JP6708916B1 - Zhuang family pharmaceutical composition for regulating replenishment and method for preparing the same - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a Zhuang family pharmaceutical composition for respiration/psychoregulation and a method for preparing the same. The present invention discloses a Zhiwan pharmaceutical composition for relieving and psychological disorders, wherein the composition comprises 10 to 60 parts by weight of Oukato Suiren, 10 to 50 parts by weight of Baotoku, and 10 to 40 parts by weight of Gaikyou-ketsu. , 10 to 30 parts by weight, Nikkei 5 to 20 parts by weight, Shishi 10 to 25 parts by weight, Rhododendron 10 to 25 parts by weight, and Kyoukyo to 10 to 30 parts by weight, and a preparation method is also provided. Advantageous effects of the present invention are as follows. INDUSTRIAL APPLICABILITY The present invention has a clear effect of adjusting the flow of qi to improve the state of imagination, preparing the dragon road, the fire tract, mental depression, debilitating spirit, physical and physical fatigue, and apathy. Provide a Zhiwan pharmaceutical composition for aspiration/psychoregulation that improves symptoms such as vergence and low breathiness, and provides a method for preparing the composition, which is easy to operate and has sufficient efficacy of a crude drug. Can be demonstrated to. [Selection diagram] None

Description

TECHNICAL FIELD The present invention belongs to the field of ethnic medicine, and specifically relates to a Zhuang family pharmaceutical composition for aspiration and psychoregulation and a method for preparing the same.

Zhuang medicines, which are an important part of ethnic medicines, have long been an effective means for the prevention and treatment of diseases in Zhuang and have played an important role in the physical health and survival development of Zhuang. According to Zhuang medicine, the human body is an organic whole, whose constituent parts are closely related and indivisible. Human body "Takumi" (top), "Corridor" (human part), "Torso" (ground), three parts, three ways (valley, airway, water supply), both roads (long road, fire road), internal organs , And “deprivation” (bone), “acceptance” (flesh), “lie” (ki), “bule” (blood), etc. are all related, interacting, functioning in synchronization with the natural world, and being constrained. It also undergoes metaplasia, and changes life and death repeatedly. If your body isn't sane enough,
Poisons, scorpions, poisons, and other toxic invades through dragons and fires, causing poor flow in the water supply, valleys, and respiratory tracts, imbalance in visceral bone and meat, or insufficient nutrition. , If the three spirits of the heavenly land are broken together, they are more likely to suffer from various diseases. For the treatment of diseases, Zhuang medicine emphasizes investigating the etiology, mainly focuses on diagnosis of diseases, and often applies appropriate prescriptions and appropriate herbal medicines. Is one of the main features of. Zhuang medicine has accumulated a wealth of experience in the treatment of gynecological diseases, and some of the unique methods of Zhuang medicine, the prescription of Zhuang medicine, have achieved clinically good results.

According to Zhuang medicine, "lie" (ki) is very important, "lie" (ki) is positive, "lie" (ki) is power, and "lie" (ki) is function. Yes, it is an expression of the power of the body's life. "Lie within" (mind) is caused mainly by the following causes. 1.Premature delivery or postpartum due to poor natural constitution, weak parents' parents, poor nutritional balance during pregnancy, or improper rhythm of life or work of pregnant women Inadequate care and malnutrition. Second, the patient suffers from acquired overwork, exhaustion of energy, physical weakness, or chronic illness and cannot be cured for a long period of time. Inappropriate diet, such as spicy food, cold food, sweet food or greasy food more than necessary, or excessive drinking, causing damage to the valley and accepting or digesting it. , Causes a decline in absorption function and cannot be ingested sufficiently or digests and absorbs subtle nutrients derived from water and cereals and cannot be converted into mood. Insufficient energy will result in impaired energy, resulting in mental disorders, divorce, and symptoms such as mental and physical fatigue, snoring, and low voice. Therefore, in particular, it adjusts the flow of qi to improve the state of emptiness, prepares the dragon road, the fire tract, and also has mental disorders, both spirits and spirits, mental/physical fatigue, snoring, and low voice. It is very important to develop a drug that can significantly improve such symptoms.

The technical problem to be solved by the present invention is to adjust the flow of qi to improve the state of imagination, and to prepare dragon roads and fire routes, and to prevent mental disorders, enthusiasm, and mental It is an object of the present invention to provide a Zhuang family pharmaceutical composition for scavenging/psychoregulation and a method for preparing the same, which improves symptoms such as physical fatigue, snoring, and low breathing.

The present invention solves the above technical problems by the following technical solutions.

A Qiwan family pharmaceutical composition for replenishment/psychotherapy, which comprises 10 to 60 parts by weight of Oukatousuren, 10 to 50 parts by weight of banana, 10 to 40 parts by weight of gall butter, 10 to 30 parts by weight of nickname, 5 to 20 parts of nikkei. Parts, 10 to 25 parts by weight of shishi, 10 to 25 parts by weight of persimmon, and 10 to 30 parts by weight of persimmon.

Further, in the above-mentioned replenishment/psychoregulatory Zhuang family pharmaceutical composition, the composition comprises 40 parts by weight of Oukatousuiren, 40 parts by weight of Bakuroku, 20 parts by weight of Gaikyo butts, 20 parts by weight of Nikkai, 10 parts by weight of Nikkei, 20 of shishi. It is prepared by using the raw materials of 20 parts by weight, 20 parts by weight of kyoko and 20 parts by weight of kyokyo. In the method for preparing a decoction of the present invention, the above-mentioned raw materials are weighed according to weight, washed and selected, put in a pot, and water is added and immersed for 0.5 to 1 hour to boil the drug solution. After decocting over high heat, switch to low heat and decoct for 20-25 minutes, filter the decoction, and add water at room temperature again 0.5-1 cm above the plane of the crude drug, After decocting on high heat until boiling, switch to low heat and decoct for 15 to 20 minutes, and include a secondary decoction step of filtering the decoction and a step of combining the primary decoction and the decoction obtained from the secondary decoction. ..

A second object of the present invention is to provide a method for preparing the above-mentioned medicinal composition for replenishment/psychotherapy Zhuang family, in which water is added 10 times to a raw material to be weighed in parts by weight, and 1 time is added to each time. Decoction 3 times per hour, filter and concentrate, dry under reduced pressure at 80°C, crush and sieve through a 100 mesh screen, add sucrose to the dry paste powder, mix evenly, and use 75% ethanol to make a soft material. (Ethanol usage 8%), stir for 15 min, granulate with a 12 mesh sieve, dry at 75°C for 4 h, sieving with a 12 mesh sieve, uniformly mix with a mixer, package and package. ..

Further, in the above-mentioned method for preparing a Zhuang pharmaceutical composition for insufflation/psychotherapy, the dosage form of the Zhuang pharmaceutical composition is a decoction.

The characteristics of the raw materials contained in the Zhuang medicine and the herbal composition according to the present invention are as follows.

Oukatousuiren: Zhuang medicine name is Gosinhvahenj, which is derived from the roots or whole strains of Polygala aureocauda Dunn, which is a plant of the family Hemelaceae. Taste: sweet, slightly warm. Efficacy: Improves the state of emptiness and regulates the flow of qi, removes the cold and expels toxins, promotes blood flow and stops bleeding. Main cure: Weakness after illness, postpartum blood loss, splenic hydrops, wind and wet bone pain, seasonal rib pain, bruising, vaginal bleeding, traumatic bleeding, etc.

Hakutoku: The name of the Zhuang medicine is Raethozduzlingz, which is derived from the fruiting body of the fungus Hericium erinaceus (Bull:Fr) Pers, which is a fungus in the family Ganoderma lucidum. Taste: sweet, flat. Efficacy: Improve the imaginary state by adjusting the valley and adjusting the flow of energy. Chief: Eating dysphoria, timidness, blood deficiency, etc.

Ginkgo citrus: The Zhuang family medicine name is yazgyangghez, and it is derived from the rhizome of Pseudodrynaria coronans (Wall.) Ching. Taste: bitter, fever. Efficacy: Improves the function of the kidneys, strengthens the muscles and bones, prepares the dragon road, and stops pain. Main cause: Excretion, low back pain, wind and bone pain, wind and toothache.

Pleurotus chinensis: The Zhuang family medicine name is Gaekdinbit, and the Asteraceae plant Artemisia lactiflora Wall. ex DC. Derived from the whole plant. Taste: Spicy, bitter, fever. Efficacy: Cleans the valley and removes the poison. Main cure: Menstrual pain, amenorrhea, gastric pain, chronic gastritis, hepatosplenomegaly, eating swelling, excretion, hernia, roots, bruises, burns and burns.

Nikkei: The name of the Zhuang family is Naengigveq, which is derived from the stem bark of the camphoraceous plant Cinnamomum cassia Presl. Taste: Spicy, sweet, heat. Efficacy: Prepare the water supply, improve the condition of emptiness and remove the cold. Main cures: Qi deficiency, blood deficiency, atrophy, gonorrhoea, cold red feet, dizziness and tinnitus, erosion of the tongue, gastric pain, excoriation, back pain, amenorrhea, menstrual pain, malignant ulcers, and phlegm.

Shishi: The name of the Zhuang family medicine is Ganoderma, and the porosomycete fungus Ganoderma sinenzin Zhao. It is derived from the fruiting body of Xu et zhang. Taste: sweet, flat. Efficacy: Ryoji and valley roads are arranged to adjust the flow of energy and improve the state of imagination. Main cure: Qi, blood, insomnia, dizziness, cough, asthma, etc.

Shakyo: The Zhuang medicine name is Sagieng, which is derived from the rhizome of the ginger family Kaempferia galangal. Taste: Spicy, fever. Efficacy: Removes wet poison, prepares valleys and stops pain. Main cure: Stomach pain, vomiting, excoriation, cholera, eating sickness, toothache, wind and wet bone pain.

Kyoukyo: The name of the Zhuang family medicine is Gitgwngq, and it is a plant belonging to the family Cynodonaceae Platycodon grandiflorus (Jacq.) A. DC. Derived from the root of. Taste: Bitter, spicy, flat. Efficacy: Prepares the airway. Main cause: Cough, sputum, sore throat, malignant ulcer, sputum, dysentery, urinary retention.

In the prescription, Okato Suiren, Hakutou are the main drugs, Gaikyotsutsu, Okukakui, Nikkei are the side drugs, Shishi and Shakyo are the public drugs, Kykyo are the mother drugs, and the whole prescription is a combination of the main and sub-parents. It is used to adjust the flow of energy and improve the state of emptiness, and it has the effect of adjusting dragon roads and fire paths.

The present invention has the following remarkable effects.

INDUSTRIAL APPLICABILITY The present invention has the clear effects of adjusting the flow of qi to improve the state of imagination, preparing the dragon road and the fire tract, and impairing mental health, exhaustion of spirits, mental and physical fatigue, and apathy Provide a Zhiwan pharmaceutical composition for aspiration/psychoregulation that improves symptoms such as vergence and low breathiness, and provides a method for preparing the composition, which is easy to operate and has sufficient efficacy of crude drugs. Can be demonstrated to.

Hereinafter, the present invention will be further described with reference to Examples, but the scope of protection of the present invention is not limited thereto.

Preparation process of Zhuang pharmaceutical composition for replenishment/psychotherapy (1) Design of production process This formula is a formula based on clinical experience. Generally, decoction is used as the dosage form and the manufacturing method is simple. There is an advantage that it is not limited by the conditions of the device. However, most of the decoctions are decocted, and it is difficult to unify their quality and mass-produce them, it is difficult to store them, they are inconvenient to carry and transport, and they are inconvenient to use. In order to solve the above-mentioned drawbacks and make it easier to be received by the majority of patients, granules, which is a dosage form suitable for general administration routes and methods, is used as a preparation dosage form of the product. Water is often used as an extraction solvent for traditional Chinese medicine decoctions, and water extraction is planned to use water because the cost is low and the drug efficacy is certain. The method of the production process is to decoct with water to obtain a dry paste, then add excipients and granulate.

(2) Screening of water extraction process conditions 1. Design of orthogonal test The factors that influence the water extraction effect are (1) number of decoctions, (2) decoction time, (3) water addition amount, and (4) crushing degree. is there. In three levels, (see details in Table 1, Table 2) for these factors, and performing an optimization of the orthogonal test, L 9 ₍₃ ⁴⁾ was performed orthogonal test using an orthogonal table.

2. Optimization index and total scoring method There are a total of 8 crude drugs that need to be extracted in the prescription of this product, of which the medicinal product is eucato sirren, which mainly contains flavonoid components, Its typical component is total flavone, and the level of total flavone content is closely related to the effectiveness of this product, which can be an optimization index for the process conditions of this product, and the extract yield is It was possible to reflect the extraction efficiency as a whole and was used as the second optimization index for the process conditions of this product. According to the principle that the weighting factor of the main component is large, the total saponin content is mainly (weighting factor 0.6), the extract yield is assisted (weighting factor 0.4), and the scoring is performed by the following equations 1 and 2. did. Overall scoring was performed according to the following simple formula 3.
Formula 1, total flavone content=total amount of saponin extracted/mass of crude drug×100%
Formula 2, extract yield=extract weight/crude drug mass×100%
Formula 3, dij=b1aij/s1+b2bij/s2+b3cij/s3
In the formula, aij, bij, and cij are the j-th index of the i-th term, s1, s2, and s3 are standard deviations of samples, and b1, b2, and b3 are weighting factors.

3. Optimization method 3.1 Orthogonal test The test is set up according to the orthogonal design test table shown in Table 2, and in the test of each group, the prescribed amount of crude drug is prepared, and the decoctions of the respective test numbers are combined and uniformly. After mixing, filtering, and concentrating the filtrate, the volume was adjusted to 1000 ml to obtain a test solution.

3.2 Measurement method Total solid content measurement 100 ml of the test solution was precisely weighed, placed in an evaporation dish dried to a certain weight at 105°C, steam-dried in a water bath, and dried under reduced pressure to a certain weight at 80°C, and weighed. Then, the amount of dry paste was calculated.

Measurement of total flavone content 1. Reagents
1.1 Polyamide powder
1.2 Rutin standard solution 5.0 mg of rutin was weighed and dissolved by adding methanol to a constant volume of 100 ml to obtain 50 μg/ml.
1.3 Ethanol: analytical grade
1.4 Methanol: analytical grade

2. Analysis step 2.1 Sample treatment: Weigh 1.5 g of dry paste sample obtained by evaporating water from the sample, add ethanol to constant volume to 2 ml, shake evenly, ultrasonically extract for 20 min, and let stand. Then, 1.0 ml of the supernatant was sucked up, and 1 g of polyamide powder was added to the evaporation dish for adsorption, and ethanol was evaporated in a water bath, and then transferred to a chromatography column. First, it was washed with 20 ml of benzene, the benzene solution was discarded, and then flavone was eluted with methanol to a fixed volume of 25 ml. The absorption value of this solution was measured at a wavelength of 360 nm. At the same time, using rutin as a standard product, a calibration curve was determined, a regression equation was determined, and the content of total flavone in the sample was calculated.

2.2 Rutin calibration curve Rutin standard solution 0, 1.0, 2.0, 3.0, 4.0, 5.0 ml is sucked into a 10 ml colorimetric tube, methanol is added to a predetermined scale and shaken evenly. Color comparison was performed at a wavelength of 360 nm. A regression equation was obtained and the content of total flavones in the sample was calculated.

3, calculation and results:
In the formula,
X-content of total flavones in the sample (mg/100g)
A-Amount of flavone in the test solution calculated from the calibration curve (μg)
M-mass of sample (g)
V _1- volume of sample for measurement (ml)
V ₂ - sample constant volume total volume (ml)
The calculation result was two significant digits.

4. Comprehensive scoring was performed on the results of orthogonal test optimization and analysis results, and visual analysis and analysis of variance were performed on the scoring results. The results are shown in Tables 4 and 5. As is clear, the three factors A, B, and C all affect the extract yield and the total flavone content, and the order of the influencing factors is B>A>C. , Showed that the difference was significant. The optimum theoretical extraction condition for water extraction by multiple comparison is preferably B3A1C1, that is, water with a prescription amount of 10 times is added, and extraction is performed once for 1 h and 3 times.
Table 1 Water extraction process L ₉ (3 ⁴ ) orthogonal test design and results (n=2)
Table 2 ANOVA table for water extraction process
Note, F _0.01 (1,2)=99, F _0.05 (1,2)=19

5. Confirmation test of the orthogonal test optimization result Add 10 times water to the decoction decocted three times according to the above process, decoct for 1 hour, filter the decoction, concentrate to 1000 ml, accurately weigh 50 ml, and add the total flavone. The total flavone content is very low and 1.5% dry paste is obtained according to the method of measuring the content of the above, which means that the active ingredient is basically extracted when the crude drug is decocted 3 times. showed that.

(3) Optimization of the drying process of concentrated paste The concentrated paste obtained by concentrating this product by the optimized water extraction process is dried under reduced pressure at 70°C, 80°C, and 90°C to a constant weight, and the dried paste is approximately 1 g, precise. The sample psoralen content was measured according to the above total flavone measurement method, and the results are shown in Table 3. The experimental results show that the drying temperature affects the total flavone content of this product, vacuum drying at 80°C is optimal, and the working efficiency can be improved without lowering the psoralen content. As a drying temperature condition of the thick paste, it was decided to perform reduced pressure drying at 80°C.
Table 3, Drying temperature test of thick paste

(4) Study on optimization of granulation molding process When the drug solution obtained according to the optimum extraction process is concentrated and dried to obtain an extract powder, and an excipient is uniformly mixed with the extract powder to produce granules. Appropriate excipients were selected depending on the yield, solubility and mouthfeel of the. The results are shown in Table 4-1.
Measurement of granule yield: The prepared granules were weighed. Granule yield=weight of accepted granules/(weight of extract powder g+weight of excipients g)×100%
Solubility measurement: Add precisely weighed granules to a 5 mL centrifuge tube that has been dried to a certain weight, add 5 mL of boiling water accurately, shake for 5 minutes, shake, centrifuge at 3000 r/min for 15 minutes, and then remove the supernatant. Was discarded, the residue was dried to a constant weight at 80° C., weighed precisely, and the dissolution rate was calculated. Dissolution rate = mass of dissolved granules / mass of granules x 100%
Mouthfeel grade: Sweetness with heavy bitterness and slight bitterness.
Table 4-1 Excipient screening results
Based on the results of the screening experiment for excipients, the excipient was sucrose.
Consideration of molding process:
Of the many factors affecting the molding process, the concentration of ethanol, the amount and factor levels in consideration of the stirring time and L ₉ ethanol _{(3 4)} Design the orthogonal test table, Table 2-2, Table 2 -3. The moldability was used as an evaluation index.
Table 4-2 Factor level table
Table 4-3 L ₉ (3 ₄ ) orthogonal test table
Table 4-4 Analysis of variance results
Note: F _0.05 (2.2)=19.00
From the analysis of variance analysis, it was found that the degree of influence of the three factors on the granule yield was A>B>C, and the factors A and B were significant. From the results of visual analysis, it was confirmed that the optimum process was A ₂ B ₂ C ₃ , and when the optimum process condition A ₂ B ₂ C ₃ test was repeated, the granule yield was almost the same as the test result in the orthogonal table. Matched See Tables 4-5. Therefore, the molding process was carried out with an ethanol concentration of 75%, an ethanol usage amount of 8%, and stirring for 15 minutes.
Table 4-5 List of verification experiment results (n=3)

(5) Examination of pilot test According to the screened prescription process, 100 times expansion was performed, three pilot tests were performed, and their batch numbers were set to 20188041, 20120402, and 20180403, respectively. Raw materials were weighed in a ratio of 100,000 g in each batch. Add 8 times amount of water, extract 3 times for 60 min each time, filter, concentrate, vacuum dry, crush and sieve with 100 mesh, add sucrose up to 100000g to dry paste powder, homogenize To 75% ethanol to make a soft material, granulate with a 12 mesh sieve, dry at 75°C for 4 h, sieving with a 12 mesh sieve, mix evenly with a mixer and package. The granule yield, particle size and solubility of each of the obtained granule samples after packaging were statistically analyzed, and the obtained results are shown in the table.
Table 5 Results of 3 batch pilot test

(6) Stability investigation test In order to provide a basis for studying the stability of this product during packaging, storage, and transportation, and to set the expiration date of the drug product, "Technical Guiding Principles for Stability Studies of Chinese Herbs and Natural Drugs" Accelerated stability test and long-term stability test were carried out on samples of 3 batches of Ryurantsugran granule according to the requirements of the granule stability test and the draft of the quality standard of this product according to the requirements described in 1. As a result of conducting a long-term room temperature investigation for 12 months and an accelerated stability investigation for 6 months on this product, the properties, identification, inspection, content measurement and microbial limit inspection of 3 batches of samples all satisfied the regulations. From this result, it is shown that the shelf life of this product can be provisionally set to 2 years, the storage condition is 30°C ± 2°C, the relative humidity is 65% ± 5%, and it is used for packaging low-density polyethylene pharmaceuticals. The composite film was used as the packaging material.

(7) Conclusion The optimal process for preparing a Zhuang pharmaceutical composition for replenishment/psychotherapy is to add 10 times water to crude drug, decoct 3 times per hour, filter, concentrate, and depressurize at 80°C. Dry, crush and sieving with a 100 mesh sieve, add sucrose to the dry paste powder, mix evenly, use 75% ethanol as a soft material (ethanol usage 8%), stir for 15 min, and sieve with 12 mesh. Granulate over 4 hours, dry at 75° C. for 4 hours, size through a 12 mesh sieve, mix evenly with a mixer, package and package.

Second, clinical example Example 1
1. The Zhiwan pharmaceutical composition contains, by weight, 40 g of Oukatousuren, 40 g of Ganoderma lucidum, 20 g of Gyokyoketsu, 20 g of Ganoderma lucidum, 10 g of Nikkei, 20 g of Shishi, 20 g of Ginger, and 20 g of Ginger.

2. Method for preparing Zhuang pharmaceutical composition:
The above raw materials are weighed according to weight, washed and sorted, put in a pot for primary decoction, specifically, water is added and soaked for 0.5 to 1 hour to boil the chemical liquid. After decocting until high, switch to low heat and decoct for 20 to 25 minutes, filter the decoction and perform secondary decoction, specifically, 0.5 to 1 cm from the plane of the crude drug in a medicinal pot. After adding water at room temperature again and decocting over high heat until the chemical solution boils, switch to low heat and decoct for 15 to 20 minutes, filter the decoction, and extract the decoction obtained from the primary decoction and the secondary decoction. I matched it. The Zhuang pharmaceutical composition according to the present invention was a decoction.

3. Dosing method: The above-mentioned granules were orally administered, and one drug/day was taken once a day in the morning and once a day for 14 days, and 1 course was taken for 14 days, and 2 courses were continuously treated.

4. Typical cases:
Mr. Rei, female, 41 years old, Ichito Kawaike, timidness, mental illness 3 years, after taking this Zhuang pharmaceutical composition according to the above-mentioned administration method, the symptoms improved.
Mr. Ushi, female, 37 years old, Ichijin Tamabayashi, spirit, mental illness 6 years, after taking this Zhuang family pharmaceutical composition according to the above-mentioned administration method, symptoms improved.

Example 2
1. The Zhuang family pharmaceutical composition contains parts by weight, 40 parts of Oukatousuren, 40 parts of Shiratou, 20 parts of oyster butter, 20 parts of oyster oyster, 10 parts of nikkei, 20 parts of shisha, 20 parts of kyokyo, and 20 parts of kyokyo. The ratio was 4:4:2:2:1:2:2:2.

2. Method for preparing Zhuang pharmaceutical composition:
After washing and selecting each of the above-mentioned raw materials weighed in parts by weight, water is added to the crude drug 10 times, and the crude drug is decocted 3 times per hour, filtered, concentrated, and dried under reduced pressure at 80° C., Pulverize and pass through a 100-mesh sieve, add sucrose to the dry paste powder, mix evenly, make a soft material using 75% ethanol (ethanol usage 8%), stir for 15 min, and granulate through a 12-mesh sieve. Then, it was dried at 75° C. for 4 hours, sized with a 12-mesh sieve, uniformly mixed with a mixer, packed and packaged to give 25 g per pack.

3. Dosing method: The above granules were orally administered once per pack, once in the morning and once in the morning, and treated for 14 days with 1 course and 2 courses continuously.

4. Clinical statistical data on patients using the drug of the present invention:
4.1 Basic data Diagnostic criteria: (1) Refer to the modern medical diagnostic criteria (developed according to the diagnostic criteria of the "Ahealth Chinese Medicine Clinical Guide"), and the subject's chief complaint indicates mental/physical fatigue and low temper , Discomfort, such as low-pitched breathing, repeats seizures for more than 3 months, has no significant organic or mental illness, requires no medication, and has no positive laboratory and physical examination results. (2) With reference to Kampo medicine diagnostic criteria (2002 version, "Principles for Clinical Research on New Kampo Medicines"), the main symptom of Qi Feng is shortness of breath, fatigue, malaise and pulsation. A person who has sweat, fluency, and tongue and has two main symptom + one secondary symptom was judged to be sick. The total number of patients who met the sub-health examination criteria and the Kampo medicine Kampo medicine blood deficiency criteria criteria was 56 for men and 64 for women, a total of 120 cases, and the age was 30 to 50 years and the medical condition was 3 to 10 years.

4.2 Grouping of Experiments Patients were randomly divided into two groups, an observation group and a control group, and each group had 60 patients.

4.3 Treatment plan Observation group: The above-mentioned granules were orally administered once per pack, once in the morning and once in the evening, and treated for 14 consecutive days for 2 courses.
Control group: Oryzanol and Vitamin B1 were orally administered at 20 mg each three times a day, and 14 days were treated as 1 course and 2 courses were treated continuously.

5. Judgment of therapeutic effect Refer to the judgment criteria of therapeutic effect for qi-type sub-health described in "Criteria for therapeutic effect of Kampo medicine sign". Short-term healing: The symptoms diagnosed by a Chinese medicine doctor disappear or disappear. Remarkable effect: The symptoms diagnosed by Kampo medicine are significantly improved. Efficacy: All symptoms diagnosed by Kampo medicine were improved but not significant. Ineffective: None of the symptoms diagnosed by the Kampo doctor are clearly improved and worsened.

6. Statistical processing The analysis was performed using SPSS20.0 statistical software, the chi-square test was performed on the count data, and the t-test was performed on the measurement data. Differences were considered statistically significant if P<0.05.

7. Experimental Results In the observation group, 32 cases were cured for a short time, 14 cases were excellent, 10 cases were effective, 4 cases were ineffective, and the total effective rate was 93.34%. In the control group, 20 cases were short. Time cure, excellent in 9 cases, effective in 11 cases, ineffective in 20 cases, the total effective rate was 66.67%. The difference in the observation group was statistically significant when compared with the control group. The clinical treatment effect of the observation group was superior to that of the control group.

Table 1 Comparison of clinical treatment effect between control group and observation group
Note, P<0.05 when compared with the control group.

8. Typical illnesses Mr. Qin, female, 43 years old, Liuzhou city person, timidness, mental illness 10 years, after taking this Zhuang pharmaceutical composition according to the above administration method, the symptoms improved.

Mr. Huang, Female, 24 years old, Hei Jian, Qi, Mental depression 4 years, After taking this Zhuang family pharmaceutical composition according to the above administration method, the symptoms improved.

Claims (4)

10 to 60 parts by weight, 10 to 50 parts by weight, 10 to 40 parts by weight of gall butter, 10 to 30 parts by weight of porcupine, 5 to 20 parts by weight of nikkei, 10 to 25 parts by weight of shish, 10 to 25 parts by weight of shakyo , and are prepared using bellflower 10-30 parts by weight of the raw material,
Characterized in that, Hoki tone paragraph break Zhuang pharmaceutical composition. Ou Kato water lily 40 parts by weight, Houtoukuu 40 parts by weight, Gaikyouketsu 20 parts by weight, Oukyakugai 20 parts by weight, 10 parts by weight of cinnamon are prepared using shish 20 parts by weight, council 20 parts by weight, and a balloon flower 20 parts by weight of the raw material ,
Hoki tone paragraph break Zhuang pharmaceutical composition according to claim 1, characterized in that. After washing each of the raw materials weighed in the above-mentioned parts by weight, water was added to the crude drug 10 times and decocted for 1 hour each time, decocted 3 times, filtered, concentrated, and dried under reduced pressure at 80°C. , Crushed and sieved with 100 mesh, add sucrose to dry paste powder, mix evenly, prepare soft material with ethanol with purity of 75% (ethanol dose is 8%), stir for 15 minutes , and mix with 12 mesh Includes the steps of sieving, granulating, drying at 75° C. for 4 hours , sieving with a 12 mesh sieve, uniform mixing with a mixer, packing and packaging.
Process for the preparation of Hoki tone paragraph break Zhuang pharmaceutical composition according to claim 1 or 2, characterized in that. The dosage form of the Zhuang pharmaceutical composition is a decoction or a granule,
Process for the preparation of Hoki tone paragraph break Zhuang pharmaceutical composition according to claim 3, characterized in that.