KR0185538B1 - Complex coughing drug and their preparation method - Google Patents

Abstract

The present invention relates to a synthetic cold medicine and a manufacturing method thereof, and more particularly, to a novel synthetic cold medicine containing panlam root, mold opening, gilyeong, hiso and almond as main ingredients, and containing white sugar as an excipient and a manufacturing method thereof. It is an excellent new drug that can cure colds and fever.

Description

[Name of invention]

Synthetic cold medicine and its manufacturing method

Detailed description of the invention

The present invention relates to a synthetic cold medicine and a method for producing the same, and more particularly, to a novel synthetic cold medicine containing white sugar as an excipient as a main ingredient, Panrameun, gyeonggae, Gilgyeong, Shiho and passersby.

Colds often include symptoms such as headaches, chills, fever, body aches, runny nose, stuffy nose, cough and sore throat.

An object of the present invention is to provide a synthetic cold medicine and a method of manufacturing the same consisting only of pure herbal medicine that can be used for the purpose of preventing and treating such cold symptoms.

The general cold medicine of the present invention contains herbal medicines of Panlam root, gyeonggae, Gilgyeong, shiho and algae as excipients, and more specifically 30 to 50% of panramus, gyeonggae, Gilgyeong, shiho and algae respectively. It is a synthetic cold medicine formulated with a percentage of 5-10% of white sugar.

In addition, the preparation method of the general cold medicine of the present invention is 30 to 50% of panlam root, gyeonghyeong, Gilgyeong, Shiho and passersby each 10% to 15%, the extract obtained by repeated extraction three times with water and concentrated to concentrate the concentrate It is summarized as a method of preparing a synthetic cold medicine, which is added to 5-10% per bag, mixed, dried in an ointment state, and then powdered and granulated.

In order to select the herbal medicines constituting the present invention, an analgesic test was conducted on mice as follows.

( next )

I. Materials

1. Sample: Group 1-Gilkyung, almond, 500 mg / kg sugar, i.p.

Group 2-gilkyung, pedestrian, sugar + hyung 500 mg / kg, i.p.

Group 3-gilkyung, pedestrian, sugar + shiho 500 mg / kg, i.p.

Group 4-Gilgyeong, almond, sugar + pancreas 500mg / kg, i.p.

Group 5-gilkyung, pedestrian, sugar plus pancreas, mold 500 mg / kg, i.p.

Group 6-Gilkyung, alpine, sugar + seahawk, plate-shaped dog 500 mg / kg, i.p.

Group 7-Gilkyung, Alpine, Sugar + Seahawk Panlamus 500mg / kg, i.p.

Group 8-Gilgyeong, Pedestrian, Sugar + Seaho, Panlam Geun, Hungyeong 500mg / kg, i.p.

Comparative Drug-Morphine (Drug)

2. Experimental animals: Males of 18-22g ICR mice

3. Appliances and Appliances

1) Tail flick unit: Ugo Basile, Varese, Italy

2) Bulb: 100W Incandescent

II. Experiment method

1. Paint the tail of the experiment animal with black magic lamp to absorb light well.

2. Turn on the main switch.

3. Determine the size of the thermal stimulus by adjusting the brightness of the bulb.

4. Hold the animal and put its tail in the groove.

5. Press the switch to light the bulb. At this time, the clock is activated and the reaction time is measured.

6. When the animal detects a heat stimulus and lifts or moves its tail, the light goes out and the clock on the display stops.

7. Determine the size of the thermal stimulus by preliminary experiments with a few animals in advance, and adjust the intensity to which the experimental animals respond easily. That is, the basic reaction time is set to 2.0 ± 0.2 seconds and animals outside this range are excluded from the experiment.

8. After that, the sample is injected into the animal and the analgesic effect is measured up to 30 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes, and 270 minutes, and the response time (seconds) to the time (minutes) is expressed as%, Calculate analgesia in AUC (Area Under the Curve).

9. Experimental drug: morphin 5mg / kg, s.c

Group 1-gilkyung, pedestrian, 500 mg / kg sugar, i.p.

Group 2-gilkyung, pedestrian, sugar + hyung 500 mg / kg, i.p.

Group 3-gilkyung, pedestrian, sugar + shiho 500 mg / kg, i.p.

Group 4-Gilgyeong, almond, sugar + pancreas 500mg / kg, i.p.

Group 5-gilkyung, pedestrian, sugar plus pancreas, mold 500 mg / kg, i.p.

Group 6-Gilkyung, alpine, sugar + seahawk, plate-shaped dog 500 mg / kg, i.p.

Group 7-Gilkyung, Alpine, Sugar + Seahawk Panlamus 500mg / kg, i.p.

Group 8-Gilgyeong, Pedestrian, Sugar + Seaho, Panlam Geun, Hungyeong 500mg / kg, i.p.

The amount of herbal medicines was blended with 9g of Gilyeong, 9g of almonds, 5g of sugar, 9g of hyunghyeong, 9g of shiho and 30g of panramus.

III. Experiment result

Sample reaction time (seconds), analgesic percentage (%) and A.U.C are listed in Table 1. These experimental values are the average of the values measured ten times.

As can be seen in the above experiment, the analgesic response time (seconds) for each minute (minutes) is calculated as Percent, and the analgesic power of the 8 groups in 30 minutes corresponds to 32.5% of the morphine. In addition, the percentage of analgesia (%) for 30, 60, 90, 180 and 270 minutes in A.U.C. shows that 77.4% of morphine analgesic lasts for 4 to 5 hours.

Gilkyung and passersby, who have been used as an expectorant in Chinese medicine, act on menopause and have been clinically applied as a cold seawater medicine. In this experiment, the herbal ingredients of Gil-Gi-Gan, Hang-In, and Sugar were grouped into 1 group, and Shiho, Hae-jae, who used for fever regression, hyung-gae, and Panram-geun, respectively. In group 4, 36.4%, 22.1%, and 29.8% were analgesic in group 8, respectively, and in groups 5, 6, and 7, 66.5%, 32.8%, and 46.4%, respectively. It can be seen that the therapeutic effect is significantly increased by combining all of the mold opening, shiho, gilyeong, passersby and sugar.

Therefore, the combination herbal of the eight groups as a constitutive herbal medicine of the general cold medicine of the present invention.

The general cold medicine of the present invention is formulated into granules, tablets, capsules, and the like, and is used for treating cold symptoms such as colds, sweating, fever, headache, fever, chills, runny nose, stuffy nose, cough, tonsillitis and mumps. Take 1 packet (containing 10 grams of granules; tablets or capsules) three times a day.

In the clinical trials for cold fever, the effective rate was 95.5%, and the treatment effect for cold was very excellent.Acute oral toxicity test in rats showed abnormalities in clinical symptoms, weight changes, and autopsy findings. It is assumed that the LD value is not less than 15 g / kg in all the subarachnoids, so that the formulation of the present invention is practically non-toxic.

Hereinafter, the examples of the present invention and stability experiments of the formulations, etc. will be described.

Example 1

1. Amount of Ingredient

2. Manufacturing Method 1

(1) 30,000 milligrams of raw herbal medicine Panlam root, 9000 milligrams of mold length, 9000 milligrams of path length, 9000 milligrams of seaweed, 9000 milligrams of algae, immerse 800 milliliters of water and immerse for 2 hours. Add 600 grams of water, boil for 1 hour 30 minutes, and extract about 200 grams of extract. Add 600 grams of water and boil for 1 hour to extract about 200 grams of extract.

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

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

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

(5) Put the finished product into the sterilizer and sterilize it.

3. Manufacturing Method 2

The product of Preparation Method 1 was mixed with a suitable amount of distilled water in a dry extract powder, and put into a granulator, and vacuum packed once per 10 grams in a granule state.

[Stability Test of Formulation]

As a result of confirming the Panram Geun, Hyeonggyeong, Gilgyeong, Shiho, algae herbal medicines for the synthetic cold medicine granules prepared according to Example 1, etc., it was confirmed that all the herbal medicines existed within the expiration date. The contents of total saponin (Table 3) in 2) and Shiho were confirmed to be within the standard in the long-term preservation test.

[Clinical Experiment on Cold Antipyretic of the Invention]

[Case Selection]

The clinical observation mainly focused on patient care, taking into account the short and easy changes in the course of the disease, and was mainly examined and followed by specialists from each hospital committee.

[Observation and Medication Symptoms]

Patients were diagnosed with influenza and early and middle body mass. Symptoms: Symptoms such as chills, fever, headache, dizziness, sore throat, nasal congestion, runny nose, sneezing, body aches, lethargy, abortion, chills, headache, nasal congestion, and body aches are the main symptoms. Patients with chronic illness or chronic disease are not within the scope of this drug.

[Treatment period]

6 days as treatment period, continue taking 3 days and observe.

[How to use and dosage]

The granules prepared according to Example 1 of the present invention are taken 2-3 times a day, each time one parcel is boiled in boiled water.

[Based on Treatment Effect]

(1) Cures: After taking 3 days of this drug, all symptoms disappear completely.

(2) Significant effect: 2/3 of all symptoms reduced after taking 3 days of this drug.

(3) Effective: All or most of the symptoms disappear after taking 6 days of this drug.

(4) Invalid: The person who does not reach the above standard.

[Precautions]

Drink plenty of warm water, avoid wind and cold, and avoid cold, raw, and fatty foods during this medication and observation period.

[Observation method]

(4) typical cases

① Son OO, female 25 years old, was examined January 10, 1996. Before the examination, the cold had already taken various medicines on the third day, but it did not work. Fever 38.2 ℃ at the time of examination, chills, headache, dizziness, nasal congestion, runny nose, weak cough, body aches, lethargy, snow, snow tongue, etc., taking the present invention three times a day, one bag once I was. After 1 day of medication, symptoms of chills, fever disappeared, dizziness, and body aches were reduced, and all symptoms stated before taking the medicine were reduced or relieved.

② Jang XX, female, 47 years old, teacher of Yukik Kookmin School, 18 January 1996. After three days of cold, he still had chills, headache, dizziness, runny nose, nasal congestion, sneezing, body aches, lethargy and mild cough, because the patient did not have a second screening on time after taking the medicine. In a January 27 visit, the patient thought he had gone on his own, taking only two days (7 bags) of medicine and found that he did not come to the second screening.

[Verification of clinical treatment effect]

ㆍ OO Hospital Oriental Medicine

(1) Formulation type: To make it convenient for the patient, the patient eliminated the time to wear down the powder, and was modified to take it in hot water.In case of taking it in the hot water, it helps the patient to sweat after taking the medicine. Becomes

(2) Rapid effect: During clinical observation, the majority of patients were treated with symptom-free effects with clear symptom effect or clear effect within 1 ~ 3 days of treatment.

(3) Reasonable prescription: Based on the dialectical treatment of medical theory, proper sweating of body fat and colds is as important as fever with anti-prescription drugs. However, although antipyretics may cause mild fever-relieving symptoms in outpatient outbreaks in ancient clinical cases, they still have the same effect after taking the drug.

ㆍ △△ hospital

(1) The present invention is effective in sweating and antipyretic, and excellent in the early cold symptoms. However, the correctness of the dialectic is very important and if the medicine and symptoms match each other, the medicine is effective in defeating the disease. According to the patient, after taking the medicine, the whole body became relaxed and the pain disappeared.

(2) The present invention was used in clinical practice, and the therapeutic effect was verified in practical clinical practice. The drug was welcomed by the patients, and it was recommended as a home winter medicine because it has excellent treatment effect for winter flu and body aches, and is convenient to carry and take.

[Acute Oral Toxicity Test of Rats of the Invention]

I. Introduction

The present invention (Example 1) is a substance prepared for the purpose of a cold medicine as a crude compound of light yellow powder. Acute toxicity of 7 days after oral administration of this test substance to rats. Re-specific toxicity test in combination according to the provisions on safety and efficacy evaluation of the Ministry of Health and Welfare No.1994-46 ('94 .9.22). Acute oral toxicity test was performed to evaluate the safety of the present invention according to the method and the toxicity test standard of the National Institute of Health and Safety Notice 94-3 ('94 .4.14).

II. Test substance and control substance

The following test substances were used for the test.

Test substance: Example 1 of the present invention

Lot Number: TR-00950-1995-520

Appearance: Light yellow powder

Storage: Store at room temperature, 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 (Specific Pathogen-Free) SD rats produced in the clean area have a temperature of 23 ± 1 ℃, a humidity of 50 ± 5%, an exhaust of 10-15 times / hr, and a fluorescent lamp contrast of 12hr cycle. In a rearing environment of roughness 150-300Lux, five animals were placed in a polycarbonate breeding box (280W × 420L × 170H mm) cage. The normal condition was observed during the 1-week period of pure breeding, and only normal animals were used for the test. The feed was freely supplied to test animals by purchasing experimental animal feed of OO Feed Co., Ltd., and drinking water was freely consumed with sterile tap water.

IV. Test Methods

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 15g / kg of the highest dose that can be administered experimentally in consideration of preliminary test results and solubility of the test substance, and to 10g / kg of the intermediate dose group and 5g / kg of the lowest dose group. Distilled water was administered to the control group (see Table 4).

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3. Visual Dissection

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

Therefore, acute toxicity test result of oral administration of the present invention in rats with three dose groups such as 15 g / kg of the highest dose group, 10 g / kg of the intermediate dose group and 5 g / kg of the lowest dose group and distilled water as a control. There were no abnormal findings due to the test substance in clinical symptoms, body weight changes and gross anatomical findings.

VI. conclusion

The present invention, a test substance, was orally administered to SD rats using three dose groups such as the highest dose group 15g / kg, the medium dose group 10g / kg, the lowest dose group 5g / kg, and the distilled water dose group as a control group. 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 the dose groups including the control group, and no clinical symptoms were observed.

2. No significant weight change was observed in all dose groups compared with the control group.

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

In conclusion, in the acute oral toxicity test of rats of the present invention, no clinical abnormalities due to the test substance were observed in clinical symptoms, weight change, autopsy findings, and LD values were more than 15 g / kg. It is assumed to be practically nontoxic under these test conditions.

Claims (3)

A comprehensive cold medicine characterized by containing the herbal medicines of Panram Geun, Hyeonggae, Gilgyeong, Shiho, and Pedestrians as well as sucrose. The composition according to claim 1, wherein the compounding ratio of each herbal contains 30 to 50% of bovine gold, 10 to 15% of gyeonghyeong, Gilgyeong, shiho and pedestrians, and 5 to 10% of white sugar. cold medicine 30 to 50% of Panlam roots, 10 to 15% of gyeonggae, Gilgyeong, Shiho and algae respectively, and the extracts obtained by repeated extraction three times with water were combined and concentrated to prepare a concentrated solution. After mixing, dried in an ointment state, and powder, granulate a method for producing a synthetic cold medicine, characterized in that the granulation.