CN113456781A - Traditional Chinese medicine composition for treating kidney-type hepatolenticular degeneration and preparation method thereof - Google Patents
Traditional Chinese medicine composition for treating kidney-type hepatolenticular degeneration and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition for treating kidney type hepatolenticular degeneration and a preparation method thereof, wherein the traditional Chinese medicine composition is prepared from the following traditional Chinese medicinal materials in parts by weight: 10-15 parts of prepared rehmannia root, 8-10 parts of eucommia bark, 8 parts of dried orange peel, 6 parts of curcuma zedoary, 8-10 parts of curcuma aromatica, 6 parts of rheum officinale, 8 parts of curcuma longa, 20 parts of salvia miltiorrhiza and 15 parts of astragalus membranaceus. The preparation method comprises the following steps: firstly preparing the prepared rehmannia root concentrated clear paste, then preparing the prepared rehmannia root dregs and the second concentrated clear paste of the other Chinese medicinal materials, and combining the two to obtain the concentrated clear paste; taking dextrin as a base material, taking the combined concentrated clear paste as an adhesive, and performing spray drying granulation to obtain granules, namely the traditional Chinese medicine composition for treating kidney-type hepatolenticular degeneration, wherein the traditional Chinese medicine composition has reasonable compatibility, good efficacy and definite copper-removing and kidney-protecting effects; compared with western medicine copper expelling medicine, the traditional Chinese medicine composition has no obvious toxic and side effects, and can be taken for a long time; compared with the traditional Chinese medicine decoction or tablet, the traditional Chinese medicine decoction or tablet has better curative effect on patients with kidney-type hepatolenticular degeneration.
Description
Technical Field
The invention belongs to the field of preparation of traditional Chinese medicine compositions, and particularly relates to a traditional Chinese medicine composition for treating kidney-type hepatolenticular degeneration and a preparation method thereof.
Background
Hepatolenticular degeneration also known as Wilson Disease (WD) is an autosomal recessive inherited disorder of copper metabolism, abnormal copper metabolism of the body is caused by mutation of ATP7B gene, excessive copper is deposited in tissues such as liver, brain, kidney and the like to cause diseases, and due to differences of race and individuals, the deposition speed, the sequence and the distribution degree of the copper ions in internal organs are different, so that complex and various clinical manifestations, such as liver cirrhosis, extrapyramidal symptoms, mental symptoms, kidney damage and the like, appear. WD patients are clinically diagnosed with liver diseases, nervous system symptoms or kidney damage as the first symptoms, and a large number of clinical studies find that the kidney lesion of WD patients is the common 3 rd damage. The document reports that WD patients have 10-20 times higher copper content in renal tissue than normal persons, and epithelial cells of renal proximal convoluted tubules, distal convoluted tubules and glomerular sac wall layers are all copper-granularized. WD is complex and diversified in clinical manifestations, and patients with renal hepatolenticular degeneration can clinically suffer from proteinuria, hematuria, reduced urine specific gravity and renal tubular acidosis, and severe patients can suffer from azotemia or uremia caused by renal dysfunction, and the treatment is troublesome. WD is one of a few treatable neurogenetic diseases, WD has better characteristics and advantages, WD has become the dominant disease species for traditional Chinese medicine treatment, the first subsidiary hospital of Anhui Chinese medicine university, which is the unit of inventor, is the central construction unit of clinical prevention and treatment of key difficult and complicated diseases (hepatolenticular degeneration) of the national traditional Chinese medicine administration, is the most authoritative hepatolenticular degeneration diagnosis and treatment base in China, and the series of achievements are obtained in clinical and basic research of WD, so that the quality of life and the life cycle of healthy people can be always obtained in early diagnosis and timely and accurate typing drug treatment according to different clinical phenotypes. Therefore, the early discovery and intervention of the WD patients on the renal damage are emphasized, the occurrence and development of the renal damage are delayed, and the method has very important significance for improving the life quality and the life cycle of the patients.
WD patients are clinically manifested as liver disease, nervous system symptoms, kidney damage and the like, and the kidney lesion of WD patients is the 3 rd common damage of WD patients.
At present, heavy metal chelating agents (such as penicillamine, trientine, dimercaptosuccinic acid, dimercaptopropanesulfonic acid sodium and the like) are common clinical medicines for WD patients, and along with the lapse of the medication time, the copper-repellent medicines have more adverse reactions, such as gastrointestinal reactions such as inappetence, nausea, vomiting and the like, anaphylactic reactions, dizziness, headache, palpitation, leukopenia or (and) thrombocytopenia, aplastic anemia and the like; some patients may also cause immune diseases such as systemic lupus erythematosus, myasthenia gravis, nephritis-pulmonary hemorrhage syndrome, etc. The life quality and even the life cycle of WD patients are affected because most patients cannot carry out long-term maintenance treatment. In addition, clinical research also finds that different clinical phenotypes, such as liver type, brain type, kidney type and the like, have different clinical curative effects and clinical outcomes for the same copper expelling drug, for example, penicillamine is generally effective to hepatolenticular degeneration of liver type, but has poor effect on brain type, and even has serious irreversible nervous system toxic and side effects. In addition, although the traditional Chinese medicine liver bean soup and liver bean tablet are clinically applied at present, the traditional Chinese medicine compound has better effects on liver type and brain type of WD patients and has poor curative effect on kidney type WD. Therefore, the inventor invents a traditional Chinese medicine composition for accurately treating WD patients with renal clinical phenotype.
Disclosure of Invention
The invention provides a traditional Chinese medicine composition for treating kidney-type hepatolenticular degeneration and a preparation method thereof, which can better improve the clinical symptoms of patients with kidney-type hepatolenticular degeneration, have the functions of protecting and repairing the kidney, and solve the problems that the existing western medicines for treating kidney injury of patients with hepatolenticular degeneration have large toxic and side effects, and the traditional Chinese medicine formula hepatolenticular soup and hepatolenticular tablets have poor treatment effect on the kidney-type hepatolenticular degeneration.
The technical scheme adopted by the invention is as follows:
the invention provides a traditional Chinese medicine composition for treating kidney type hepatolenticular degeneration, which comprises the following traditional Chinese medicinal materials in parts by weight: 10-15 parts of prepared rehmannia root, 8-10 parts of eucommia bark, 8 parts of dried orange peel, 6 parts of curcuma zedoary, 8-10 parts of curcuma aromatica, 6 parts of rheum officinale, 8 parts of curcuma longa, 20 parts of salvia miltiorrhiza and 15 parts of astragalus membranaceus.
The invention also provides a preparation method of the traditional Chinese medicine composition for treating kidney-type hepatolenticular degeneration, which is characterized by comprising the following steps:
taking the traditional Chinese medicinal materials of the traditional Chinese medicine composition according to the formula of the invention;
step 1, crushing radix rehmanniae preparata into coarse powder, soaking the coarse powder for 24 hours by using ethanol with the mass concentration of 60% as a solvent, percolating the coarse powder to obtain a percolate, filtering the percolate to obtain a first filtrate, concentrating the first filtrate under reduced pressure to obtain a radix rehmanniae preparata concentrated clear paste with the relative density of 1.10-1.15 at the temperature of 45-50 ℃, and keeping radix rehmanniae preparata dregs for later use;
step 2, mixing the radix rehmanniae preparata dregs with the rest Chinese medicinal materials, adding ethanol with the mass concentration of 60% for reflux extraction twice to obtain ethanol extract, mixing, filtering, recovering ethanol to obtain a second filtrate, and concentrating the second filtrate under reduced pressure to obtain a second concentrated clear paste with the relative density of 1.10-1.15 at the temperature of 60 ℃;
step 3, combining the second concentrated clear paste obtained in the step 2 with the prepared rehmannia root concentrated clear paste obtained in the step 1 to obtain combined concentrated clear paste; and (3) taking dextrin as a base material, taking the combined concentrated clear paste as an adhesive, and performing spray drying granulation to obtain granules, namely the traditional Chinese medicine composition for treating kidney-type hepatolenticular degeneration.
The invention has the following advantages: the traditional Chinese medicine composition is prepared by combining prepared rehmannia root, eucommia bark, dried orange peel, curcuma zedoary, curcuma aromatica, rhubarb, curcuma longa, salvia miltiorrhiza and astragalus according to specific dosage and a specific process, has good efficacy and obvious curative effect for treating kidney-type hepatolenticular degeneration, mainly because the main pathogenesis of kidney-type hepatolenticular degeneration is kidney essence deficiency and phlegm-blood stasis, aiming at the pathogenesis, the prepared rehmannia root in the formula has the functions of nourishing yin and tonifying kidney, and the eucommia bark has the functions of tonifying liver and kidney and strengthening tendons and bones, and is a monarch drug; the dried orange peel is pungent, bitter and warm, and is in charge of spleen and lung channels, has the effects of regulating qi, strengthening spleen, eliminating dampness and reducing phlegm, the curcuma zedoary and the curcuma aromatica have the effects of breaking blood and promoting qi circulation, and the rhubarb is cold and bitter, is in charge of spleen, stomach, heart, liver and large intestine channels, has the effects of promoting diuresis, removing jaundice, eliminating phlegm and detoxifying, removing blood stasis and stimulating the menstrual flow, and purging and attacking accumulation, is used as a ministerial drug, and has the effects of eliminating dampness and reducing phlegm, removing blood stasis and stimulating the menstrual flow and the like; turmeric has the functions of promoting blood circulation, promoting qi circulation and stimulating the menstrual flow, salvia has the functions of promoting blood circulation, regulating menstruation, removing blood stasis and relieving pain, astragalus has the functions of tonifying qi and strengthening spleen, and is an adjuvant and guiding drug together; the traditional Chinese medicinal materials are applied in a combined manner, and the effects of tonifying kidney, eliminating phlegm and removing blood stasis are achieved synergistically, the formula of the traditional Chinese medicinal composition is reasonable in compatibility, both symptoms and root causes are treated, and the accurate treatment characteristic of the traditional Chinese medicine on the kidney-type hepatolenticular degeneration is fully reflected; the traditional Chinese medicine composition is high in safety and good in compliance, and the formula is developed according to a kidney tonifying, phlegm eliminating and blood stasis removing method, so that the copper expelling effect is lasting and mild when kidney-type hepatolenticular degeneration is treated, the advantages of overcoming toxic and side effects of strong copper expelling agents such as metal complexing agents and the like are achieved, the traditional Chinese medicine composition can be taken for a long time, discomfort symptoms such as anorexia and abdominal discomfort cannot occur, kidney damage and kidney functions of patients with kidney-type hepatolenticular degeneration can be obviously improved, the life quality of the patients is improved, and the traditional Chinese medicine composition has good clinical compliance. Compared with traditional Chinese medicine liver bean soup and liver bean tablet, the traditional Chinese medicine composition has better curative effect on patients with kidney-type hepatolenticular degeneration.
Detailed Description
The technical solutions in the embodiments of the present invention are clearly and completely described below, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments of the present invention without making any creative effort, shall fall within the protection scope of the present invention. In addition, techniques not described or not described in detail in the following examples are conventional techniques and thus will not be described in detail.
The invention provides a traditional Chinese medicine composition for treating kidney type hepatolenticular degeneration, which comprises the following traditional Chinese medicinal materials in parts by weight: 10-15 parts of prepared rehmannia root, 8-10 parts of eucommia bark, 8 parts of dried orange peel, 6 parts of curcuma zedoary, 8-10 parts of curcuma aromatica, 6 parts of rheum officinale, 8 parts of curcuma longa, 20 parts of salvia miltiorrhiza and 15 parts of astragalus membranaceus.
The Chinese medicinal composition is in the form of granule or capsule. Preferably, granules are used.
The invention also provides a preparation method of the traditional Chinese medicine composition for treating kidney-type hepatolenticular degeneration, which comprises the following steps:
taking the traditional Chinese medicinal materials of the traditional Chinese medicine composition according to the formula;
step 1, crushing radix rehmanniae preparata into coarse powder, soaking the coarse powder for 24 hours by using ethanol with the mass concentration of 60% as a solvent, percolating the coarse powder to obtain a percolate, filtering the percolate to obtain a first filtrate, concentrating the first filtrate under reduced pressure to obtain a radix rehmanniae preparata concentrated clear paste with the relative density of 1.10-1.15 at the temperature of 45-50 ℃, and keeping radix rehmanniae preparata dregs for later use;
step 2, mixing the radix rehmanniae preparata dregs with the rest Chinese medicinal materials, adding ethanol with the mass concentration of 60% for reflux extraction twice to obtain ethanol extract, mixing, filtering, recovering ethanol to obtain a second filtrate, and concentrating the second filtrate under reduced pressure to obtain a second concentrated clear paste with the relative density of 1.10-1.15 at the temperature of 60 ℃;
step 3, combining the second concentrated clear paste obtained in the step 2 with the prepared rehmannia root concentrated clear paste obtained in the step 1 to obtain combined concentrated clear paste; and (3) taking dextrin as a base material, taking the combined concentrated clear paste as an adhesive, and performing spray drying granulation to obtain granules, namely the traditional Chinese medicine composition for treating kidney-type hepatolenticular degeneration.
In the step 1 of the method, the percolate with the dosage of 3 times of the weight of the prepared rehmannia root is collected and filtered to obtain the first filtrate.
In the step 2 of the method, 60% ethanol is added for reflux extraction twice to obtain ethanol extract, 60% ethanol with the mass concentration 8 times of the total weight of the radix rehmanniae preparata residues and the rest Chinese medicinal materials is added for the first time and refluxed for 2.0 hours, 60% ethanol with the mass concentration 6 times of the total weight of the radix rehmanniae preparata residues and the rest Chinese medicinal materials is added for the second time and refluxed for 1.5 hours, and the ethanol extract obtained by two times of extraction is combined.
In the step 3 of the method, spray drying granulation is carried out according to the following process parameters: the material temperature is 70 ℃, the air inlet temperature is 80-130 ℃, and the air outlet temperature is 60 ℃; and finishing the grains by adopting an upper sieve with 10 meshes and a lower sieve with 60 meshes.
The present invention will be described in detail with reference to the following examples.
Examples
The embodiment provides a traditional Chinese medicine composition for treating kidney-type hepatolenticular degeneration, which is prepared from the following traditional Chinese medicinal materials in parts by weight: 10-15 g of prepared rehmannia root, 8-10 g of eucommia bark, 8g of dried orange peel, 6g of curcuma zedoary, 8-10 g of curcuma aromatica, 6g of rheum officinale, 8g of curcuma longa, 20g of salvia miltiorrhiza and 15g of astragalus membranaceus.
The traditional Chinese medicine composition disclosed by the invention is composed of prepared rehmannia root, eucommia bark, dried orange peel, curcuma zedoary, curcuma aromatica, rheum officinale, turmeric, salvia miltiorrhiza and astragalus membranaceus, and the formula is added with a preparation for eliminating phlegm and removing stasis and resolving masses on the basis of tonifying liver and kidney, so that the effects of tonifying kidney, eliminating phlegm and removing stasis are achieved together, the compatibility is reasonable, and both the symptoms and root causes are treated.
Example 1 the efficacy of the Chinese medicinal composition of the invention was compared between high and low dose groups. The traditional Chinese medicine composition granule high-dose group (15 g of prepared rehmannia root, 10g of eucommia bark, 8g of dried orange peel, 6g of curcuma zedoary, 10g of curcuma aromatica, 6g of rhubarb, 8g of curcuma longa, 20g of salvia miltiorrhiza and 15g of astragalus membranaceus) treats 42 renal WD patients (high-dose group), and simultaneously, the traditional Chinese medicine composition granule low-dose group (10 g of prepared rehmannia root, 8g of eucommia bark, 8g of dried orange peel, 6g of curcuma aromatica, 8g of curcuma aromatica, 6g of rhubarb, 8g of curcuma longa, 20g of salvia miltiorrhiza and 15g of astragalus membranaceus) treats 38 renal WD patients (low-dose group) and results show that the clinical total effective rate of the high-dose group is 95.2%, the clinical total effective rate of the low-dose group is 92.1%, the clinical total effective rate of the high-dose group is slightly higher than that of the low-dose group, but the difference is not statistically significant (P is more than 0.05).
Example 2 comparison of different dosage forms of the Chinese medicinal composition of the present invention. The traditional Chinese medicine composition granules of the invention treat 40 cases of kidney type WD patients (granule group), and are simultaneously provided with traditional Chinese medicine composition capsules to treat 41 cases of kidney type WD patients (capsule group), and the results show that the clinical total effective rate of the granule group reaches 95.0 percent, the capsule group is 92.7 percent, the clinical total effective rate of the granule group is slightly higher than that of the capsule group, but the difference has no statistical significance (P is more than 0.05).
Example 3 the curative effect of the traditional Chinese medicine composition is compared with that of common western medicines. The traditional Chinese medicine composition granules of the invention treat 45 patients with renal WD (treatment group) and simultaneously set a control group (penicillamine) for oral administration for 30 cases, and the results show that the clinical total effective rate of the treatment group reaches 95.6 percent and the control group is 66.7 percent, which shows that the traditional Chinese medicine composition granules of the invention are obviously superior to the penicillamine control group (P is less than 0.05). The Chinese medicinal composition granules can integrally regulate and reconstruct a copper removal way of a natural biliary tract of a human body, improve WD (white-red-yellow) kidney damage indexes, improve the life quality of patients and improve the clinical effective rate.
Example 4 the efficacy of the Chinese medicinal composition of the invention is compared with that of the common Chinese medicaments. The traditional Chinese medicine composition granule treats 40 cases of kidney type WD patients (treatment group), and simultaneously, a control group (traditional Chinese medicine liver bean soup) is orally taken for 30 cases, and the result shows that the clinical total effective rate of the treatment group reaches 95.0 percent and the control group is 63.3 percent, which shows that the traditional Chinese medicine composition granule of the invention is obviously superior to the traditional Chinese medicine liver bean soup control group (P is less than 0.05).
Example 5 the efficacy of the Chinese medicinal composition of the invention is compared with that of the common Chinese medicaments. The traditional Chinese medicine composition granule treats 30 cases of kidney type WD patients (treatment group), and simultaneously, a control group (traditional Chinese medicine GaoDouling tablet) is orally taken for 30 cases, the result shows that the total clinical effective rate of the treatment group reaches 93.3 percent, the control group is 68.7 percent, the two groups of curative effect difference is obvious after statistical treatment, and the traditional Chinese medicine composition granule of the invention is obviously superior to the traditional Chinese medicine GaoDouling tablet control group (P is less than 0.05) and has higher safety. A large number of clinical and basic researches prove that the traditional Chinese medicine composition can reverse early-stage renal damage of patients with renal WD and improve renal functions, and has definite clinical curative effect.
The preparation method of the traditional Chinese medicine composition comprises the following steps:
step 1, crushing the prepared rehmannia root into coarse powder, soaking the coarse powder for 24 hours by using ethanol with the mass concentration of 60% as a solvent, percolating, collecting percolate (3 times of the weight of the prepared rehmannia root in the formula, namely unit mL), filtering, concentrating the filtrate under reduced pressure to obtain a concentrated solution with the relative density of 1.10-1.15 (45-50 ℃), namely a prepared rehmannia root percolate concentrated clear paste, and reserving dregs;
step 2, mixing the prepared rehmannia root dregs and the rest Chinese medicinal materials, adding 60% ethanol by mass concentration, and performing reflux extraction twice; wherein, the prepared rehmannia root dregs and ethanol with the mass concentration of 60 percent which is 8 times of the total weight of the rest Chinese medicinal materials are added for the first time, and the reflux is carried out for 2.0 hours; adding the radix rehmanniae preparata dregs and 60% ethanol with the mass concentration 6 times of the total weight of the rest Chinese medicinal materials for the second time, refluxing for 1.5 hours, combining the two ethanol extract solutions, filtering, recovering ethanol, and concentrating the filtrate under reduced pressure to obtain concentrated extract with the relative density of 1.10-1.15 (60 ℃);
and 3, combining the concentrated clear paste obtained in the step 2 with the prepared rehmannia root diacolation concentrated clear paste obtained in the step 1, taking a proper amount of dextrin as a base material, taking the combined concentrated clear paste as an adhesive, performing spray drying granulation (the process parameters are that the material temperature is 70 ℃, the air inlet temperature is 80-130 ℃, the air outlet temperature is 60 ℃), performing granulation (an upper sieve is 10 meshes, and a lower sieve is 60 meshes), subpackaging and packaging to obtain the granular traditional Chinese medicine composition, namely the traditional Chinese medicine composition for treating kidney-type hepatolenticular degeneration.
In the preparation method, the rhubarb is raw rhubarb, free anthraquinone which is the main purgative component of the rhubarb is easy to form bound anthraquinone after being extracted by water, and the purgative effect of the rhubarb is weakened, so the raw rhubarb needs to be percolated and extracted at low temperature and then used as medicine; in order to take the extraction efficiency of fat-soluble components and water-soluble components into consideration, ethanol with the mass concentration of 60% is used as an extraction solvent, and meanwhile, in order to ensure the taste and the dissolubility of finished product particles, the medicinal materials are not crushed and are used as the medicine.
It is understood that the above preparation method is only illustrative for preparing granules, and other dosage forms can be prepared.
The traditional Chinese medicine composition is used for treating patients with kidney-type hepatolenticular degeneration, and can achieve the following effects:
(1) good efficacy and remarkable curative effect: according to the congenital endowment deficiency of the patient with the disease and the deposition of copper toxin in the liver, brain and kidney. Kidneys store essence, which is the congenital source, livers store blood, essence and blood can be transformed into each other, brains are marrow sea, kidney yin is insufficient, and marrow can not be generated to fill brains. Therefore, the prepared rehmannia root in the formula of the invention has the effects of nourishing yin and tonifying kidney, and the eucommia bark has the effects of tonifying liver and kidney and strengthening tendons and bones, and is a monarch drug together. The dried orange peel is pungent, bitter and warm, and is in charge of spleen and lung channels, has the effects of regulating qi, strengthening spleen, eliminating dampness and reducing phlegm, the curcuma zedoary and the curcuma aromatica have the effects of breaking blood and promoting qi circulation, and the rhubarb is cold and bitter, is in charge of spleen, stomach, heart, liver and large intestine channels, has the effects of promoting diuresis, removing jaundice, eliminating phlegm and detoxifying, removing blood stasis and stimulating the menstrual flow, and purging and attacking accumulation, is used as a ministerial drug, and has the effects of eliminating dampness and reducing phlegm, removing blood stasis and stimulating the menstrual flow and the like; turmeric has the functions of promoting blood circulation, promoting qi circulation and stimulating the menstrual flow, salvia has the functions of promoting blood circulation, regulating menstruation, removing blood stasis and relieving pain, astragalus has the functions of tonifying qi and strengthening spleen, and are used as adjuvant and guiding drugs together. The medicines are combined for application, the effects of tonifying kidney, eliminating phlegm and removing blood stasis are achieved, the compatibility is reasonable, the treatment effect is simultaneous and principal and subordinate to the treatment effect, and the treatment characteristic of traditional Chinese medicine on hepatolenticular degeneration is fully reflected.
(2) The formula of the invention is developed according to a kidney tonifying, phlegm eliminating and blood stasis removing method, has reasonable compatibility, is suitable for kidney type hepatolenticular degeneration patients, has lasting and mild copper expelling effect, has the advantages of overcoming the toxic and side effects of strong copper expelling agents such as metal complexing agents and the like, is suitable for clinical treatment of patients with kidney damage WD, and can be taken by patients for a long time to maintain treatment after symptom relief. Meanwhile, the traditional Chinese medicine composition has no obvious adverse reaction and good patient compliance.
Compared with the prior art, the invention at least has the following advantages: (1) the medicine effect is good, and the copper-removing and kidney-protecting effects are clear; (2) compared with western medicine copper expelling medicine, the traditional Chinese medicine composition has no obvious toxic and side effects, and can be taken for a long time; (3) compared with the traditional Chinese medicine liver bean soup (tablet), the traditional Chinese medicine has better curative effect on kidney type liver bean-shaped nuclear degeneration patients.
The clinical data of the traditional Chinese medicine composition for treating kidney-type hepatolenticular degeneration are as follows:
through a large amount of clinical practices, WD is considered to be autosomal recessive inheritance, the genetic defect of the family is obvious, the congenital deficiency is caused, and the deficiency of essence and qi in the kidney is the basis of the pathogenesis of WD. Congenital kidney essence deficiency, kidney yang deficiency, opening and closing difficulty, water dampness upwelling and phlegm accumulation; then, the decline of the fire from the gate of life can not warm and transport the spleen yang, the spleen fails to transport and transform, and dampness can gather and generate phlegm; kidney yin deficiency with internal fire of deficiency type scorching the body fluids as phlegm. Phlegm turbidity, viscosity and greasiness, stagnation and difficulty in removing, which can obstruct qi movement and affect qi and blood circulation, can cause internal stagnation of blood stasis. Phlegm and blood stasis are both pathological products and pathogenic factors, and phlegm and fluid are not transformed and stagnate in blood vessels to cause internal stagnation of blood stasis; stagnant blood can also produce phlegm when it stays inside. Phlegm and blood stasis are formed and affect each other, and finally cause the combination of phlegm and blood stasis.
The inventor finds that phlegm and blood stasis are caused by the kidney WD throughout the whole period of the kidney WD, the mutual combination of phlegm and blood stasis is the mark, and the deficiency of kidney essence is the basis through a large amount of long-term clinical researches, and experimental researches show that early glomerular injury indexes of WD patients include serum cystatin C (CysC), urine immunoglobulin G (UIgG), Urine Albumin Creatinine Ratio (UACR), Urine Transferrin (UTRF) and renal tubular injury indexes of urine beta 2 microglobulin (U beta 2-MG), the traditional Chinese medicine composition is developed by adopting a kidney tonifying, phlegm eliminating and blood stasis removing method according to the pathogenesis of kidney essence deficiency and phlegm stasis, can better improve the clinical symptoms and the indexes of a kidney type WD patient and has obvious kidney protection effect.
The inventor proves that the congenital deficiency of patients with renal WD is proved through a large number of clinical practices and basic researches, the deficiency of kidney essence is the basis of the disease, and the mutual accumulation of phlegm and blood stasis is the key of pathogenesis of the WD. The 'deficiency of kidney essence and mutual accumulation of phlegm and blood stasis' is the basic pathogenesis of a kidney type WD patient, therefore, a kidney tonifying, phlegm eliminating and blood stasis removing method is established aiming at the basic pathogenesis of the kidney type WD patient, and the traditional Chinese medicine composition disclosed by the invention can better improve the clinical symptoms and physicochemical indexes of the kidney type WD patient, has an obvious kidney protection effect, and is beneficial to further improving the clinical curative effect of the WD kidney damage patient. Comparing different dosages (high dosage group and low dosage group), different dosage forms (granules and capsules) and three traditional Chinese and western medicines (penicillamine, liver bean soup and liver bean tablet) of the traditional Chinese medicine composition, the specific curative effect results are shown in the following table:
clinical curative effect comparison table for treating kidney type WD patients by using traditional Chinese medicine composition
The results show that the traditional Chinese medicine composition has definite clinical curative effect on patients with renal WD, the clinical total curative effect of the high-dose group is higher than that of the low-dose group, but the difference of the two groups has no statistical significance (P is more than 0.05); the granules group was slightly higher than the capsules group, but the difference between the two groups was not statistically significant (P > 0.05). Compared with three traditional Chinese and western medicines (penicillamine, liver bean soup and liver bean tablet) which are commonly used clinically, the results show that the traditional Chinese medicine composition has definite clinical curative effect on patients with renal WD and is obviously superior to the three traditional Chinese and western medicines (P <0.05) which are commonly used at present.
The above are preferred embodiments of the present invention, the scope of the present invention is not limited to these embodiments, and variations and substitutions which can be easily conceived by those skilled in the art within the technical scope of the present invention are included in the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.
Claims (7)
1. The traditional Chinese medicine composition for treating kidney type hepatolenticular degeneration is characterized by comprising the following traditional Chinese medicinal materials in parts by weight: 10-15 parts of prepared rehmannia root, 8-10 parts of eucommia bark, 8 parts of dried orange peel, 6 parts of curcuma zedoary, 8-10 parts of curcuma aromatica, 6 parts of rheum officinale, 8 parts of curcuma longa, 20 parts of salvia miltiorrhiza and 15 parts of astragalus membranaceus.
2. The traditional Chinese medicine composition for treating kidney-type hepatolenticular degeneration according to claim 1, wherein said traditional Chinese medicine composition is any one of the traditional Chinese medicine dosage forms prescribed in pharmacy.
3. The traditional Chinese medicine composition for treating kidney damage of patients with hepatolenticular degeneration according to claim 1 or 2, wherein the traditional Chinese medicine composition is any one of granules and capsules.
4. A method for preparing the traditional Chinese medicine composition for treating renal hepatolenticular degeneration according to any of claims 1 to 3, characterized in that it comprises the following steps:
taking each Chinese medicinal material of the Chinese medicinal composition according to the formula of any one of claims 1 to 3;
step 1, crushing radix rehmanniae preparata into coarse powder, soaking the coarse powder for 24 hours by using ethanol with the mass concentration of 60% as a solvent, percolating the coarse powder to obtain a percolate, filtering the percolate to obtain a first filtrate, concentrating the first filtrate under reduced pressure to obtain a radix rehmanniae preparata concentrated clear paste with the relative density of 1.10-1.15 at the temperature of 45-50 ℃, and keeping radix rehmanniae preparata dregs for later use;
step 2, mixing the radix rehmanniae preparata dregs with the rest Chinese medicinal materials, adding ethanol with the mass concentration of 60% for reflux extraction twice to obtain ethanol extract, mixing, filtering, recovering ethanol to obtain a second filtrate, and concentrating the second filtrate under reduced pressure to obtain a second concentrated clear paste with the relative density of 1.10-1.15 at the temperature of 60 ℃;
step 3, combining the second concentrated clear paste obtained in the step 2 with the prepared rehmannia root concentrated clear paste obtained in the step 1 to obtain combined concentrated clear paste; and (3) taking dextrin as a base material, taking the combined concentrated clear paste as an adhesive, and performing spray drying granulation to obtain granules, namely the traditional Chinese medicine composition for treating kidney-type hepatolenticular degeneration.
5. The method of claim 4, wherein in step 1, 3 times the amount of radix rehmanniae Preparata by weight of the percolate is collected and filtered to obtain the first filtrate.
6. The method for preparing a Chinese medicinal composition for treating kidney-type hepatolenticular degeneration as claimed in claim 4, wherein in said step 2 of adding 60% by weight ethanol for reflux extraction twice, the first time is adding 60% by weight ethanol, 8 times the total weight of the residue of radix rehmanniae preparata and the rest of the Chinese medicinal materials, and refluxing for 2.0 hours, the second time is adding 60% by weight ethanol, 6 times the total weight of the residue of radix rehmanniae preparata and the rest of the Chinese medicinal materials, and refluxing for 1.5 hours, the two ethanol extracts are combined.
7. The method for preparing a Chinese medicinal composition for treating renal hepatolenticular degeneration according to any of claims 4 to 5, wherein in step 3, spray drying granulation is performed according to the following process parameters: the material temperature is 70 ℃, the air inlet temperature is 80-130 ℃, and the air outlet temperature is 60 ℃; and finishing the grains by adopting an upper sieve with 10 meshes and a lower sieve with 60 meshes.
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103272171A (en) * | 2013-04-26 | 2013-09-04 | 杨文明 | Traditional Chinese medicine for treating hopatolenticular degeneration and its preparation method and use |
| CN106692886A (en) * | 2017-03-17 | 2017-05-24 | 鲍远程 | Traditional Chinese medicine composition for treating hepatolenticular degeneration and preparation method thereof |
| CN110327446A (en) * | 2019-08-15 | 2019-10-15 | 安徽中医药大学第一附属医院 | It is a kind of to treat hepatolenticular degeneration liver fibrosis Chinese medicine composition and application |
| CN110613834A (en) * | 2019-09-09 | 2019-12-27 | 安徽中医药大学 | Application of compound formula of Chinese and western medicines in treating hepatolenticular degeneration associated reproductive system damage disease |
-
2021
- 2021-07-28 CN CN202110859788.1A patent/CN113456781A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103272171A (en) * | 2013-04-26 | 2013-09-04 | 杨文明 | Traditional Chinese medicine for treating hopatolenticular degeneration and its preparation method and use |
| CN106692886A (en) * | 2017-03-17 | 2017-05-24 | 鲍远程 | Traditional Chinese medicine composition for treating hepatolenticular degeneration and preparation method thereof |
| CN110327446A (en) * | 2019-08-15 | 2019-10-15 | 安徽中医药大学第一附属医院 | It is a kind of to treat hepatolenticular degeneration liver fibrosis Chinese medicine composition and application |
| CN110613834A (en) * | 2019-09-09 | 2019-12-27 | 安徽中医药大学 | Application of compound formula of Chinese and western medicines in treating hepatolenticular degeneration associated reproductive system damage disease |
Non-Patent Citations (2)
| Title |
|---|
| 杨文明，等: "治疗肝豆状核变性中医药研究进展", 《中国实验方剂学杂志》 * |
| 高雁楠: "Wilson病患者早期肾损伤指标变化及补肾祛痰化瘀法对Wilson病早期肾损伤临床研究", 《中国优秀硕士学位论文全文数据库医药卫生科技辑》 * |
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