27.42 ± 22.86, 27.08 ± 17.17, and 11.92 ± 19.44, respectively. Cough frequency was significantly reduced (P <0.01) compared with the control group.

)Table 2-2: Effect of the composition of the present invention on cough induced by sulfur dioxide (

)

Note: Compared with the control group, * P <0.05, ** P <0.01.

The cough latency and coughing frequency of the animals administered with the composition of the present invention at a high dose and at a moderate dose were significantly prolonged (P <0.05). This suggests that the composition of the present invention has a remarkable effect on the relief of cough and the effect is better than that of the sake.

Ⅱ. Experimental study on the dandruff effect of the composition of the present invention

One. Experimental material

1.1 Experimental animals

72 healthy KM mice weighing 18-20 g were divided into male half and female half in Beijing Vital River Experimental Animal Technology Co. The warranty number is SCXK (BJ) 2002-0003. The mice were marked with 5% picric acid, and 5 mice were confined in each case. These mice were housed in a pharmacy laboratory of the Hebei Medical University Pharmacy Research Laboratories for 12 hours at light / day, at a temperature of 20 to 23 ° C and a relative humidity of 40 to 60%. The mice were housed in total grain feed from the Hebei Experimental Animal Center and water was ingested in an unlimited amount. Mice were placed in a dietary environment for 3 days.

1.2 Experimental Drugs

The composition of the present invention: 1 g of dry powder corresponds to 4.5 g of crude drug. The clinical drug dose for an adult is 22 g of herbal medicine / day, i.e., 0.37 g of herbal medicine / kg of weight (standard weight of 60 kg). The drug was provided by Shijiazhuang Eing Pharmaceuticals as batch no. 20060801. The drug was combined with 0.5% CMC-Na prior to use to prepare the required concentration of suspension.

Chungcheon Sangmang: Provided by Shijiazhuang Eing Pharmaceutical Company. The human clinical dose of this drug is 69 g of herbal medicine per day. Prior to use, the drug was combined with 0.5% CMC-Na to prepare the required concentration of suspension.

Ammonium chloride: 30 mg / tablet, Xinan Pharmaceutical Company, Batch number: 660500005.

2. Experimental Method

2.1 Dose setting principle

The maximum clinical dose of the composition of the present invention is 22 g of herbal medicine / day, i.e., 0.37 g of herbal medicine / kg (standard weight of 60 kg). The doses administered to the mice were 5, 10 and 20 times that of the above clinical doses, i.e. 1.85 g, 3.7 g and 7.4 g of herbal medicine / kg / day (low dose group, &Lt; / RTI &gt; The drug was administered to 11.5 g of herbal medicine / kg / day, ie, 10 times the clinical dose, in the Chungcheon fortification group. The control and positive drug groups were set separately.

2.2 Routes of Administration and Dose

Each day, from 9:00 am to 10:00 am, the mice in each group were given the drug in the gastrointestinal tract, consistent with clinically recommended oral dosing regimens. The dose was adjusted to 0.1 ml / 10 g body weight for 5 consecutive days.

2.3 Dose and Grouping

According to the dose setting principle, mice were divided into the following six groups. See Table 2-3.

&Lt; tb &gt; &lt; tb &gt; &lt; SEP &gt;

2.4 Experimental Process

KM mice were randomly divided into 6 groups, with half of 12 mice per group being male and half being female. Each group was a control group, an ammonium chloride group, a Jungcheon hot pot group, a cordine phosphate group, a high dose group, a heavy dose group, and a low dose group of the composition of the present invention. All animals received 0.1 ml / 10 g of the drug in the gastrointestinal tract for five consecutive days. The control group received 0.5% CMC-Na. After 0.5 hour from the final administration, 0.1 ml (5 mg) / 10 g of phenol red was injected intraperitoneally into each group of mice (after 16 hours fasting). After 0.5 hour of injection, the mice were sacrificed. The organs were removed and the organ was exposed and the organ located between the thyroid cartilage and bronchus was cut. The organs were placed in a test tube with 2 ml of saline solution and 0.1 ml of sodium hydroxide (or 1-2 drops) was added and mixed well; The OD value was measured with a 540 nm enzyme label meter and the content of phenol red (μg / ml) according to the curve was calculated using phenol red to set the standard curve and compared with the control.

2.5. Statistical method

). 동물군 간의 차이는 일원 분산 분석법으로 수행하였다.Experimental data were analyzed with SPSS 11.5. Statistical results were expressed as normal ± standard deviation (

). Differences among the fauna were analyzed by one-way ANOVA.

3. Experimental Results

The dandruff effect of the composition of the present invention was observed by the organ phenol red method. The results shown in Table 2.4 show that the content of phenol red in the trachea of the control mice was 0.43 ± 0.12 μg / ml, and the content of phenol red in the trachea of the low, medium and high dose groups of the composition of the present invention was 0.82 ± 0.34 μg / ml, 1.23 ± 0.31 μg / ml and 1.48 ± 0.61 μg / ml, respectively.

)Table 2-4: Results of the dandruff effect of the pharmaceutical composition of the present invention (

)

Note: Comparisons with model groups: * P <0.05, ** P <0.01.

A significant increase in the phenol content was observed in the inventive composition group (P &lt; 0.01 or P &lt; 0.05), as compared to the model group and the Jungcheon supernatant group. This suggests that the composition of the present invention has a remarkable effect on the germane, and the effect is better than that of the sake.

Ⅲ. The general anti-inflammatory effect of the composition of the present invention

One. Experimental material

1.1 Animals: SD rats weighing 160-180 g, half male and half female. Beijing Vital River Experimental Animal Technical Co. And the guarantee number was SCXK (BJ) 2002-0003.

1.2 Drugs and reagents

(1) Test drug: 1 g of dry powder corresponds to 4.5 g of crude drug. The clinical drug dose for an adult is 22 g of herbal medicine / day, i.e., 0.37 g of herbal medicine / kg of weight (standard weight of 60 kg). The medicines were provided by Shijiazhuang Eing Pharmaceuticals Co., Ltd. as Batch No. 20060801. Prior to use, the above medicament was formulated with 0.5% CMC-Na to prepare a suspension of the required concentration.

(2) Positive control drug: The dexamethasone tablet was manufactured by Tianjin Tianyao Pharmaceutical Co., Ltd, batch number: 20060711. The license number was Guo Yao Jun, H12020686 (guo yao zhun zi H12020686). The drug was combined with 0.5% CMC before use.

(3) Karaginin: manufactured by Sigma. One day prior to use, the drug was pulverized into fine powder and blended with a saline solution for injection, formulated into a uniform 1% suspension, and stored in a 4 ° C refrigerator.

1.3. Apparatus: Apparatus for measuring the foot volume of a rat (draining, drainage).

2. Methods and results

2.1 Animals and Drug Administration: Sixty rats for the experiment were randomly divided into six groups: the model group (0.5% CMC of the same volume was administered in the gastrointestinal tract), the Jungcheon bath group (7.5 of the human clinical dose The same amount of 8.7 g / kg as the gavage was administered to the gastrointestinal tract), a positive drug group (dosed with 0.1 g / kg of dexamethasone equivalent to 7.5 times the human clinical dose) into the gastrointestinal tract, , And low dose groups (administered in the gastrointestinal tract, respectively, 5.6 g / kg, 2.8 g / kg and 1.4 g / kg, which are equivalent to 15, 7.5, and 3.75 times the human clinical dose, respectively) . Each animal group consisted of 10 rats. The drug was administered for 3 consecutive days and 60 minutes after the last dose the models were set.

2.2 Voix Pedis Swelling Method: See Chen, Qi. chief editor. Volume of left hind paw of each rat was measured and recorded prior to drug administration according to Study Methodology of Pharmacology of Traditional Chinese Medicine, People's Health Publishing House, 1993, 364p. Sixty minutes after the final administration, 1% carrageenine was subcutaneously injected into the left hind leg of each rat subcutaneously in 0.1 ml per one rat, and the volume of the left hind paw was measured and recorded every hour and measured six times in succession. The results were recorded and edema and inhibition rates were calculated according to the following equation.

Statistical analysis of variance and T-test was performed by SPSS 10.0.

2.3. The results of the general anti-inflammatory effect of the composition of the present invention are shown in Tables 2-5. The left leg edema of rats induced by carrageenin infusion was significantly inhibited by the injection of the compositions of the present invention at doses of 5.6 g / kg and 2.8 g / kg. After 1 hour, the model was established and the inhibition rate was significantly different from that of the control group. The inhibitory effect was maintained for 6 hours (p <0.05 and p <0.01, respectively). This result showed that administration of the composition of the present invention at a high dose and at a moderate dose significantly inhibited left-foot edema of rats induced by injection of carrageenin. In addition, the compositions of the present invention, 5.6 g / kg and 2.8 g / kg, significantly inhibited the granuloma formation of rat's tampon (p <0.01 and p <0.05, respectively) compared to the control group. All of these effects of the composition of the present invention were better than the effects of the Jungcheon pottery group.

Table 2-5: Effect of the pharmaceutical composition of the present invention on carrageenin-induced left leg edema in rats

Note: Comparison with model group, * p <0.05, ** p <0.01. (The number in parentheses is the suppression rate of edema)

3. CONCLUSIONS: The composition of the present invention has a remarkable inhibitory effect on general inflammation, and this effect is superior to the effect of Jung-Chun Sang-In.

Bronchial asthma is a chronic inflammatory disease caused by many cells and cellular components. This can cause airway hyperresponsiveness that causes asthma, dyspnea, chest compressions, and repeated coughing attacks. The etiology is associated with atopic allergies. At the same time, the etiology of some patients has not been confirmed. Both symptomatic and etiologic treatments are used. Because herbal compounds have a wide variety of effects, they have unique advantages in the treatment of bronchial asthma. Therefore, pharmacodynamic studies of the compositions of the present invention are based on discoloration, asthma relief, flushing and dandruff effects, and focus on improving symptoms by gonadal, cough relief, and anti-inflammatory actions. At the same time, these studies extensively evaluated the therapeutic effect and mechanism of the medicament by observing the effect of the composition of the present invention on related mechanisms such as allergic reactions, mast cell degranulation, immunomodulation, and the like.

The pharmacokinetic study results show that when the composition of the present invention is administered at a high dose and at a moderate dose, the expression time of asthma and quality is significantly prolonged in asthma induced by a mixed solution of histamine and acetylcholine chloride in guinea pig Suggesting that the latency of asthma in guinea pigs induced by OVA can also be significantly prolonged. In the late stage reaction asthma induced by multiple attack of OVA, when the composition of the present invention is administered at a high dose and a moderate dose, the latency period of the final asthma induced by OVA can be significantly prolonged and eosinophils The ratio can be reduced. In addition, when the composition of the present invention is administered at a high dose and at a moderate dose, the production of leukotriene B4 in the alveolar lavage fluid can be inhibited. In addition, the histopathology of alveoli shows that administration of the composition of the present invention at a high dose, a low dose and a low dose can reduce the number of eosinophils infiltrating the bronchial wall and improve the pathological damage caused by inflammation of bronchial lung tissue It is possible. These results suggest that the composition of the present invention has a remarkable therapeutic effect in both the late stage reaction and the early stage reaction of bronchial asthma and has an effect of remarkably suppressing the production of the inflammatory cells and mediators involved.

Animal experiments such as cough relief, genomics, and anti-inflammatory effects were employed to observe clinically relevant symptoms and symptom improvement effects of the composition of the present invention. The results suggest that administration of the compositions of the present invention at high doses, at moderate doses, and at low doses significantly prolongs the cough latency induced by sulfur dioxide in mice and reduces the frequency of coughing of the rats. The results of the tracheal phenol red test show that when the composition of the present invention is administered at a high dose, a low dose, and a low dose, the secretion of phenol red is remarkably increased in mouse organs. The results of the anti-inflammatory test results suggest that administration of the composition of the present invention at a high throughput and at a moderate dose significantly inhibits the left leg edema of rats induced by carrageenin injection and the granuloma formation of rat tamper. Significant differences were found in the composition of the present invention compared to the control group at 1 hour after model setting, and the difference was maintained for 6 hours. These results suggest that the composition of the present invention has a significant effect on cough relief, gonadal and inflammation, and has an excellent effect of assisting improvement of asthmatic symptoms.

Below In the embodiment  In the present invention, Traditional Chinese medicine  The production method of the composition is specifically described, but the scope of the present invention is not limited thereto.

Example

Example  One

Preparation of tablets (temporary name: LIAN HUA asthma relief tablets) of the composition of the present invention:

Formulation Composition:

63 g of mahwang (honey-bake), 210 g of corn syrup, 210 g of sake,

84 g of Bacillus, 84 g of Kantuha, 84 g of alum (processed in alum)

84 g of element (roasted), 210 g of nose, 84 g of passerine (roasted)

84 g of gold, 84 g of pickle, 210 g of mustard,

210g of silkworm, 84g of brassiere.

Manufacturing method:

a) taking 84 g of golden and 42 g of gold and pulverizing them into fine powder for use in the subsequent step,

b) In order to use in the next step, 8 parts by volume of 60% ethanol is added, and the mixture is stirred for 1.5 hours each time Heating and refluxing three times, recovering ethanol from the extract solution under reduced pressure, and concentrating the solution to obtain an extract having a relative density of 1.08 at 60 ° C,

c) In order to use in the next step, the relative amounts of nuclides, nuclides, starch, silkworms and ligaments are taken according to the preparation ratio, 9 times water is added and the mixture is stirred for 2 hours each time for 2 hours. And concentrating the solution to obtain an extract having a relative density at 60 ° C of 1.08 and combining the extract with the extract of step b)

d) mixing the fine powder of step a) with the combined extract of step c), adding an appropriate amount of adjuvant to the mixture to obtain granules by spray granulation, drying and then filtering out the granules with a mesh sieve and waiting ,

e) preparing the granules of step d) by means of a conventional process into tablets.

Example  2

Preparation of Capsules of the Composition of the Invention:

Formulation Composition:

61 g of mahwah, 198 g of corn syrup, 223 g of sake,

78 g of Bacillus subtilis, 92 g of Kantouhwa, 73 g of ash,

85 g of element, 188 g of radix, 87 g of passageways,

88 grams of gold, 79 grams of selectivity, 221 grams of sardine,

218 grams of silkworm, 81 g of brassiere.

Manufacturing method:

a) taking 88 g of golden and 36.5 g of gold and pulverizing them into fine powder for use in the subsequent step,

b) For use in the next step, fill in the relative amounts of yam, white moss, cork bark, horticulture, element, passerine and horseshoe and the rest according to the preparation ratio, add six times 50% ethanol, Heating and refluxing three times, recovering ethanol from the extract solution under reduced pressure, and concentrating the solution to obtain an extract having a relative density of 1.05 at 60 ° C,

c) In order to use in the next step, the relative amount of nodule, nadir, pickle, silkworm, and allium are taken according to the preparation ratio, 7 times of water is added, and the mixture is stirred twice for 1 hour each time. And concentrating the solution to obtain an extract having a relative density of 1.05 at 60 DEG C and combining the extract with the extract of step b)

d) mixing the fine powder of step a) with the combined extract of step c), adding an appropriate amount of adjuvant to the mixture to obtain granules by spray granulation, drying and then filtering out the granules with a mesh sieve and waiting ,

e) preparing the granules of step d) as a capsule through a conventional process.

Example  3

Preparation of powder of the present invention:

Formulation Composition:

50 g of mahwah, 253 g of corn syrup, 166 g of sake,

66 g of Baekje, 101 g of Kwanghwanghae, 101 g of ash,

66 g of element, 166 g of radix, 101 g of phosphorus,

66 grams of gold, 66 grams of electrowet, 253 grams of acorns,

253 grams of silkworm, 66 grams of brassiere.

Manufacturing method:

a) taking the inverse of gold and 1/2 amount according to the preparation ratio and pulverizing them into fine powder for use in the subsequent step,

b) In order to use in the next step, 10% by volume of 80% ethanol is added, and the mixture is stirred for 3 hours each time with a relative amount of yam, white moss, alfalfa, Heating and refluxing three times, recovering ethanol from the extract solution under reduced pressure, and concentrating the solution to obtain an extract having a relative density of 1.10 at 60 DEG C,

c) In order to use in the next step, the relative amounts of nuclides, nuclides, selectivities, silkworms and ligaments are taken in accordance with the preparation ratio, 10 times water is added and the mixture is stirred twice for 4 hours each time. And concentrating the solution to obtain an extract having a relative density at 60 ° C of 1.10 and combining the extract with the extract of step b)

d) pulverizing the fine powder of step a) and the combined extract of step c) through a conventional process.

Example  4

Preparation of an oral solution of the composition of the present invention:

Formulation Composition:

76 g of mahwah, 166 g of corn syrup, 253 g of sake,

101 g of Baekje, 66 g of Kwandong, 66 g of ash,

101 g of element, 253 g of radix, 66 g of passageways,

101 g of gold, 101 g of the pickle, 166 g of the pickle,

166 grams of silkworm, 101 grams of brassiere.

Manufacturing method:

a) taking the inverse of gold and 1/2 amount according to the preparation ratio and pulverizing them into fine powder for use in the subsequent step,

b) For use in the next step, fill in the relative amounts of yam, yam, bark, alfalfa, gabbro, element, passerine and whitestock with the rest relative to the preparation rate, add 6 volumes of 80% ethanol, Heating and refluxing three times, recovering ethanol from the extract solution under reduced pressure, and concentrating the solution to obtain an extract having a relative density of 1.05 to 1.10 at 60 ° C,

c) In order to use in the next step, the relative amount of nodule, nadir, pickle, silkworm, and allium are taken according to the preparation ratio, 7 times of water is added, and the mixture is stirred twice for 1 hour each time. And concentrating the solution to obtain an extract having a relative density of 1.05 to 1.10 at 60 DEG C and combining the extract with the extract of step b)

d) making the extract of step c) and the fine powder of step a) into an oral solution through a conventional process.

Example  5

Preparation of Soft Capsules of the Composition of the Invention:

Formulation Composition:

70 g of mahwah, 241 g of corn syrup, 245 g of sake,

98 g of Bacillus subtilis, 94 g of Kwanghwa, 95 g of ash,

94 g of element, 230 g of radix, 92 g of passageways,

91 g of gold, 97 g of Seonyae, 237 g of Seaweed,

231 g of silkworm powder, and 91 g of brassiere.

Manufacturing method:

a) taking, for use in the subsequent step, the gold and 1/3 amount of inverse according to the preparation rate and pulverizing them into fine powder,

b) In order to use in the next step, 10 parts by volume of 50% ethanol is added to each portion of the mixture in a relative amount of the yam, yam, bark, alfalfa, Heating and refluxing three times, recovering ethanol from the extract solution under reduced pressure, and concentrating the solution to obtain an extract having a relative density of 1.05 to 1.10 at 60 ° C,

c) In order to use in the next step, the relative amounts of nuclides, nuclides, selectivities, silkworms and ligaments are taken in accordance with the preparation ratio, 10 times water is added and the mixture is stirred twice for 4 hours each time. And concentrating the solution to obtain an extract having a relative density of 1.05 to 1.10 at 60 DEG C and combining the extract with the extract of step b)

d) making the microcrystalline powder of step a) and the combined extract of step c) into a soft capsule through a conventional process.

Example  6

Preparation of pills of the invention composition:

Formulation Composition:

76 g of mahwah, 253 g of bark of alfalfa, 253 g of powder,

101 g of Baekje, 101 g of Kwanghwanghae, 101 g of ash,

101 g of element, 253 g of radix, 101 g of phosphorus,

101 g of gold, 101 g of the pickle, 253 g of the seaweed,

253 grams of silkworm, 101 g of brassiere.

Manufacturing method:

a) taking the inverse of gold and 2/3 amount according to the preparation rate and pulverizing them into a fine powder for use in the subsequent step,

b) In order to use in the next step, 8 parts by volume of 60% ethanol is added, and the mixture is stirred for 1.5 hours each time Heating and refluxing three times, recovering ethanol from the extract solution under reduced pressure, and concentrating the solution to obtain an extract having a relative density of 1.05 to 1.10 at 60 ° C,

c) In order to use in the next step, the relative amount of nodule, nodule, alopecia, alopecia, and allium are taken according to the preparation ratio, and 8 times of water is added, and the mixture is stirred twice for 3 hours each time. And concentrating the solution to obtain an extract having a relative density of 1.05 to 1.10 at 60 DEG C and combining the extract with the extract of step b)

d) making the pellet of step a) and the combined extract of step c) into a pellet through a conventional process.

Example  7

Preparation of the tincture of the present invention composition:

Formulation Composition:

50 g of mahwah, 166 g of corn syrup, 166 g of sake,

66 g of Baekje, 66 g of Kwanghwanghae, 66 g of ash,

66 g of element, 166 g of water, 66 g of passageways,

66 grams of gold, 66 grams of election,

166 grams of silkworm, 66 grams of brassiere.

Manufacturing method:

a) taking the inverse of gold and 1/2 amount according to the preparation ratio and pulverizing them into fine powder for use in the subsequent step,

b) In order to use in the next step, 9 parts of 75% ethanol is added, taking up the relative amounts of yam, yam, bark, alfalfa, hawthorn, Heating and refluxing three times, recovering ethanol from the extract solution under reduced pressure, and concentrating the solution to obtain an extract having a relative density of 1.05 to 1.10 at 60 ° C,

c) For use in the next step, the relative amounts of nuclides, nuclides, juveniles, silkworms and ligaments are taken according to the preparation rate, 8.5 times water is added and the mixture is diluted twice for 2.5 hours each time, And concentrating the solution to obtain an extract having a relative density of 1.05 to 1.10 at 60 DEG C and combining the extract with the extract of step b)

d) making the tincture composition through a conventional process with the fine powder of step a) and the combined extract of step c).

Example  8

Preparation of Syrups of the Composition of the Invention:

Formulation Composition:

50 g of mahwah, 166 g of corn syrup, 166 g of sake,

66 g of Baekje, 66 g of Kwanghwanghae, 66 g of ash,

66 g of element, 166 g of water, 66 g of passageways,

66 grams of gold, 66 grams of election,

166 grams of silkworm, 66 grams of brassiere.

Manufacturing method:

a) taking the inverse of gold and 1/2 amount according to the preparation ratio and pulverizing them into fine powder for use in the subsequent step,

b) For use in the next step, 7.5 parts of 70% ethanol is added, taking 1.5 hours each time, in the relative amounts of yam, yam, bark, alfalfa, Heating and refluxing three times, recovering ethanol from the extract solution under reduced pressure, and concentrating the solution to obtain an extract having a relative density of 1.05 to 1.10 at 60 ° C,

c) In order to use in the next step, the relative amounts of nuclides, nuclides, selectivities, silkworms and ligaments are taken according to the preparation ratio, 8 times the amount of water is added and the mixture is stirred twice for 2 hours each time, And concentrating the solution to obtain an extract having a relative density of 1.05 to 1.10 at 60 DEG C and combining the extract with the extract of step b)

d) Making a syrup through the usual process with the fine powder of step a) and the combined extract of step c).

Example  9

Preparation of Suppositories of the Composition of the Invention:

Formulation Composition:

50 g of mahwah, 253 g of corn syrup, 166 g of sake,

66 g of Baekje, 101 g of Kwanghwanghae, 101 g of ash,

66 g of element, 166 g of radix, 101 g of phosphorus,

66 grams of gold, 66 grams of electrowet, 253 grams of acorns,

253 grams of silkworm, 66 grams of brassiere.

Manufacturing method:

a) taking the inverse of gold and 2/3 amount according to the preparation rate and pulverizing them into a fine powder for use in the subsequent step,

b) For use in the next step, fill in the relative amounts of yam, yam, bark, alfalfa, hawthorn, element, passerine and whitestock with the rest relative to the preparation rate, add six volumes of 50% ethanol, Heating and refluxing three times, recovering ethanol from the extract solution under reduced pressure, and concentrating the solution to obtain an extract having a relative density of 1.05 to 1.10 at 60 ° C,

c) In order to use in the next step, the relative amount of nodule, nadir, pickle, silkworm, and allium are taken according to the preparation ratio, 7 times of water is added, and the mixture is stirred twice for 1 hour each time. And concentrating the solution to obtain an extract having a relative density of 1.05 to 1.10 at 60 DEG C and combining the extract with the extract of step b)

d) Making the supernatant of step a) and the combined extract of step c) into a suppository through a conventional process.

Example  10

Preparation of gelatase of the present invention composition:

Formulation Composition:

76 g of mahwah, 166 g of corn syrup, 253 g of sake,

101 g of Bacillus subtilis, 66 g of Ganoderma lucidum, 66 g of ash,

101 g of element, 253 g of radix, 66 g of passageways,

101 g of gold, 101 g of the pickle, 166 g of the pickle,

166 grams of silkworm, 101 grams of brassiere.

Manufacturing method:

a) taking the inverse of gold and 3/4 amount according to the preparation ratio and pulverizing them into fine powder for use in the subsequent step,

b) In order to use in the next step, 10 parts by volume of 50% ethanol is added to each portion of the mixture in a relative amount of the yam, yam, bark, alfalfa, Heating and refluxing three times, recovering ethanol from the extract solution under reduced pressure, and concentrating the solution to obtain an extract having a relative density of 1.05 to 1.10 at 60 ° C,

c) In order to use in the next step, the relative amounts of nuclides, nuclides, selectivities, silkworms and ligaments are taken in accordance with the preparation ratio, 10 times water is added and the mixture is stirred twice for 4 hours each time. And concentrating the solution to obtain an extract having a relative density of 1.05 to 1.10 at 60 DEG C and combining the extract with the extract of step b)

d) The step of making the gelatinized product of the fine powder of step a) and the combined extract of step c) through a conventional process.

Example  11

Preparation of Spray Agent of the Invention Composition:

Formulation Composition:

70 g of mahwah, 241 g of corn syrup, 245 g of sake,

98 g of Bacillus subtilis, 94 g of Kwanghwa, 95 g of ash,

94 g of element, 230 g of radix, 92 g of passageways,

91 g of gold, 97 g of Seonyae, 237 g of Seaweed,

231 g of silkworm, 91 g of brassiere.

Manufacturing method:

a) taking the inverse of gold and 1/2 amount according to the preparation ratio and pulverizing them into fine powder for use in the subsequent step,

b) In order to use in the next step, take up the relative amounts of yam, yam, bark, alfalfa, hawthorn, element, passerine and whitestock with the rest relative to the preparation rate and add 6 volumes of 80% ethanol, Heating and refluxing three times, recovering ethanol from the extract solution under reduced pressure, and concentrating the solution to obtain an extract having a relative density of 1.05 to 1.10 at 60 ° C,

c) In order to use in the next step, the relative amounts of nuclides, nuclides, alopecia, chrysanthemum, and allium are taken according to the preparation ratio, 10 times water is added and the mixture is stirred twice for 1 hour each time. And concentrating the solution to obtain an extract having a relative density of 1.05 to 1.10 at 60 DEG C and combining the extract with the extract of step b)

d) Making the sprayed product of the fine powder of step a) and the combined extract of step c) through a conventional process.

Example  12

Preparation of powder of the present invention:

82 g of corn, 150 g of corn syrup, 270 g of corn syrup,

50 g of Bacillus thuringiensis, 130 g of Kantouhwa, 55 g of anti-

130 g of element, 155 g of radix, 55 g of lead,

130 g of gold, 55 g of pickles, 280 g of pickled ginger,

280 grams of silkworm, 130 g of bridges.

Manufacturing method:

Taking the combined amount of the composition of each herbal medicine raw material, pulverizing it into powder, sieving the powder, and making it into a powder.

Claims (11)

A medicinal composition for treating bronchial asthma, the medicinal composition being prepared from the following herbal ingredient-containing composition:
40 to 90 parts by weight of mahogany, 136 to 300 parts by weight of corn syrup, 146 to 300 parts by weight of corn syrup,
46 to 151 parts by weight, 46 to 151 parts by weight of Ganoderma lucidum, 46 to 151 parts by weight,
46 to 151 parts by weight of the element, 146 to 300 parts by weight of the base, 46 to 151 parts by weight of the binder,
From 46 to 151 parts by weight of gold, from 46 to 151 parts by weight, from 146 to 300 parts by weight,
146 to 300 parts by weight of silkworm, 46 to 151 parts by weight of silkworm. 2. The herbal composition according to claim 1, wherein the composition is prepared with the following herbal ingredient-containing composition:
50 to 76 parts by weight of mahwang, 166 to 253 parts by weight of corn syrup, 166 to 253 parts by weight of sake,
66 to 101 parts by weight, 66 to 101 parts by weight of Ganoderma lucidum, 66 to 101 parts by weight,
66 to 101 parts by weight of the element, 166 to 253 parts by weight of the base, 66 to 101 parts by weight of the binder,
66 to 101 parts by weight of gold, 66 to 101 parts by weight, 166 to 253 parts by weight,
166 to 253 parts by weight of silkworm, 66 to 101 parts by weight of silicate. 3. The herbal composition according to claim 2, wherein the composition is prepared by mixing the following herbal ingredients:
70 parts by weight of mahwang, 241 parts by weight of corn syrup, 245 parts by weight of jujube,
98 parts by weight of bagasse, 94 parts by weight of Ganoderma lucidum, 95 parts by weight of aspartame,
94 parts by weight of the element, 230 parts by weight of norbornene, 92 parts by weight of propylene glycol,
91 parts by weight of gold, 97 parts by weight of Seetae, 237 parts by weight of Seeds,
231 parts by weight of silkworm, 91 parts by weight of tie. 3. The herbal composition according to claim 2, wherein the composition is prepared by mixing the following herbal ingredients:
63 parts by weight of mahwah, 210 parts by weight of corn syrup, 210 parts by weight of sake,
84 parts by weight of bagasse, 84 parts by weight of Ganoderma glutinosa, 84 parts by weight of glutaraldehyde,
84 parts by weight of element, 210 parts by weight of radix, 84 parts by weight of runner,
84 parts by weight of gold, 84 parts by weight of persimmon, 210 parts by weight of cordierite,
210 parts by weight of silkworm, 84 parts by weight of bridged. 3. The herbal composition according to claim 2, wherein the composition is prepared by mixing the following herbal ingredients:
61 parts by weight of mahwah, 198 parts by weight of corn syrup, 223 parts by weight of sake,
78 parts by weight of bagasse, 92 parts by weight of Ganoderma glutinosa, 73 parts by weight of glutaraldehyde,
85 parts by weight of the device, 188 parts by weight of the novolak, 87 parts by weight of the passenger,
88 parts by weight of gold, 79 parts by weight, 221 parts by weight,
218 parts by weight of silkworm, and 81 parts by weight of tie. 2. The herbal composition according to claim 1, wherein the composition is prepared with the following herbal ingredient-containing composition:
77 to 88 parts by weight of maize, 136 to 165 parts by weight of corn syrup, 255 to 300 parts by weight of sake,
46 to 65 parts by weight of bagasse, 110 to 151 parts by weight of Ganoderma glutinosa, 46 to 65 parts by weight of glutaraldehyde,
105 to 151 parts by weight of the device, 146 to 165 parts by weight of the raw material, 46 to 65 parts by weight of the carrier,
103 to 151 parts by weight of gold, 46 to 65 parts by weight,
255 to 300 parts by weight of silkworm, 103 to 151 parts by weight of silkworm. The Chinese medicine composition according to any one of claims 1 to 6, wherein the Chinese yam is a honey-baking yam, the Chinese cabbage is a roasted Chinese cabbage, the Chinese cabbage is crushed, the Chinese cabbage is roasted, and the roast is roasted Chinese cabbage. The composition according to any one of claims 1 to 6, wherein the composition is in the form of a capsule, a tablet, a powder, an oral solution, a soft capsule, a pill, a tincture, a syrup, a suppository, a gel, Or an injection. 7. The composition according to any one of claims 1 to 6,
a) taking the inverse of the amount of gold and 1/3 to 3/4 according to the preparation ratio and pulverizing them into fine powder for use in the subsequent step,
b) For use in the next step, the first mixture is formed by filling in the opposite half of the yam, white moss, white moss, horticulture, element, passerine, Ethanol was recovered from the extract solution under reduced pressure and the solution was concentrated to obtain a concentrate having a relative density of 1.05 to 1.10 at 60 ° C Obtaining an extract,
c) For use in the next step, the second mixture is formed by taking the pitch, the nose, the seawater, the pickle, the silkworm and the bridge according to the preparation rate, adding 7 to 10 L of water per kg of the second mixture, The solution is concentrated to obtain an extract having a relative density of 1.05 to 1.10 at 60 DEG C, and the extract is combined with the extract of step b).
d) mixing the micronized powder of step a) with the combined extract of step c) to obtain the herbal composition. a) taking in the gold and 1/2 positive inverse according to the preparation rate and pulverizing them into a fine powder for use in the subsequent step,
b) For use in the next step, the first mixture is formed by filling in the opposite half of the yam, white moss, white moss, horticulture, element, passerine, Ethanol was recovered from the extract solution under reduced pressure and the solution was concentrated to obtain a concentrate having a relative density of 1.05 to 1.10 at 60 ° C Obtaining an extract,
c) For use in the next step, the second mixture is formed by taking the pitch, the nose, the seawater, the pickle, the silkworm and the bridge according to the preparation rate, adding 7 to 10 L of water per kg of the second mixture, And the solution is concentrated to obtain an extract having a relative density of 1.05 to 1.10 at 60 DEG C and combining the extract with the extract of step b)
d) mixing the fine powder of step a) with the combined extract of step c), adding adjuvant to the mixture, obtaining granules by spray granulation, drying and then filtering out the granules with a mesh sieve, and
e) preparing the granules of step d) with a tablet of the herbal composition
7. The method for producing a tablet according to any one of claims 1 to 6, comprising the steps of: 11. The method of claim 10,
a) taking in the gold and 1/2 positive inverse according to the preparation rate and pulverizing them into a fine powder for use in the subsequent step,
b) For use in the next step, the first mixture is formed by filling in the flakes of magma, bagasse, alfalfa, cornflower, element, passerine, Volatile ethanol is added and heated and refluxed three times for 1.5 hours each time, ethanol is recovered from the extract solution under reduced pressure and the solution is concentrated to obtain an extract having a relative density of 1.05 to 1.10 at 60 DEG C,
c) For use in the next step, the second mixture is formed by taking the formula, nose, nose, pickle, silkworm and joint according to the preparation rate, adding 9 L of water per kg of the second mixture, Mixing the bath liquids by filtration to obtain an extract having a relative density of 1.05 to 1.10 at 60 ° C. and combining the extract with the extract of step b)
d) mixing the fine powder of step a) with the combined extract of step c), adding adjuvant to the mixture, obtaining granules by spray granulation, drying and then filtering out the granules with a mesh sieve, and
e) preparing the granules of step d) with a tablet of the herbal composition
&Lt; / RTI &gt; wherein the tablet comprises a herbal composition.