WO2019132416A1 - Method for producing herbal medicinal tablet formulation for treating obesity which can be prescribed based on sasang constitutional medicine - Google Patents

Abstract

A method for producing an herbal medicinal tablet formulation for treating obesity which can be prescribed based on Sasang constitutional medicine according to an embodiment of the present invention comprises: a step of producing Ephedra sinica powder concentrated and quantified to have an ephedrine content of 3.0-4.0% from Ephedra sinica which shows a 0.5-2.5% difference in the ephedrine content depending on the production area and collection time; a step of determining, based on constitutions based on Sasang constitutional medicine, the weight amount of the Ephedra sinica powder concentrated and quantified to have an ephedrine content of 3.0-4.0%, and then, with respect to the weight amount of the Ephedra sinica powder, producing a powder for preventing side effects by constitutions, which is for preventing and suppressing side effects by constitutions based on Sasang constitutional medicine; a step of mixing the Ephedra sinica powder and the preventative powder, wherein preparation is performed by varying the ratio of the weight amounts of the Ephedra sinica powder and the preventative powder by factoring in the body weight, degree of obesity, constitutions based on Sasang constitutional medicine, and side effects; a step of tableting the prepared mixed powder of the Ephedra sinica powder and the preventative powder; a step of performing coating after the tableting; and a step of selecting faulty products and performing packaging after the coating step, wherein labels are attached that include information on the preparation based on the body weight, degree of obesity, constitutions based on Sasang constitutional medicine, and side effects.

Description

How to make tablets for medicinal herbs that can be prescribed according to ideological medicine

The present invention relates to a tablet preparation for treating obesity medicinal herbs which can be prescribed according to medical science, more specifically, it can confirm the clinical efficacy of weight loss while using the same amount of medicines as desired prescription, To maintain the safety of herbal medicines by controlling the adverse reactions of drugs and to quantify and take into consideration the constitution and weight / obesity according to the ideological medicine, and to manufacture by standardized use, and to maintain personalized treatment and stable treatment rate by weight / And can be prescribed according to the ideology medicine which can solve the problem of the existing herbal medicine diet such as odor, bitter taste, excessive dose of the herbal medicine specific herbal medicine (hereinafter, used as "sensory nervous"), And a method for producing the same.

Ephedra sinica Stapf is a perennial shrub plant of Mahwang and its medicinal herbs are dried and used in various diseases such as fever, seawater, asthma and edema in Oriental medicine.

The major component of mahwang is composed of alkaloids such as L-ephedrine, pseudoephedrine, norephedrine, and norpseudoephedrine, among which ephedrine accounts for 30 to 90% of total alkaloids.

Ephedrine is a sympathetic stimulant that inhibits appetite, increases heat production and metabolism, inhibits cholesterol absorption in the small intestine, and increases energy expenditure in adipose tissue to accelerate body fat breakdown.

Because of the sympathetic stimulation of ephedrine, mahwah is associated with cardiovascular, autonomic, and digestive symptoms such as headache, tachycardia, elevated blood pressure, nausea, and nausea. , And are used as medicines under the professional prescription of Oriental medicine.

Due to the safety concerns caused by the side effects of mahwang, problems related to the use and capacity of mahwang were raised in and out of the Korean traditional medicine industry. In 2007, the Oriental Obesity Society developed clinical guidelines for the use of mahwang suitable for obesity treatment and weight loss. Respectively.

However, only the maximum daily dose of ephedrine is listed, but there is a lack of usefulness in clinical practice because specific and clear criteria are not provided.

The total alkaloid content in mahwang is 0.5 ~ 2.5%. In the Korean Pharmacopoeia, the total alkaloid (ephedrine and caustic ephedrine) content in mahwang should be at least 0.7%.

However, the content of ephedrine in the total alkaloid of mahwang showed 30 ~ 90% variation depending on the harvesting time and growth environment. Also, when comparing the amount of ephedrine extract in the mahwang, the amount of ephedrine in the control liquid containing mahwang Since epididymal concentrations of Ephedrine vary from the origin of the medicinal materials to the formulations of the medicinal materials, the transfer process and the absorption distribution, the blood concentration of the patients may vary. Therefore, the stability of the drug Side, and the safety of treatment are both considerably unstable factors.

Generally, in oriental medicine, it distinguishes the constitution according to the strength of the function of the book (臟 腑). Especially, in the case of taeeumin, soeumin, and soyangin, the physiological characteristics have an important influence on obesity. In the case of Taeumin, the ability of absorption of nutrients is strong and fattening is easy, while the divergence and discharge ability of heat and wastes are decreased. In case of soeumin, the digestive absorption power is weak and the muscle mass is low due to the new arsenic (肾 大 脾 小) In the case of Soyangin, it is necessary to prescribe obesity in consideration of the constitution, because it is caused by hypertrophy due to stress due to hyperplasia (脾 大 肾 小) and deterioration and excretion function is weak. The physiological characteristics of obesity according to specific constitution are as follows.

As for the obesity characteristics of Taeumin, the digestive function and the absorption of the intestines are active compared with other constitutions, and the average BMI is the highest among the constitutions, and the most is the moderate obesity or the high obesity. (WHR, waist-hip ratio) and metabolic circulation is lowered, causing hypertension, paralysis, hyperlipidemia, fatty liver, diabetes mellitus, diabetes mellitus, And Taeumin are small, large, voided, small, and moist constitution, weak skin, lungs and respiratory tract, and cause atopy, allergic dermatitis, Rhinitis, bronchial asthma, urticaria and the like.

In addition, the obesity characteristics of Sooin are compared with other constitutions, weak gastrointestinal function, poor exercise capacity of the intestines, easy digestive disorders, constipation and diarrhea are often accompanied, the mean BMI is the lowest among constitutions, Korean obesity (dry obesity) often occurs due to lack of muscle mass due to insufficient metabolism. Therefore, there is a lot of drop in basal metabolism caused by the lack of muscle mass, and the most fragile constitution appeals to chronic fatigue due to weak physical strength. Decreased metabolic function due to low muscle mass is generally a constitution that affects most side effects (diarrhea, fatigue and other hypoglycemic symptoms) during dieting. It is constitutionally deficient in ovaries and blood circulation falls and hands and feet get cold and cold. . In the body type, the upper body is poor and the whole body looks dull, and relatively abdominal, thigh lower body obesity is high, and lower body edema is frequently appealed.

As for the Soyangin's obesity characteristics, the Soyangin is a typical pyknic constitution with spleen, large kidney, kidney and small digestive power, but it has poor control over stress, Gastritis due to binge eating, binge eating, and digestive disorders. Frequent eating of alcohol or frequent nightwash is prone to diseases such as reflux esophagitis and gastric ulcers. Digestion is good, but the excretion is not good and the probability of getting constipation is higher than other constitution. Mainly body fat is concentrated on the upper body and the lower body is weak, so degenerative diseases of the lumbar spine due to obesity and degenerative knee osteoarthritis may occur. The lower body is thin and the abdomen is swollen forward.

On the other hand, it is a great advantage and feature that the herbal preparation is manufactured in such a manner that it has various mixing ratios according to the degree of the constitution and the pathology of the patient, It is difficult to confirm the clinical efficacy of the extract as well as the yield of the extract is not constant, and it is inconvenient to eat because of the odor, bitter taste and excessive amount of herbal medicine after taking the medicine, There was a problem that the Chinese medicine preparation could not be used easily.

The present invention has been made in order to solve such a problem, and it is an object of the present invention to provide a method and an apparatus for determining the clinical efficacy of weight loss while using the same amount of medicinal materials as desired prescription, , It is possible to maintain the stability of herbal medicines by controlling the adverse reactions of the herbal medicines and to quantitatively and standardize the medicines according to the sickness medicine and the weight / The present invention provides a method for producing a tablet preparation for herbal medicine for obesity treatment (hereinafter, referred to as "persimmon tablets") that can be prescribed according to ideology medicine that can solve the problems of conventional herbal diets such as unusual odor, bitter taste, .

According to the embodiment of the present invention, the preparation method of herbal medicine for obesity treatment of herbal medicine is characterized in that the content of ephedrine of mahwang varying from 0.5 to 2.5% in the ephedrine content is 3.0 to 4.0% And determining a weight amount of the concentrated and quantified ephedrine powder concentrated and quantified to an ephedrine content of 3.0 to 4.0% according to the sasang medicine sieve, and determining the weight of the ephedrine powder based on the weight of the ephedrine powder Comprising the steps of: preparing an anti-adverse effect agent for each constitution to prevent or inhibit adverse effects caused by sasang medicine, and mixing the anti-adverse agent with the anti-adverse agent, and taking into account the weight, the degree of obesity, And a weight ratio of the antioxidants is different. The method according to claim 1, further comprising the steps of: preparing a mixture of the safflower powder and the anti-acid powder prepared as described above; And attaching a label containing the preparation contents.

When the ephedrine content is kept constant at 3 to 3.1%, the weight of the edible powder is about 360 g in the case of sunflower, 297 g in the case of the noise, and about 360 g in the case of soybean, and the weight The weight of the anti-obesity agent is about 9: 1 in the sun, 10: 1 in the noise, and 9: 1 in the soybean. The ephedrine content is 60-90 mg per day for normal weight, overweight, -12mg, moderate, 90-120mg for high-level obesity, and 130-140mg for tolerance, moderate, and high-level obesity.

The step of preparing a concentrated and quantified ephedrine powder having an ephedrine content of 3.0 to 4.0% is firstly quantified to be 7 brix by measuring the brix every 2 hours in a hydraulic transferring step, And secondly quantifying the data to be 30 to 35 by the Brix measurement every time,

The second quantification step may further include filtering the foreign substance with a sieve of 45-mesh scale. The step of preparing a mah-up powder concentrate and quantified to have an ephedrine content of 3.0 to 4.0% Freeze-drying at 30 to 35 Brix, wherein the freeze-drying is performed at a temperature of -30 to -40 ° C for 8 hours, and a drying condition is 30 to 40 ° C At a temperature of at least 60 hours, and measuring the ephedrine content of the freeze-dried paraffin powder, labeling the paraffin-free paraffin powder, and packing the freeze-dried paraffin powder and the anti- .

According to the embodiment of the present invention, the clinical efficacy of the weight loss can be confirmed, and the indicator component can be quantified for the first time in the herbal medicine ingredient of the diet, It is possible to maintain the safety of the treatment by controlling the adverse reaction at the same time as maintaining the stability. In addition, it is possible to shorten the treatment period to 3 months or less compared with other medicines or herbal medicines and quantitatively and quantitatively considering the constitution, weight, It is possible to prescribe according to the ideology medicine which can solve the problems of existing traditional Chinese medicine diet such as the customized treatment, the stable treatment rate by weight / obesity degree, inconvenience of taking the odor, bitter taste, It is possible to provide a method of manufacturing a tablet preparation for treating obesity of Chinese medicine.

FIG. 1 is a photograph of a tablet preparation for treating obesity of oriental medicine according to the embodiment of the present invention.

FIG. 2 is a graph showing a weight loss ratio after 3 months of tablet preparation for treating obesity according to the embodiment of the present invention.

FIG. 3 is a graph showing a change in body fat mass after three months of tablet preparation of herbal medicine for the treatment of obesity according to the embodiment of the present invention.

FIG. 4 is a graph showing an analysis of lipase inhibitory activity of a tablet preparation for treating obesity according to an embodiment of the present invention.

FIG. 5 is a flowchart showing a preparation method of a Chinese medicine for preventing obesity treatment of tablets according to the embodiment of the present invention and a method for producing an anti-adverse effect agent for each constitution.

FIG. 6 is a flowchart illustrating a method of preparing a tablet preparation for treating obesity according to an embodiment of the present invention.

FIGS. 7 to 9 are graphs showing the results of a comparison of the results of the experiments for preparing four kinds of mahwah which are different from each other in terms of mountain and gathering time in order to prepare a tablet preparation of herbal medicine obesity treatment tablet according to the embodiment of the present invention, Lt; RTI ID = 0.0 > ephedrine < / RTI >

FIGS. 10 and 11 illustrate the pattern relationship between brix and ephedrine contents in the preparation of a tablet preparation of herbal medicine for the treatment of obesity according to the embodiment of the present invention using the results shown in FIGS. 7 to 9 .

Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings so that those skilled in the art can easily carry out the present invention. The present invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. In order to clearly illustrate the present invention, parts not related to the description are omitted, and similar parts are denoted by like reference characters throughout the specification.

Throughout the specification, when an element is referred to as "comprising ", it means that it can include other elements as well, without excluding other elements unless specifically stated otherwise.

As shown in FIG. 1, the tablet preparation for treating obesity of obesity according to the embodiment of the present invention has hardness like the tablet preparation of the general tablets, and disintegrates rapidly without taking the burden when it is taken with water. It is 5.00 ± 30mm which is about half the size of regular rectangular tablet formulations and has a disintegration time of less than 30 minutes and has a hardness of about 12.0kp when it is applied on a large or rough surface due to the nature of herbal medicines. Respectively.

In order to constitute the tablet preparation for treating obesity of obesity according to the embodiment of the present invention according to the embodiment of the present invention, the following Experimental Example 1 was conducted on the patient 100 who visited the Oriental Medicine Clinic of the present applicant.

(Experimental Example 1)

In order to constitute a tablets preparation for treating obesity according to the embodiment of the present invention, the tablets of circles, rectangles, triangular shapes, square tablets, general size of tablets, Table 1 shows the results of questionnaire survey on the degree of hardness and the degree of hardness on the hand, as good, good, moderate, and poor, respectively, of less than 1/2 general size and 20 minutes, 30 minutes, 40 minutes, .

Table 1 is a table showing the results of survey on the size, disintegration degree, degree of hand appearance, and hardness of a tablet preparation for herbal medicine obesity treatable according to the embodiment of the present invention.

	Very good	good	usually	Poor
shape
Rectangle 7	Rectangle 17	Rectangle 34	42 people preferred different shapes
size	1/2 General size About 20	1/2 General size Accuracy 31	1/2 General size Accuracy 19	Prefer 30 sides to general size or 1/2 general size or less
Disintegration	Within 30 minutes 18	Within 30 minutes 23	Within 30 minutes 29	I prefer less than 20 minutes
Degree of hardness and hardness	It does not get buried in your hands and does not break well 17	It does not get buried in your hands and does not break easily 24	Not to be buried in your hands

As shown in Table 1, 58 out of 100 people in general had a preference for a rectangular shape, and the size was smaller than the general size or about half of the size was about 70 people, and the load hardness and disintegration It was found that 68 people prefered to hardness not to bite on the hand and hard to break even in the hardness and disintegration degree of general tablets formulation, and 70 people preferred to disintegrate into water within 30 minutes.

As a result, tablet preparations for treating obesity of obesity according to the embodiment of the present invention can be prescribed in a plastic container for one month with a rectangular tablet preparation, and they can be eaten with water after a meal, There is no concern about deterioration when exposed to air, the volume is not so large, the problem is that it stains at the hands by hand, and the problem is that when eating ordinary medicinal materials due to rapid disintegration without problems such as odor of herbal medicine, Problems and the like could be solved.

Meanwhile, the tablet preparation for herbal medicine for obesity which can be prescribed according to the embodiment of the present invention according to the embodiment of the present invention is characterized in that the content of ephedrine, which is a target substance (effective ingredient) To 4.0%. In order to alleviate the side effects of the safflower, the safflower safflower which achieved the stability of the efficacy with constant ephedrine content and the prescription of the safflower safflower, that is, safflower, taeeumin, And a disintegrating agent for providing hardness and disintegration time of the tablet preparation, wherein the weight ratio of the ephedrine powder to the anti-adverse effect agent for each constitution (hereinafter referred to as " To 10: 1 to 9 to 11: 1.

The efficacy and safety of ephedrine and ephedrine in the treatment of obesity were investigated in a study published in the September, 2017 issue of the Journal of the Korean Rheumatism Association. And the first double-blind placebo-controlled pilot study in adolescents ", which was published in the International Journal of Obesity, 2000, and published in the 2000 issue of the journal" Safety and efficacy of treatment with an ephedrine / caffeine mixture. " The effect of caffeine and caffeine on body weight gain was more pronounced in comparison to the control group, and in the international journal "Obesity", the 2013 paper "The Effect of Leptin, Caffeine / Ephedrine and Their Combination Upon Visceral Fat Mass Weight Loss. "During the 25 weeks of the study, the combined effect of ephedrine and leptin alone resulted in significant weight loss , There is the inconvenience of maintaining the prescribed six months in most cases appear to be such.

According to the embodiment of the present invention, the tablets of herbal medicine for the treatment of obesity can be administered at a dose of 240 mg / day for pseudoephedrine and 150 mg / day for ephedrine in the case of OTC medicines in the US FDA. If we lose 5% of body weight, we will recognize the efficacy of the medication. If we lose 10% of the weight, it will be a successful weight loss. Especially, weight loss of 5-10% In the Clinical Practice Guidelines of the Obesity Society of Korea, the goal of weight loss for obese patients is to aim for 5-10% reduction of initial body weight over 3-6 months, based on adults. Considering the US FDA approved ephedrine content 150 mg / day within 3 months.

In addition, the tablet preparation for herbal medicine for obesity according to the embodiment of the present invention, which is prescribable according to the embodiment of the present invention, has been shown to inhibit the lipase activity as the ephedrine content is increased as shown in Experimental Example 4, Possible ephedrine content for each constitution classified as noise, Soyangin, Taeumin, and Taenin within the range of 150mg / day of US FDA approved ephedrine, with proper weight loss effect within 3 months, The weight ratio of the anti-adverse agent can be determined.

First, the prescription of anti-adverse effect agents for each constitution to eliminate the side effects of each sulfuric acid according to each constitution medicine is as follows.

As shown in Table 2 below, the prescription of anti-adverse effect agents according to the constitution shows a pharmacological effect complementing the side effects caused by dietary constituents, , Korean Journal of Oriental Medicine, Korean Herbal Medicine, Journal of Korean Oriental Medical Preservation, and Theses.

Table 2 shows the side effects of Sasang Constitutional Medicine, the prescription of anti-adverse effect agents to prevent them, and the pharmacological effects of each medicinal substance.

Side effects by constitution	Anti-adverse effects by constitution	Pharmacological effect of each medicinal substance
Taeumin: skin, lung, respiratory weakness, atopy, allergic dermatitis, rhinitis, bronchial asthma, urticaria, etc.	Prevention of Side Effects by Constitutional Constituents: Taxa 1, Gakyung 1, Kang Geun 1, Seok Changpo 1, Dry Ratio 2, Nain 2, Nunja 1, Passer 1, Mush 2, Lunar 2	Gastrointestinal endocrine cell function regulation Anti-lipid, antioxidant, allergic anti-inflammatory anti-obesity effect
Soyangin: clinically caused constipation, acne, urinary inflammation, etc.	Prevention of Side Effects by Soyangin constitution Prescription powder: talc 2, gypsum 1, mint 1, gardenia 1, mold 1, rhubarb 1, ganache 1, sorghum 2,	Weight loss, improvement of lipid metabolism, increase of heat metabolism, improvement of constipation, inhibition of fat accumulation
Soothers: Dizziness, fatigue and other symptoms of hypoglycemia, the most complaints	Prevention of side effects according to the constitution of Sooin Ingredients Prescription: Ginseng 1, Hwanggi 2, Baekje 1, Broiler 1, Ginger 1, Baek Bokseong 1 Control 1, Sansa 1, Dip 1,	Immunopotentiating effect, cytoprotective effect against oxidative stress, hypoglycemic effect, anti-inflammatory effect, treatment of Atobi dermatitis, pain relief, sedation, parasympathetic effect in the intestinal tract, etc.

Experimental Example 2 shows that the maximum amount of ephedrine within the range of the US FDA 1-day ephedrine is kept constant at 2.8-3.3%, and the weight of the peroxidic acid by the constitution and the anti- We analyzed patients who visited our clinic during the year 2017 with different weight ratios. According to the analytical report of the patient who visited the Applicant's clinic during the year of 2017, the amount of the peroxide may vary depending on the collection time of the ephedra and the collection place, but when the ephedrine content is kept constant at 3.0 to 4.0% The weight ratio of the anti-adverse effect agent to each of the constituents was about 8 to 10: 1, 10 to 10: 1 for noise, 9 to 11: 1 for noise, 8 to 10 for soybean, 1, the amount of ephedrine was increased to 3.0, as shown in Table 3 and Table 4, when the weight loss ratio and adverse effects were analyzed in 278 patients who were re-visited after 3 months of composition according to each constitution. To 4.0%, which is the result of weight gain within the effective range of each constitution.

Table 3 is a table showing the results of experiments on the appropriate weight of peroxidic acid for each constitution of medical science.

Ma sulfate weight (g)	400	380	360	340	320	300	280
Taeumin	Weight loss side effect within effective range	Weight loss side effect within effective range	Weight loss side effect within effective range	Less effective weight loss	Less effective weight loss	Less effective weight loss	Less effective weight loss
Sooth	Weight loss side effect within effective range	Weight loss side effect within effective range	Weight loss side effect within effective range	Weight loss side effect within effective range	Weight loss side effect within effective range	Weight loss side effect within effective range	Less effective weight loss
Soyangin	Weight loss side effect within effective range	Weight loss side effect within effective range	Weight loss within the effective range	Less effective weight loss	Less effective weight loss	Less effective weight loss	Less effective weight loss

According to the results of Table 3, the weight of persulfuric acid showing weight reduction effect within the effective range by constitution when the ephedrine content was fixed to 3.0 to 4.0% was determined, and the weight of persulfuric acid Stability by constitution It is analyzed that it does not appease side effect by showing weight reduction within effective range by different weight of prevention of side effect according to constitution.If one of the patients who visited here complained side effect, And the weight reduction within the effective range means that the weight loss is less than 5% when measured after 3 months.

Table 4 shows weight loss and side effects of body weight reduction and prevention of side effects by constitution.

Prevent side effects by constitution Powder / Weight	20g	30g	40g	50g	60g	70g	80g
Taeumin / (Mt. sulfuric acid 360g)	The effective range appeals My Weight Loss Side Effects	The effective range appeals My Weight Loss Side Effects	Weight loss within the effective range	Less effective weight loss	Weight loss within the effective range	Less effective weight loss	Weight loss within the effective range
Soothers / (300g of hemp sulfuric acid)	The effective range appeals My Weight Loss Side Effects	Weight loss within the effective range	The effective range appeals My Weight Loss Side Effects	The effective range appeal in weight loss side effects below	The effective range appeal in weight loss side effects below	Weight loss within the effective range Side Effect appeal	Weight loss within the effective range
Soyangin / (360g of hemp sulfuric acid)	The effective range Appeal reduced my weight my weight loss side effects, adverse appealed effective range	Reduced my weight effective range of side effects appeals within the weight loss side effects complained effective range	Weight loss within effective range Weight loss within effective range	Weight loss under effective range Under weight range under effective range	Weight loss within the range of effect	Weight loss within range of effect	Weight loss within the range of effect

That is, in the case of Taeumin, the weight loss in the effective range was shown to 360 g of the magic sulfuric acid. However, when the ratio of the anti-adverse effect agent to the saccharide acid and the constitution was more than 8 to 10: 1, , And those who complained of side effects.

However, when the ratio of the anti-adverse effect agent to the anti-adverse effect of moxifloxacin is higher than 9 to 11: 1, the weight loss in the effective range may be lowered , And those who complained of side effects.

However, when the ratio of the anti-adverse effect agent to the anti-adverse effect of moxifloxacin is higher than 9 to 11: 1, the weight loss in the effective range may be lowered , And those who complained of side effects.

The height, initial weight, body fat mass and initial muscle mass of the patients who visited the oriental medicine clinic of the present applicant in 2017, which are used in Experimental Example 2 and shown in Table 3 and Table 4, are as follows.

Table 5 summarizes the information on the height, initial weight, initial exercise volume, and initial muscle mass of the patients in 2017.

Item	Average	Standard Deviation	Minimum value	Maximum value
Key (cm)	161.37	6.49	142.00	186.80
Initial weight (kg)	72.23	15.16	50.08	161.64
Initial body fat (kg)	28.12	8.82	12.60	67.86
Initial muscle mass (kg)	24.01	4.75	17.10	54.7

Taking each constitution into consideration, considering the weight ratio of the anti-adverse effect agent for constitutional sulfuric acid to the persulfate as in the case of Experimental Example 2, the tablet preparation for herbal medicine obesity treatment which can be prescribed according to prescribed medicinal medicine was applied for 3 months -12 weeks). As a result of analyzing the weight loss ratio of 278 persons, the average weight loss was 6.88 kg as shown in FIG. 2, and the difference was statistically significant (p-value = 0.000).

The success of weight loss in the treatment of obesity is defined as a reduction in body weight of 5-10%. The weight loss rate of this composition is reduced by an average of 9.37%, which is close to a successful weight loss in both medical and clinical aspects .

As shown in Table 6, 243 patients (87.4%) out of 278 patients lost more than 5% of their body weight, and 115 patients (41.4%) out of 278 patients had more than 10% of their body weight . Therefore, 87.4% (87 of 100 patients) of the patients who visited the Nubeyan clinic can lose more than 5% of their body weight.

 Table 6 is a table showing the weight loss percent distribution of patients in the present invention.

division	Number of patients	percent
More than 5% weight loss	243 people	87.4%
10% or more weight loss	115	41.4%

As shown in FIG. 3, when the initial body fat amount was compared with the body fat amount after 3 months, the body fat amount was averaged 5.77 kg, and the difference was statistically significant (p-value = 0.000). There was a mean decrease of 0.56 kg in muscle mass, which was also statistically significant (p-value = 0.000). However, the p-value is a probability value that is influenced by the sample size. When the sample size increases, the p-value tends to approach zero. In other words, it is necessary for the analyst to judge whether there is substantial significance in the difference of the result, not only the statistical significance, because it can result in a small difference in the data with a sufficient or large sample size. In muscle mass, the change of about 0.56kg was observed before and after the actual treatment, and the weight loss effect of our clinic is mainly originated from the effect of body fat loss. In addition, as shown in Table 7, the average body weight of the patients was 7.99% less than that of the first visit, and the average obesity was 9.89% less than the first visit. The composition has an effective weight loss effect even in normal body weight, but shows a successful weight loss particularly in obese subjects (including obesity and altitude obesity).

Table 7 is a table summarizing the weight loss percentages for obesity status of the patients in the present invention.

division	Weight Loss Percent
normal	Average 7.99% weight loss
Overweight	Average 8.02% reduction
obesity	Average 9.36% reduction
Altitude obesity	Average 9.89% reduction

In addition, as shown in Table 8, regardless of the degree of obesity, in the weight-based analysis, among the 278 patients, the number of patients of 50 kg was 39, the number of patients of 60 kg was 117, the number of patients of 70 kg was 66, The number of patients was 26, 90kg and 100kg or more, respectively. Table 8 shows weight loss by weight regardless of obesity.

weight	Average weight loss	Weight loss standard deviation	Average weight loss ratio	Weight loss ratio standard deviation
50kg stand	4.74kg	1.94kg	8.33%	3.35%
60kg stand	5.80kg	2.28kg	8.93%	3.46%
70kg stand	7.67kg	2.79kg	10.25%	3.55%
80kg stand	7.75kg	4.05kg	9.12%	4.77%
90kg stand	9.78kg	5.26 kg	10.37%	5.52%
100kg stand	12.89kg	4.84kg	11.06%	3.88%
Sum	6.87kg	3.51kg	9.37%	3.81%

As shown in Table 8, as the body weight increases from 50 kg to over 100 kg, the average weight loss also increases. However, in the mean weight loss ratio, the average weight loss rate of 70kg patients is 10.25%, which is higher than that of 80kg patients. The minimum and maximum weight loss ratios of 70kg patients were 3.27% and 20.96%, respectively. The minimum and maximum weight loss ratios of 80kg patients were -0.99% and 18.27%, respectively, and patients were reduced by 0.60%. The average weight loss rate increased to 9.89% except for patients with increased weight and patients with 0% of 80kg patients. Therefore, there was a patient with increased body weight in the 80 kg group, which may have affected the mean weight loss ratio. Based on the clinical data, the weight loss effect of the composition is close to a successful reduction in medical and clinical sense, Considering the time, rapid reduction is being achieved in a short period of 10 weeks compared to other drugs (herbal medicine, herbal medicine).

This is because, even in the process of compound preparation, it is possible to extract mahwang alone, to quantify the surface component to maintain the stability of the drug, to control the content of the surface component in consideration of body weight and obesity, And the duration of the treatment was reduced, which was conducive to the improvement of the cure rate.

Meanwhile, among the compositions of tablet preparations for treating obesity of obesity according to the embodiment of the present invention, in general, obesity is a sensitive problem in the case of taeeumin, and therefore, Lipase inhibition efficacy test.

(Experimental Example 4)

The measurement of lipase activity of tablets prepared with Taehumin Yong Sasang medicine was based on 4-dinitrophenyl butyrate as a substrate.

(0.5 mg / mL) was dissolved in 0.1 molar potassium phosphate buffer, and the lipase inhibitory potency of the herbal tablet for treating obesity treatment prescribed by Taeumin Injection Medicine was determined to be 0.04 %, 0.08%, 0.12%, 0.16%, and 0.2%, and the concentration was repeated 10 times per concentration.

0.4 mL of 4-dinitrophenylbutyrate solution was added to a mixed solution of 0.1 mL of the prepared pancreatic lipase solution and 0.1 mL of hypotonic M solution, 0.1 mL of 1 M Tris-HCl solution was added, and the mixture was incubated at 37 ° C. for 5 minutes .

The activity of the lipase was then determined by measuring the absorbance of the 4-dinitrophenol liberated by lipase with a spectrophotometer at 360 nm.

Experimental results were shown as relative values with Lipase as the control (100%). The results of the experiment were shown to be significant when the P value was 0.05% or less through the statistical program SPSS as shown in Table 9 and Table 10.

Table 9 shows the lipase activity raw data.

Table 10 is a table showing the lipase activity on Taeumin phosphorus tolerance.

density	Lipase activity
0.00%	100.20 ± 1.14
0.04%	102.50 ± 2.17
0.08%	91.05 ± 3.19
0.12%	84.51 + - 2.73
0.16%	82.44 + - 2.55
0.20%	80.48 + - 3.41

As shown in Table 10 and FIG. 4, the tablet preparation of herbal medicine for obesity which can be prescribed according to taeuminin medicine, showed significant lipase inhibition ability from 0.08% concentration and inhibited the lipase activity in the body and was ingested with fat diet It can also be used to lower the body fat utilization rate.

On the other hand, the patient's obesity (or BMI) and the composition of the composition according to the constitution can be standardized as shown in Table 11 by using the daily content of ephedrine from the results of the experiment on patients who visited the clinic.

Table 11 is a table showing the usage of tablets prepared by medicinal herbs according to their constitution. Here, tablets 1 to 4 represent the differentiation of herbal tablets treated with herbal medicine.

division	Ephedrine Content (1 day)	usage
Feeling 1	60-90 mg	Normal weight, overweight, early obesity
Feeling 2	80-120 mg	Overweight, obesity
Sense 3	90-120 mg	Moderate, high obesity
Detection 4	130-140 mg	Tolerance, moderate, high obesity

 5 to 11, a method of manufacturing a tablet preparation for obesity treatment according to an embodiment of the present invention will be described in detail with reference to FIGS. 5 to 11. FIG. 6 is a flowchart showing a method of manufacturing a tablet preparation for treating obesity according to the embodiment of the present invention. Fig. 6 is a flow chart showing a preparation method of a tablet preparation for treating obesity of obesity according to an embodiment of the present invention And FIGS. 7 to 9 are graphs showing the results of the comparison of the results of the comparison of the results of the present invention with those of the comparative tablets of the present invention. Figs. 10 and 11 are graphs showing the results of measurement of ephedrine content every two hours for each lot in Figs. 7 to 9 When possible prescription medicine for the treatment of obesity ephedra powders produced tablet formulation in accordance with the teachings medicine according to an embodiment of the present invention by using the results shown are graphs for explaining the relationship between the pattern and Blix ephedrine content.

7 to 9, the sequence 1 is the pseudoephedrine content and the sequence 2 is the ephedrine content%.

Although the method for preparing a tablet preparation for treating obesity according to the embodiment of the present invention is generally provided by various methods such as tablet, pill, powder, granule preparation, concentrated liquid formulation and distillation agent for herbal medicine, These problems are solved by considering the fact that they are not suitable as a therapeutic agent for obesity, such as giving a unique smell of herbal preparation, bitter taste, tackiness, and unsatisfactory feeling due to excessive amount, The present invention provides a tablet preparation for obesity treatment which can be prescribed according to the ideological medicine so as to achieve the therapeutic effect of obesity without side effects according to the constitution by constitution.

First, as shown in FIG. 7 and Table 12, the content of ephedrine is 0.185 in China and 0.360 in Pakistan, while the content of ephedrine is 0.09% and 0.18% Almost double the difference between 2.8 ~ 3.3% that can treat obesity within 3 months as well as the day can not be reached is not too far.

 Table 12 shows the data on the four spawes of different production and sampling periods.

Extraction time	Experimental material	origin	Extract liquid weight						Briggs		Total alkaloid
			Vessel	Raw material	Total weight	Extract weight	Extraction rate	Average	Measure	Average	Pseudoephedrine	Ephedrine	dose	Quantitative average	Extraction amount sum correction	Extraction amount sum correction average
6hr	S1-1	China Spring	174.73	30.00	313.02	108.29	36.1%	136.40	6.4%	5.5%	0.04%	0.14%	0.18%	0.15%	0.28%	0.27%
	S1-2		176.00	30.00	324.15	118.15	39.4%		6.1%		0.03%	0.13%	0.16%		0.26%
	S1-3		181.65	30.00	343.16	131.51	43.8%		5.3%		0.03%	0.12%	0.15%		0.27%
	S1-4		189.65	30.00	354.27	134.62	44.9%		5.2%		0.03%	0.12%	0.15%		0.27%
	S1-5		172.79	30.00	346.64	143.85	48.0%		4.8%		0.03%	0.11%	0.14%		0.27%
	S1-6		146.20	30.00	265.85	89.65	29.9%		8.3%		0.04%	0.18%	0.22%		0.31%
	S1-7		174.74	30.00	369.29	164.55	54.9%		4.4%		0.03%	0.10%	0.13%		0.29%
	S1-8		176.02	30.00	333.31	127.29	42.4%		5.6%		0.03%	0.12%	0.15%		0.26%
	S1-9		181.65	30.00	376.73	165.08	55.0%		4.6%		0.02%	0.10%	0.12%		0.27%
	S1-10		189.65	30.00	400.67	181.02	60.3%		4.0%		0.02%	0.08%	0.10%		0.25%
	S2-1	Chinese Autumn	172.80	30.00	378.30	175.50	58.5%	164.77	3.8%	4.1%	0.04%	0.07%	0.11%	0.12%	0.27%	0.26%
	S2-2		146.19	30.00	336.60	160.41	53.5%		4.1%		0.04%	0.08%	0.12%		0.26%
	S2-3		174.74	30.00	355.28	150.54	50.2%		4.5%		0.03%	0.07%	0.10%		0.20%
	S2-4		176.01	30.00	397.11	191.10	63.7%		3.5%		0.03%	0.07%	0.10%		0.28%
	S2-5		181.67	30.00	388.45	176.78	58.9%		3.8%		0.03%	0.07%	0.10%		0.24%
	S2-6		189.66	30.00	373.35	153.69	51.2%		4.3%		0.04%	0.09%	0.13%		0.27%
	S2-7		172.87	30.00	415.24	212.37	70.8%		3.2%		0.03%	0.07%	0.10%		0.34%
	S2-8		146.18	30.00	317.20	141.02	47.0%		4.6%		0.05%	0.09%	0.14%		0.26%
	S2-9		174.74	30.00	372.42	167.68	55.9%		3.9%		0.04%	0.08%	0.12%		0.27%
	S2-10		176.00	30.00	324.61	118.61	39.5%		5.2%		0.05%	0.10%	0.15%		0.25%
	S3-1	Pakistan	181.64	30.00	357.51	145.87	48.6%	160.64	6.0%	5.8%	0.04%	0.18%	0.22%	0.24%	0.43%	0.53%
	S3-2		189.64	30.00	317.80	98.16	32.7%		8.1%		0.05%	0.27%	0.32%		0.48%
	S3-3		172.80	30.00	299.95	97.15	32.4%		8.2%		0.05%	0.29%	0.34%		0.50%
	S3-4		146.19	30.00	299.02	122.83	40.9%		7.0%		0.06%	0.25%	0.31%		0.52%
	S3-5		174.73	30.00	411.89	207.16	69.1%		4.3%		0.03%	0.16%	0.19%		0.61%
	S3-6		176.01	30.00	415.79	209.78	69.9%		4.2%		0.03%	0.15%	0.18%		0.60%
	S3-7		181.66	30.00	354.54	142.88	47.6%		6.1%		0.04%	0.22%	0.26%		0.50%
	S3-8		189.64	30.00	428.12	208.48	69.5%		4.4%		0.04%	0.15%	0.19%		0.62%
	S3-9		172.79	30.00	398.96	196.17	65.4%		4.5%		0.03%	0.15%	0.18%		0.52%
	S3-10		146.18	30.00	354.08	177.90	59.3%		5.0%		0.03%	0.17%	0.20%		0.49%
	S4-1	Kyrgyzstan	174.75	30.00	347.54	142.79	47.6%	123.90	6.2%	7.0%	0.02%	0.19%	0.22%	0.24%	0.42%	0.41%
	S4-2		182.70	30.00	332.59	119.89	40.0%		7.2%		0.03%	0.22%	0.32%		0.53%
	S4-3		168.83	30.00	290.56	91.73	30.6%		9.2%		0.04%	0.26%	0.34%		0.49%
	S4-4		186.91	30.00	329.61	112.70	37.6%		7.7%		0.03%	0.23%	0.31%		0.50%
	S4-5		179.74	30.00	327.90	118.16	39.4%		7.2%		0.03%	0.22%	0.19%		0.31%
	S4-6		146.19	30.00	326.11	149.92	50.0%		5.8%		0.02%	0.17%	0.18%		0.36%
	S4-7		174.73	30.00	338.70	133.97	44.7%		6.3%		0.02%	0.20%	0.26%		0.47%
	S4-8		182.69	30.00	316.97	104.28	34.8%		7.5%		0.03%	0.23%	0.19%		0.29%
	S4-9		168.82	30.00	320.16	121.34	40.4%		7.0%		0.03%	0.21%	0.18%		0.30%
	S4-10		186.90	30.00	361.13	144.23	48.1%		6.1%		0.02%	0.19%	0.20%		0.39%

Therefore, in order to extract ephedrine, which is an effective ingredient of the tablet preparation for obesity treatment which can be prescribed according to the embodiment of the present invention according to the embodiment of the present invention, from the natural ingredient, mahwang, it is necessary to concentrate and quantify the active ingredient.

Here, quantification is used to maintain the ephedrine content of ma sulfuric acid at a constant value, and the glycosidic meter Brix is used. Brix is precisely Brix%, which indicates the amount of solute dissolved in the aqueous solution in%, which is a soluble solid. The higher the Bricks, the higher the soluble solids contained in the salt, protein and acid as well as the sugar content This means that a very widely used brix can be measured and used as a measure of the proportion of ephedrine content.

To this end, a method for preparing an anti-adverse agent according to the present invention for treating obesity tablet tablets and an anti-adverse effect agent for constitution according to the present invention is described in Table 2, (S10). Subsequently, during the hydrotreating step, the epifentin, which is an active ingredient, is first concentrated and quantitated (S20) by measuring the brix.

The hydraulic transfer process is performed by applying hydraulic pressure to facilitate the transfer of water. Generally, after washing with water, it is added to water at a temperature of 10 to 20 DEG C for about 15 to 20 hours (S21), the respective components are boiled at a temperature of 95 to 100 DEG C for 4 to 5 hours to extract an extract having a high yield (S21), and a blix is measured for each heating time (S23) brix (S24). If the brix of the extracted liquid is not 7 brix or more, the heating time is increased. If the brix of the extracted liquid is 7 brix or more, the foreign matter is filtered using a 100 mesh nanofilter (S25). In order to prevent microorganisms, the mixture is kept cooled to 40 to 50 DEG C and stored with stirring to prevent precipitation of solid content (S26).

In a method for preparing an anti-adverse agent for arthritis and an anti-adverse effect agent according to the present invention, ephedrine is firstly quantified to 7 brix or more using a hydraulic transferring process As shown in Figs. 10 and 11, the brix was increased by the heating time of the hydrotreating process, but the ephedrine content of mahwang was about 7 brix , It is not necessary to use unnecessary energy in a situation where the yield of the effective component is kept constant to some extent.

 (Experimental Example 5)

The measurement of the brix in the hydraulic transfer process and the measurement of the content of ephedrine in each brix were carried out as follows.

S4 (Chinese, Spring), S2 (Chinese, Autumn), S3 (Pakistan), S4 (Chinese, Spring) Kyrgyzstan), the same specimen was divided into 10 batches. The extraction conditions were 10 times of the weight of the experimental material, and the extract was made in 2 hours from 100 ℃ after heating. The total amount of alkaloids and ephedrine was measured by HPLC and Shimadzu 20-A series. The total amount of alkaloids and ephedrine was measured using a Brix analyzer (Refractometer, ATAGO PAL-1) .

[Quantitative Test]

Measured as total alkaloid [ephedrine (C10H15NO: 165.23) and pseudoephedrine (C10H15NO: 165.23)]. Approximately 50 mg of standard solution: ephedrine hydrochloride standard product (preliminarily dried at 105 ° C for 3 hours) 2) to make exactly 20 mL. Take exactly 2 mL of this solution and add diluted methanol (1 → 2) to make exactly 100 mL.

Test solution: About 5 mL of the extract is precisely weighed into a centrifuge tube with stopper, 20 mL of diluted methanol (1 → 2) is added, shaken for 30 minutes, and centrifuged to take the supernatant

Next, in order to keep each of the materials at a constant concentration, the mixture is boiled at a temperature of 95 to 100 ° C., and extracted until the concentration reaches 7 to 10 brix, and then quantified. Repeat this procedure twice with 20 mL of diluted methanol (1 → 2) in the residue. Add the diluted methanol (1 → 2) together to make exactly 100 mL.

Detector: ultraviolet absorbance photometer (measuring wavelength 210 nm)

Column: A 5 to 10 μm octadecylsilyl silica gel for liquid chromatography is filled in a stainless steel pipe having an inner diameter of 4 to 6 mm and a length of 15 to 20 cm

Constant temperature around 45 ° C

Mobile phase: Sodium lauryl sulfate solution (1 → 128) * Acetonitrile * Phosphoric acid mixture (640: 360: 1)

The results are shown in Tables 13 and 14.

Brix (% Brix)	2 hr	4hr	6hr
China (Spring)	3.30	4.30	5.50
China (fall)	3.00	3.80	4.10
Pakistan	4.10	5.10	5.80
Kyrgyzstan	3.60	5.30	7.00

Total alkaloid (%)	2 hr	4hr	6hr
China (Spring)	0.28	0.26	0.27
China (fall)	0.32	0.26	0.26
Pakistan	0.55	0.67	0.53
Kyrgyzstan	0.44	0.46	0.41

As can be seen in Tables 13 and 14, the hydraulic transfer process is still insufficient to make the ephedrine content of about 3% to 4%, even at 7 brix, on the average of about 0.41% In this case, it is known that the active ingredient such as ephedrine is destroyed. Therefore, second ephedrine concentration extraction and quantification are performed using a vacuum low-temperature concentration process (S30).

 In order to concentrate the extraction liquid extracted during the hydrotreating process to a high concentration and then concentrate while increasing the concentration while lowering the heating temperature in a vacuum state, the extract is vacuum-reduced at a low pressure of 08 to 09 bar and a condensation temperature of 50 to 55 ° C And concentrated for 5 to 6 hours.

Meanwhile, at this time, the concentration is made constant by using Brix, and the concentrate is quantitatively obtained by secondarily determining the concentration of each material to be 30 to 35 brix.

Here, in order to increase the ephedrine content and increase the concentration of the ephedrine, it is judged whether the concentration of the magenta concentrate is 30 to 35 brix or not by using the Brix densitometer because the increase in the brix according to the vacuum decompression The total alkaloid-corrected average content was also increased. However, it was found that crystals occurred in the case of 10 to 20 blox during freeze-drying, and the ephedrine content was influenced by temperature and pressure rather than 40-blox.

In addition, although it can be concentrated to 30 brix through the hydraulic transfer process, in this case, as described above, the content of ephedrine is reduced rather than heat and the concentration time is increased by 2 to 3 times more.

Table 15 summarizes the problems that occur when increasing the brix through the hydraulic transfer process.

	10brix	20brix	30brix	40brix	50brix
Total alkaloid correction Average content%	1.1%	1.9%	2.8%	3.5%	5%
problem	Crystallization during freeze-drying	Crystallization during freeze-drying	Effective ephedrine content close	Reduction of ephedrine content (temperature, pressure effect)	Reduction of ephedrine content (temperature, pressure effect)

The concentration of ephedrine is secondarily quantified by the vacuum low-temperature concentration process, quantified, and the concentrates obtained by mixing and concentrating the concentrates differing by lot arrangement are subjected to freeze-drying (S40). Freeze-drying is performed by freezing the sample, Is a drying method that removes water by using only the property of sublimation of water, and it is easy to absorb moisture, including a large number of dried materials, rather than simple hot air drying, wind drying and high temperature drying There is an advantage that re-hydration can be easily performed completely.

Therefore, according to the embodiment of the present invention, the tablet preparation for obesity treatment prescribed by the constitution has an effect of disintegrating within 30 minutes when taken along with water.

 On the other hand, even in the case of the concentrated concentrated raffinate of 30 to 35 brix, the content of ephedrine, the active ingredient of the concentrated raffinate, may be lowered depending on the freezing temperature and the freezing time. %, Respectively.

The concentration of 2.8% ephedrine concentrated in the secondary quantification was divided into a 3000 ml tray of the freeze dryer, and the content of ephedrine was measured by varying the temperature and the freezing time, and is shown in Table 16.

Table 16 shows the% change in ephedrine content by freezing temperature and time.

Temperature (℃)	-0 to -10 ° C	-10 to -20 ° C	-20 to -30 ° C	-30 to -40 ° C	-40 to -50 ° C	-50 to -60 ° C
Time (h)	18 hours	14 hours	10 hours	8 hours	5 hours	3 hours
Total alkaloid corrected average content	2.8%	2.78%	2.77%	2.8%	2.5%	2.41%

As a result of the above test, it was considered that the freezing time at the temperature of -40 to -50 ° C would be appropriate in terms of the time of 3 to 5 hours. However, in order to maintain the total alkaloid corrected average content, ie, ephedrine content, It is suitable to freeze at -30 to -40 占 폚 for 8 hours which can be maintained within the range.

Then, drying was proceeded, and in order to preserve the% of ephedrine, the drying temperature, the pressure and the time were experimented and shown in Table 17.

Table 17 shows the% change in ephedrine content according to the drying conditions.

Item	01	02	03	04	05	06	07
Temperature (℃)	-30	-20	-10	0	10	20	30
Pressure (mb)	50	50	50	5	5	0	0
Time (h)	12 hours	18 hours	24 hours	28 hours	32 hours	48 hours	60 hours
Total alkaloid corrected average content	2.31%	2.50%	2.52%	2.55%	2.56%	2.6%	2.81%

As can be seen from Table 17, the freezing conditions were a temperature of -30 to -40 ° C. and a freezing time of 8 hours. The drying conditions were as follows: 30 to 40 ° C., Was effectively preserved as it was, and a mahjong powder having high concentration and yield was obtained.

The lyophilized phase dried in the lyophilization process (S40) is pulverized to prepare a powder having a size of 40 to 45 mesh, and sieved (sieved) with a sieve having a size of 40 to 45 mesh to sort the pulverized powdery medicines to a predetermined size (S50) .

The ephedrine content of the thus-manufactured powder of the magpatin powder of a predetermined size (S60) is measured (S60), and a certain amount of the magenta powder preparation and the herbal medicine powder for each side effect preventing powder are packed in a sealed bag (S70).

Now, referring to FIG. 6, a method of manufacturing a tablet preparation for obesity treatment that can be prescribed according to the constitutional medicine according to an embodiment of the present invention will be described.

In a method of manufacturing a tablet preparation for obesity treatment according to the embodiment of the present invention, the antiepileptic agent and the anti-adverse agent according to the constitution are weighed and mixed according to the ephedrine content of the ephedrine powder (S110).

At this time, the prescription is confirmed by referring to the list of the patient's body weight, obesity degree, sickness constitution, side effects, etc. (S120), and when the prescription needs to be corrected, the amount of epididymal body, The amount of the inhibitor is modified within a range of 8 to 10: 1 to 9 to 11: 1 (S121).

When the prescription is confirmed by referring to the list of the patient's body weight, obesity degree, sickness constitution, side effects, etc., when the prescription is not necessary, disintegrant or croscarmellose sodium, microcrystalline cellulose, magnesium stearate (S130) as shown in FIG. 1, and the tablet is sized to have a thickness of 590. + -. 010 mm, a diameter of 176. + -. 020 mm, and a weight of 646 mg. + -. 50% as shown in FIG.

After the tableting process (S130), the coating liquid is mounted on the sprayer fixing frame so as to prevent the active ingredient from being broken when exposed to air, and the liquid control nozzle of each sprayer is opened. The pressure of the liquid pump is adjusted to 1 to 2 bar And the initial liquid is flowed for about 3 minutes. Then, the pressure and the amount of the liquid pump are adjusted and coated (S140).

Coating conditions are 2 ~ 7 rpm rotation speed of 60 ~ 250 ml / min with pressure of 5 ~ 6 kg / ㎠ at 12 Fmm nozzle size.

Coated with the coating solution, and then cooled and dried at 25 to 30 ° C for 20 minutes while rotating at a low speed. The defective products were selected, packed in a container for 90 days in order to be eaten three times a day for 3 months, Attach the label on which the prescription is recorded, such as percentage of content and constitution.

(Experimental Example 6)

In order to determine whether the tablet preparation for obesity treatment of herbal medicine prepared by the preparation method of herbal medicine for obesity treatment according to the embodiment of the present invention is effective for decreasing obesity, 93 subjects were given 10 days or 5 After one minute, the effect of inhibiting appetite, convenience of taking, absorption rate and preference were confirmed.

There was a difference in the contents of medicines according to sasang constitution, but the results of the present invention were not confirmed.

(Experimental Method)

(1) no effect on appetite suppression after three months of use, no, normal, excellent

(2) In order to confirm the convenience of taking, it was confirmed that there was no convenience, normal, and very good for those who ingested the traditional hotpot or capsule.

(3) In order to confirm the absorption rate, it was confirmed that there was no convenience, normal, and very good for those who ingested conventional hotpot or capsule.

(4) In order to confirm the overall preference, four types of preference were selected: none, normal, and excellent.

Since the composition of tablets made by oriental medicines according to the embodiment of the present invention is mainly for body fat loss, it has clinical efficacy of weight loss according to sasang constitution, We will first examine whether there is a clinical effect of weight loss without side effects.

Table 18 shows the results of the clinical efficacy evaluation for the taeumin.

	An appetite-suppressing effect	convenience	Absorption rate	preference
Very good	39	64	51	50
has exist	30	39	38	27
usually	19	0	3	5
Not at all	5	0	One	One
system	93	93	93	93

As shown in Table 18, 74% of the 93 patients were effective in inhibiting the appetite. The convenience was 93%, and the absorption rate was improved to 95% Therefore, the tablet preparation for treating obesity according to the embodiment of the present invention according to the embodiment of the present invention and the preparation method thereof are more convenient than the other methods of taking the traditional herbal medicine, and the preference And the absorption rate was improved, and it was confirmed that the medicament according to Example 6 had an appetite suppressing effect.

The tablet preparation for treating obesity of obesity according to the embodiment of the present invention and the method of preparing the herbal medicine according to the embodiment of the present invention are particularly effective for the herbal medicine even if the same disease is different according to the constitution and degree of pathology, It is possible to provide the convenience and effective effect of the person who ingests it by increasing the yield of the active ingredient and quantifying it.

In addition, the tablet preparation for herbal medicine for the treatment of obesity according to the embodiment of the present invention and the preparation method thereof can provide a medicine with lower stability, which is more convenient to take and can absorb quickly.

It will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention as defined by the appended claims.

Claims (7)

1. Producing ephedrine powder having concentration of ephedrine of ephedrine varying from 0.5% to 2.5% depending on the origin and gathering time to have an ephedrine content of 3.0 to 4.0%

   The amount of ephedrine is adjusted to a concentration of 3.0 ~ 4.0%, and the weight of ephedrine powder is determined according to the epidemiological constitution of the ephedrine powder, and the amount of the ephedrine powder is determined to prevent or suppress side effects according to the epidemiological constitution Comprising the steps of:

   Mixing the safflower sauce with the safflower at different weight ratios of the safflower sauce and the safflower sauce taking into account the weight, the degree of obesity, the sausage medicine, and side effects;

   Subjecting the mixed powder of the prepared magenta powder and the anti-oxidant to the prepared powder,

   A post-tableting step,

   The method according to claim 1, wherein the method comprises the steps of selecting and packaging defects after the coating step, and displaying labeling including the weight, obesity, medicinal qualities, and preparations according to side effects. Way.
2. The method according to claim 1,

   When the ephedrine content is kept constant at 3 to 4%, the weight of the ephedrine powder is about 360 g in the case of sunflower, 297 g in the case of noise and about 360 g in case of Soyangin, and the weight Wherein the weight ratio of the anti-obesity agent is 8 to 10: 1 for the sun, 9 to 11: 1 for the noise, and 8 to 10: 1 for the soybean.
3. The method according to claim 1,

   The above-mentioned ephedrine content can be determined on the basis of one day on the basis of normal weight, overweight, 60 to 90 mg against the initial obesity, overweight, obesity to 80 to 12 mg, moderate to severe obesity, 90 to 120 mg, tolerance, moderate, A method for preparing a tablet preparation for obesity treatment of Chinese herbal medicine which can be prescribed according to Sasang Medicine, which is standardized at 140 mg.
4. The method according to claim 1,

   The step of preparing a concentrated and quantified ephedrine acid concentrate having an ephedrine content of 3.0 to 4.0% is firstly quantified to be 7 to 8 by a brix measurement every 2 hours in a hydraulic transfer bath,

   And a second step of quantitatively quantifying the compound to be 30 to 35 brix by measuring the brix every 2 hours in a low-temperature vacuum concentration step.
5. 5. The method of claim 4,

   Further comprising the step of filtering the foreign substance with a sieve of 45 mesh scale after the second quantification step.
6. 5. The method of claim 4,

   The step of preparing the concentrated and quantified ephedrine concentrate to have an ephedrine content of 3.0 to 4.0% may further comprise lyophilizing the secondary quantified ephedrine powder of 30 to 35 brix,

   During the freeze-drying, the freezing condition is a temperature of -30 to -40 ° C, a freezing time of 8 hours, a drying condition of 30 to 40 ° C, a minimum of 60 hours or more, A method of manufacturing a therapeutic tablet formulation.
7. The method according to claim 6,

   A method of labeling and labeling the ephedrine content of the freeze-dried parvovirus acid powder, and packaging the freeze-dried parvovirus acid powder and the side effect-preventing acidic agent by a certain amount in an airtight manner.

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