CN115957272A - Dampness-eliminating pharmaceutical composition, and preparation and application thereof - Google Patents
Dampness-eliminating pharmaceutical composition, and preparation and application thereof Download PDFInfo
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Abstract
The invention discloses a dampness eliminating pharmaceutical composition, a preparation and an application thereof, wherein the dampness eliminating pharmaceutical composition comprises the following components in parts by weight: 5-25 parts of angelica dahurica, 5-25 parts of fried radish seed, 1-10 parts of flos caryophyllata, 5-25 parts of ligusticum wallichii, 5-20 parts of cinnamon, 5-25 parts of rhizoma acori graminei, 5-25 parts of fried rhizoma atractylodis, 5-25 parts of agastache rugosus and 5-25 parts of fried fennel. The pharmaceutical composition for eliminating dampness is added with pharmaceutically acceptable auxiliary materials to prepare a preparation. The dampness eliminating pharmaceutical composition and the preparation thereof can be used for preparing medicines for treating phlegm-dampness internal retention syndrome.
Description
Technical Field
The invention belongs to the field of medicines, and particularly relates to a damp-clearing pharmaceutical composition, and a preparation and application thereof.
Background
The "damp pathogen" is one of six exogenous pathogens (wind, cold, summer-heat, dampness, dryness and fire) in the theory of traditional Chinese medicine. Dampness pertains to yin pathogen and is turbid and sticky. When it invades the body, it can damage the yang-qi of the body, easily stagnate the viscera and meridians, obstruct the functioning of qi movement, and cause the body to have the symptoms of heaviness and heaviness. Dampness is the disease, and its secretion and excretion are characterized by unclear nature. Dampness stagnation in some viscera and difficult to resolve results in damp pathogen being a disease, which has long disease course, repeated attack and lingering and difficult to cure.
The aromatic dampness-resolving medicine is used for treating dampness syndrome in clinical traditional Chinese medicine, and the aromatic dampness-resolving medicine is a traditional Chinese medicine with the main effects of removing turbid qi with aromatics and resolving dampness and activating spleen. However, most of the fragrant and damp-resolving herbs are pungent, warm, fragrant and dry in nature, which are apt to impair yin and consume qi, so they should be used with cautions for yin deficiency and fluid consumption, red tongue, dry mouth and qi deficiency and hypodynamia. This has greatly limited the use of aromatized wet-type drugs.
Disclosure of Invention
Aiming at the defects in the prior art, the invention aims to provide a damp-clearing pharmaceutical composition, and a preparation and an application thereof. The pharmaceutical composition and the preparation thereof have the effects of eliminating dampness through aroma, strengthening spleen and regulating qi, and can be used for treating symptoms related to spleen deficiency and dampness obstruction, such as epigastric and abdominal fullness and stuffiness, poor appetite, abdominal pain and loose stool, greasy taste and anorexia, nausea and vomiting, heavy limbs, yellow body and eyes, body swelling and fat and the like.
The purpose of the invention is realized by the following technical scheme:
the damp-clearing pharmaceutical composition comprises the following components in parts by weight: 5-25 parts of angelica dahurica, 5-25 parts of fried radish seed, 1-10 parts of flos caryophyllata, 5-25 parts of ligusticum wallichii, 5-20 parts of cinnamon, 5-25 parts of rhizoma acori graminei, 5-25 parts of fried rhizoma atractylodis, 5-25 parts of agastache rugosus and 5-25 parts of fried fennel.
Preferably, the damp-clearing pharmaceutical composition comprises the following components in parts by weight: 10-20 parts of angelica dahurica, 10-20 parts of fried radish seed, 2-6 parts of flos caryophyllata, 10-20 parts of ligusticum wallichii, 6-15 parts of cinnamon, 10-20 parts of rhizoma acori graminei, 10-20 parts of fried rhizoma atractylodis, 10-20 parts of agastache rugosus and 10-20 parts of fried fennel.
More preferably, the dampness eliminating pharmaceutical composition comprises the following components in parts by weight: 12-18 parts of angelica dahurica, 12-18 parts of fried radish seed, 3-4 parts of flos caryophyllata, 12-18 parts of ligusticum wallichii, 8-12 parts of cinnamon, 12-18 parts of rhizoma acori graminei, 12-18 parts of fried rhizoma atractylodis, 12-18 parts of agastache rugosus and 12-18 parts of fried fennel.
In the pharmaceutical composition, the wrinkled gianthyssop herb and the grassleaf sweelflag rhizome are monarch drugs, the wrinkled gianthyssop herb takes the aromatic qi to change the damp turbidity in the interior, can repel dirty, regulate the middle warmer and stop vomiting, the grassleaf sweelflag rhizome changes the damp and pleases the spleen, and mainly dispels the damp obstruction of the middle warmer, and the wrinkled gianthyssop herb and the grassleaf sweelflag rhizome are aromatic products and are monarch drugs for use together. The ministerial drugs comprise rhizoma atractylodis, radix angelicae, semen raphani, clove and fennel, the rhizoma atractylodis is used for drying dampness and strengthening spleen, the radix angelicae is used for drying dampness and stopping leucorrhea, the two drugs have the functions of relieving exterior syndrome and dispelling wind, the dampness is also used for assisting the dampness to externally reach, the dampness is sticky and greasy, the qi movement is easily blocked, the semen raphani is used for depressing qi and reducing phlegm, the clove is used for warming middle-jiao and depressing adverse qi, the fennel is used for regulating qi and harmonizing stomach, the qi and the stomach are rebuilt, the spleen and stomach ascending and descending and transportation and transformation are rebuilt, the rhizoma atractylodis is used for strengthening the spleen and stomach transportation and transformation, the qi and blood biochemical source is used for protecting the vital qi, the dampness is not damaged, the dampness is dispelled on the surface, the dampness is dissolved on the inside, the exterior and the inside are treated at the same time, and the evil is not remained. The adjuvant drugs comprise rhizoma Ligustici Chuanxiong and cortex Cinnamomi, rhizoma Ligustici Chuanxiong has effects of promoting qi and blood circulation, cortex Cinnamomi has effects of tonifying fire and supporting yang, and warming and dredging channels, and can be used together to enhance the effect of monarch drug in dispelling cold and dampness. The whole formula has the effects of aromatizing, eliminating dampness, promoting qi circulation, harmonizing stomach, strengthening spleen, regulating qi, smoothing qi movement of the whole body, eliminating pathogenic factors without leaving pathogenic factors, and eliminating dampness without damaging vital qi.
The damp-clearing pharmaceutical composition can be added with pharmaceutically acceptable auxiliary materials and prepared into preparations such as granules, tablets, powder, pills and the like.
The dampness-eliminating pharmaceutical composition and the preparation thereof have the effects of eliminating dampness with aromatics, invigorating spleen and regulating qi, and can be used for treating spleen deficiency and dampness stagnation related symptoms, such as epigastric and abdominal fullness and oppression, poor appetite, abdominal pain and loose stool, greasy taste and anorexia, nausea and vomiting, tiredness and heaviness of limbs, yellow body and eyes, swelling and fat body and the like.
Compared with the prior art, the invention has the following beneficial effects:
1. the dampness-eliminating pharmaceutical composition and the preparation thereof can effectively eliminate dampness in vivo, especially dampness staying in spleen and stomach of middle jiao, can effectively relieve the symptom of phlegm-dampness internal resistance, and have simple formula, safety and no side effect.
2. The traditional dampness-dispelling medicines and the aromatic dampness-resolving medicines are mostly pungent, warm, fragrant and dry products, are easy to damage yin and consume qi, and are limited in use.
3. The preparation of the pharmaceutical composition has reasonable design of preparation process, improves the paste yield, effectively prevents and treats the loss of the volatile oil components in the decoction process, improves the utilization degree, and has the advantages of short production period, stable quality, convenient taking, small dosage and the like, and good use effect.
Detailed description of the preferred embodiments
The present invention will be further described with reference to the following examples, but the present invention is not limited to these examples.
Example 1
A pharmaceutical composition for eliminating dampness comprises the following components: 5 g of angelica dahurica, 25 g of fried radish seed, 1g of flos caryophyllata, 5 g of ligusticum wallichii, 20g of cassia seed, 5 g of rhizoma acori graminei, 25 g of fried rhizoma atractylodis, 25 g of agastache rugosus and 5 g of fried fennel.
Example 2
A damp-clearing pharmaceutical composition comprises the following components: 25 g of angelica dahurica, 5 g of fried radish seed, 10 g of flos caryophyllata, 25 g of ligusticum wallichii, 5 g of cassia seed, 25 g of rhizoma acori graminei, 5 g of fried rhizoma atractylodis, 5 g of agastache rugosus and 25 g of fried fennel.
Example 3
A pharmaceutical composition for eliminating dampness comprises the following components: 10 g of angelica dahurica, 10 g of fried radish seed, 6 g of flos caryophyllata, 10 g of ligusticum wallichii, 15 g of cassia seed, 20g of rhizoma acori graminei, 20g of fried rhizoma atractylodis, 10 g of agastache rugosus and 10 g of fried fennel.
Example 4
A pharmaceutical composition for eliminating dampness comprises the following components: 20g of angelica dahurica, 20g of fried radish seed, 2 g of flos caryophyllata, 20g of ligusticum wallichii, 6 g of cassia seed, 10 g of rhizoma acori graminei, 10 g of fried rhizoma atractylodis, 20g of agastache rugosus and 20g of fried fennel.
Example 5
A pharmaceutical composition for eliminating dampness comprises the following components: 18 g of angelica dahurica, 12 g of fried radish seed, 3 g of flos caryophyllata, 18 g of ligusticum wallichii, 8 g of cassia seed, 18 g of rhizoma acori graminei, 12 g of fried rhizoma atractylodis, 18 g of agastache rugosus and 12 g of fried fennel.
Example 6
A damp-clearing pharmaceutical composition comprises the following components: 12 g of angelica dahurica, 18 g of fried radish seed, 4 g of clove, 12 g of hemlock parsley, 12 g of cassia seed, 12 g of grassleaf sweelflag rhizome, 18 g of fried rhizoma atractylodis, 12 g of wrinkled gianthyssop herb and 18 g of fried fennel.
Example 7
A pharmaceutical composition for eliminating dampness comprises the following components: 15 g of angelica dahurica, 15 g of fried radish seed, 3 g of flos caryophyllata, 15 g of ligusticum wallichii, 10 g of cassia seed, 15 g of rhizoma acori graminei, 15 g of fried rhizoma atractylodis, 15 g of agastache rugosus and 15 g of fried fennel.
Example 8
A pharmaceutical composition for eliminating dampness comprises the following components: 5 g of angelica dahurica, 5 g of fried radish seed, 1g of flos caryophyllata, 5 g of ligusticum wallichii, 5 g of cassia seed, 5 g of rhizoma acori graminei, 5 g of fried rhizoma atractylodis, 5 g of agastache rugosus and 5 g of fried fennel.
Example 9
A damp-clearing pharmaceutical composition comprises the following components: 25 g of angelica dahurica, 25 g of fried radish seed, 10 g of flos caryophyllata, 25 g of ligusticum wallichii, 20g of cassia seed, 25 g of rhizoma acori graminei, 25 g of fried rhizoma atractylodis, 25 g of agastache rugosus and 25 g of fried fennel.
Example 10
A granule of a damp-clearing pharmaceutical composition is prepared by weighing the medicinal materials according to the weight of the pharmaceutical composition in any one of the embodiments 1-9, crushing the medicinal materials, and preparing the following steps:
(1) Extracting volatile oil from radix Angelicae Dahuricae, flos Caryophylli, parched rhizoma Atractylodis, and herba Agastaches, collecting the water solution after extracting volatile oil with another container, and collecting the residue;
(2) Mixing the dregs of the decoction obtained in the step (1) with fried radish seeds, ligusticum wallichii, cinnamon seeds, rhizoma acori graminei and fried fennel, and then decocting the mixture twice with water respectively: adding 10 times of water for the first time, and decocting for 1 hour, and adding 8 times of water for the second time, and decocting for 1 hour. Filtering, mixing decoctions, standing for 24 hr, filtering to remove precipitate, preferably filtering with 180-200 mesh screen;
(3) Combining the decoction prepared in the step (2) with the aqueous solution in the step (1), and concentrating under reduced pressure to obtain a thick paste with the relative density of 1.30-1.35 (50 ℃);
(4) Adding a proper amount of dextrin into the thick paste obtained in the step (3), drying, crushing, uniformly mixing with 0.2wt% of sucralose powder, granulating by taking 70-80wt% of ethanol as a wetting agent, drying, grading, sieving to prepare granules, and drying;
(5) And (3) adding the dried granules into the volatile oil extracted in the step (2), and uniformly mixing to obtain the composition.
Application example 1-the effect and mechanism of the dampness eliminating pharmaceutical composition for improving spleen deficiency and dampness obstruction type obese rats
1. Materials and apparatus
SD male rats: SPF grade, 8 weeks old, body mass 210 to 220g, henan province experimental animal center; superoxide dismutase (SOD), glutathione (GSH) and Malondialdehyde (MDA) detection kit: nanjing is built into a bioengineering institute; glucose and insulin detection kit: shanghai science and technology, inc.; total Cholesterol (TC), triglyceride (TG) detection kit: beijing Solaibao science and technology, inc.; an ultrasonic cleaning machine: model JM-03D-40, shenzhen Jie alliance cleaning equipment Limited; ultraviolet-visible spectrophotometer: model 721N, shanghai electric analyzer, ltd; electronic analytical balance: model FA2004, shanghai precision instruments ltd; a blood sugar tester: GA-3 type, shanghai Polymu medical instruments Ltd; full-automatic biochemical analyzer: AU480 type, beckman coulter commercial china ltd; transfer printing electrophoresis apparatus: model DYCZ-40K, beijing, six Biotech limited.
2. Method of producing a composite material
2.1 grouping, modeling and administration
2.1.1 grouping: the method of grouping by grouping according to body constitution comprises 10 groups of control group, model group and administration group.
2.1.2 modeling of spleen deficiency and dampness obstruction type obese rats: according to the research on the weight-reducing effect of spleen deficiency and dampness resistance type obese rats by Zhao Nan, zhu Yilin, zheng Lixin, pottery, tibet rolling, zhang Nan, wang Chun, zbuilt army, tianshimin, wang Linyuan, spleen invigorating, diuresis inducing and turbidity eliminating prescription [ J ]. Ningqiu traditional Chinese medicine, 2022,15 (12): 2297-2303 document, rats are fed with high-calorie feed (15% of cane sugar and 15% of lard are added in the maintenance feed), and simultaneously are irrigated to the stomach for 16 days and swim for 3 weeks by combining rock sugar water, so that a spleen deficiency and dampness resistance type simple obese rat model is established. Food intake was recorded weekly and body mass weighed 1 time. After feeding for 2 weeks, rats given high calorie feed were ranked according to body mass gain, 1/3 obese resistant rats with lower body mass gain were eliminated, and obese sensitive rats were selected as model group rats.
2.1.3 dosing: the granular preparation of the pharmaceutical composition of the present invention was gavaged at a dose of 200mg/kg in the administration group (the granular preparation used in the present application example was prepared by the preparation method described in example 10 using the pharmaceutical dose described in example 8) with reference to the conversion standard of the human and animal dose in Experimental zoology, and the control group and the model group were gavaged at the administration group dose of 0.9-dose NaCl solution 1 time a day until the end of 12 weeks.
2.2 index detection
2.2.1 measurement of rat body Mass
During the test period, the rat body mass was weighed by a scale with a division value of 0.1g at a fixed time every week.
2.2.2 measurement of serum lipid metabolism index and oxidative stress index in rat
After 12 weeks, the rats were fasted for 12 hours, 3mL of blood was collected from the abdominal aorta under anesthesia, and the serum was centrifuged and separated, and stored in a refrigerator at-20 ℃. Taking blood serum to be detected, detecting contents of TC and TG in the blood serum by a colorimetric method, detecting activity of SOD in the blood serum by a xanthine oxidase method, determining concentration of GSH in the blood serum by a micro enzyme labeling method, and determining content of MDA in the blood serum by a thiobarbituric acid method.
2.2.3 measurement of serum glucose and insulin content in rat
Taking blood serum to be detected, determining Fasting Blood Glucose (FBG) value by glucose oxidase method, and detecting fasting insulin (F) by enzyme-linked immunosorbent assay INS ) The content of (b) is measured according to the kit instructions. Calculating the insulin resistance index (H) according to equation (1) OMA-IR ）。
Formula (1) H OMA-IR =F BG ×F INS /22.5
In the formula:
H OMA-IR -insulin resistance index;
F BG -fasting blood glucose value, mmol/L;
F INS -fasting insulin content, mU/L.
3. Results and analysis
3.1 changes in body Mass and serum lipid metabolism indices of rats in each group
Long-term high-fat diet interferes with lipid metabolism, energy metabolism and intestinal microecology, triggers lipid metabolism abnormality, and causes obesity. As can be seen from Table 1, the initial body mass, TG and TC contents of each group of ratsThe difference has no statistical significance (P>0.05 Comparable to each other). The quality, TG and TC contents of the 12-week-end model group and the administration group are higher than those of the control group, and the difference has statistical significance (P<0.05). The quality, TG and TC contents of the administered group are reduced compared with those of the model group, and the difference has statistical significance: (P<0.05). The results show that the drug group can effectively reduce the body mass and TG and TC contents of the IR rat. See table 1 for details.
3.2 Change in serum oxidative stress index in groups of rats
Obesity can trigger metabolic abnormalities, cause immune cell activation and infiltration, induce inflammation, trigger peroxidative stress. As shown in Table 2, the SOD activity and GSH concentration in the model group and the administered group were lower than those in the control group, and the differences were statistically significant (P<0.05 ); the MDA content is higher than that of the control group, and the difference has statistical significance (P<0.05). Compared with the model group, the SOD activity and the GSH concentration of the administration group are increased, and the difference has statistical significance (P<0.05 ); the MDA content of the administration group is reduced, and the difference has statistical significance (P<0.05). The administration group can effectively increase the SOD activity and GSH concentration of IR rats and reduce the MDA content. See table 2 for details.
3.3 changes in serum glucose and insulin levels in various groups of rats
Under physiological conditions, insulin can regulate and control the stability of blood sugar by taking measures such as glucose intake and inhibiting hepatic glycogen output. As shown in Table 3, the differences between the model group and the administered group, i.e., FBG, FINS and HOMA-IR, were statistically significant compared to the control group: (P<0.05). The administered groups showed an increase in FBG, FINS and HOMA-IR compared with the model group, and the differences were statistically significant (P<0.05). The administration group can effectively reduce FBG, FINS and HOMA-IR levels of the IR rats. See table 3 for details.
Application example 2, which is based on AMPK signal pathway, to study the action mechanism of the dampness-eliminating pharmaceutical composition for improving spleen deficiency and dampness-retention type obese mice
1. Materials and instruments
1.1 Experimental animals
The mice are bred in the experimental animal center of Yunnan university of traditional Chinese medicine under the breeding conditions: the temperature of room temperature is 22-26 ℃, the relative humidity is 50% -60%, the ventilation environment is good, the mice are fed adaptively for 1 week in a quiet and clean environment, the mice eat and enter water freely during the period, and the circadian rhythm is illuminated.
1.2 drugs and reagents
The high-fat feed consists of 78.8 percent of basic feed, 1 percent of cholesterol, 10 percent of yolk powder, 10 percent of lard and 0.2 percent of bile salt, and is purchased from a Zhengzhou Huaxing laboratory animal farm; streptozotocin (STZ), batch No.: c12797481, beijing Desheng Jia navigation technologies, inc.
1.3 Main Instrument
660 blood glucose meter, DXC600 full-automatic biochemical analyzer, beckman usa; ti-E optical microscope, nikon, japan.
2 method
2.1 animal grouping, modeling and administration
2.1.1 grouping: the method of grouping by grouping according to body constitution comprises 10 groups of control group, model group and administration group.
2.1.2 modeling of spleen deficiency and dampness obstruction type obese mice: after feeding with high-fat feed for 3 weeks, increasing water-wet bedding factors (50 g bedding and 100mL water) from 4 weeks, and molding for 10 weeks. Modeling screening indexes and symptom scoring reference: construction and evaluation of a Simplex obese mouse model of Zhumeng, wanglixin, fengyou, zhangjia, zhao Tianci, kuohou, spleen deficiency and dampness resistance type [ J ]. Chinese medicine journal of basic medicine, 2021,27 (02): 247-250+ 328.DOI. (2) The model building body mass is increased by more than 20.0 percent, and the screening index and symptom score are more than or equal to 10 points, and the model building body is determined to be a spleen deficiency and dampness retention type simple obese mouse.
2.1.3 dosing: mice successfully molded were randomly divided into 2 groups, namely a model group and an administration group (24 mg/kg), wherein a granular formulation of the pharmaceutical composition of the present invention (the granular formulation used in the present application example was prepared according to the preparation method described in example 10 using the pharmaceutical dose described in example 4) was administered to the administration group at 10 am every day, and the control group and the model group were administered with the corresponding volume of physiological saline at 1 time/day for 6 weeks.
2.2 index detection
2.2.1 changes in body Mass and blood glucose in mice of each group
The body mass and the blood sugar of the mice (tail vein blood sampling blood sugar concentration) are respectively detected on 2, 14, 28 and 42 days after the model is successfully made.
2.2.2 Change in blood lipid levels in groups of mice
And (3) after the administration period is finished, killing the mice by an eyeball picking method, taking blood, standing for 30min, centrifuging for 10min (4 ℃, 4000 r/min), extracting upper serum, numbering, and placing in a full-automatic biochemical analyzer for detection.
3. Statistical treatment
Using SPSS25.0 software to analyze and measure data with (
) Expressing that the data of the experimental groups which meet normal distribution and have uniform variance are subjected to variance analysis, every two groups are compared by adopting LSD (least squares) test, and if the data do not meet the normal distribution or have uniform variance, nonparametric test is adopted; to be provided withP<A difference of 0.05 is statistically significant.
4. Results
4.1 Change in body Mass of mice in Each group
As shown in Table 4, the body mass was increased on days 2, 14, 28 and 42 in the model group and the administration group mice, respectively, as compared with the control group, and the difference was statistically significant (seeP<0.05). The mice in the administration group had a statistically significant difference in body mass decreased at days 28 and 42 compared with the model group (seeP<0.05). See table 4 for details.
4.2 Effect on fasting plasma glucose in obese type 2 diabetic mice
As shown in Table 5, the differences between the mice in the model group and the mice in the administration group, which were elevated in fasting glucose at day 2, day 14, day 28 and day 42, were statistically significant (seeP<0.05). Compared with the model group, the fasting blood glucose of the mice in the administration group is reduced at 14, 28 and 42 days, and the difference has statistical significance (P<0.05). See table 5 for details.
4.3 changes in blood lipid in groups of mice
As shown in Table 6, the model mice showed statistically significant differences in the increase in TC, TG and LDL-C and the decrease in HDL-C, as compared with the control mice: (P<0.05 ); mice in the administration group had decreased TG and increased HDL-C, and the differences were statistically significant (P<0.05). Compared with the model group, the mice in the administration group have reduced TG and increased HDL-C, and the difference has statistical significance (P<0.05). See table 6 for details.
Application example 3-application of the dampness-eliminating pharmaceutical composition of the invention to clinical observation of patients with spleen deficiency and dampness-retention obesity
1. General data
86 patients with spleen deficiency dampness obstruction type obesity diagnosed and treated by outpatient service of department of spleen and stomach disease in traditional Chinese medicine hospital of Yunnan province from 27 days at 1 month of 2022 to 1 day at 6 months of 2022 are collected; the control group and the treatment group were divided into 43 cases by using a random number table method. 23 men and 20 women in the control group; age 18-30 years, mean (23.21 ± 4.49) years; body Mass Index (BMI) 23 to 28kg/m 2 Average (25.84. + -. 2.98) kg/m 2 (ii) a The body fat percentage is 28 to 40 percent, and the average is (35.25 +/-5.04)%. 26 men and 17 women in the treatment group; age 17 to 35 years, mean (25 ± 6.28) years; (BM)I）24.5~29.5kg/m 2 Average (26.15. + -. 3.15) kg/m 2 (ii) a The body fat percentage is 29 to 39 percent, and the average is (35.26 +/-5.25)%. The general data of both groups were statistically analyzed and the differences were not statistically significant (P>0.05 Comparable to each other).
In 43 cases of the control group, diet exercise therapy is adopted, and diet is based on nutrition balance and low energy according to expert consensus on obesity prevention and treatment of Chinese residents, wherein the daily energy intake is averagely reduced by 30 to 50 percent or reduced by 500kcal or the daily energy intake is limited to the dietary energy limit of 1000 to 1500 kcal. Keeping the daily intake of 20-25% of protein, 20-30% of fat energy supply ratio and 45-60% of carbohydrate energy supply ratio. Ensures the intake of vitamins, proteins and trace elements, strictly controls the intake of animal fat, avoids eating fast food, sweet food, fried food, carbonated beverage and the like, and reduces night as much as possible. The exercise mainly adopts aerobic exercise combined with resistance exercise, and can also mainly adopt moderate and low-intensity aerobic exercise such as jogging, rope skipping, bicycle riding, badminton playing, fast walking and the like through changing the exercise mode or adopting high-intensity intermittent exercise, specific items are selected according to the preference of patients and external conditions, the exercise time is 30min respectively in the morning and in the afternoon, and the exercise is preferably carried out in a segmented intermittent mode 3 times per week every other day. The treatment group is orally taken together with the dampness eliminating drug combination particle preparation on the basis of the treatment method of the control group, and the dampness eliminating drug combination particle preparation is prepared according to the preparation method of the embodiment 10 by adopting the drug dosage of the embodiment 1. Three times a day, 100mL once, warm-heat taking, five days as a course of treatment.
2. Observation index
2.1 clinical efficacy
Calculating the integral of the symptoms of the spleen deficiency and dampness obstruction of obesity in the guidelines (trial) of clinical research on new Chinese medicines, and respectively recording the main symptoms (edema, obesity, fatigue, tiredness, heaviness and weakness of limbs) as 0, 2, 4 and 6 according to the absence, the degree, the middle degree and the severity; the secondary symptoms (anorexia, oliguria, pale red tongue, thin and greasy coating, deep and thready pulse) are counted for 0, 1,2 and 3 points according to none, mild, moderate and severe symptoms respectively. The traditional Chinese medicine syndrome integral is the sum of scores of major symptoms and minor symptoms, and the curative effect is evaluated by combining the diagnosis of simple obesity and the evaluation standard of curative effect.
The clinical cure is as follows: the traditional Chinese medicine syndrome integral is reduced by more than or equal to 95 percent, or the body fat rate and the BMI reach the normal standard of the same age, and the related symptoms disappear.
The effect is shown: the traditional Chinese medicine syndrome integral is reduced by more than or equal to 70 percent but fails to meet the clinical healing standard, or the body fat rate is reduced by more than or equal to 5 percent, and the BMI is reduced by more than or equal to 4kg/m 2 But does not reach the normal standard, the relevant symptoms basically disappear.
The method has the following advantages: the traditional Chinese medicine syndrome integral is reduced by more than or equal to 30 percent but fails to reach the significance standard, or the body fat rate is reduced by more than or equal to 3 percent, and the BMI is reduced by more than or equal to 2kg/m 2 But does not reach the obvious standard, and the related symptoms are obviously improved.
And (4) invalidation: does not meet any of the above criteria.
Total effective rate = (number of clinical recovery cases + number of significant cases + number of effective cases)/number of total cases × 100%.
2.2 fat factors
3mL of venous blood (fasting) of the elbow before and after treatment of two groups of patients are extracted and centrifuged, the centrifugation speed, radius and time are 3500r/min, 8cm and 10min respectively, serum is separated, and the levels of glucagon-like peptide (GLP \8259; 2), adiponectin (APN) and lipocalin 2 (LCN 2) are determined by enzyme-linked immunosorbent assay (the kit is purchased from Shanghai Runhyu Biotech, ltd.).
2.3 adverse reactions
The occurrence of adverse reactions (nausea, diarrhea, muscle soreness) was recorded in both groups of patients during the treatment period.
3. Statistical method
Data were analyzed using SPSS24.0 software. The counting data are expressed in percentage by chi 2 Checking; measure data to
Indicate, adopttAnd (6) checking.P<0.05 indicates that the difference is statistically significant.
4. Results
4.1 comparison of clinical efficacy of two groups
The total effective rate of the treatment group is 90.70% (39/43), which is significantly higher than 72.1% (31/43) of the control group, and the difference is countedThe academic significance ofP<0.05). See table 7 for details.
4.2 comparison of adipokine levels before and after treatment
Before treatment, the levels of two groups of fat factors GLP \82592, APN and LCN2 are compared, and the difference has no statistical significance (P>0.05 Comparable to each other). After treatment, the levels of the adipokines in the two groups are statistically significant compared to the levels of GLP-2, LCN2, APN in the same group before treatment (P<0.05 And the treatment groups have more obvious reduction of GLP-2 and LCN2 and more obvious increase of APN, and the difference has statistical significance (1)P<0.05). See table 8 for details.
4.3 comparison of adverse reaction occurrence
The total incidence rate of adverse reactions in the treatment group is 9.3% (4/43), the control group is 7% (3/43), and the difference has no statistical significance (P>0.05). See table 9 for details.
Claims (8)
1. The damp-clearing pharmaceutical composition is characterized by comprising the following components in parts by weight: 5-25 parts of angelica dahurica, 5-25 parts of fried radish seed, 1-10 parts of flos caryophyllata, 5-25 parts of ligusticum wallichii, 5-20 parts of cinnamon, 5-25 parts of rhizoma acori graminei, 5-25 parts of fried rhizoma atractylodis, 5-25 parts of agastache rugosus and 5-25 parts of fried fennel.
2. The damp-clearing pharmaceutical composition according to claim 1, which comprises the following components in parts by weight: 10-20 parts of angelica dahurica, 10-20 parts of fried radish seed, 2-6 parts of flos caryophyllata, 10-20 parts of ligusticum wallichii, 6-15 parts of cinnamon, 10-20 parts of rhizoma acori graminei, 10-20 parts of fried rhizoma atractylodis, 10-20 parts of agastache rugosus and 10-20 parts of fried fennel.
3. The damp-clearing pharmaceutical composition according to claim 2, comprising the following components in parts by weight: 12-18 parts of angelica dahurica, 12-18 parts of fried radish seed, 3-4 parts of flos caryophyllata, 12-18 parts of ligusticum wallichii, 8-12 parts of cinnamon, 12-18 parts of rhizoma acori graminei, 12-18 parts of fried rhizoma atractylodis, 12-18 parts of agastache rugosus and 12-18 parts of fried fennel.
4. The preparation of the dampness eliminating pharmaceutical composition of any one of claims 1 to 3, wherein the preparation is prepared by adding pharmaceutically acceptable auxiliary materials into the dampness eliminating pharmaceutical composition.
5. The formulation of the damp-clearing pharmaceutical composition according to claim 4, wherein the formulation is a granule.
6. The method of preparing granules of the dampness-eliminating pharmaceutical composition of claim 5, comprising the steps of:
(1) Extracting volatile oil from radix Angelicae Dahuricae, flos Caryophylli, parched rhizoma Atractylodis, and herba Agastaches, collecting the water solution after extracting volatile oil with another container, and collecting the residue;
(2) Mixing the residues in the step (1) with fried radish seed, ligusticum wallichii, cinnamon, rhizoma acori graminei and fried fennel, decocting twice with water respectively, filtering, combining the decoctions, standing, and filtering out precipitates;
(3) Combining the decoction liquid prepared in the step (2) with the aqueous solution in the step (1), and concentrating under reduced pressure to obtain thick paste with the relative density of 1.30-1.35 at 50 ℃;
(4) Adding dextrin into the thick paste obtained in the step (3), drying, crushing, mixing with 0.2wt% of sucralose powder, granulating with 70-80wt% of ethanol as a wetting agent, drying, granulating, sieving to prepare granules, and drying;
(5) And (2) adding the dried granules into the volatile oil extracted in the step (1), and uniformly mixing to obtain the composition.
7. Use of the pharmaceutical composition for eliminating dampness of any one of claims 1 to 3, characterized in that the pharmaceutical composition for eliminating dampness is used for preparing a medicament for treating spleen deficiency damp-blocking syndrome.
8. The use of the preparation of the damp-clearing pharmaceutical composition according to claim 4, wherein the preparation of the damp-clearing pharmaceutical composition is used for preparing a medicament for treating spleen deficiency damp-obstruction syndrome.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109350718A (en) * | 2018-11-30 | 2019-02-19 | 柏荣琪 | Clearing damp Chinese medicine composition and preparation method thereof |
| CN111602734A (en) * | 2020-06-30 | 2020-09-01 | 广东永祥中药饮片厂股份有限公司 | Dampness eliminating tea and preparation method thereof |
| WO2022068391A1 (en) * | 2020-09-29 | 2022-04-07 | 江苏康缘药业股份有限公司 | Composition capable of dispelling dampness and reducing fat, preparation method therefor and use thereof |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109350718A (en) * | 2018-11-30 | 2019-02-19 | 柏荣琪 | Clearing damp Chinese medicine composition and preparation method thereof |
| CN111602734A (en) * | 2020-06-30 | 2020-09-01 | 广东永祥中药饮片厂股份有限公司 | Dampness eliminating tea and preparation method thereof |
| WO2022068391A1 (en) * | 2020-09-29 | 2022-04-07 | 江苏康缘药业股份有限公司 | Composition capable of dispelling dampness and reducing fat, preparation method therefor and use thereof |
Non-Patent Citations (1)
| Title |
|---|
| 贺又舜,伍参荣,赵国荣,胡建中,黄开颜: "甘露消毒丹对柯萨奇病毒体外抑制作用的实验研究", 中国中西医结合杂志 * |
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