CN115957272B - Pharmaceutical composition for eliminating dampness, preparation and application thereof - Google Patents
Pharmaceutical composition for eliminating dampness, preparation and application thereof Download PDFInfo
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Abstract
The invention discloses a medicinal composition for eliminating dampness, a preparation and application thereof, wherein the medicinal composition for eliminating dampness comprises the following components in parts by weight: 5-25 parts of radix angelicae, 5-25 parts of fried radish seeds, 1-10 parts of flos caryophylli, 5-25 parts of ligusticum wallichii, 5-20 parts of cinnamomum cassia seeds, 5-25 parts of rhizoma acori graminei, 5-25 parts of fried rhizoma atractylodis, 5-25 parts of wrinkled gianthyssop and 5-25 parts of fried fennel. The medicinal composition for eliminating dampness is added with pharmaceutically acceptable auxiliary materials to prepare a preparation. The medicinal composition and the preparation thereof can be used for preparing medicaments for treating phlegm-dampness internal resistance syndromes.
Description
Technical Field
The invention belongs to the field of medicines, and in particular relates to a medicinal composition for eliminating dampness, and a preparation and application thereof.
Background
The "damp evil" is one of six pathogenic factors (wind, cold, summer-heat, dampness, dryness and fire) in the theory of traditional Chinese medicine. Dampness belongs to yin evil and is heavy and turbid in nature and sticky. Damp invasion of body can damage yang qi of body, and can easily leave viscera and channels to obstruct qi movement, so that heavy and serious symptoms appear in human body. The pathogenic dampness is a disease, and the nature of secretion and excretion has the characteristic of dirty and turbid. Because of the damp viscosity, stagnates in certain viscera and tissues, and is difficult to resolve, the damp evil is a disease, and the disease is long in multiple courses, repeated in attacks and difficult to heal.
The traditional Chinese medicine is generally used for treating damp-syndrome by aromatic dampness-resolving herbs, and the aromatic dampness-resolving herbs refer to traditional Chinese medicines with the main effects of clearing away turbid and resolving dampness and activating spleen. However, most of the damp-resolving herbs are pungent, warm, fragrant and dry in nature and easy to damage yin and consume qi, so they should be used with cautions for yin deficiency, fluid consumption, red tongue, dry mouth and qi deficiency and hypodynamia. This places a great limit on the use of aromatic wet drugs.
Disclosure of Invention
Aiming at the defects existing in the prior art, the invention aims to provide a medicinal composition for eliminating dampness, and a preparation and application thereof. The pharmaceutical composition and the preparation thereof have the effects of resolving dampness with aromatics, strengthening spleen and regulating qi, and can be used for treating spleen deficiency and damp obstruction related symptoms, such as epigastric and abdominal fullness, anorexia, abdominal pain, loose stool, greasy mouth, anorexia, nausea, vomiting, limb heaviness, yellow body and eyes, body swelling and the like.
The invention aims at realizing the following technical scheme:
the medicinal composition for eliminating dampness comprises the following components in parts by weight: 5-25 parts of radix angelicae, 5-25 parts of fried radish seeds, 1-10 parts of flos caryophylli, 5-25 parts of ligusticum wallichii, 5-20 parts of cinnamomum cassia seeds, 5-25 parts of rhizoma acori graminei, 5-25 parts of fried rhizoma atractylodis, 5-25 parts of wrinkled gianthyssop and 5-25 parts of fried fennel.
Preferably, the dampness removing pharmaceutical composition comprises the following components in parts by weight: 10-20 parts of radix angelicae, 10-20 parts of fried radish seeds, 2-6 parts of flos caryophylli, 10-20 parts of ligusticum wallichii, 6-15 parts of cinnamomum cassia seeds, 10-20 parts of rhizoma acori graminei, 10-20 parts of fried rhizoma atractylodis, 10-20 parts of wrinkled gianthyssop and 10-20 parts of fried fennel.
More preferably, the pharmaceutical composition for eliminating dampness comprises the following components in parts by weight: 12-18 parts of radix angelicae, 12-18 parts of fried radish seeds, 3-4 parts of flos caryophylli, 12-18 parts of ligusticum wallichii, 8-12 parts of cinnamomum cassia seeds, 12-18 parts of rhizoma acori graminei, 12-18 parts of fried rhizoma atractylodis, 12-18 parts of wrinkled gianthyssop and 12-18 parts of fried fennel.
In the medicine composition, agastache rugosus and grassleaf sweelflag rhizome are monarch drugs, agastache rugosus takes the fragrant qi to dissolve the turbid dampness in the interior, can prevent the dirt from harmonizing the middle energizer and arrest vomiting, grassleaf sweelflag rhizome has the effects of resolving dampness and nourishing the spleen, and mainly removes middle-jiao dampness resistance, and agastache rugosus and grassleaf sweelflag rhizome are aromatic and are used as monarch drugs. The ministerial drugs comprise rhizoma atractylodis, radix angelicae, radish seed, clove and fennel, the rhizoma atractylodis has the effects of drying dampness and strengthening spleen, the radix angelicae has the effects of relieving exterior syndrome and dispelling wind, the dampness is removed, the dampness is more aided by the external evil, the dampness is sticky and greasy, qi movement is easy to be blocked, the radish seed reduces qi and eliminates phlegm, the clove warms middle and reduces adverse qi, the fennel regulates qi and harmonizes stomach, the three drugs are all qi-flowing and stomach-regulating drugs, the ascending and descending transportation and transformation of spleen and stomach are reconstructed, the rhizoma atractylodis has the effect of strengthening spleen, the four drugs are combined, the spleen transportation and transformation effect is enhanced, qi and blood are biochemically active to protect vital qi, so that the dampness is removed without hurting the vital qi, the fragrance of monarch drugs is matched, the dampness in the exterior syndrome is removed, the interior evil is removed, and the evil is not retained. The adjuvant drugs include rhizoma Ligustici Chuanxiong and cortex Cinnamomi, and the adjuvant drugs are used for promoting qi and blood circulation, invigorating fire and yang, warming and dredging channels, and enhancing cold dampness. All Fang Fangxiang has effects of eliminating dampness, promoting qi circulation, regulating stomach, invigorating spleen, regulating qi, promoting qi circulation, eliminating pathogenic factors, eliminating dampness, and eliminating body resistance.
The medicinal composition for eliminating dampness can be added with pharmaceutically acceptable auxiliary materials to prepare preparations such as granules, tablets, powder, pills and the like.
The dampness-dispelling pharmaceutical composition and the preparation thereof have the effects of dispelling dampness with aromatics, strengthening spleen and regulating qi, and can be used for treating spleen deficiency and dampness obstruction related symptoms, such as epigastric and abdominal fullness, anorexia, abdominal pain, loose stool, greasy mouth, anorexia, nausea, vomiting, limb heaviness, body and eye yellowing, body swelling and the like.
Compared with the prior art, the invention has the beneficial effects that:
1. the medicinal composition and the preparation thereof for eliminating dampness can effectively eliminate the dampness in the body, especially the dampness in the spleen and stomach in middle-jiao, can effectively relieve the symptoms of phlegm-dampness internal resistance, and have simple formula, safety and no side effect.
2. The traditional damp-dispelling herbs and the aromatic damp-resolving herbs are mostly pungent, warm, fragrant and dry, are easy to hurt yin and consume qi, and are limited in use, so that the pharmaceutical composition overcomes the defects, and can invigorate the spleen and regulate qi while dispelling dampness, so that the damp is removed without hurting the healthy energy.
3. The preparation of the pharmaceutical composition has reasonable design of the preparation process, improves the ointment yield, effectively prevents and controls the loss of the volatile oil components of the medicine in the decoction process, improves the utilization rate, and has the advantages of short production period, stable quality, convenient administration, small dosage and the like, and has good use effect.
Detailed Description
The present invention will be further described with reference to examples, but the present invention is not limited to the examples.
Example 1
A pharmaceutical composition for eliminating dampness comprises the following components: radix angelicae 5 g, fried radish seed 25 g, flos caryophylli 1g, rhizoma ligustici wallichii 5 g, cinnamon 20g, rhizoma acori graminei 5 g, fried rhizoma atractylodis 25 g, wrinkled gianthyssop 25 g and fried fennel 5 g.
Example 2
A pharmaceutical composition for eliminating dampness comprises the following components: 25 g of angelica dahurica, 5 g of fried radish seed, 10 g of flos caryophylli, 25 g of ligusticum wallichii, 5 g of cinnamon, 25 g of rhizoma acori graminei, 5 g of fried rhizoma atractylodis, 5 g of wrinkled gianthyssop 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 caryophylli, 10 g of ligusticum wallichii, 15 g of cinnamon, 20g of rhizoma acori graminei, 20g of fried rhizoma atractylodis, 10 g of wrinkled gianthyssop 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 caryophylli, 20g of ligusticum wallichii, 6 g of cinnamon, 10 g of rhizoma acori graminei, 10 g of fried rhizoma atractylodis, 20g of wrinkled gianthyssop and 20g of fried fennel.
Example 5
A pharmaceutical composition for eliminating dampness comprises the following components: 18 g of dahurian angelica root, 12 g of fried radish seed, 3 g of flos caryophylli, 18 g of szechuan lovage rhizome, 8 g of cassia seed, 18 g of grassleaf sweelflag rhizome, 12 g of fried rhizoma atractylodis, 18 g of wrinkled giant hyssop and 12 g of fried fennel.
Example 6
A pharmaceutical composition for eliminating dampness comprises the following components: 12 g of angelica dahurica, 18 g of fried radish seed, 4 g of flos caryophylli, 12 g of ligusticum wallichii, 12 g of cinnamon, 12 g of rhizoma acori graminei, 18 g of fried rhizoma atractylodis, 12 g of wrinkled gianthyssop 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 caryophylli, 15 g of ligusticum wallichii, 10 g of cinnamon, 15 g of rhizoma acori graminei, 15 g of fried rhizoma atractylodis, 15 g of wrinkled gianthyssop and 15 g of fried fennel.
Example 8
A pharmaceutical composition for eliminating dampness comprises the following components: radix angelicae 5 g, fried radish seed 5 g, flos caryophylli 1g, rhizoma ligustici wallichii 5 g, cinnamon 5 g, rhizoma acori graminei 5 g, fried rhizoma atractylodis 5 g, wrinkled gianthyssop 5 g and fried fennel 5 g.
Example 9
A pharmaceutical composition for eliminating dampness comprises the following components: 25 g of angelica dahurica, 25 g of fried radish seed, 10 g of flos caryophylli, 25 g of ligusticum wallichii, 20g of cinnamon, 25 g of rhizoma acori graminei, 25 g of fried rhizoma atractylodis, 25 g of wrinkled gianthyssop and 25 g of fried fennel.
Example 10
The medicinal materials of the medicinal composition according to any one of the embodiments 1-9 are weighed and crushed according to the weight of the medicinal composition, and the medicinal composition is prepared according to the following steps:
(1) Extracting volatile oil from radix Angelicae Dahuricae, flos Caryophylli, parched rhizoma Atractylodis and herba Agastaches, collecting the aqueous solution after extracting volatile oil in another container, and keeping the residue;
(2) Mixing the residues in the step (1) with the fried radish seeds, the ligusticum wallichii, the cinnamon, the grassleaved sweetflag rhizome and the fried fennel, and respectively adding water for decoction twice: adding 10 times of water for the first time, decocting for 1 hour, 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, and preferably filtering with 180-200 mesh sieve;
(3) Combining the decoction obtained in the step (2) with the aqueous solution obtained in the step (1), and concentrating under reduced pressure to obtain 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, granulating, sieving, granulating and drying;
(5) Adding the dried particles into the volatile oil extracted in the step (2), and uniformly mixing to obtain the product.
Application example 1-the pharmaceutical composition for eliminating dampness of the invention improves the action and mechanism of spleen deficiency and dampness obstruction type obese rats
1. Materials and instruments
SD male rats: SPF grade, 8 weeks of age, body mass 210-220 g, henan province laboratory animal center; superoxide dismutase (SOD), glutathione (GSH) and Malondialdehyde (MDA) detection kit: nanjing builds the institute of bioengineering; glucose, insulin detection kit: shanghai Sean Biotech Co., ltd; total Cholesterol (TC), triglyceride (TG) detection kit: beijing Soy Bao technology Co., ltd; ultrasonic cleaner: JM-03D-40 type, shenzhen clean Equipment Co., ltd; ultraviolet visible spectrophotometer: model 721N, shanghai electric analysis instruments Co., ltd; electronic analytical balance: FA2004, shanghai precision instruments, inc; blood glucose meter: GA-3, shanghai mu medical instruments inc; full-automatic biochemical analyzer: AU480, beckmann Kort trade company, china; transfer electrophoresis apparatus: DYCZ-40K, beijing six biotechnology Co.
2. Method of
2.1 grouping, modeling and administration
2.1.1 grouping: the method of grouping according to the body quality is adopted, and the method is divided into a control group, a model group and a dosing group, wherein each group comprises 10 animals.
2.1.2 modeling of spleen deficiency wet-resistance obese rats: reference Zhao Zinan, zhu Yilin, zheng Lixin, pottery, cai Xiang, zhang Nan, wang Chun, zhang Jianjun, tian Shimin, wang Linyuan. Study of the weight-reducing effect of spleen-tonifying, dampness-removing and turbidity-relieving formulation on spleen-deficiency dampness-blocking type obese rats [ J ]. Chinese medicine in the world, 2022,15 (12): 2297-2303 literature, rats were given high calorie feed (15% sucrose and 15% lard were added to the maintenance feed), and simultaneously were irrigated with brown sugar water for 16 days and swim for 3 weeks to establish a spleen-deficiency dampness-blocking type simple obese rat model. Food intake was recorded every week, and the body mass was weighed 1 time. After 2 weeks of feeding, rats given high calorie feed were reordered according to body mass gain, 1/3 obese resistant rats with lower body mass gain were eliminated, and obese sensitive rats were screened as model group rats.
2.1.3 dosing: the administration group was perfused with a dose of 200mg/kg (the granular preparation used in this application example was prepared by the preparation method described in example 10 using the drug dose described in example 8), and the control group and the model group were perfused with a dose of 0.9% nacl solution 1 time a day until the end of week 12, with reference to the standard of conversion of human and animal doses in experimental zoology.
2.2 index detection
2.2.1 measurement of rat Mass
During the test, rats were weighed periodically weekly with a scale of 0.1 g.
2.2.2 determination of serum lipid metabolism index and oxidative stress index of rat
Rats on the 12 weekends are fasted for 12 hours, blood is taken from the aorta on the lower abdomen under anesthesia for 3mL, and serum is centrifuged and separated for preservation at-20 ℃. Taking serum to be detected, detecting the contents of TC and TG in the serum by a colorimetric method, determining the activity of SOD in the serum by a xanthine oxidase method, determining the concentration of GSH in the serum by a micro enzyme labeling method, and determining the MDA content in the serum by a thiobarbituric acid method.
2.2.3 determination of serum glucose and insulin content in rats
Taking serum to be detected, measuring Fasting Blood Glucose (FBG) value by glucose oxidase method, and detecting fasting insulin (F) by ELISA INS ) Is tested according to the instructions of the kit. Calculating insulin resistance index (H) according to formula (1) OMA-IR ）。
Formula (1) H OMA-IR =F BG ×F INS /22.5
Wherein:
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 index of groups of rats
Long-term high-fat diet interferes with lipid metabolism, energy metabolism and intestinal microecology, triggering abnormal lipid metabolism, and causing obesity. As can be seen from Table 1, the difference of initial body mass, TG and TC contents of each group of rats has no statistical significanceP>0.05 With comparability). The quality, TG and TC contents of the 12-weekend model group and the administration group are higher than those of the control group, and the difference is statistically significantP<0.05). Compared with the model group, the quality, TG and TC content of the administration group are reduced, and the difference has statistical significanceP<0.05). The medicine group can effectively reduce the body mass and TG and TC content of the IR rat. Details are shown in Table 1.
3.2 changes in serum oxidative stress index in groups of rats
Obesity can trigger metabolic abnormality, cause immune cell activation and infiltration, induce inflammation, and trigger peroxidation stress. As can be seen from Table 2, the SOD activity and GSH concentration of the model group and the administration group are lower than those of the control group, and the difference is statistically significantP<0.05 A) is provided; MDA content is highIn the control group, the difference has statistical significanceP<0.05). Compared with the model group, the SOD activity and GSH concentration of the administration group are increased, and the difference has statistical significanceP<0.05 A) is provided; MDA content of the administration group is reduced, and the difference has statistical significanceP<0.05). The administration group can effectively increase SOD activity and GSH concentration of IR rats and reduce MDA content. Details are shown in Table 2.
3.3 changes in serum glucose and insulin levels in groups of rats
Under physiological state, insulin can regulate and control the stability of blood sugar through the measures of glucose intake, hepatic glycogen output inhibition and the like. As can be seen from Table 3, the model group and the administration group are higher in FBG, FINS, HOMA-IR than the control group, and the difference is statistically significantP<0.05). Compared with the model group, the FBG, FINS, HOMA-IR of the administration group is increased, and the difference has statistical significanceP<0.05). Demonstrating that the dosing group was effective in reducing the FBG, FINS, HOMA-IR levels in IR rats. Details are shown in Table 3.
Application example 2-discussing the action mechanism of the dampness-dispelling pharmaceutical composition of the invention for improving spleen deficiency dampness-blocking obese mice based on AMPK Signal pathway
1. Materials and instruments
1.1 laboratory animals
Mice were kept in the university of chinese medicine laboratory animal center in Yunnan, raising conditions: the room temperature is 22-26 ℃, the relative humidity is 50% -60%, the ventilation environment is good, the mice are adaptively fed for 1 week in a quiet and clean environment, and the mice eat and feed water freely and are illuminated in a circadian rhythm.
1.2 drugs and Agents
The high-fat feed consists of 78.8% of basic feed, 1% of cholesterol, 10% of yolk powder, 10% of lard and 0.2% of bile salt, and is purchased from Zhengzhou Huaxing experimental animal farms; streptozotocin (STZ), lot number: c12797481, beijing de shengjia navigation technologies.
1.3 major instrumentation
660 blood glucose detector, DXC600 full-automatic biochemical analyzer, beckman, usa; ti-E optical microscope, nikon corporation, japan.
2 method
2.1 grouping, modeling and administration of animals
2.1.1 grouping: the method of grouping according to the body quality is adopted, and the method is divided into a control group, a model group and a dosing group, wherein each group comprises 10 animals.
2.1.2 modeling of spleen deficiency wet-resistance obese mice: after 3 weeks of feeding with high fat diet, the water wet litter factor (50 g litter plus 100 mL) was increased from week 4 and the mold was co-molded for 10 weeks. Modeling screening index and symptom score reference: zhu Mengmeng, wang Lixin, kai Yu, zhang Zegu, zhao Tianci, ge Shaoqin. Construction and evaluation of model of spleen deficiency and dampness resistance type simple obesity mice J. Chinese basic medicine, 2021,27 (02): 247-250+328.DOI:10.19945/J. Cnki. Issn.1006-3250.2021.02.018, (1) stool water content higher than that of normal mice was defined as loose stool mice. (2) The mass of the model building body is increased by more than 20.0%, and the screening index and symptom score are more than or equal to 10 minutes, thus the model building body is defined as a spleen deficiency dampness obstruction type simple obese mouse.
2.1.3 dosing: mice that were successfully molded were randomly divided into 2 groups, which were model group and administration group (24 mg/kg), and the granular formulation of the pharmaceutical composition of the present invention was administered 10:00 a day in the morning (the granular formulation used in this application example was prepared by the preparation method described in example 10 using the pharmaceutical dose described in example 4), and the control group and model group were administered with the corresponding volumes of physiological saline 1/d 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 blood sugar (blood sampling of tail vein and blood sugar concentration measurement) of the mice are respectively detected on days 2, 14, 28 and 42 after the successful molding.
2.2.2 changes in blood lipid levels in mice of groups
At the end of the administration period, mice were sacrificed by eyeball-picking and blood was taken, left to stand for 30min, centrifuged for 10min (4 ℃ C., 4000 r/min), the upper serum was extracted, numbered, and placed in a full-automatic biochemical analyzer for detection.
3. Statistical treatment
SPSS25.0 software is adopted for analysis, and data are measured to obtain the product
) The data of the experimental group meeting normal distribution and having uniform variance is subjected to variance analysis, LSD (least squares) test is adopted for comparison between the groups, and if the normal distribution or the variance is not met, non-parametric test is adopted; to be used forP<A difference of 0.05 is statistically significant.
4. Results
4.1 variation of body Mass in mice of groups
As shown in Table 4, the model group, the dosing group mice showed increased mass on days 2, 14, 28 and 42, and the difference was statistically significantP<0.05). Compared with the model group, the quality of mice in the administration group is reduced at 28 th and 42 th days, and the difference has statistical significanceP<0.05). Details are shown in Table 4.
4.2 Effect on fasting blood glucose in obese type 2 diabetic mice
As shown in Table 5, the mice in the model group, the administration group, and the mice in the administration group were increased in blood glucose level at the 2 nd, 14 th, 28 th and 42 th sky, and the difference was statistically significantP<0.05). Compared with the model group, the fasting blood glucose of the mice in the administration group is reduced on days 14, 28 and 42, and the difference is statistically significantP<0.05). Details are shown in Table 5.
4.3 changes in blood lipid in mice of groups
The results are shown in Table 6, and compared with the control group, model group mice TC,TG, LDL-C increase, HDL-C decrease, difference has statistical significanceP<0.05 A) is provided; the TG of the mice of the administration group is reduced, HDL-C is increased, and the difference has statistical significanceP<0.05). Compared with the model group, the administration group mice have reduced TG and raised HDL-C, and the difference has statistical significanceP<0.05). Details are shown in Table 6.
Application example 3-clinical observation of the dampness-dispelling pharmaceutical composition of the invention for treating spleen deficiency dampness-blocking obese patients
1. General data
86 cases of spleen deficiency and damp obstruction type obese patients diagnosed and treated by the department of spleen and stomach diseases outpatient service in traditional Chinese medicine hospitals in Yunnan province are collected from 27 days of 1 month in 2022 to 6 months of 1 day; the control group and the treatment group were divided into 43 cases by a random number table method. 23 men and 20 women in the control group; age 18-30 years, average (23.21±4.49) years; body Mass Index (BMI) of 23-28 kg/m 2 Average (25.84.+ -. 2.98) kg/m 2 The method comprises the steps of carrying out a first treatment on the surface of the The body fat rate is 28-40%, and the average (35.25+/-5.04)%. 26 men and 17 women in the treatment group; age 17-35 years, average (25±6.28) years; (BMI) 24.5-29.5 kg/m 2 Average (26.15.+ -. 3.15) kg/m 2 The method comprises the steps of carrying out a first treatment on the surface of the The body fat percentage is 29-39%, and the average (35.26+/-5.25)%. The two groups of general data are statistically analyzed, and the difference has no statistical significanceP>0.05 With comparability).
In 43 cases of the control group, diet exercise therapy is adopted, and diet is based on the principle of balanced nutrition and low energy, wherein the average daily energy intake is reduced by 30-50% or 500kcal or the daily energy intake is limited to 1000-1500 kcal of restricted diet energy according to the national expert for obesity prevention and treatment. The daily intake of 20-25% of protein, 20-30% of fat energy supply ratio and 45-60% of carbohydrate energy supply ratio are maintained. Guaranteeing the intake of vitamins, proteins and trace elements, strictly controlling the intake of animal fat, avoiding taking fast food, sweet food, fried food, carbonated beverage and the like, and reducing night as much as possible. The sports are mainly aerobic sports and anti-resistance sports, and can also be mainly middle-low-strength aerobic sports such as jogging, rope skipping, riding a bicycle, badminton playing, fast walking and the like by changing the sports mode or adopting high-strength intermittent sports, the specific projects are selected according to preference of patients and external conditions, and the sports are preferably carried out in a sectional intermittent mode for 30min in the morning and afternoon, 3 times per week and every other day. The treatment group is combined with the pharmaceutical combination granule preparation for eliminating dampness of the invention on the basis of the treatment method of the control group for oral administration, and the pharmaceutical combination granule preparation for eliminating dampness is prepared by adopting the preparation method of the embodiment 10 and adopting the pharmaceutical dosage of the embodiment 1. Three times a day, 100mL at a time, warm administration and five days as a treatment course.
2. Observation index
2.1 clinical efficacy
Calculating by referring to the integral of the damp obstruction syndrome of the spleen deficiency of obesity in the clinical study guidelines (trial) of the new traditional Chinese medicine, and respectively recording 0, 2, 4 and 6 points of main symptoms (edema, obesity, fatigue, heaviness and limb weakness) according to the non-weight, the mild weight, the moderate weight and the severe weight; the secondary symptoms (anorexia, oliguria, pale red tongue, thin and greasy coating and deep and thready pulse) are recorded as 0, 1,2 and 3 respectively according to the condition of no, mild, moderate and severe. The traditional Chinese medicine syndrome integration is the sum of the main symptoms and the secondary symptoms, and the curative effect is evaluated by combining with the diagnosis and curative effect evaluation criteria of simple obesity.
Clinical recovery: the integral drop of the symptoms of the traditional Chinese medicine is more than or equal to 95 percent, or the body fat rate and BMI reach the normal standard of the same age, and the related symptoms disappear.
The effect is shown: the integral drop of the symptoms of the traditional Chinese medicine is more than or equal to 70 percent, but does not reach the clinical cure standard, or the body fat rate is more than or equal to 5 percent, and the BMI is more than or equal to 4kg/m 2 But does not meet the normal standard, the related symptoms are basically disappeared.
The method is effective: the integral drop of the symptoms of the traditional Chinese medicine is more than or equal to 30 percent, but does not reach the obvious effect standard, or the body fat rate is more than or equal to 3 percent, and the BMI is more than or equal to 2kg/m 2 But the obvious effect standard is not reached, and the related symptoms are obviously improved.
Invalidation: does not meet any of the criteria described above.
Total effective rate= (number of clinical recovery cases + number of significant cases + number of effective cases)/total case number x 100%.
2.2 fat factor
3mL of elbow venous blood (fasting) before and after treatment of two groups of patients were extracted and subjected to centrifugation at 3500r/min, 8cm and 10min for each of the centrifugation rate, radius and time, serum was separated, and glucagon-like peptide (GLP ⁃ 2), adiponectin (APN) and lipocalin 2 (LCN 2) levels were measured by an ELISA (kit is available from Shanghai Runfu Biotechnology Co.).
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. Count data is expressed in percent, using χ 2 Checking; metering data to
Representation, use oftAnd (5) checking.P<0.05 indicates that the difference is statistically significant.
4. Results
4.1 comparison of two groups of clinical efficacy
The total effective rate of the treatment group is 90.70% (39/43), which is obviously higher than 72.1% (31/43) of the control group, and the difference has statistical significanceP<0.05). See Table 7 for details.
4.2 comparison of fat factor levels before and after treatment
Before treatment, the two groups of fat factors GLP ⁃, APN and LCN2 are compared, and the difference has no statistical significanceP>0.05 With comparability). After treatment, the two groups of fat factors have statistically significant difference compared with GLP-2 and LCN2 reduction and APN increase before treatment in the same groupP<0.05 And GLP-2 and LCN2 of the treatment group are obviously reduced, APN is obviously increased, and the difference has statistical significanceP<0.05). Details are shown in Table 8.
4.3 comparison of adverse reactions
The total incidence rate of adverse reaction of the treatment group is 9.3 percent (4/43), the control group is 7 percent (3/43), and the difference has no statistical significanceP>0.05). See Table 9 for details.
Claims (8)
1. The medicinal composition for eliminating dampness for treating spleen deficiency and dampness retention is characterized by comprising the following components in parts by weight: 5-25 parts of radix angelicae, 5-25 parts of fried radish seeds, 1-10 parts of flos caryophylli, 5-25 parts of ligusticum wallichii, 5-20 parts of cinnamomum cassia seeds, 5-25 parts of rhizoma acori graminei, 5-25 parts of fried rhizoma atractylodis, 5-25 parts of wrinkled gianthyssop and 5-25 parts of fried fennel.
2. The pharmaceutical composition for eliminating dampness for treating spleen deficiency and dampness obstruction syndrome according to claim 1, which is characterized by comprising the following components in parts by weight: 10-20 parts of radix angelicae, 10-20 parts of fried radish seeds, 2-6 parts of flos caryophylli, 10-20 parts of ligusticum wallichii, 6-15 parts of cinnamomum cassia seeds, 10-20 parts of rhizoma acori graminei, 10-20 parts of fried rhizoma atractylodis, 10-20 parts of wrinkled gianthyssop and 10-20 parts of fried fennel.
3. The pharmaceutical composition for eliminating dampness for treating spleen deficiency and dampness obstruction syndrome according to claim 2, which is characterized by comprising the following components in parts by weight: 12-18 parts of radix angelicae, 12-18 parts of fried radish seeds, 3-4 parts of flos caryophylli, 12-18 parts of ligusticum wallichii, 8-12 parts of cinnamomum cassia seeds, 12-18 parts of rhizoma acori graminei, 12-18 parts of fried rhizoma atractylodis, 12-18 parts of wrinkled gianthyssop and 12-18 parts of fried fennel.
4. A formulation of a pharmaceutical composition for the treatment of damp-retention due to spleen deficiency according to any one of claims 1 to 3, wherein the formulation is prepared by adding pharmaceutically acceptable excipients to the pharmaceutical composition for the treatment of damp-retention due to spleen deficiency.
5. The formulation of a pharmaceutical composition for the treatment of spleen deficiency and damp obstruction according to claim 4, wherein the formulation is a granule.
6. The method for preparing the granules of the dampness eliminating pharmaceutical composition for treating spleen deficiency and dampness obstruction syndrome according to claim 5, which is characterized by comprising the following steps:
(1) Extracting volatile oil from radix Angelicae Dahuricae, flos Caryophylli, parched rhizoma Atractylodis and herba Agastaches, collecting the aqueous solution after extracting volatile oil in another container, and keeping the residue;
(2) Mixing the residues obtained in the step (1) with the fried radish seeds, the ligusticum wallichii, the cinnamon, the rhizoma acori graminei and the fried fennel, respectively adding water for decocting for two times, filtering, mixing the decoctions, standing, and filtering out precipitates;
(3) Combining the decoction obtained in the step (2) with the aqueous solution obtained 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, uniformly mixing with 0.2wt% of sucralose powder, granulating by taking 70-80wt% of ethanol as a wetting agent, drying, granulating, sieving, granulating and drying;
(5) Adding the dried particles into the volatile oil extracted in the step (1), and uniformly mixing to obtain the product.
7. The use of a pharmaceutical composition for the treatment of spleen deficiency and dampness obstruction syndromes according to any of claims 1 to 3, wherein the pharmaceutical composition for the treatment of spleen deficiency and dampness obstruction syndromes is used for preparing a medicament for the treatment of spleen deficiency and dampness obstruction syndromes.
8. The use of the preparation of the pharmaceutical composition for eliminating dampness for treating spleen deficiency dampness retention according to claim 4, wherein the preparation of the pharmaceutical composition for eliminating dampness for treating spleen deficiency dampness retention is used for preparing a medicament for treating spleen deficiency dampness retention.
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| 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 |
| CN112167624A (en) * | 2020-09-29 | 2021-01-05 | 江苏康缘药业股份有限公司 | Composition with effects of clearing damp and reducing fat and preparation method and application thereof |
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