KR19980043964A - General cough medicine and its manufacturing method - Google Patents

Abstract

The present invention relates to a synthetic cough medicine and a method for manufacturing the same, and more particularly, a new synthetic cough medicine containing a crude drug of Hapja, gimo, Astragalus, Femo, Sangbaekpi, Schisandra chinensis, Almond and Ginseng as main ingredients, and containing white sugar as an excipient and its The present invention relates to a manufacturing method, which is an excellent new drug that can treat cough, sputum and asthma by enhancing lung function.

Description

[Name of invention]

General cough medicine and its manufacturing method

Detailed description of the invention

The present invention relates to a comprehensive cough medicine and a method for manufacturing the same, and more specifically, to cough by strengthening the pulmonary function containing the herbal medicines of Hapja, gimo, Astragalus, Falcon, Sangbaekpi, Schisandra chinensis, Almond and Ginseng as main ingredients and containing white sugar as an excipient. The present invention relates to a new synthetic cough medicine that can treat asthma, phlegm, and asthma.

Chronic bronchitis is a common disease in Korea. Cough, sputum, and asthma are the main symptoms. They do not cure well, and they have seizures repeatedly. If not treated in time, the disease may continue to develop, resulting in emphysema and pulmonary heart disease. Therefore, prevention and treatment of these diseases is very important.

The purpose of the present invention is to develop a comprehensive cough medicine composed of pure herbal medicine, reduce the strong pharmacological mechanism or side effects, etc. found in the medicinal ingredients, and have a milder antitussive action, a new comprehensive cough medicine that can treat chronic bronchitis and its manufacturing method To provide.

Comprehensive cough medicine of the present invention contains white sugar as eight herbal medicines and excipients of Hapja, gimo, Astragalus, fetus, Sangbaekpi, Schisandra chinensis, Ginseng, and Ginseng, more specifically 30 to 35% of Hapchae, 5 ~ 10% Jimo, It is a general cough medicine formulated with a percentage of 10-15% Astragalus, 5-10% Femo, 10-15% Schisandra chinensis, 1-5% Schisandra chinensis, 5-10% Almond and 5-15% Ginseng, and 5-10% Per 100%. .

In addition, the preparation method of the general cough medicine of the present invention is 30 ~ 35%, 5 ~ 10% of the hair, 10 to 15% of the yellow rice, 10 ~ 15%, 10 ~ 15% of baekjapi, 1 ~ 5% of Schisandra chinensis, 5 ~ 10%, ginseng 10-15%, and then extract extracted by repeated extraction three times with water and concentrated to prepare a concentrated solution, and then add 5-10% per bag, mix and dry in an ointment It is summarized as a method for producing a comprehensive cough medicine, characterized in that the powder, granulation.

In order to select a medicinal herb of the present invention, an antitussive action test for guinea pigs was conducted as follows.

(next)

I. Material

1.Sample: Group 1-Hap, Felt, Feline, Almond

Group 2-Hap, Ginseng, Astragalus, Schisandra chinensis

Group 3-Hap, Gimmo, Femo, Almond, Ginseng, Astragalus, Schisandra chinensis

Group 4-Gimmo, Femo, Almond, Ginseng, Astragalus, Schisandra chinensis, Morus alba

Group 5-Hap, Gimmo, Femo, Almond, Ginseng, Astragalus, Schisandra chinensis

Comparative Drug-Codeine Phosphate (Drug)

2.Laboratory animals: 250-400 g male guinea pig

3. Appliances and Appliances:

1) stimulator type 215/1 (Hugo Sachw Electronik Co.)

2) Dynograph Recorder (Senso-Medics Co.)

3) Cannula (PE-200, Intramedic, clay-Adams Co.)

4) Centrifuge

5) pin set

6) Surgical scissors

7) suture, suture needle, syringe

8) Various Potatoes, Race Needles

9) animal cage, animal fixture

II. Experiment method

Male guinea pigs of 1.250-400 g were reared at a temperature of 23 ± 1 ° C, a relative humidity of 55 ± 5%, and a contrast shift of 12 hours.

2. Water and feed were provided for free intake.

3. The guinea pig was fixed on the surgical plate and the cannula was inserted into the bronchus.

4. The electrode used for electrical stimulation was applied to the bronchus and the electrical stimulation was applied to cause coughing.

5. The electrical stimulation parameters were applied for 5 seconds with square wave pulses with 1 ms pulse, 2 volts, and 40 Hz vibration.

6. The cough response was recorded in a polygraph and four to five coughs were induced during one stimulation.

7. The experimental group was 5-10 guinea pigs and 5ml / kg body weight was administered orally using saline as a control solution.

8. Each group of herbal medicines were mixed with fine powder, mixed with 20 ml of physiological saline, and the main components were extracted. The filtrate and the filtrate were combined to make 25 ml. The test solution was administered with 1, 2, 3 and 4 ml per kg of body weight.

9. Codein phosphate was used as a comparator and 3, 6, 8, 12 mg / kg body weight was used.

10.Evaluation of antitussive effect

1) Record the coughing response by giving electric stimulation before each drug administration.

2) Each cough reaction was recorded by giving electric stimulation at 10, 20, 30, 45, 60, 75, and 90 minutes after drug administration.

3) The time of no coughing response to one stimulus was 0 and the time of 1 was 1.

4) The antitussive effect of each drug was obtained by determining the percentage of coughing response for 75 minutes after drug administration, and 50% antitussive dose, At D50, was obtained by Litchfield and Wilcoxon method.

5) group wall drug administration group: 1 group. Happa, Jimo, Femo, Almond Blend

Group 2 Hap, Ginseng, Astragalus, Schisandra chinensis

Group 3; Hap, Gimmo, Femo, Almond, Ginseng, Astragalus, Schisandra chinensis

Group 4, hairy, falcon, almond, ginseng, Astragalus, Schisandra chinensis, lettuce extract

Group 5; Hap, Gimmo, Femo, Almond, Ginseng, Astragalus, Schisandra chinensis

The amount of the herbal wall compound is 25g in total, 5g in hair, 5g in shell, 5g in almond, 9g in ginseng,

It was set as 10 g of Astragalus, 3 g of Schizandra chinensis and 10 g of Morus bark.

Ⅲ.Experimental Results

In guinea pigs given physiological saline, there was little effect on cough response induced by electrical stimulation until 90 minutes after administration.

2. The antitussive effect of Codeine phosphate on each dose time showed a rapid action after administration, showing the maximum antitussive effect between 20-30 minutes, and the effect disappeared over time.

3. The antitussive effect of each dose on time of sample 5 showed a maximum antitussive effect at 20-40 minutes, and also disappeared over time.

At D50, which is a dose of 4.50% antitussive effect, is calculated as Codeine phosphate, which is a narcotic antitussive, is 6.58 mg / kg, and At D50 of the formulation of Group 5 is 17.43 mg / kg. Codeine phosphate, a sex antitussive drug, showed about one-third strong effect.

5. In oriental medicine, the symptoms of seawater and familiarity are considered as seawater caused by wind heat, and shallow water caused by ruins. In addition, ginseng, Hwanggi, Schisandra chinensis group, Sangbaekpi, the mother of Jihaengcheon, and Ginseng, Pedestrian, Jimo, Pamo, and Baekbaekpi with cough, sea cough Each of them was combined and administered. The results showed that At D50 in Group 1 was 35.26 mg / kg, At D50 in Group 2 was 37.14 mg / kg, 27.19 mg / kg in Group 3, and At D50 in Group 4 was 27.71 mg / kg. It was found that they correspond to 48%, 46.9%, 64.1%, and 60.7% of the antitussive effect of.

In other words, it can be seen that the antitussive effect of the compounding agent of the 5th group is significantly increased due to the experimental results of the ingredients as described above was able to achieve the present invention.

Synthetic cough medicine of the present invention is formulated into granules, tablets, capsules, etc., and for the purpose of treating cough, sputum, and asthma by strengthening pulmonary function, 1 packet (once granules containing 1.6 grams; tablets or capsules) three times a day for adults. Take it.

In the clinical trial for the treatment of chronic bronchitis, the present invention had an effective rate of 91.7%, was easy to take, and proved to be a new drug with excellent treatment effect for cough.

On the other hand, in the acute oral toxicity test of rats of the present invention, no unusual abnormalities were observed in clinical symptoms, weight change, autopsy findings, and LD ₅₀ value was found to be a very toxic drug with low toxicity of more than 5.5 g / kg in male and female mode. Could.

Hereinafter, examples of the present invention and experimental stability examples of the formulation will be described.

Example 1

1. Amount of Ingredient

In 1 bag (1600 milligrams)

Main ingredient total (fresh) 4000 mg

Main ingredient Sulfur (weak) 1600 mg

Main ingredient, Morus alba (1,600 mg)

Principal Ingredient Liner (Pharmaceutical) 800 mg

Principal Ingredients (Pharmacopoeia) 800 mg

Main ingredient (raw) 800 milligrams

Main ingredient Schizandra chinensis (480 mg)

(As Shuzandrin

1.92 milligrams)

Main ingredient White hemp (weak) 1440 mg

(As ginsenoside Rb-1

2.88 milligrams)

Immersion dry x 800 milligrams

Excipient white sugar (pharmaceutical) 800 mg

2. Manufacturing method 1

(1) 25 grams of raw herbal medicines, Astragalus, each 10 grams of white and white skin, almonds, Jimo, 5 grams of famo, 3 grams of Schisandra chinensis, 9 grams of white ginseng into 800 grams of water, soak for 2 hours, and apply heat for 2 hours, extract 300 Extract the grams. Add 600 grams of water and boil for 1 hour 30 minutes to extract about 200 grams. Add 600 grams of water and boil for 1 hour to extract about 200 grams of extract.

(2) Divide the extract extracted three times, filter it, combine it in one place, and make a concentrated solution by heating.

(3) Add 100 grams of concentrate to 5 grams per bag, mix well, and place in a vacuum drying box to dry to 20 grams of ointment.

(4) Put the ointment into a granulator and process it into a powder. Put it in a dry box and dry it once more to get 10 grams of finished product.

3. Manufacturing Method 2

The dried extract powder, which is the product of Preparation Method 1, contains an appropriate amount of distilled water, and is put into a granulator and vacuum-packed once in a granule state at a capacity of 1.6 grams.

[Stability Test of Formulation]

The synthetic cough medicine granules prepared according to Example 1 were confirmed by the method described in Hapja, Astragalus, Morus alba, algae, chymo, famo, Schisandra chinensis, and White ginseng herb by the method described in the notification, etc., especially Schisandra chinensis As a result of the content test of Suzandrin (Table 1) and Ginsenoside Rb ₁ (Table 2) in white ginseng, it was confirmed that all products passed the criteria within the standard.

TABLE 1

Content of Schizandrarin in Schizandra chinensis

TABLE 2

Content of Ginseng (Ginsenoside Rb ₁ ) in the Formulation

[Clinical Experiment on Treatment of Chronic Bronchitis of the Invention]

I. Introduction

Chronic bronchitis is a common disease in Korea, with an incidence rate of 3 to 5%, the elderly accounting for about 10 to 15%, and especially in cold regions. The disease is a major symptom of cough, sputum, and asthma. It does not heal well, repeated seizures, if not treated in time, the disease will continue to be severe and later in the development of emphysema and pulmonary heart disease can be prevented Healing is important.

Ⅱ.General Data

The origin of this case was 436 cases including ○○, △△ hospitals, among which 346 outpatients and 90 inpatients were included.

1. Gender: The cases are 252 males and 184 females. The ratio is male to female = 5: 1, as shown in Table 3.

TABLE 3

Two military sex comparisons

X ³ = 3.66 P0.05 Sex differences are insignificant.

When comparing the sexes of the two groups, the sex difference was not apparent at P0.05.

2.Age: Table 4

TABLE 4

Age comparison

The minimum age of the observation group was 23 years, and the maximum age was 80 years. The minimum age of the control group was 21 years and the maximum age was 78 years.

Two groups age comparison: t = 0.759, P0.25.

3. Disease: Classification of disease conditions (US, Slight, Medium) are shown in Table 5.

TABLE 5

Comparison of two military conditions

X ² = 5.41 P0.05

Statistical analysis of the two groups of diseases is P0.05.

4. Disease progress: It is shown in Table 6.

TABLE 6

Comparison of the duration of illness between the two groups

X ² = 5.97 P0.05

The shortest course of disease in the treatment group was 3 years, the longest period was about 40 years, and the shortest course of disease in the control group was 3 years, and the longest period was 40 years. There was no statistically significant difference in the course of illness between the two groups.

5. Apologetics: Table 7 shows.

TABLE 7

Dialectic comparison of two groups

X ² = 1.14 P0.25

Among the two groups, there was no significant difference among the variables.

6. Merger Lungs: Table 8 shows.

TABLE 8

Comparing Lungs in Two Groups

X ² = 0.146 P0.5

There is no significant difference between the two groups.

7. Symptom comparison: Table 9 shows.

TABLE 9

Comparison of symptoms between two groups

Each item P0.9

There was no significant difference in the comparison of symptoms between the two groups at P0.90.

9. Snow, veins: Table 10-1 describes the snow phase and Table 10-2 describes the veins.

TABLE 10-1

Comparing the Snow of Two Armies

Sulfur X ² = 0.436 P0.75, Sulfur X ² = 0.7 P0.5

Table 10-2

Comparison of pulses between two groups

X ² = 2.962 P0.25

The comparison of the vein between the two groups shows no significant difference.

Ⅲ.Case Selection

1. Diagnosis Criteria for Diagnosis:

(1) Disposal (肺 氣虛): less cough, sputum, shortness of breath after overwork, weak winds, cold sweats, easy cold, tongue pink, tongue thin, white, slow and thin.

(2) Biyangheo (脾陽 虛): cough is heavy and stuffy, sputum, white, stool is thin and thin, the tongue is thick and pale, there is a trace of teeth, the tongue is white.

(3) Spleen Xinjiang concession 腎陽虛): cough worsens at night, sputum, asthma, irregular breathing, fatigue Lethargy, limbs cold, a lot of urine at night, thick tongue, white tongue, weak pulse, thin.

2. ○○ Hospital diagnosis criteria: Cough, sputum is the main symptom, and invented for 3 months or more every year with asthma

3. Other diseases that exclude symptoms such as cough, sputum, and asthma, such as pulmonary tuberculosis, pneumonia, pulmonary sarcoma, heart disease, heart failure, bronchial dilatation, bronchial asthma, chronic rhinitis, were not selected.

Examination of the prolongation and resolution of chronic bronchitis in accordance with the above-mentioned diagnosis standard Inpatients are observed. Of the 436 cases in this group, 336 in the observation group and 100 in the control group all meet the above criteria.

IV.

1. Distribution: 436 cases were randomly divided into 336 observation groups and 100 control groups.

436 patients were randomly divided into 1,2,3,4, 1 to 3 as observation group, 4 as control group, and 100 control group were observed.

2. In 336 cases of observation group, the present invention was taken 3 times a day, 1 packet each time.

3. 100 control group took lung protectant (服 利 肺 片) three times a day, five times each time.

4. Treatment Period: Two groups of 30 days were taken as one treatment period to terminate the treatment effect after the treatment period.

5. Observation items: medical history, symptoms, lung weight, tongue, pulse, chest, lung function measurement, blood Urine test, liver function test

Ⅴ. Analysis of treatment effect

1. Conditions and Conditions of Treatment:

(1) Criteria for chronic bronchitis

i) cough

Hardness (+): Does not cough during the day and does not affect normal life and work.

Medium (++): Symptoms are between hardness + and (+).

Moderate (+++): Day and night coughing severely affects work and sleep.

ii) phlegm

Small (+): sputum is 10-50 ml at day and night, 5-25 ml at night and at dawn.

Medium (++): The amount of sputum is 51-100 ml at day and night, 26-50 ml at night and at dawn.

Multi (+++): sputum is more than 100 ml during the day and night, and more than 50 ml at night and at dawn.

Observe sputum appearance and color Record it.

iii) asthma

Hardness (+): Asthma sometimes causes seizures but does not affect sleep and normal life to a lesser degree.

Moderate (++): The condition is between mildness and moderateness.

Moderate (+++): Asthma symptoms are pronounced and cannot lie down, affecting sleep and normal life.

iv) squeaking asthma

Small (+): Occasionally, it appears when coughing or breathing deeply and quickly.

Middle (++): Sound is scattered.

Multi (+++): The sound is filled in the lungs.

(2) Criteria for Determination of Chronic Bronchitis Effect

i) Clinical management: The cough, sputum, asthma and the sound of the lungs are weak, or the symptoms of cough, sputum and asthma have improved by more than 90%.

ii) Significant effect: Symptoms of cough, sputum and asthma improved more than 60%, and symptoms and lung sounds were significantly improved.

iii) Improvement: Symptoms of cough, sputum and asthma improved more than 30%, and symptoms and lung sounds improved (+++ → ++ or ++ → +).

iv) Invalidation: Cough, sputum, asthma symptoms, and noisy sound in the lungs were unchanged, and the improvement was less than 30% or worse.

(3) Criteria for Determination of Comprehensive Treatment Effect for Chronic Bronchitis

i) Cough and phlegm are two criteria for determining conditions:

① Clinical management: Cough and phlegm have all improved, and the condition is less than mild.

② clear effect: cough and sputum have reached a clear standard of effectiveness, one of the symptoms reached the clinical management criteria, the other symptoms have a clear effect or improved.

③ improvement: one of the symptoms of cough, sputum reaches the standard of improvement, other symptoms are ineffective.

④ invalidity: cough, sputum are all unchanged, or less than the standard of improvement, cough, sputum all became worse than before.

ii) The four criteria of coughing, sputum, asthma and sounding in the lungs are the criteria for determining the effectiveness of treatment.

① Clinical management: Of the four symptoms of cough, sputum, asthma, and lung sound symptoms reached the clinical management criteria, one symptom has a clear effect.

② Significant effect: Of the four symptoms of cough, sputum, asthma, and lungs, three of the symptoms are clearly effective, one of the symptoms has reached the improvement criteria, or two symptoms of clinical management criteria, two symptoms A clear standard of efficacy or improvement was reached, or one symptom reached clinical management criteria, two symptoms of clear efficacy criteria, and one symptom of improvement criteria.

③ improvement: The scope of the improvement should be that the symptoms are not obvious effects or invalid criteria.

④ invalid: cough, sputum, asthma, four symptoms of sound in the lungs are all ineffective or one of the symptoms improved, one of the four symptoms became worse, the rest did not improve.

2. Treatment Result:

(1) Total therapeutic effect: It is shown in Table 11.

TABLE 11

Comparison of Total Treatment Effects of Two Groups

^{X 2 = 18.51 P0.005X 2 = 32.62} P0.005

The effective rate of the observed group was 91.7%, the control rate was 50.9%, the effective rate of the control group was 75%, the control rate was 18%, and the difference between the two groups was P0.005. .

(2) Symptom treatment effect

i) Major Symptoms Therapeutic Effects: Table 12.

TABLE 12

Comparison of main symptomatic treatment effects of two groups

ii) Secondary symptoms comparison: Table 13 below.

TABLE 13

Secondary Symptom Comparison Table

Comparison of symptomatic effect of the two groups showed that the effective rate of the observation group was better than that of the control group, and statistically secondary symptom wind In addition to the symptoms of cold sweating and dyspnea, each symptom is clearly different (P0.01 and P0.05). In part of the group cases, the patient had an outpatient infection and some had a cold during the medication period.

(3) snow veins

i) Change in Sulfur: It is shown in Table 14.

TABLE 14

Changes before and after lingual treatment

ii) Changes in tongues: Table 15 shows.

TABLE 15

Changes before and after treatment of tongue

iii) Change in vein: It is shown in Table 16.

TABLE 16

Changes before and after treatment

Patients in this group are primarily deprived and spleen It is belong to kidney yang, relatively thin tongue, thick, teeth traces before treatment, thin tongue white, white, white, smooth smooth, many wedges are weak, thin the most, fast veins are separated Conforms to

After the treatment, the symptoms of diminished bleeding were improved and the vena cava improved. From 69 cases to 143 cases, the congested condition increased from 69 to 143 cases, and the remission was increased from 59 cases to 99 cases. To be clear that you are gone.

3.Laboratory Indicators

(1) Comparison before and after pulmonary function treatment of two groups: Table 17.

TABLE 17

Comparison of Pulmonary Function Changes in Two Groups

In the observation group, 189 cases of pulmonary function test showed that each index had different degree of improvement and was statistically different than the control group.

(2) Comparison before and after leukocyte treatment: Table 18 shows.

TABLE 18

Comparison of Leukocyte Changes in Two Groups

After treatment of the two groups, the number of leukocytes is lower than before treatment, and the difference is apparent, indicating that the present invention has an effect of reducing inflammation after treatment.

Poor response: Two patients had a slight dry mouth, dizziness, and dry stools during the course of treatment, but did not affect continuous treatment.

Liver and kidney function test results after the treatment of this group demonstrate that the drug is harmless to liver and kidney function.

Case Study 1

Zhang X, male, 64, executive

The patient has had asthma for over 30 years, usually coughing from dawn, sputum sputum, shortness of breath, sweating, chills, waist My knee was weak, I was tired all the time, my stools were thin, and I had a lot of urine at night.

Physical examination: weak breathing of the lungs, asthma, sounds from the lungs, low and wet blisters, limb edema (+), dark and thick tongue, white and smooth tongue, weak and thin veins. Pulmonary pulmonary pulmonary pattern increases, causing emphysema.

During diagnosis: Cough, asthma symptoms. Kidney concessions.

○ ○ Hospital shear: Chronic asthma bronchitis, emphysema, chronic monocolitis.

After 2 weeks of treatment with the present invention, all cough, sputum and asthma were reduced, and cold sweat, chills and hunger The knee's soreness improved, the stools decreased from 2-3 times daily to 1-2 times, the night sleep was better, and the urine volume was lower than before. Four weeks after taking the medication, the above-mentioned symptoms were basically eliminated, the vaginal sulcus was smooth, the tongue was smooth, the white symptom, the weak veins and the lungs were all better, and the lungs were noisy. There was a little low and damp bleeding, but also lower leg edema and constitution.

Case Study 2

Jean X, X, Male, 63 Years, Adult

The patient has chronic asthma for more than 20 years, causing repeated seizures when the weather is cold and easily catching a common cold 7-7 times a year. As a result of the cold wind in February, asthma became severe and sputum was heavy and white, and my chest was stuffy and my breathing was difficult. I had a seizure easily after I stopped taking it.

Physical examination: Nerve fatigue, stamina, weak breathing sounds, wet blisters, thin tongue, thin, white veins. There is an increase in the pattern of the lung and emphysema.

Medium diagnosis: Chronic asthmatic bronchitis, emphysema. After 2 weeks of taking the present invention, asthma weakened and sputum decreased, limb paralysis helplessness improved, and after 4 weeks of taking medicine, asthma basically disappeared, paralysis helplessness, cold sweat, bad wind, etc. The tongue was thin and white, the vein was relieved, and the dry and moist blisters of the lungs disappeared. Six months after the observation, the general condition of the patient was improved. Sometimes there was cough sputum but no asthma, and only 6 months had a variable cold.

Ⅵ. Discussion

The incidence and development of chronic bronchitis is related to bad energy entering the lungs, spleen, and kidneys and damaged, resulting in repeated seizures of cough, sputum, and asthma.

Based on the theory that “when the bad energy gathers, the qi is absolutely absent” and “the bad qi can't work when the right one is inside,” it improves through treatment of 336 cases of chronic bronchitis. Has achieved a therapeutic effect. The total effective rate is 91.7%, which is superior to the control group. P0.005. This drug has certain treatment effects such as constitution, prevention of colds and reduction of acute seizures, and shows excellent effect on cough, sputum and asthma. It improves depending on the condition of the disease and is good for lung function.

Clinical pathology experiments have demonstrated that the drug has the ability to protect the lungs, help the qi, stop coughing, and clear the lungs to clear phlegm. The doctor: Pulmonary weakness, spleen Cough, phlegm, asthma symptoms, fatigue, lethargy, chills, tongue, whiteness, weakness of outpatient infection, weakness and weakness. Chronic bronchitis and chronic hypotonic emphysema all have the symptoms described above.

In 336 cases, the drug had dried mouth and hardened stool during the course of one month of medication, but it did not affect the continuous medication and no adverse reactions.

Ⅶ.Conclusion

General cough medicine of the present invention Intestinal protection, gibogang, cough Treats asthma, cleans the lungs and cleans the walls, destroys the spleen The treatment effect was good for the chronic bronchitis prolongation and relieving patients of kidney limber. It is effective in reaching 91.7%, and it is a new drug to treat chronic bronchitis with high dose and convenience.

[Acute Oral Toxicity Test of Rats of the Invention]

I. Introduction

The present invention (Example 1) is a substance prepared for the purpose of cough medicine as a herbal compound of dark brown powder. Acute Toxicity When Observed 7 Days After Oral Administration of This Test Substance Into Rats And acute oral toxicity test were conducted to evaluate the safety of the present invention according to the toxicology test standards of the drug 94-3 ('94 .4.14) of the National Institute of Health and Safety.

Ⅱ.Test substance and control substance

The following test substances were used for the test.

Test substance: Formulation Example 1 of the present invention

Lot number: ZP-00995-1995-527

Appearance: Brown Brown Powder

Storage: Room temperature preservation, airtight container

Ⅲ.Test System and Breeding Environment

The test area is an animal laboratory of the National Institute of Health and Safety, and the SPF rats produced in the clean area have a temperature of 23 ± 1 ° C, a humidity of 50 ± 5 ° C, an exhaust of 10-15 times / hr, and a fluorescent light intensity 12hr cycle. In the rearing environment of roughness 150-300Lux, five animals were placed in a cage of polycarbonate breeding box (280W × 420L × 170H mm). The normal condition was observed during the 1-week period of pure breeding, and only normal animals were used for the test. Feed was freely supplied to test animals by purchasing experimental animal feed from ○○ Feed Co., Ltd., and drinking water was freely consumed with sterile tap water.

Ⅳ. Test Method

1.Group Separation and Dose Setting

Animals determined to be healthy during the acclimatization period were weighed, and individuals close to the average body weight were selected and grouped using a random method. Individual identification of animals was carried out using the hair coloring method and tag labeling method by breeding box.

The dose should be set to 5.5g / kg of the highest dose that can be administered experimentally in consideration of preliminary test results and solubility of the test substance. / kg and distilled water was administered to the control group (see Table 19).

TABLE 19

Dosage by Group

Immediately before administration of the test substance, the body weight of the test animals ranged from 168-216g for males and 137-173g for females, and was about 6 weeks old.

2. Preparation and administration of test substance

The present invention was prepared by distilled water immediately before administration at a concentration of 0.275 g / ml for the highest dose group, 0.25 g / ml for the middle dose group, and 0.225 g / ml for the lowest dose group. The dose of the test substance was calculated according to the weight measured immediately before administration, and the rat was orally administered once.

3. Clinical observation

Clinical symptoms for all test animals were taken every hour for 6 hours after administration on the day of administration. From 1 to 7 days after administration was observed once a day.

4.weight measurement

All test animals used in the test were weighed on the day (0 day), 1, 3, 5, and 7 days after administration of the test substance.

5 autopsy

After the end of the test, the animals were lightly anesthetized with CO ₂ and killed by sublingual artery and abdominal aortic amputation. The appearance and internal organ abnormalities were visually observed in detail, and the body weight was measured immediately before the autopsy.

6. Statistical interpretation of data

Bartlett's test for homogeneity of variance was performed to determine the weight change by administration, and then one-way analysis of variance test was performed to compare the control group and the test substance administration group, and the significance was tested at the P0.05 level.

7.Retention of basic test data

Fundamental data such as tissue specimens and other records obtained during the testing process are stored in the National Institute of Health and Safety Research and Archives.

Ⅴ.Test Results and Discussion

1.LD ₅₀ Chi and Clinical Symptoms

There were no deaths in any of the dose groups, including the control group, and no clinical symptoms were observed. The LD ₅₀ value is estimated to be 5.5 g / kg or more in male and female mode.

2.weight change

No significant body weight change was observed in all dose groups compared to the control group (Table 20).

TABLE 20

Changes of body weight in rats treated orally with this product

3. Visual seawater findings

There were no deaths in the control group and all dose groups, and no gross abnormalities were observed in the surviving individuals.

Therefore, in rats, the acute toxicity of the present invention was administered once orally with three administration groups such as the highest dose group 5.5g / kg, the medium dose group 5g / kg, the lowest dose group 4.5g / kg and distilled water as a control. the test results were clinical symptoms, body weight changes and gross anatomical abnormalities were unusual due to the test substance was not observed in findings, LD ₅₀ values sexes mode 5.5g / kg or more.

Ⅵ.Conclusion

The present invention, a test substance, was used as a control group in three dose groups and a distillation group, such as the highest dose group 5.5g / kg, the medium dose group 5g / kg, and the lowest dose group 4.5g / kg in the SD rat. After oral administration, an acute toxicity test was performed for 7 days. As a result, the following conclusions were obtained under these test conditions.

1. There were no deaths in all dose groups, including the control group, and no clinical symptoms were observed.

2. No significant weight change was observed in both dose groups compared to the control group.

3. There were no deaths in control and all dose groups, and no gross abnormalities were observed in surviving individuals.

Taken together, the above results were clinical symptoms, weight change, in autopsy findings characteristic due to the test substance in the acute oral toxicity test on rats of the present invention is observed, not less than LD ⁵⁰ value sexes mode 5.5g / kg It is considered to be low toxicity under these test conditions.

Claims (3)

A comprehensive cough medicine characterized by containing excipients of wild herbs and white sugars of Hapja, gimo, Astragalus, fenugreek, Schisandra chinensis, Schisandra chinensis, Almond and Ginseng. According to claim 1, wherein the blending ratio of each herbal is 30 ~ 35%, 5 ~ 10% gimo, 10 ~ 15% Astragalus, 5 ~ 10%, 10 ~ 15% Schisandra chinensis, 1 ~ 5% Schizandra chinensis 5 A comprehensive cough medicine characterized by a percentage ratio of 10% to 10% to 15% of ginseng and 5 to 10% per bag. 30% to 35%, 5% to 10%, 10% to 15%, 10% to 15%, 10% to 15%, 10% to 15%, 10 to 15% Schisandra chinensis, 1% to 5% Schisandra chinensis, 5% to 10% Ginseng, 10% to 15% Ginseng The extract obtained by repeating the extraction three times with water and then combined and concentrated to prepare a concentrated solution, and then added to 5 ~ 10% per bag, mixed and dried in an ointment, powder, granulated Method for preparing cough medicine.