CN114450021A - Traditional Chinese medicine composition for preparing medicine for treating edema - Google Patents
Traditional Chinese medicine composition for preparing medicine for treating edema Download PDFInfo
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- CN114450021A CN114450021A CN201980031448.0A CN201980031448A CN114450021A CN 114450021 A CN114450021 A CN 114450021A CN 201980031448 A CN201980031448 A CN 201980031448A CN 114450021 A CN114450021 A CN 114450021A
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/36—Skin; Hair; Nails; Sebaceous glands; Cerumen; Epidermis; Epithelial cells; Keratinocytes; Langerhans cells; Ectodermal cells
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/10—Antioedematous agents; Diuretics
Abstract
A Chinese medicinal composition is prepared from fructus Aurantii Immaturus, Atractylodis rhizoma, Ginseng radix, fructus Lycii, colla Corii Asini, Polygoni Multiflori radix, semen Cassiae, and Aloe. Pharmacological experiments show that: the medicinal composition has good regulation and control effects on the level of the edematous thyroid gland of a rat, the content of urine protein, a cyclic nucleotide system, serum protein and blood fat level, has significant difference compared with a model group, and has good treatment effect on the edematous caused by various reasons.
Description
The invention relates to a new application of a traditional Chinese medicine composition, in particular to an application of the traditional Chinese medicine composition in preparing a medicine for treating edema, and belongs to the technical field of traditional Chinese medicines.
Edema refers to the swelling of the tissue due to excessive fluid accumulation in the interstitial spaces of the body. Depending on the extent of distribution, edema may manifest as either local or systemic edema. The mild, moderate and severe edema can be classified according to the degree of edema, the mild edema is only seen in eyelid and soft tissue under the orbit, the subcutaneous tissue of the anterior tibia and the ankle, the mild depression of the tissue can be seen after finger pressure, and the weight can be increased by about 5%. Medium: loose tissues all over the body can have visible edema, and obvious or deep tissue depressions can appear after finger pressure, which is slow to recover. And (3) severe degree: severe edema of the tissues of the whole body, low-drop body, tense and shiny skin, and even fluid exudation, which may be accompanied by pleural effusion, abdominal effusion and coleopteran effusion.
The mechanisms of edema include imbalance of fluid exchange between the inside and outside of the body and imbalance of fluid exchange between the inside and outside of blood vessels. The main reasons of imbalance of fluid exchange (sodium water retention) in vitro and in vivo are imbalance of glomerular filtration function and renal tubule reabsorption function, which causes sodium water retention and increase of extracellular fluid, including decrease of glomerular filtration rate, renal blood flow redistribution, increase of reabsorbed sodium water of proximal tubule, and increase of reabsorbed sodium water of distal tubule and collecting duct; although body tissue fluid generates a little bit of backflow under the effect of effective filter-pressing pressure, the dynamic balance of fluid inside and outside blood vessels can be maintained through lymphatic backflow, if the dynamic balance is damaged, the fluid inside and outside the blood vessels is unbalanced, edema is generated, and the main reasons for damaging the dynamic balance are reduction of plasma colloid osmotic pressure, increase of fluid static pressure in capillary vessels, increase of capillary permeability, obstruction of lymphatic backflow and retention of sodium and water assisted by a renin-angiotensin-aldosterone system.
At present, the treatment of edema mainly adopts the modes of causal treatment, symptomatic treatment, water and sodium intake limitation, close monitoring of liquid inflow and outflow, and the like. The drug therapy of edema is mainly western medicine therapy, and the drugs for therapy are mainly diuretics, dehydrated drugs, plasma products and albumin. Drugs such as diuretics can discharge excessive body fluid in a short time, but long-term application of diuretics often causes adverse reactions such as imbalance of electrolytes and body fluid balance in the body, blood pressure drop, metabolic disturbance, impaired glucose tolerance and the like.
According to traditional Chinese medicine dialectical evidence, edema refers to a disease which is caused by the condition of exogenous pathogenic factors, eating disorder or overstrain, the failure of lung to regulate, the failure of spleen to transport, the failure of kidney to gasify and the failure of bladder to open and close, and causes retention of water in the body and the overflow of skin, and shows the clinical manifestations of edema of the head, face, eye curtain, limbs, abdomen and back and even the whole body. The formation of edema is related to wind attacking the exterior, external infection of water dampness, improper diet, and physical weakness and internal injury. Edema is localized in the lung, spleen and kidney, while the key is in the kidney. The etiological factors are wind pathogen, water dampness, sore toxicity and blood stasis. The pathogenesis of the disease is characterized by the loss of the lung to regulate the flow, the loss of the spleen to transmit, the loss of the kidney to open and close, the retention of water and the flooding to form swelling. The nature of the disease is always deficient and marked with excess, and the disease is divided into yin water and yang water, which can be transformed into each other under certain conditions.
The traditional Chinese medicine treatment of edema is carried out by combining treatment and conditioning, and has the advantages of obvious symptom improvement, diuresis for inducing diuresis for removing edema, moderate and stable reaction, less adverse reaction and the like. The traditional Chinese medicine is used for treating edema, so that the traditional Chinese medicine can induce diuresis to alleviate edema and recover the functions of visceral organs, is beneficial to controlling the development of diseases, avoids the damage to the visceral organs and avoids the adverse reaction brought by hormone medicine treatment.
For the treatment of edema, compared with western medicines, the traditional Chinese medicine has unique advantages and becomes an effective and feasible treatment means.
Chinese patent CN100453105C discloses a composition with functions of relaxing bowels, expelling toxin, losing weight and reducing fat and a preparation method thereof. The composition is prepared from eight traditional Chinese medicines of polygonum multiflorum, aloe, cassia seed, medlar, donkey-hide gelatin, ginseng, bighead atractylodes rhizome and immature bitter orange, and has a good treatment effect on constipation caused by toxin accumulation and yin fluid deficiency. Related products are already on the market and have the product name 'hou hui cathartic capsule'.
The invention relates to a new application of a traditional Chinese medicine composition in treating edema, which is developed on the basis of the Chinese patent of invention CN 100453105C.
The traditional Chinese medicine composition is mainly prepared from immature bitter orange, bighead atractylodes rhizome, ginseng, wolfberry fruit, donkey-hide gelatin, polygonum multiflorum, cassia seed and aloe.
The traditional Chinese medicine composition comprises the following components in parts by weight:
50-200 parts of immature bitter orange, 20-100 parts of largehead atractylodes rhizome, 30-600 parts of aloe
30-150 donkey-hide gelatin of medlar, 30-150 fleece-flower root, 25-400
30-500 parts of cassia seed and 20-100 parts of ginseng.
Preferably, the traditional Chinese medicine composition comprises the following components in parts by weight:
80-150 parts of immature bitter orange, 20-80 parts of largehead atractylodes rhizome, 100 parts of aloe and 200 parts of aloe
30-100 donkey-hide gelatin of medlar, 30-100 fleece-flower root, 60-150
80-180 parts of cassia seed and 20-80 parts of ginseng;
preferably, the traditional Chinese medicine composition comprises the following components in parts by weight:
80-120 parts of immature bitter orange, 30-50 parts of largehead atractylodes rhizome, 120 parts of aloe and 160 parts of common aloe
50-80 donkey-hide gelatin of medlar, 40-80 fleece-flower root, 80-120
100 portions of cassia seed and 20 to 50 portions of 150 portions of ginseng;
in one of the more preferable cases, the traditional Chinese medicine composition comprises the following components in parts by weight:
immature bitter orange 110, largehead atractylodes rhizome 50 and aloe 130
Wolfberry fruit 70 donkey-hide gelatin 60 fleece-flower root 80
Cassia seed 100 ginseng 30;
in a more preferable embodiment, the traditional Chinese medicine composition comprises the following components in parts by weight:
immature bitter orange 120 bighead atractylodes rhizome 50 aloe 160
75 donkey-hide gelatin of Chinese wolfberry fruit, 75 fleece-flower root, 120
Cassia seed 140 ginseng 50.
The fundamental pathological changes of edema include loss of the lung-qi, loss of the spleen-qi, loss of the kidney-qi and dysfunction of the triple energizer. The chapter "Jingyue full book. swelling" notes: the pattern of edema refers to the condition of the three related organs of lung, spleen and kidney, and the water covering the lung is the most yin, so it is the kidney; hydrate in qi, so it is targeted at the lung; water only fears earth, so it is localized in the spleen. "
The theory of traditional Chinese medicine considers that:
the spleen governs transportation and transformation, including transporting and transforming food and water. The spleen can absorb and distribute water, and prevent stagnation of water in vivo. The water taken by the human body needs to be absorbed and transformed by the spleen to be distributed throughout the body to play the role of nourishing and moistening; meanwhile, the spleen transfers the excess water utilized by various tissues and organs to the lung and kidney in time, and the excess water is transformed into sweat and urine through the qi transformation of the lung and kidney and then discharged out of the body. The spleen governs transportation and transformation of water, and can nourish the tissues and organs of the body and prevent water from staying abnormally in the body, thereby maintaining the relative balance of water metabolism. On the other hand, if the spleen transports and transforms into the functional market of water, water can not distribute and stagnate in the body, and edema can be produced. In the traditional Chinese medicine composition, the immature bitter orange and the bighead atractylodes rhizome are used as monarch drugs, and the immature bitter orange and the bighead atractylodes rhizome enter spleen channels together, so that the traditional Chinese medicine composition can eliminate dampness, promote diuresis, invigorate spleen and replenish qi. The combination of the two drugs can eliminate dampness, strengthen spleen, induce diuresis and reduce edema, and quickly discharge retained water in body.
The normal metabolism of water is closely related to the normal function of the five zang-organs, and the balance between yin and yang, especially yang qi, qi transformation with yang hyperactivity, and water transformation with qi transformation. Kidneys govern the zang-fu organs of water. The spleen governs transportation and transformation of water, which is the pivotal point of water metabolism. The lung governs water, which is the upper source of water. The liver governs smoothing flow of qi and regulates qi movement, while qi movement governs water movement. Heart governs blood vessels to promote blood circulation and promote diuresis. Drinking water enters the stomach, the water in the middle energizer is transported and transformed by the spleen qi, and the liver qi is used for dispersing essence in the upper energizer; the heart and lung live together in the upper jiao, the water in the upper jiao is clear water, the clear water can spread to muscle striae, skin and hair, limbs and bones through the lung qi and the heart vessels, and the metabolic waste is changed into sweat and the like to be discharged out of the body; the turbid in the clear fluid can descend the lung qi to reach the lower energizer; the water entering the kidney is turbid, while the turbid clear water rises to the heart and lung through the transpiration of kidney qi to participate in metabolism again, while the turbid clear water is sent to the bladder through the opening and closing of kidney qi to be discharged. If a problem occurs in a certain organ during water metabolism, water will be retained in the body to form edema and edema. Therefore, the fleece-flower root, the ginseng and the donkey-hide gelatin are used as ministerial drugs, the ginseng is used for entering spleen, lung, heart and kidney channels, the fleece-flower root is used for entering liver, heart and kidney channels, and the donkey-hide gelatin is used for entering the lung, liver and kidney channels, and are used together to regulate five internal organs and triple energizer, smooth water passage and maintain water balance in vivo. In addition, the cassia seed and the aloe are used as adjuvant drugs, and both of the cassia seed and the aloe enter liver and large intestine channels, so that the liver governs smoothing flow of qi and regulates qi movement, and qi movement leads to water movement to assist in promoting metabolism of water in vivo; when the large intestine discharges dregs, it can remove the residual water, which is a way to excrete body fluid and can eliminate edema.
The whole process of water metabolism requires the coordination of physiological functions of the five zang-organs and six fu-organs, and mainly involves the functional activities of the lung, spleen and kidney. The fundamental pathological changes of edema include loss of the lung-qi, loss of the spleen-qi, loss of the kidney-qi and dysfunction of the triple energizer. The chapter "Jingyue full book. swelling" notes: the pattern of edema refers to the condition of the three related organs of lung, spleen and kidney, and the water covering the lung is the most yin, so it is the kidney; hydrate in qi, so it is targeted at the lung; water only fears earth, so it is localized in the spleen. The syndrome of edema is mainly in the kidney, and in the formula, wolfberry fruit is used as a guiding drug, enters the kidney channel, guides the drugs to directly reach the kidney channel, and promotes the metabolism of the aqueous solution in the human body.
In the traditional Chinese medicine formula, the traditional Chinese medicine has a remarkable curative effect of clinically treating edema caused by various reasons.
In particular, the edema of the present invention includes systemic edema and local edema.
Preferably, the generalized edema includes cardiac edema, renal edema, hepatic edema, malnutritional edema, and drug-induced edema.
Preferably, the local edema is edema caused by local vein, lymphatic return obstruction or capillary permeability increase.
The invention also provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps:
(1) grinding colla Corii Asini into fine powder, and sieving with 80 mesh sieve;
(2) reflux-extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae and Aloe with 60% ethanol for 2 times, mixing extractive solutions, and filtering to obtain filtrate I;
(3) decocting fructus Lycii, Atractylodis rhizoma and fructus Aurantii Immaturus in water twice, mixing decoctions, filtering, concentrating to obtain fluid extract with relative density of 1.10-1.20 (80 deg.C), cooling to room temperature, adding ethanol to make ethanol content 60%, standing for 24 hr, filtering, and collecting filtrate II;
(4) and (3) combining the filtrate I obtained in the step (2) and the filtrate II obtained in the step (3), concentrating the mixture into thick paste with the relative density of 1.30-1.35 (70 ℃), drying the thick paste, crushing the dried thick paste, and adding the donkey-hide gelatin fine powder prepared in the step (1) to obtain the traditional Chinese medicine composition.
The traditional Chinese medicine composition prepared by the steps is directly prepared into clinically acceptable formulations, such as oral pharmaceutical preparations, by the conventional process or by adding pharmaceutically acceptable excipients.
Preferably, the oral pharmaceutical preparation is a clinically conventional oral dosage form such as pills, granules, capsules, tablets, oral liquid or syrup.
Further preferably, the oral pharmaceutical preparation is a capsule.
Compared with the prior art, the invention has the following remarkable technical effects:
animal pharmacological tests show that the traditional Chinese medicine composition can effectively treat or eliminate rat edema, repair kidney tissues and relieve kidney injury. Animal experiments show that after the traditional Chinese medicine composition is used for treating kidney yin deficiency edema, the contents of T4, cAMP/cGMP, Cre and BUN in rats are obviously reduced, and the contents of cGMP are obviously increased, which shows that the thyroid axis function of the rats is better recovered, the yin deficiency symptom is well treated, and the kidney function is recovered. After the rats with yang-deficiency edema are treated by the traditional Chinese medicine composition, cGMP, Cre and BUN are remarkably reduced, and T4, cAMP and cAMP/cGMP are remarkably increased, which shows that the thyroid axis function of the rats is better recovered, the yang-deficiency symptom is relieved, the renal function is recovered, the yang-deficiency state is relieved, the urine protein content is remarkably reduced, and the edema state is relieved.
The following examples are provided to further disclose the present invention, and it should be noted that these examples are only preferred embodiments of the present invention, and do not limit the scope of the present invention as claimed.
Example 1
The prescription is as follows:
immature bitter orange 200g white atractylodes rhizome 20g aloe 30g
30g of medlar, 150g of donkey-hide gelatin, 25g of fleece-flower root
500g of cassia seed, 100g of ginseng.
The preparation method comprises the following steps:
(1) grinding colla Corii Asini into fine powder, and sieving with 80 mesh sieve;
(2) reflux-extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae and Aloe with 60% ethanol for 2 times, mixing extractive solutions, and filtering to obtain filtrate I;
(3) decocting fructus Lycii, Atractylodis rhizoma and fructus Aurantii Immaturus in water twice, mixing decoctions, filtering, concentrating to obtain fluid extract with relative density of 1.10-1.20 (80 deg.C), cooling to room temperature, adding ethanol to make ethanol content 60%, standing for 24 hr, filtering, and collecting filtrate II;
(4) mixing the filtrate I obtained in the step (2) and the filtrate II obtained in the step (3), concentrating into thick paste with the relative density of 1.30-1.35 (70 ℃), drying, grinding, and adding the donkey-hide gelatin fine powder prepared in the step (1) to obtain the traditional Chinese medicine composition. The obtained Chinese medicinal composition is prepared into pills by a conventional pill preparation process.
Example 2
The prescription is as follows:
immature bitter orange 50g white atractylodes rhizome 100g aloe 600g
150g of medlar, 30g of donkey-hide gelatin, 400g of fleece-flower root
30g of cassia seed, 20g of ginseng.
The preparation method comprises the following steps: the preparation method is the same as that of example 1.
The obtained Chinese medicinal composition is prepared into syrup according to conventional syrup preparation process.
Example 3
The prescription is as follows:
immature bitter orange 150g white atractylodes rhizome 20g aloe 200g
100g of medlar, 30g of donkey-hide gelatin, 150g of fleece-flower root
80g of cassia seed and 20g of ginseng.
The preparation method of the traditional Chinese medicine composition comprises the following steps: the preparation method is the same as that of example 1.
The obtained Chinese medicinal composition is prepared into granules according to the conventional granule preparation process.
Example 4
The prescription is as follows:
immature bitter orange 80g white atractylodes rhizome 80g aloe 100g
30g of medlar, 100g of donkey-hide gelatin, 60g of tuber fleeceflower root
180g of cassia seed and 80g of ginseng.
The preparation method of the traditional Chinese medicine composition comprises the following steps: the preparation method is the same as that of example 1.
The obtained Chinese medicinal composition is prepared into oral liquid according to conventional oral liquid preparation process.
Example 5
The prescription is as follows:
immature bitter orange 80g white atractylodes rhizome 50g aloe 160g
80g of medlar, 40g of donkey-hide gelatin, 120g of polygonum multiflorum and 40g of tuber of multiflorum
100g of cassia seed, 20g of ginseng.
The preparation method of the traditional Chinese medicine composition comprises the following steps: the preparation method is the same as that of example 1.
The obtained Chinese medicinal composition is prepared into capsules according to the conventional capsule preparation process.
Example 6
The prescription is as follows:
immature bitter orange 120g, white atractylodes rhizome 30g, aloe 120g
50g of medlar, 80g of donkey-hide gelatin, 80g of tuber fleeceflower root, 80g
150g of cassia seed and 50g of ginseng.
The preparation method of the traditional Chinese medicine composition comprises the following steps: the preparation method is the same as that of example 1.
The obtained Chinese medicinal composition is prepared into tablets according to the conventional tablet preparation process.
Example 7
The prescription is as follows:
immature bitter orange 110g white atractylodes rhizome 50g aloe 130g
70g of medlar, 60g of donkey-hide gelatin, 80g of fleece-flower root
Semen Cassiae 100g Ginseng radix 30g
The preparation method of the traditional Chinese medicine composition comprises the following steps: the preparation method is the same as that of example 1
The obtained Chinese medicinal composition is prepared into capsules according to the conventional capsule preparation process.
Example 8
The prescription is as follows:
immature bitter orange 120g white atractylodes rhizome 50g aloe 160g
75 g of medlar, 75 g of donkey-hide gelatin, 120g of fleece-flower root
Cassia seed 140 g ginseng 50g
The preparation method of the traditional Chinese medicine composition comprises the following steps: the preparation method is the same as that of example 1
The obtained Chinese medicinal composition is prepared into capsules according to the conventional capsule preparation process.
Comparative example 1
The prescription is as follows:
immature bitter orange 120g white atractylodes rhizome 30g rhubarb 120g
50g of medlar, 80g of donkey-hide gelatin, 80g of tuber fleeceflower root, 80g
150g of bunge cherry seed and 50g of ginseng.
The preparation method comprises the following steps:
(1) grinding colla Corii Asini into fine powder, and sieving with 80 mesh sieve;
(2) reflux-extracting Ginseng radix, Polygoni Multiflori radix, semen Pruni, and radix et rhizoma Rhei with 60% ethanol for 2 times, mixing extractive solutions, filtering, and collecting filtrate I;
(3) decocting fructus Lycii, Atractylodis rhizoma and fructus Aurantii Immaturus in water twice, mixing decoctions, filtering, concentrating to obtain fluid extract with relative density of 1.10-1.20 (80 deg.C), cooling to room temperature, adding ethanol to make ethanol content 60%, standing for 24 hr, filtering, and collecting filtrate II;
(4) mixing the filtrate I obtained in the step (2) and the filtrate II obtained in the step (3), concentrating into thick paste with the relative density of 1.30-1.35 (70 ℃), drying, grinding, and adding the donkey-hide gelatin fine powder prepared in the step (1) to obtain the traditional Chinese medicine composition.
The obtained Chinese medicinal composition is prepared into capsules according to the conventional capsule preparation process.
Comparative example 2
The prescription is as follows:
areca peel 120g atractylodes rhizome 30g aloe 120g
50g of wolfberry fruit, 80g of donkey-hide gelatin and 80g of fleece-flower root
150g of cassia seed and 50g of ginseng.
The preparation method of the traditional Chinese medicine composition comprises the following steps:
(1) grinding colla Corii Asini into fine powder, and sieving with 80 mesh sieve;
(2) reflux-extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae, and Aloe with 60% ethanol for 2 times, mixing extractive solutions, filtering, and collecting filtrate I;
(3) decocting fructus Lycii, rhizoma Atractylodis, and pericarpium Arecae with water twice, mixing decoctions, filtering, concentrating to obtain fluid extract with relative density of 1.10-1.20 (80 deg.C), cooling to room temperature, adding ethanol to make ethanol content reach 60%, standing for 24 hr, filtering, and collecting filtrate II;
(4) mixing the filtrate I obtained in the step (2) and the filtrate II obtained in the step (3), concentrating into thick paste with the relative density of 1.30-1.35 (70 ℃), drying, grinding, and adding the donkey-hide gelatin fine powder prepared in the step (1) to obtain the traditional Chinese medicine composition.
The obtained Chinese medicinal composition is prepared into capsules according to the conventional capsule preparation process.
In order to verify the efficacy of the Chinese medicinal composition in treating edema, the inventor conducts experimental research, and the following description is made by taking edema of renal origin (yin deficiency and yang deficiency) as an example, but the inventor intends to show that the inventor also conducts pharmacological experimental research on edema caused by other reasons described in the specification, and the composition of the invention can achieve the same or similar effects, which is not described herein.
(one) to,The traditional Chinese medicine composition has a therapeutic effect on renal (yang-deficiency) edema model rats.
1 Material
1.1 animals:
male SD-grade rats, weight 180-220 g, laboratory animal license number: SCXK (Shandong) 20140007, provided by Jinanpunyue laboratory animal Breeding Co., Ltd, was acclimatized prior to the experiment for one week.
1.2 drugs, reagents
1.2.1 medicaments
Capsules obtained in examples 7 and 8 of the present invention
Comparative example 1 Capsule
Positive drug bumetanide tablet
1.2.3 dosage for rats
Example 7 capsules: 0.378g/kg (high dose), 0.189g/kg (medium dose), 0.0945g/kg (low dose);
example 8 capsules: 0.378 g/kg;
comparative example 1 capsule: 0.378 g/kg;
bumetanide tablets: 0.18 mg/kg.
Administered by drenching at a dose of 10 ml/kg.
1.2.4 reagents: rat Motilin (MTL), Gastrin (GAS), Vasoactive Intestinal Peptide (VIP) kit.
2. Test method
2.2.1 Molding method
Rats were intraperitoneally injected with hydrocortisone at a volume of 3.75mg/ml per day, and were injected with doxorubicin (0.9% sodium chloride solution diluted to 0.4 mg/ml) at a volume of 1ml/100g in the caudal vein on the afternoon and afternoon on days 1 and 8 of molding, respectively, at a volume of 3.5mg/kg on days 1 and 8, respectively, for 10 days in total.
2.2.2 grouping
70 rats successfully modeled by yang-deficiency edema are randomly divided into 7 groups, each group comprises 10 rats, and the rats are respectively a model group, a positive drug group, a comparative drug group, an example 7 dose group and an example 8 dose group;
another 10 normal rats were selected as a blank group.
2.2.3 after the injection molding is finished on the 2 nd day, the medicine liquid with the corresponding dosage is respectively filled in each administration group; the blank control group and the model group were given the same amount of distilled water.
The administration is performed 1 time daily for a fixed period of 2 weeks.
2.2.4 detection
After 24 hours of the last drenching, blood is taken from abdominal artery, placed for 2 hours at room temperature, centrifuged at low temperature, and serum is taken.
Detecting Cre, BUN, TG, TC, ALB, TP and urine protein; cAMP, cGMP; t3, T4.
3. Results and conclusions
3.1 results of the experiment
Note: in contrast to the blank group,@P＜0.05， *P＜0.01；
in contrast to the model set,△P＜0.05， #P＜0.01；
compared with the positive medicine group,&P＜0.05， ￥P＜0.01。
note: in contrast to the blank group,@P＜0.05， *P＜0.01；
in contrast to the model set,△P＜0.05， #P＜0.01；
compared with the positive medicine group,&P＜0.05， ￥P＜0.01。
note: in contrast to the blank group,@P＜0.05， *P＜0.01；
in contrast to the model set,△P＜0.05， #P＜0.01；
compared with the positive medicine group,&P＜0.05， ￥P＜0.01。
3.2 conclusion of the experiment
3.2.1 thyroid levels are shown in Table 1. Compared with the blank group, the rats T3 and T4 in the other groups are obviously reduced (P is less than 0.05, and P is less than 0.01); compared with the model group, the rats T3 and T4 in each administration group are obviously increased (P is less than 0.05, and P is less than 0.01); compared with the positive medicine group, the high and medium dosage rats have larger rise amplitude (P is less than 0.05, P is less than 0.01), the low dosage group has no difference, the control dosage group has smaller rise amplitude, and the difference is obvious (P is less than 0.05, P is less than 0.01).
3.2.2 urine protein content is shown in Table 1. Compared with the blank group, the urine protein content of rats in other groups is obviously increased (P is less than 0.05, and P is less than 0.01); compared with the model group, the urine protein content of the rats in each administration group is obviously reduced (P is less than 0.05, and P is less than 0.01); compared with the positive drug, the high and medium dose groups of the invention have larger descending amplitude (P is less than 0.05, P is less than 0.01), the low dose group has no difference, and the comparative group has smaller descending amplitude and obvious difference (P is less than 0.05, P is less than 0.01).
3.2.3 renal function indices are shown in Table 2. Compared with the blank group, the Cre and BUN contents of the rats in other groups are obviously increased (P is less than 0.05, and P is less than 0.01); compared with the model group, the contents of Cre and BUN of rats in each administration group are obviously reduced (P is less than 0.05, and P is less than 0.01); compared with the positive medicine group, the high and medium dosage groups of the invention have larger reduction amplitude (P is less than 0.05, P is less than 0.01), the low dosage group has no difference, the comparative dosage group has smaller reduction amplitude, and the difference is obvious (P is less than 0.05, P is less than 0.01).
3.2.4 Cyclic nucleotide System see Table 2. the remaining groups of rats had decreased cAMP and cAMP/cGMP and increased cGMP (P < 0.05, P < 0.01) compared to the blank group; compared with the model group, rats in each administration group have obviously increased cAMP and cAMP/cGMP and obviously reduced cGMP (P is less than 0.05 and P is less than 0.01); compared with the positive drug, the high and medium dose groups of the invention have larger increasing or decreasing amplitude (P < 0.05, P < 0.01), the low dose group has no difference, and the control group has smaller increasing or decreasing amplitude and obvious difference (P < 0.05, P < 0.01).
3.2.5 serum protein and blood lipid levels are shown in Table 3. Compared with the blank group, the TP and ALB of the rats in other groups are reduced, and the TG and TC are increased (P is less than 0.05 and P is less than 0.01); compared with the model group, TP and ALB of each administration group are obviously increased, TG and TC are obviously reduced (P is less than 0.05, and P is less than 0.01); compared with the positive medicine group, the high and medium dosage group rats have larger increasing or decreasing amplitude (P is less than 0.05, P is less than 0.01), the low dosage group rats have no difference, the comparative group rats have smaller increasing or decreasing amplitude, and the difference is obvious (P is less than 0.05, P is less than 0.01).
(II),The traditional Chinese medicine composition has a treatment effect on renal (yin deficiency) edema model rats.
1 Material
1.1 animals:
male SD-grade rats, weight 180-220 g, laboratory animal license number: SCXK (Shandong) 20140007, provided by Jinanpunyue laboratory animal Breeding Co., Ltd, was acclimatized prior to the experiment for one week.
1.2 drugs, reagents
1.2.1 medicaments
Capsule obtained in example 8 of the present invention
Comparative example 2 the obtained capsule
Positive drug bumetanide tablet
1.2.3 dosage for rats
Example 8 capsules: 0.378g/kg (high dose), 0.189g/kg (medium dose), 0.0945g/kg (low dose);
comparative example 2 capsule: 0.378 g/kg;
bumetanide tablets: 0.18 mg/kg.
Administered by drenching at a dose of 10 ml/kg.
1.2.4 reagents: rat Motilin (MTL), Gastrin (GAS), Vasoactive Intestinal Peptide (VIP) kit.
2. Test method
2.2.1 Molding method
The rats were intragastrically administered thyroxine (15 mg/ml) daily in the morning in a physical quantity of 1ml/100 g; further, doxorubicin (0.9% sodium chloride solution diluted to 0.4 mg/ml) was injected into the tail vein at a rate of 1ml/100g body mass in the afternoon on day 1 and afternoon on day 8 of molding, and the injection was carried out at a rate of 4mg/kg on day 1 and 3.5mg/kg body mass on day 8, for a total of 10 days of molding.
2.2.2 grouping and administration 60 rats successfully molded by yin deficiency edema were taken, and each rat was randomly divided into 6 groups, 10 rats in each group were respectively a model group, a positive drug group, a comparative drug group and three dose groups of the invention;
another 10 normal rats were selected as a blank group.
2.2.3 after the injection molding is finished on the 2 nd day, the medicine liquid with the corresponding dosage is respectively filled in each administration group; the blank control group and the model group were given the same amount of distilled water.
The administration is performed 1 time daily for a fixed period of 2 weeks.
2.2.4 detection
After 24 hours of the last drenching, blood is taken from abdominal artery, placed for 2 hours at room temperature, centrifuged at low temperature, and serum is taken.
Detecting Cre, BUN, TG, TC, ALB, TP and urine protein; cAMP, cGMP; t3, T4.
3. Results and conclusions
3.1 results of the experiment
Note: in contrast to the blank group,@P＜0.05， *P＜0.01；
in contrast to the model set,△P＜0.05， #P＜0.01；
compared with the positive medicine group,&P＜0.05， ￥P＜0.01。
note: in contrast to the blank group,@P＜0.05， *P＜0.01；
in contrast to the model set,△P＜0.05， #P＜0.01；
compared with the positive medicine group,&P＜0.05， ￥P＜0.01。
note: in contrast to the blank group, @P＜0.05， *P＜0.01；
in contrast to the model set,△P＜0.05， #P＜0.01；
compared with the positive medicine group,&P＜0.05， ￥P＜0.01。
3.2 conclusion of the experiment
Thyroid levels 3.2.1 are shown in Table 4. Compared with the blank group, the rats T3 and T4 in the other groups are obviously increased (P is less than 0.05, and P is less than 0.01); compared with the model group, the rats T3 and T4 in each administration group are obviously reduced (P is less than 0.05, and P is less than 0.01); compared with the positive drug, the high and medium dosage rats have larger reduction amplitude (P is less than 0.05, P is less than 0.01), the low dosage group has no difference, and the rats in the comparative group have smaller reduction amplitude and obvious difference (P is less than 0.05, P is less than 0.01).
3.2.2 urine protein content is shown in Table 4. Compared with the blank group, the urine protein content of rats in other groups is obviously increased (P is less than 0.05 and P is less than 0.01); compared with the model group, the urine protein content of the rats in each administration group is obviously reduced (P is less than 0.05, and P is less than 0.01); compared with the positive drug, the high and medium dosage rats have larger reduction amplitude (P is less than 0.05, P is less than 0.01), the low dosage group has no difference, and the rats in the comparative example group have smaller reduction amplitude and obvious difference (P is less than 0.05, P is less than 0.01).
3.2.3 renal function indices are shown in Table 5. Compared with the blank group, the Cre and BUN contents of the rats in other groups are obviously increased (P is less than 0.05, and P is less than 0.01); compared with the model group, the contents of Cre and BUN of rats in each administration group are obviously reduced (P is less than 0.05, and P is less than 0.01); compared with the positive drug, the high and medium dosage rats have larger reduction amplitude (P is less than 0.05, P is less than 0.01), the low dosage group has no difference, and the rats in the comparative group have smaller reduction amplitude and obvious difference (P is less than 0.05, P is less than 0.01).
3.2.4 Cyclic nucleotide System see Table 5. the remaining groups of rats had elevated cAMP and cAMP/cGMP and reduced cGMP (P < 0.05, P < 0.01) compared to the blank group; in the yin deficiency edema group, compared with the model group, rats in each administration group have obviously reduced cAMP and cAMP/cGMP, and obviously increased cGMP (P is less than 0.05, and P is less than 0.01); compared with the positive drug, the high and medium dose rats have larger reduction or increase amplitude (P < 0.05, P < 0.01), the low dose group has no difference, and the rats in the comparative group have smaller reduction or increase amplitude and obvious difference (P < 0.05, P < 0.01).
3.2.5 serum protein and blood lipid levels are shown in Table 6. Compared with the blank group, the TP and ALB of the edema group due to yin deficiency are reduced, and the TG and TC are increased (P is less than 0.05 and P is less than 0.01); compared with the model group, TP and ALB of each administration group are obviously increased, TG and TC are obviously reduced (P is less than 0.05, and P is less than 0.01); compared with the positive drug, the high and medium dose rats have larger reduction or increase amplitude (P < 0.05, P < 0.01), the low dose group has no difference, and the rats in the comparative group have smaller increase or decrease amplitude and obvious difference (P < 0.05, P < 0.01).
Claims (10)
- A Chinese medicinal composition for treating edema is prepared from fructus Aurantii Immaturus, Atractylodis rhizoma, Aloe, fructus Lycii, colla Corii Asini, Polygoni Multiflori radix, semen Cassiae, and Ginseng radix.
- The use of claim 1, wherein the edema comprises generalized edema, localized edema.
- The use of claim 2, wherein the generalized edema comprises cardiogenic edema, nephrogenic edema, hepatogenic edema, malnutritional edema, drug-induced edema.
- The use of claim 2, wherein the localized edema is edema due to local venous, lymphatic return obstruction, or increased capillary permeability.
- The use of claim 1, wherein the traditional Chinese medicine composition comprises the following components in parts by weight:50-200 parts of immature bitter orange, 20-100 parts of largehead atractylodes rhizome, 30-600 parts of aloe30-150 donkey-hide gelatin of medlar, 30-150 fleece-flower root, 25-40030-500 parts of cassia seed and 20-100 parts of ginseng.
- The use of claim 5, wherein the traditional Chinese medicine composition comprises the following components in parts by weight:80-150 parts of immature bitter orange, 20-80 parts of largehead atractylodes rhizome, 100 parts of aloe and 200 parts of aloe30-100 donkey-hide gelatin of medlar, 30-100 fleece-flower root, 60-15080-180 parts of cassia seed and 20-80 parts of ginseng.
- The use of claim 6, wherein the traditional Chinese medicine composition comprises the following components in parts by weight:80-120 parts of immature bitter orange, 30-50 parts of largehead atractylodes rhizome, 120 parts of aloe and 160 parts of common aloe50-80 donkey-hide gelatin of medlar, 40-80 fleece-flower root, 80-120100 portions of cassia seed and 20 to 50 portions of 150 portions of ginseng.
- The use of claim 7, wherein the traditional Chinese medicine composition comprises the following components in parts by weight:immature bitter orange 110 bighead atractylodes rhizome 50 aloe 130Wolfberry fruit 70 donkey-hide gelatin 60 fleece-flower root 80Cassia seed 100 ginseng 30.
- The use of any one of claims 1 to 8, wherein the Chinese medicinal composition is prepared into a clinically acceptable dosage form by conventional procedures directly or with the addition of pharmaceutically acceptable excipients.
- Use according to claim 9, wherein the clinically acceptable dosage form is an oral pharmaceutical formulation, preferably the oral formulation is a pill, granule, capsule, tablet, oral liquid or syrup; further preferably, the oral formulation is a capsule.
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| CN1748765A (en) * | 2004-09-17 | 2006-03-22 | 鲁南制药集团股份有限公司 | Composition with catharsis and toxin expelling, fat reducing and weight reducing function and preparing method |
| CN106176909A (en) * | 2016-07-16 | 2016-12-07 | 江南大学 | A kind of method that Radix Ginseng Rhizoma Atractylodis Macrocephalae Poria Radix Glycyrrhizae prepares four gentleman's enzyme beverage |
| CN109464570A (en) * | 2018-11-23 | 2019-03-15 | 鲁南制药集团股份有限公司 | A kind of head luxuriant growth Tongbian capsule preparation process |
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| KR100919852B1 (en) * | 2007-11-15 | 2009-09-30 | 한국 한의학 연구원 | A composition for the prevention and treatment of edema or dermatitis containing Glehnia littoralis Fr. Schmidt et Miquel extract as an active ingredient |
| CN106123496A (en) * | 2016-06-30 | 2016-11-16 | 鲁南制药集团股份有限公司 | A kind of drying means of Chinese medical concrete |
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| CN1748765A (en) * | 2004-09-17 | 2006-03-22 | 鲁南制药集团股份有限公司 | Composition with catharsis and toxin expelling, fat reducing and weight reducing function and preparing method |
| CN106176909A (en) * | 2016-07-16 | 2016-12-07 | 江南大学 | A kind of method that Radix Ginseng Rhizoma Atractylodis Macrocephalae Poria Radix Glycyrrhizae prepares four gentleman's enzyme beverage |
| CN109464570A (en) * | 2018-11-23 | 2019-03-15 | 鲁南制药集团股份有限公司 | A kind of head luxuriant growth Tongbian capsule preparation process |
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