CN117379505A - Traditional Chinese medicine composition for treating chronic kidney disease - Google Patents
Traditional Chinese medicine composition for treating chronic kidney disease Download PDFInfo
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- CN117379505A CN117379505A CN202310552959.5A CN202310552959A CN117379505A CN 117379505 A CN117379505 A CN 117379505A CN 202310552959 A CN202310552959 A CN 202310552959A CN 117379505 A CN117379505 A CN 117379505A
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Classifications
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- A—HUMAN NECESSITIES
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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- A61K36/481—Astragalus (milkvetch)
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Abstract
The invention provides a traditional Chinese medicine composition for treating chronic kidney disease, which consists of astragalus, red sage root, leech, ledebouriella root, stiff silkworm, cicada slough, aconite root, rehmannia root and other medicines. Clinical application proves that the medicine has the efficacy of treating chronic kidney disease.
Description
Technical Field
The invention relates to a traditional Chinese medicine composition, in particular to a traditional Chinese medicine composition for treating chronic kidney diseases, and belongs to the field of traditional Chinese medicines.
Background
Chronic kidney disease (Chronic Kidney Diseases, CKD) is a chronic kidney structure and dysfunction (history of kidney damage greater than 3 months) caused by a variety of causes, including normal and abnormal pathological lesions of glomerular filtration rate, abnormal blood or urine composition, and imaging abnormalities, or a decline in glomerular filtration rate of over 3 unknown causes (< 60ml/min 1.73m 2).
CKD has now become a global public health problem. Cross-sectional survey reports of epidemiology of chronic kidney disease in China show that the prevalence of CKD in China is 10.8%. If CKD is not effectively treated it will continue to progress, eventually into End-stage renal disease (End-Stage Renal Disease, ESRD). In recent years, the morbidity and mortality of ESRD are increasing, and patients need to receive kidney replacement therapy (including hemodialysis, peritoneal dialysis, kidney transplantation, etc.) to sustain life, which brings long-term physiological and psychological affliction and economic burden to the patients.
Modern medicine mainly comprises drug treatment, nutrition support, substitution treatment and the like for treating the CKD, and the treatment means have limitations. CKD belongs to the category of "guan ge" and "drown toxin" in traditional Chinese medicine, and its etiology and pathogenesis are complex, mainly the deficiency and the excess are the principal, the deficiency has the differences of qi, blood, yin and yang, and the excess has the differences of damp-heat stasis toxin. The traditional Chinese medicine has unique advantages in treating chronic kidney disease, and in the treatment process, the principle of dialectical treatment is adhered to, and the traditional Chinese medicine is taken orally as a main component, and is combined with traditional Chinese medicine characteristic therapies such as external washing, acupoint application, colon dialysis and the like, so that the symptoms of patients can be relieved, the progress of chronic kidney disease can be delayed, and the life quality of the patients can be improved.
Disclosure of Invention
The application aims at providing a traditional Chinese medicine composition for treating chronic kidney diseases, a preparation method of the traditional Chinese medicine composition and application of the traditional Chinese medicine composition in preparation of medicines for treating chronic kidney diseases.
Scheme one:
the application provides a traditional Chinese medicine composition for treating chronic kidney diseases, which is prepared from the following raw materials: astragalus root, red sage root, leech, ledebouriella root, stiff silkworm, cicada slough, aconite root, rehmannia root, cornus officinalis, cherokee rose fruit, raspberry, rhubarb, achyranthes root, chinese yam, red paeony root and dendrobium.
Preferably, the traditional Chinese medicine composition is prepared from the following raw materials: 20-80 parts of astragalus membranaceus, 15-60 parts of radix salviae miltiorrhizae, 2-10 parts of leech, 10-40 parts of radix sileris, 7-28 parts of stiff silkworm, 7-28 parts of periostracum cicada, 5-20 parts of radix aconiti carmichaeli, 10-40 parts of rehmannia glutinosa, 10-40 parts of dogwood, 10-40 parts of cherokee rose fruit, 15-60 parts of raspberry, 15-60 parts of rheum officinale, 15-60 parts of achyranthes bidentata, 10-40 parts of Chinese yam, 10-40 parts of radix paeoniae rubra and 10-40 parts of dendrobium nobile.
Further preferably, the traditional Chinese medicine composition is prepared from the following raw materials: 26-69 parts of astragalus membranaceus, 18-50 parts of radix salviae miltiorrhizae, 3-8.4 parts of leech, 12-32 parts of radix sileris, 9-23 parts of stiff silkworm, 9-23 parts of periostracum cicada, 6-16 parts of radix aconiti carmichaeli, 12-32 parts of rehmannia glutinosa, 12-32 parts of dogwood, 12-32 parts of cherokee rose, 18-50 parts of raspberry, 18-50 parts of rheum officinale, 18-50 parts of achyranthes bidentata, 12-32 parts of Chinese yam, 12-32 parts of radix paeoniae rubra and 12-32 parts of dendrobium nobile.
Still more preferably, the traditional Chinese medicine composition is prepared from the following raw materials: 35-60 parts of astragalus membranaceus, 23-41 parts of radix salviae miltiorrhizae, 4-7.5 parts of leech, 15-27 parts of radix saposhnikoviae, 11-20 parts of stiff silkworm, 11-20 parts of periostracum cicada, 7.5-13 parts of radix aconiti carmichaeli, 15-27 parts of rehmannia glutinosa, 15-27 parts of dogwood, 15-27 parts of cherokee rose fruit, 23-41 parts of raspberry, 23-41 parts of rheum officinale, 23-41 parts of achyranthes bidentata, 15-27 parts of Chinese yam, 15-27 parts of radix paeoniae rubra and 15-27 parts of dendrobium nobile.
Most preferably, the traditional Chinese medicine composition is prepared from the following raw materials: 45 parts of astragalus membranaceus, 30 parts of salvia miltiorrhiza, 6 parts of leech, 20 parts of radix saposhnikoviae, 15 parts of stiff silkworm, 15 parts of cicada slough, 10 parts of aconite, 20 parts of rehmannia, 20 parts of dogwood, 20 parts of cherokee rose, 30 parts of raspberry, 30 parts of rheum officinale, 30 parts of achyranthes bidentata, 20 parts of Chinese yam, 20 parts of red paeony root and 20 parts of dendrobium;
or 41 parts of astragalus membranaceus, 35 parts of salvia miltiorrhiza, 5 parts of leech, 23 parts of radix sileris, 13 parts of stiff silkworm, 17 parts of cicada slough, 8.5 parts of aconite, 23 parts of rehmannia, 18 parts of dogwood, 23 parts of cherokee rose fruit, 25 parts of raspberry, 35 parts of rheum officinale, 25 parts of achyranthes bidentata, 18 parts of Chinese yam, 17 parts of radix paeoniae rubra and 24 parts of dendrobium;
or 52 parts of astragalus membranaceus, 27 parts of salvia miltiorrhiza, 7 parts of leech, 18 parts of radix saposhnikoviae, 17 parts of stiff silkworm, 13 parts of cicada slough, 11 parts of aconite, 18 parts of rehmannia, 23 parts of dogwood, 18 parts of cherokee rose fruit, 37 parts of raspberry, 25 parts of rheum officinale, 37 parts of achyranthes bidentata, 23 parts of Chinese yam, 25 parts of red paeony root and 17 parts of dendrobium nobile.
In the above technical scheme, the traditional Chinese medicine composition can be any form formed by or prepared from the above raw materials, and comprises the following components: the raw materials are respectively crushed and then mixed to form a composition; or the composition is obtained by mixing the raw materials and crushing the mixture; or mixing the above raw materials, extracting by conventional extraction method to obtain extract, and refining and purifying to obtain effective part, or further preparing the above extract and effective part into conventional oral dosage form by conventional preparation process.
The conventional extraction method comprises soaking extraction, decocting extraction, reflux extraction, percolation extraction, ultrasonic extraction, microwave extraction, etc.; the extraction solvent comprises water or conventional organic solvents such as ethanol, methanol, ethyl acetate, petroleum ether, isopropanol, etc.; the refining and purifying process comprises extraction, column chromatography separation, high performance liquid chromatography separation and the like.
The conventional oral dosage forms comprise tablets, capsules, granules, pills, powder and oral liquid. The preparation of the dosage form requires the addition of common pharmaceutically acceptable auxiliary materials, including: fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, matrices, and the like. The filler comprises: starch, pregelatinized starch, lactose, mannitol, chitin, microcrystalline cellulose, sucrose, and the like; the disintegrating agent comprises: starch, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, crosslinked polyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, crosslinked sodium carboxymethyl cellulose, and the like; the lubricant comprises: magnesium stearate, sodium lauryl sulfate, talc, silica, and the like; the suspending agent comprises: polyvinylpyrrolidone, microcrystalline cellulose, sucrose, agar, hydroxypropyl methylcellulose, and the like; the binder includes starch slurry, polyvinylpyrrolidone, hydroxypropyl methylcellulose, etc.
Scheme II:
the traditional Chinese medicine composition can be added in the form of an extract besides the form of raw materials. Thus, as another aspect of the present application, the present application further provides a traditional Chinese medicine composition for treating chronic kidney disease, the traditional Chinese medicine composition is prepared from the following raw materials: 20-80 parts of astragalus extract, 15-60 parts of red sage root extract, 2-10 parts of leech extract, 10-40 parts of divaricate saposhnikovia root extract, 7-28 parts of stiff silkworm extract, 7-28 parts of cicada slough extract, 5-20 parts of aconite extract, 10-40 parts of rehmannia root extract, 10-40 parts of dogwood extract, 10-40 parts of cherokee rose fruit extract, 15-60 parts of raspberry extract, 15-60 parts of rheum officinale extract, 15-60 parts of achyranthes root extract, 10-40 parts of Chinese yam extract, 10-40 parts of red paeony root extract and 10-40 parts of dendrobium nobile extract.
Preferably, the traditional Chinese medicine composition is prepared from the following raw materials: 26-69 parts of astragalus extract, 18-50 parts of red sage root extract, 3-8.4 parts of leech extract, 12-32 parts of divaricate saposhnikovia root extract, 9-23 parts of stiff silkworm extract, 9-23 parts of cicada slough extract, 6-16 parts of aconite extract, 12-32 parts of rehmannia root extract, 12-32 parts of dogwood extract, 12-32 parts of cherokee rose fruit extract, 18-50 parts of raspberry extract, 18-50 parts of rheum officinale extract, 18-50 parts of achyranthes root extract, 12-32 parts of Chinese yam extract, 12-32 parts of red paeony root extract and 12-32 parts of dendrobium extract.
Further preferably, the traditional Chinese medicine composition is prepared from the following raw materials: 35-60 parts of astragalus extract, 23-41 parts of red sage root extract, 4-7.5 parts of leech extract, 15-27 parts of divaricate saposhnikovia root extract, 11-20 parts of stiff silkworm extract, 11-20 parts of cicada slough extract, 7.5-13 parts of aconite extract, 15-27 parts of rehmannia root extract, 15-27 parts of dogwood extract, 15-27 parts of cherokee rose fruit extract, 23-41 parts of raspberry extract, 23-41 parts of rheum officinale extract, 23-41 parts of achyranthes root extract, 15-27 parts of Chinese yam extract, 15-27 parts of red paeony root extract and 15-27 parts of dendrobium.
Most preferably, the traditional Chinese medicine composition is prepared from the following raw materials: 45 parts of astragalus extract, 30 parts of red sage root extract, 6 parts of leech extract, 20 parts of divaricate saposhnikovia root extract, 15 parts of stiff silkworm extract, 15 parts of cicada slough extract, 10 parts of aconite extract, 20 parts of rehmannia root extract, 20 parts of dogwood extract, 20 parts of cherokee rose fruit extract, 30 parts of raspberry extract, 30 parts of rheum officinale extract, 30 parts of achyranthes root extract, 20 parts of Chinese yam extract, 20 parts of red paeony root extract and 20 parts of dendrobium extract;
Wherein the extracts are water extracts of the raw materials respectively.
Scheme III:
the traditional Chinese medicine composition can be added in the form of granules besides the form of raw materials or extracts. Thus, as another aspect of the present application, the present application further provides a traditional Chinese medicine composition for treating chronic kidney disease, the traditional Chinese medicine composition is prepared from the following raw materials: 20-80 parts of astragalus membranaceus particles, 15-60 parts of red sage root particles, 2-10 parts of leech particles, 10-40 parts of radix saposhnikoviae particles, 7-28 parts of stiff silkworm particles, 7-28 parts of cicada slough particles, 5-20 parts of aconite particles, 10-40 parts of rehmannia root particles, 10-40 parts of dogwood particles, 10-40 parts of cherokee rose particles, 15-60 parts of raspberry particles, 15-60 parts of rheum officinale particles, 15-60 parts of achyranthes bidentata particles, 10-40 parts of Chinese yam particles, 10-40 parts of red paeony root particles and 10-40 parts of dendrobium nobile particles.
Preferably, the traditional Chinese medicine composition is prepared from the following raw materials: 26-69 parts of astragalus membranaceus particles, 18-50 parts of red sage root particles, 3-8.4 parts of leech particles, 12-32 parts of divaricate saposhnikovia root particles, 9-23 parts of stiff silkworm particles, 9-23 parts of cicada slough particles, 6-16 parts of aconite particles, 12-32 parts of rehmannia root particles, 12-32 parts of dogwood particles, 12-32 parts of cherokee rose fruits, 18-50 parts of raspberry particles, 18-50 parts of rheum officinale particles, 18-50 parts of achyranthes roots, 12-32 parts of Chinese yam particles, 12-32 parts of red paeony root particles and 12-32 parts of dendrobium nobile particles.
Further preferably, the traditional Chinese medicine composition is prepared from the following raw materials: 35-60 parts of astragalus membranaceus particles, 23-41 parts of red sage root particles, 4-7.5 parts of leech particles, 15-27 parts of divaricate saposhnikovia root particles, 11-20 parts of stiff silkworm particles, 11-20 parts of cicada slough particles, 7.5-13 parts of aconite particles, 15-27 parts of rehmannia root particles, 15-27 parts of dogwood particles, 15-27 parts of cherokee rose fruits, 23-41 parts of raspberry particles, 23-41 parts of rheum officinale particles, 23-41 parts of achyranthes bidentata particles, 15-27 parts of Chinese yam particles, 15-27 parts of red paeony root particles and 15-27 parts of dendrobium nobile particles.
Most preferably, the traditional Chinese medicine composition is prepared from the following raw materials: 45 parts of astragalus membranaceus particles, 30 parts of salvia miltiorrhiza particles, 6 parts of leech particles, 20 parts of radix sileris particles, 15 parts of stiff silkworm particles, 15 parts of cicada slough particles, 10 parts of aconite particles, 20 parts of rehmannia particles, 20 parts of dogwood particles, 20 parts of cherokee rose fruits, 30 parts of raspberry particles, 30 parts of rheum officinale particles, 30 parts of achyranthes bidentata particles, 20 parts of Chinese yam particles, 20 parts of red paeony root particles and 20 parts of dendrobium nobile particles;
Wherein the particles are respectively prepared from water extracts of the raw materials according to a conventional process or are commercially available traditional Chinese medicine particles.
Scheme IV:
as another aspect of the present application, the present application provides an application of the traditional Chinese medicine composition in preparing a medicine for treating chronic kidney disease.
The raw material medicines used in the application are all collected in Chinese pharmacopoeia (2020 edition). Wherein the radix astragali is preferably radix astragali, the radix et rhizoma Rhei is preferably radix Rumicis, the rehmanniae radix is preferably radix rehmanniae, and the Achyranthis radix is preferably Achyranthis radix.
The beneficial effects of this application:
the basic pathogenesis of chronic kidney disease is the deficiency of the principal and secondary aspects of the disease. Deficiency of the spleen and kidney is the root cause of the disease, spleen is the congenital root, kidney is the acquired root, spleen qi which is not congenital cannot be transformed, kidney qi which is not acquired cannot be produced, and spleen and kidney are complementary to each other, so it is mainly indicated for tonifying spleen and kidney. Kidney governs water, kidney qi evaporates and transforms water, spleen governs transportation and transformation, turbid qi is expelled from body by kidney qi, kidney deficiency evaporates and transforms into weak, damp turbidity is accumulated in body, qi stagnation and stasis are generated, turbid phlegm is generated, or turbid toxin is accumulated into toxin, and phlegm, turbid toxin and stasis are generated as pathogenic excess. In the formula of the invention, astragalus root supplements qi of the whole body, dogwood, cherokee rose fruit, achyranthes root, yam and raspberry tonify spleen and kidney, strengthen kidney essence, dried rehmannia root and dendrobium stem nourish kidney yin, and aconite root is added to assist in warming yang and invigorating pulse; the compatibility of the red sage root, the leech and the red paeony root can remove blood stasis without damaging new blood, and the rheum officinale can clear away heat and toxic materials, break mass and reduce swelling; then, wind-repellent silkworm, cicada slough and other pungent-flavor herbs are combined to dispel wind and detoxify, unblock kidney collaterals and open the Xuanfu, which is a specific application of wind-repellent herbs in the treatment of chronic diseases. The whole prescription can tonify liver and kidney, can obviously reduce Creatinine (CR), urea nitrogen (BUN) and Uric Acid (UA) of patients with chronic kidney disease when clinically used for treating patients with chronic kidney disease, and can improve glomerular filtration rate (eGFR), and the total effective rate reaches 93.8%.
Drawings
Various other advantages and benefits will become apparent to those of ordinary skill in the art upon reading the following detailed description of the preferred embodiments. The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the invention. In the drawings:
FIG. 1 is a graph of HE staining (magnification ×400) of each group of rats of Experimental example 3; wherein A. Normal group; B. a model group; C. fosinopril group; D. a low dose group of compositions; E. dose groups in the composition; F. high dose group of compositions.
Detailed Description
Exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the present invention are shown in the drawings, it should be understood that the present invention may be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art.
Example 1
The formula comprises the following components: 45g of raw astragalus, 30g of red sage root, 6g of leech, 20g of divaricate saposhnikovia root, 15g of stiff silkworm, 15g of cicada slough, 10g of aconite root, 20g of dried rehmannia root, 20g of dogwood, 20g of cherokee rose fruit, 30g of raspberry, 30g of rheum officinale, 30g of achyranthes root, 20g of Chinese yam, 20g of red paeony root and 20g of dendrobium;
The preparation method comprises the following steps:
step 1, decocting: decocting radix Aconiti lateralis (soaking for 30 min, heating and decocting for 30 min), adding other materials, decocting for 2 times, wherein the water amount added for the first time is 10 times of the total mass of the materials, and decocting for 2 hr; the water adding amount for the second time is 8 times of the total mass of the medicinal materials, and the medicinal materials are decocted for 1 hour; filtering with 100 meshes, and mixing the two liquid medicines in a liquid storage tank;
step 2, concentrating: pumping the filtrate into a spherical concentrating evaporator, and concentrating to obtain soft extract with relative density of 1.30-1.33.
Step 3, vacuum drying under reduced pressure: placing the concentrated solution in a vacuum drying oven, and drying.
Step 4, crushing: pulverizing the dried dry extract in pulverizer, bagging, and sealing for storage.
Example 2
The formula comprises the following components: 41g of raw astragalus, 35g of red sage root, 5g of leech, 23g of divaricate saposhnikovia root, 13g of stiff silkworm, 17g of cicada slough, 8.5g of aconite root, 23g of dried rehmannia root, 18g of common macrocarpium fruit, 23g of cherokee rose fruit, 25g of raspberry, 35g of rheum officinale, 25g of achyranthes root, 18g of Chinese yam, 17g of red paeony root and 24g of dendrobium.
Example 3
The formula comprises the following components: 52g of raw astragalus, 27g of red sage root, 7g of leech, 18g of divaricate saposhnikovia root, 17g of stiff silkworm, 13g of cicada slough, 11g of aconite, 18g of dried rehmannia root, 23g of dogwood, 18g of cherokee rose fruit, 37g of raspberry, 25g of rheum officinale, 37g of achyranthes root, 23g of Chinese yam, 25g of red paeony root and 17g of dendrobium.
Example 4
The formula comprises the following components: 43g of raw astragalus, 33g of red sage root, 5.5g of leech, 22g of divaricate saposhnikovia root, 14g of stiff silkworm, 16g of cicada slough, 9g of aconite root, 22g of dried rehmannia root, 19g of dogwood, 22g of cherokee rose fruit, 27g of raspberry, 33g of rheum officinale, 27g of achyranthes root, 19g of Chinese yam, 19g of red paeony root and 22g of dendrobium.
Example 5
The formula comprises the following components: 48g of raw astragalus, 28g of red sage root, 6.5g of leech, 19g of divaricate saposhnikovia root, 16g of stiff silkworm, 14g of cicada slough, 10.5g of aconite, 19g of dried rehmannia root, 22g of dogwood, 19g of cherokee rose, 35g of raspberry, 27g of rheum officinale, 35g of achyranthes root, 22g of Chinese yam, 23g of red paeony root and 18g of dendrobium.
Example 6
The formula comprises the following components: 39g of raw astragalus, 36g of red sage root, 4.7g of leech, 24g of divaricate saposhnikovia root, 12g of stiff silkworm, 18g of cicada slough, 8.2g of aconite, 24g of dried rehmannia root, 18g of dogwood, 24g of cherokee rose fruit, 36g of raspberry, 30g of rheum officinale, 36g of achyranthes root, 18g of Chinese yam, 20g of red paeony root and 20g of dendrobium.
Example 7
The formula comprises the following components: 54g of raw astragalus, 25g of red sage root, 7g of leech, 18g of divaricate saposhnikovia root, 18g of stiff silkworm, 12g of cicada slough, 11.5g of aconite root, 18g of dried rehmannia root, 24g of common macrocarpium fruit, 18g of cherokee rose fruit, 25g of raspberry, 35g of rheum officinale, 25g of achyranthes root, 24g of Chinese yam, 22g of red paeony root and 23g of dendrobium.
Example 8
The formula comprises the following components: 33g of raw astragalus, 44g of red sage root, 3.7g of leech, 28g of divaricate saposhnikovia root, 10.5g of stiff silkworm, 21g of cicada slough, 7g of aconite, 28g of dried rehmannia root, 14g of dogwood, 28g of cherokee rose, 20g of raspberry, 48g of rheum officinale, 20g of achyranthes root, 30g of Chinese yam, 14g of red paeony root and 30g of dendrobium.
Example 9
The formula comprises the following components: 62g of raw astragalus, 22g of red sage root, 7.8g of leech, 14g of divaricate saposhnikovia root, 21g of stiff silkworm, 10.5g of cicada slough, 14g of aconite, 14g of dried rehmannia root, 28g of dogwood, 14g of cherokee rose fruit, 48g of raspberry, 20g of rheum officinale, 48g of achyranthes root, 14g of Chinese yam, 30g of red paeony root and 14g of dendrobium.
Example 10
The formula comprises the following components: 29g of raw astragalus, 47g of red sage root, 3.3g of leech, 30g of divaricate saposhnikovia root, 9.5g of stiff silkworm, 22g of cicada slough, 6.5g of aconite, 30g of dried rehmannia root, 13g of dogwood, 30g of cherokee rose fruit, 22g of raspberry, 46g of rheum officinale, 23g of achyranthes root, 29g of Chinese yam, 15g of red paeony root and 28g of dendrobium.
Example 11
The formula comprises the following components: 66g of raw astragalus, 20g of red sage root, 8g of leech, 13g of divaricate saposhnikovia root, 22g of stiff silkworm, 9.5g of cicada slough, 15g of aconite root, 13g of dried rehmannia root, 30g of common macrocarpium fruit, 13g of cherokee rose fruit, 46g of raspberry, 22g of rheum officinale, 45g of achyranthes root, 15g of Chinese yam, 28g of red paeony root and 15g of dendrobium.
Example 12
The formula comprises the following components: 24g of raw astragalus, 53g of red sage root, 2.7g of leech, 34g of divaricate saposhnikovia root, 8g of stiff silkworm, 25g of cicada slough, 6g of aconite root, 34g of dried rehmannia root, 11.5g of common macrocarpium fruit, 34g of cherokee rose fruit, 17g of raspberry, 56g of rheum officinale, 18g of achyranthes root, 38g of Chinese yam, 12g of red paeony root and 37g of dendrobium.
Example 13
The formula comprises the following components: 72g of raw astragalus, 17g of red sage root, 9g of leech, 11.5g of divaricate saposhnikovia root, 25g of stiff silkworm, 8g of cicada slough, 17g of aconite root, 11.5g of dried rehmannia root, 34g of dogwood, 11.5g of cherokee rose fruit, 55g of raspberry, 18g of rheum officinale, 57g of achyranthes root, 12g of Chinese yam, 38g of red paeony root and 12g of dendrobium.
Example 14
The formula comprises the following components: 22g of raw astragalus, 56g of red sage root, 2.5g of leech, 37g of divaricate saposhnikovia root, 7.5g of stiff silkworm, 26g of cicada slough, 6g of aconite, 37g of dried rehmannia root, 10g of dogwood, 37g of cherokee rose fruit, 16g of raspberry, 52g of rheum officinale, 16g of achyranthes root, 35g of Chinese yam, 14g of red paeony root and 35g of dendrobium.
Example 15
The formula comprises the following components: 76g of raw astragalus, 16g of red sage root, 9.5g of leech, 10g of divaricate saposhnikovia root, 26g of stiff silkworm, 7.5g of cicada slough, 17g of aconite, 10g of dried rehmannia root, 37g of dogwood, 10g of cherokee rose fruit, 53g of raspberry, 17g of rheum officinale, 55g of achyranthes root, 14g of Chinese yam, 32g of red paeony root and 11g of dendrobium.
The compositions of examples 2-15 were prepared in the same manner as in example 1.
Example 16
The formula comprises the following components: 45g of raw astragalus extract, 30g of red sage root extract, 6g of leech extract, 20g of divaricate saposhnikovia root extract, 15g of stiff silkworm extract, 15g of cicada slough extract, 10g of aconite root extract, 20g of dried rehmannia root extract, 20g of dogwood extract, 20g of cherokee rose fruit extract, 30g of raspberry extract, 30g of rheum officinale extract, 30g of achyranthes root extract, 20g of Chinese yam extract, 20g of red paeony root extract and 20g of dendrobium extract.
Example 17
The formula comprises the following components: 41g of raw astragalus extract, 35g of red sage root extract, 5g of leech extract, 23g of divaricate saposhnikovia root extract, 13g of stiff silkworm extract, 17g of cicada slough extract, 8.5g of aconite extract, 23g of dried rehmannia root extract, 18g of dogwood extract, 23g of cherokee rose fruit extract, 25g of raspberry extract, 35g of rhubarb extract, 25g of achyranthes root extract, 18g of Chinese yam extract, 17g of red paeony root extract and 24g of dendrobium extract.
Example 18
The formula comprises the following components: 52g of raw astragalus extract, 27g of red sage root extract, 7g of leech extract, 18g of divaricate saposhnikovia root extract, 17g of stiff silkworm extract, 13g of cicada slough extract, 11g of aconite root extract, 18g of dried rehmannia root extract, 23g of dogwood extract, 18g of cherokee rose fruit extract, 37g of raspberry extract, 25g of rhubarb extract, 37g of achyranthes root extract, 23g of Chinese yam extract, 25g of red paeony root extract and 17g of dendrobium extract.
Example 19
The formula comprises the following components: 39g of raw astragalus extract, 36g of red sage root extract, 4.7g of leech extract, 24g of divaricate saposhnikovia root extract, 12g of stiff silkworm extract, 18g of cicada slough extract, 8.2g of aconite extract, 24g of raw rehmannia root extract, 18g of dogwood extract, 24g of cherokee rose fruit extract, 36g of raspberry extract, 30g of rheum officinale extract, 36g of achyranthes root extract, 18g of Chinese yam extract, 20g of red paeony root extract and 20g of dendrobium extract.
Example 20
The formula comprises the following components: 54g of raw astragalus extract, 25g of red sage root extract, 7g of leech extract, 18g of divaricate saposhnikovia root extract, 18g of stiff silkworm extract, 12g of cicada slough extract, 11.5g of aconite root extract, 18g of dried rehmannia root extract, 24g of dogwood extract, 18g of cherokee rose fruit extract, 25g of raspberry extract, 35g of rhubarb extract, 25g of achyranthes root extract, 24g of Chinese yam extract, 22g of red paeony root extract and 23g of dendrobium extract.
Example 21
The formula comprises the following components: 29g of raw astragalus extract, 47g of red sage extract, 3.3g of leech extract, 30g of divaricate saposhnikovia root extract, 9.5g of stiff silkworm extract, 22g of cicada slough extract, 6.5g of aconite extract, 30g of raw rehmannia root extract, 13g of dogwood extract, 30g of cherokee rose fruit extract, 22g of raspberry extract, 46g of rheum officinale extract, 23g of achyranthes root extract, 29g of Chinese yam extract, 15g of red paeony root extract and 28g of dendrobium extract.
Example 22
The formula comprises the following components: 66g of raw astragalus extract, 20g of red sage root extract, 8g of leech extract, 13g of divaricate saposhnikovia root extract, 22g of stiff silkworm extract, 9.5g of cicada slough extract, 15g of aconite root extract, 13g of dried rehmannia root extract, 30g of dogwood extract, 13g of cherokee rose fruit extract, 46g of raspberry extract, 22g of rhubarb extract, 45g of achyranthes root extract, 15g of Chinese yam extract, 28g of red paeony root extract and 15g of dendrobium extract.
Example 23
The formula comprises the following components: 22g of raw astragalus extract, 56g of red sage root extract, 2.5g of leech extract, 37g of divaricate saposhnikovia root extract, 7.5g of stiff silkworm extract, 26g of cicada slough extract, 6g of aconite root extract, 37g of raw rehmannia root extract, 10g of dogwood extract, 37g of cherokee rose fruit extract, 16g of raspberry extract, 52g of rhubarb extract, 16g of achyranthes root extract, 35g of Chinese yam extract, 14g of red paeony root extract and 35g of dendrobium extract.
Example 24
The formula comprises the following components: 76g of raw astragalus extract, 16g of red sage root extract, 9.5g of leech extract, 10g of divaricate saposhnikovia root extract, 26g of stiff silkworm extract, 7.5g of cicada slough extract, 17g of aconite root extract, 10g of raw rehmannia root extract, 37g of dogwood extract, 10g of cherokee rose fruit extract, 53g of raspberry extract, 17g of rhubarb extract, 55g of achyranthes root extract, 14g of Chinese yam extract, 32g of red paeony root extract and 11g of dendrobium extract.
The extracts described in examples 16 to 24 above were aqueous extracts of the respective crude drugs.
Example 25
The formula comprises the following components: 45g of raw astragalus extract, 30g of red sage root extract, 6g of leech extract, 20g of divaricate saposhnikovia root extract, 15g of stiff silkworm extract, 15g of cicada slough extract, 10g of aconite root extract, 20g of dried rehmannia root extract, 20g of dogwood extract, 20g of cherokee rose fruit extract, 30g of raspberry extract, 30g of rheum officinale extract, 30g of achyranthes root extract, 20g of Chinese yam extract, 20g of red paeony root extract and 20g of dendrobium extract.
Example 26
The formula comprises the following components: 41g of raw astragalus particles, 35g of red sage particles, 5g of leech particles, 23g of divaricate saposhnikovia root particles, 13g of stiff silkworm particles, 17g of cicada slough particles, 8.5g of aconite particles, 23g of dried rehmannia root particles, 18g of dogwood particles, 23g of cherokee rose fruits, 25g of raspberry particles, 35g of rheum officinale particles, 25g of achyranthes bidentata particles, 18g of Chinese yam particles, 17g of red paeony root particles and 24g of dendrobium particles.
Example 27
The formula comprises the following components: 52g of raw astragalus particles, 27g of red sage particles, 7g of leech particles, 18g of divaricate saposhnikovia root particles, 17g of stiff silkworm particles, 13g of cicada slough particles, 11g of aconite particles, 18g of dried rehmannia root particles, 23g of dogwood particles, 18g of cherokee rose fruits, 37g of raspberry particles, 25g of rheum officinale particles, 37g of achyranthes bidentata, 23g of Chinese yam particles, 25g of red paeony root particles and 17g of dendrobium nobile particles.
The granules described in the above examples 25-27 are prepared by concentrating the water extracts of the raw materials and then preparing the granules according to the conventional process.
Experimental example 1 formulation screening
Formula 1
The composition is as follows: 45g of raw astragalus, 30g of red-rooted salvia root, 20g of winged euonymus twig, 20g of divaricate saposhnikovia root, 15g of stiff silkworm, 15g of cicada slough, 10g of aconite (decocted first), 20g of dried rehmannia root, 20g of dogwood, 20g of cherokee rose fruit, 30g of gorgon fruit, 30g of rheum officinale, 30g of mistletoe and 20g of Chinese yam;
efficacy: spleen and kidney tonifying, blood circulation promoting and blood stasis removing effects
Compatibility: astragalus root, radix astragali, fructus corni, cherokee rose fruit, gorgon euryale seed, mistletoe, chinese yam and dried rehmannia root have the functions of invigorating spleen and kidney and reinforcing kidney essence, and are added with aconite root to assist in warming yang and invigorating pulse; the compatibility of the red sage root and the winged euonymus twig can promote blood circulation to remove blood stasis, and the rhubarb can clear away heat and toxic materials, break mass and reduce swelling; wind-dispelling and detoxicating herbs such as Fang Feng, jiang Can and Chan tui are combined.
Curative effect: clinical observations were performed on 42 patients with CKD (stages 3-5), and the results showed that patients had Cr and BUN decreased before treatment and that had gfr increased before treatment. Wherein 8 cases are effective, 9 cases are effective, 16 cases are stable, 9 cases are ineffective, the total effective rate is 78.6%, and the effective rate is 19%.
Formulation 2
The composition is as follows: 45g of raw astragalus, 30g of red sage root, 6g of leech, 20g of divaricate saposhnikovia root, 15g of stiff silkworm, 15g of cicada slough, 10g of aconite (decocted first), 20g of dried rehmannia root, 20g of dogwood, 20g of cherokee rose fruit, 30g of raspberry, 30g of rheum officinale, 30g of achyranthes root, 20g of Chinese yam, 20g of red paeony root and 20g of dendrobium;
efficacy: kidney-tonifying, blood-activating and collaterals-dredging
Compatibility: radix astragali supplements qi of the whole body, fructus Corni, fructus Rosae Laevigatae, radix Achyranthis bidentatae, rhizoma Dioscoreae, fructus Rubi, and has effects of invigorating spleen and kidney, consolidating kidney essence, radix rehmanniae, herba Dendrobii, nourishing kidney yin, and radix Aconiti lateralis Preparata for warming yang and dredging collaterals; the compatibility of the red sage root, the leech and the red paeony root can remove blood stasis without damaging new blood, and the rheum officinale can clear away heat and toxic materials, break mass and reduce swelling; then, wind-repellent silkworm, cicada slough and other pungent-flavor herbs are combined to dispel wind and detoxify, unblock kidney collaterals and open the Xuanfu, which is a specific application of wind-repellent herbs in the treatment of chronic diseases.
Curative effect: clinical observations of 65 patients with CKD (stage 3-5) show that Cr and BUN of the patients are reduced and EGFR is increased compared with those before treatment. Wherein, the total effective rate of 20 cases, 27 cases, 14 cases, and 4 cases is invalid, the total effective rate is 93.8%, and the effective rate is 72.3%.
Through comparison, the formula 2 is based on the formula 1 to remove winged euonymus twig, gorgon fruit and mistletoe, and leech, red paeony root, raspberry, radix achyranthis bidentatae and dendrobium are added to promote blood circulation to remove blood stasis, and the radix achyranthis bidentatae can remove blood stasis and dredge channels, also can tonify liver and kidney, and has the effects of nourishing kidney yin of dendrobe and dried rehmannia root, so that turbid pathogenic factors are removed, kidney collaterals are dredged, kidney essence is supplemented, and biochemical activity is achieved. From the clinical effect, the total effective rate and the obvious efficiency of the formula 2 for treating chronic kidney disease are obviously better than those of the formula 1.
Experimental example 2 clinical observations
1 object of observation
115 CKD (stage 3-5) patients retrospectively enrolled in the clinic of the nephrology department of Beijing TCM hospital on days 1 of 2022, 1 of 2022 and 31 of 2022 were divided into 65 test and 50 control groups according to the treatment method. Wherein the average age of the test group is 65.49 + -9.92 years old, 40 men and 25 women; the average age of the control group was 62.86.+ -. 11.47 years, 22 men and 28 women. The two general data were compared, the differences were statistically significant (P > 0.05), and were comparable.
2 diagnostic criteria
2.1 Western diagnostic criteria
Kidney damage (including abnormal kidney pathology examination, abnormal kidney imaging examination, abnormal urine examination and abnormal blood examination related to kidney disease) occurs for more than 3 months, or glomerular filtration rate of unknown cause is less than 60 ml/(min.1.73 m) 2 ) For more than 3 months. The standard for the classification of CKD refers to guidelines established by the United states kidney disease foundation, and the stage 3-5 of CKD refers to glomerular filtration rate < 60 ml/(min.1.73 m) 2 ). And calculating the eGFR according to the CKD-EPI formula. The formula for additional gfr: eGFR=141× (SCr/κ) α×0.993 age [ ×1.018 female][. Times.1.159 Male]Kappa=0.7 in women, scr is less than or equal to 0.7, alpha= -0.329, scr > 0.7, alpha= -1.209 in men, kappa=0.9, scr is less than or equal to 0.9, alpha= -0.411, scr > 0.9, alpha= -1.209 in men.
2.2 criteria for the symptoms and signs of traditional Chinese medicine
The diagnosis standard of spleen and kidney deficiency and turbid toxin and stasis is formulated according to the traditional Chinese medicine symptom diagnosis standard of chronic renal failure issued by the national ministry of health (2002) and the clinical research guidelines (trial) of new traditional Chinese medicines:
(1) spleen and kidney deficiency syndrome: main symptoms are as follows: lassitude, debilitation, shortness of breath, lazy speaking, anorexia, soreness of the waist and knees. Secondary symptoms: a gastric and abdominal distention, a loose stool, a pale mouth, a thirst, a pale tongue with teeth marks and a deep and thready pulse.
(2) Syndrome of turbid toxin and blood stasis: (1) turbid dampness pattern: main symptoms are as follows: nausea, vomiting, heaviness of the limbs, poor appetite and anorexia. Secondary symptoms: gastric and abdominal distention, sticky and greasy mouth and thick and greasy tongue coating. (2) damp-heat syndrome: main symptoms are as follows: nausea, vomiting, heavy weight, drowsiness, anorexia, dry mouth and bitter taste. Secondary symptoms: abdominal distention and sticky and greasy mouth and yellow and greasy tongue coating. (3) Water vapor syndrome: main symptoms are as follows: edema, hydrothorax, ascites. (4) blood stasis syndrome: main symptoms are as follows: dark complexion and lumbago. Secondary symptoms: skin with wrong nails, numbness of limbs, dark purple tongue with ecchymosis, and astringent or thready and astringent pulse.
2.3 inclusion criteria
The age is 18-85 years. The eGFR of CKD patients is less than or equal to 60 ml/(min.1.73 m) 2 ). The dialectical pattern of the traditional Chinese medicine accords with the pattern of spleen and kidney deficiency and turbid toxin stasis. The medical record data is complete.
2.4 exclusion criteria
Patients who have received kidney replacement therapy such as hemodialysis, peritoneal dialysis or kidney transplantation; severe complications such as uremic pericarditis, uremic encephalopathy, cerebral infarction, limb disorder, acute myocardial infarction, cerebral hemorrhage, and hemorrhage of digestive tract, amputation, etc.; serious primary diseases such as heart, brain, liver and hematopoietic system are not controlled; currently, immunotherapy or active immune disease patients are performed.
3 methods of treatment
3.1 control group: is used for reducing blood pressure, reducing blood sugar, reducing uric acid, correcting anemia, and correcting mineral substance and bone metabolism abnormality. Treatment was 3 months.
3.2 test group: the formula is added on the basis of a control group, and the formula comprises the following medicines: 45g of raw astragalus, 30g of red sage root, 6g of leech, 20g of divaricate saposhnikovia root, 15g of stiff silkworm, 15g of cicada slough, 10g of aconite (decocted first), 20g of dried rehmannia root, 20g of dogwood, 20g of cherokee rose fruit, 30g of raspberry, 30g of rheum officinale, 30g of achyranthes root, 20g of Chinese yam, 20g of red paeony root and 20g of dendrobium. The preparation is taken twice a day in the morning and evening, 200ml is decocted each time, and the treatment course is 3 months.
4 observation of curative effect
4.1 observations index
Two groups of patients were treated with urea nitrogen (BUN), creatinine (CR), uric Acid (UA), glomerular filtration rate (gfr), albumin (ALB), hemoglobin (HGB).
4.2 statistical methods
Statistical analysis using SPSS 26.0 software runs, all statistical tests using double-sided tests, P values less than or equal to 0.05 were considered statistically significant for the differences tested. The measurement data is statistically described by adopting mean ± standard deviation; metering data setThe inter-group t-test is used for the persons with the normal distribution in the inter-group comparison, the t-test is used for the persons with the uniform variance, and the correction t-test (t' -test) is used for the persons with the irregular variance; the non-conforming normal distributor was tested with Wilcoxon rank sum. Counting data and grade data are statistically described by adopting frequency numbers (composition ratios); the counting data adopts χ 2 Testing, or Fisher's exact probability method testing; the grade data is verified by non-parametric test.
5 results
5.1 comparison of renal function in two groups of patients before and after treatment
Table 1 comparison of renal function before and after treatment for two groups of patients
Note that: in contrast to the pre-treatment of this group, # P＜0.05， ## p is less than 0.01, the test group is compared with the control group, △ P＜0.05。
laboratory indicators of renal function in patients were assessed and universal Cr, BUN, eGFR, UA was selected, with Cr, BUN, eGFR and UA levels before and after treatment in both groups being shown in table 1. The Cr, BUN, eGFR and UA levels before and after treatment were compared by themselves and between groups, respectively.
Control Cr, BUN, UA was elevated before and after treatment and effr was reduced before treatment, with CR, UA, eGFR levels statistically significant (P < 0.05). Test group Cr, BUN, UA was significantly lower than before, eGFR was elevated than before, and the difference was statistically significant (P < 0.05). Inter-group comparison, post-treatment group CR, BUN, UA and eGFR compared to control group post-treatment, the differences were statistically significant (P < 0.05).
5.2 effective rate of two groups of patients
The results are shown in Table 2.
TABLE 2 effective rate of two groups of patients
| Group of | Has obvious effect | Effective and effective | Stabilization | Invalidation of | Total effective rate |
| Control group | 0 | 3 | 2 | 45 | 10％ |
| Test group | 20 | 27 | 14 | 4 | 93.8％ △ |
Note that: the test group was compared with the control group, △ P < 0.05, total effective rate= (effective + stable)/total number of people x 100%.
Through clinical comprehensive curative effect evaluation, the total effective rate of the test group is 93.8%; the total effective rate of the control group is 10%, and the difference has statistical significance.
Conclusion 6
Creatinine, a metabolite that is excreted in the body through urine, is a common indicator of kidney filtration. Urea nitrogen is a metabolic end product of body proteins, an indicator of the filtration function of the glomeruli. Glomerular filtration is one of the most important functions of the kidney, expressed as glomerular filtration rate (gfr). Therefore, the accurate evaluation of the eGFR is of great significance in judging the stage of CKD, evaluating the renal function progress, evaluating the effect of intervention treatment, judging the time for starting renal replacement treatment and the like. Uric acid is the end product of purine metabolism, and is often accompanied by elevated serum uric acid when renal function is impaired. The study compares the kidney function index improvement conditions of two groups of patients in a group and a group, and finds that the improvement effect is obvious after the treatment of the test group and the difference compared with the control group has statistical significance.
Experimental example 3 pharmacodynamics observation of the Chinese medicinal composition of the present invention on chronic renal failure rats
1 materials and methods
1.1 animals
SPF-grade male SD rats, 60, purchased from Beijing Vitolihua laboratory animal technologies Co., ltd., license number: SCXK (Beijing) 2021-0011, weight 280-300 g, 14-18 weeks. Experiments were performed after 1 week of the adaptive feeding in the animal house at Beijing university of traditional Chinese medicine.
1.2 principal drugs and Agents
Experimental drugs:
the formula comprises the following components: 45g of raw astragalus, 30g of red sage root, 6g of leech, 20g of divaricate saposhnikovia root, 15g of stiff silkworm, 15g of cicada slough, 10g of aconite root, 20g of dried rehmannia root, 20g of dogwood, 20g of cherokee rose fruit, 30g of raspberry, 30g of rheum officinale, 30g of achyranthes root, 20g of Chinese yam, 20g of red paeony root and 20g of dendrobium;
the preparation method comprises the following steps: decocting radix Aconiti lateralis (soaking for 30 min, heating and decocting for 30 min), adding other materials, decocting for 2 times, wherein the water amount added for the first time is 10 times of the total mass of the materials, and decocting for 2 hr; the water adding amount for the second time is 8 times of the total mass of the medicinal materials, and the medicinal materials are decocted for 1 hour; filtering with 100 meshes, and mixing the two liquid medicines in a liquid storage tank; pumping the filtrate into a spherical concentrating evaporator, and concentrating to obtain soft extract with relative density of 1.30-1.33.
Positive control drug: fosinopril sodium tablet (Zhongshanghai Guibao pharmaceutical Co., ltd.);
adenine (Shanghai Yuan leaf biotechnology Co., ltd., product number: S18009)
2 method
2.1 animal model building and grouping
2.1.1 establishment of model for chronic renal failure
According to the literature (Liu Hongyan, yang Aihua, liu Xuemei, liu Liqiu. Study of chronic renal failure model of rats due to adenine [ J ]. Chinese laboratory diagnostics, 2011,15 (12): 2014-2017), animal models were made using 200mg/kg adenine for daily gastric lavage, 4 weeks continuously, blood was taken from the inner canthus of the eyes of rats after 4 weeks of modeling, and serum creatinine levels were detected to indicate that serum creatinine was significantly elevated compared to normal rats, so that the chronic renal failure model was successfully established at this time. Rats were randomly divided into model groups, low, medium and high dose groups of the traditional Chinese medicine composition and fosinopril groups.
2.1.2 Experimental grouping and handling
The experiments were divided into 6 groups, namely a normal group, a model group, a fosinopril group, and a low, medium and high dose group of the traditional Chinese medicine composition. After the low, medium and high dosage groups of the traditional Chinese medicine composition establish a chronic renal failure model according to the method, respectively preparing the traditional Chinese medicine composition into 1.58g/ml, 3.16g/ml and 6.32g/ml, and carrying out 1ml of the traditional Chinese medicine composition for 100g -1 *d -1 And the stomach is irrigated for 2 weeks. Fosinopril group: fosinopril sodium was formulated at 0.66mg per 1ml drug to 1ml x 100g -1 *d -1 And the stomach is irrigated for 2 weeks. Normal group: the same volume of physiological saline is irrigated for 6 weeks; model group: after the chronic renal failure model is established according to the method, the same volume of physiological saline is infused for 2 weeks. All rats were placed in a metabolic cage at 6 weeks to collect urine, after which the rats were sacrificed and serum was collected. Simultaneously collecting kidney specimens, respectively fixing in 4% formaldehyde solution, embedding paraffin, and freezing at-80deg.C.
2.2 detection index and method
2.2.1 serum creatinine, urea Nitrogen, and 24h urine protein levels
After 24h urine is collected by adopting a metabolism cage, the full-automatic biochemical analyzer detects 24h urine protein quantification. The vena cava was collected with 4ml, and serum was collected by centrifugation, and the serum was detected by a full-automatic biochemical analyzer for creatinine (Scr) and urea nitrogen (BUN).
2.2.2 renal pathological changes
The pathological changes of kidney tissues are observed under a common optical microscope by adopting HE staining. Pathological changes in kidney tissue were scored according to the criteria of the literature (Taal M W, zandi-Nejad K, wening B, et al Proinl: (1) presence or absence of protein tubes; (2) the presence or absence of renal interstitial fibrosis; (3) the presence or absence of tubular dilation; (4) infiltration of cells of renal interstitial inflammation. Each lesion was scored as 1,2,3 and 0 for no lesions at all, 8 high-power fields were randomly scored and averaged for each slice, and the data were statistically processed.
3 results
3.1 renal function test
After 6 weeks of the experiment, serum Scr and BUN and 24h urine protein quantification were significantly increased (P < 0.01) in the model group, the low, medium and high dose dosing group, the fosinopril group, and the rats.
The high dose group and the fosinopril group of the traditional Chinese medicine composition can be compared with the model group, and the serum Scr concentration (P < 0.05) can be regulated downwards; compared with the model group, the BUN of fosinopril group (P < 0.05), low-dose group (P < 0.05), medium-dose group (P < 0.01) and high-dose group (P < 0.01) of the traditional Chinese medicine composition is reduced; compared with the model group, the high-dose group of the traditional Chinese medicine composition has the most obvious 24h urine protein amount down-regulation (P < 0.01). In addition, the Chinese medicinal composition has no statistical difference (P > 0.05) between the Scr and BUN and 24h urine protein groups compared with the model group. The results are shown in Table 3.
Table 3 comparison of blood Scr, BUN, 24h urine protein levels of rats of each group (X.+ -. SD, n=10)
Note that: in comparison with the normal group, # P<0.05， ## P<0.01; in comparison with the set of models, * P<0.05， ** P<0.01; and (3) withThe positive drug groups are compared with each other, △ P<0.05， △△ P<0.01。
3.2 renal pathological lesions and scoring
The kidney tissue structure of the normal group rat is clear, and no obvious pathological change exists. The model group rats have obvious expansion of a large number of renal tubules, apoptosis necrosis of epithelial cells of the renal tubules, large-area interstitial fibrosis, protein tubes, particle tubes and obvious infiltration of inflammatory cells. The kidney pathological changes of rats in the low, medium and high dose groups and the fosinopril group of the traditional Chinese medicine composition are obviously reduced compared with those of rats in the Mod group. The normal group kidney pathology scores were significantly lower than the model group, while the low (P < 0.05), medium (P < 0.05), high (P < 0.01) dose groups and fosinopril group (P < 0.01) pathology scores were all lower than the model group. The difference between the low, medium and high dose groups of the traditional Chinese medicine composition and the fosinopril group is not statistically significant (P > 0.05). The results are shown in Table 4 and FIG. 1.
TABLE 4 rat tubular interstitial injury score (X+ -SD) for each group
| Group of | n | Tubular interstitial injury score |
| Normal group | 10 | 1.60±0.84 |
| Model group | 10 | 9.60±0.96 ## |
| Fosinopril group | 10 | 7.70±0.95 ##** |
| Low dose group of compositions | 10 | 8.10±0.88 ##* |
| Dosage groups in compositions | 10 | 7.90±0.99 ##* |
| High dose group of compositions | 10 | 7.60±0.52 ##** |
Note that: in comparison with the normal group, # P<0.05， ## P<0.01; in comparison with the set of models, * P<0.05， ** P<0.01; in comparison with the positive drug group, △ P<0.05， △△ P<0.01。
Claims (10)
1. the traditional Chinese medicine composition for treating chronic kidney disease is characterized by being prepared from the following raw materials: 20-80 parts of astragalus membranaceus, 15-60 parts of radix salviae miltiorrhizae, 2-10 parts of leech, 10-40 parts of radix sileris, 7-28 parts of stiff silkworm, 7-28 parts of periostracum cicada, 5-20 parts of radix aconiti carmichaeli, 10-40 parts of rehmannia glutinosa, 10-40 parts of dogwood, 10-40 parts of cherokee rose fruit, 15-60 parts of raspberry, 15-60 parts of rheum officinale, 15-60 parts of achyranthes bidentata, 10-40 parts of Chinese yam, 10-40 parts of radix paeoniae rubra and 10-40 parts of dendrobium nobile.
2. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition is prepared from the following raw materials: 26-69 parts of astragalus membranaceus, 18-50 parts of radix salviae miltiorrhizae, 3-8.4 parts of leech, 12-32 parts of radix sileris, 9-23 parts of stiff silkworm, 9-23 parts of periostracum cicada, 6-16 parts of radix aconiti carmichaeli, 12-32 parts of rehmannia glutinosa, 12-32 parts of dogwood, 12-32 parts of cherokee rose, 18-50 parts of raspberry, 18-50 parts of rheum officinale, 18-50 parts of achyranthes bidentata, 12-32 parts of Chinese yam, 12-32 parts of radix paeoniae rubra and 12-32 parts of dendrobium nobile.
3. The traditional Chinese medicine composition according to claim 2, wherein the traditional Chinese medicine composition is prepared from the following raw materials: 35-60 parts of astragalus membranaceus, 23-41 parts of radix salviae miltiorrhizae, 4-7.5 parts of leech, 15-27 parts of radix saposhnikoviae, 11-20 parts of stiff silkworm, 11-20 parts of periostracum cicada, 7.5-13 parts of radix aconiti carmichaeli, 15-27 parts of rehmannia glutinosa, 15-27 parts of dogwood, 15-27 parts of cherokee rose fruit, 23-41 parts of raspberry, 23-41 parts of rheum officinale, 23-41 parts of achyranthes bidentata, 15-27 parts of Chinese yam, 15-27 parts of radix paeoniae rubra and 15-27 parts of dendrobium nobile.
4. The traditional Chinese medicine composition according to claim 3, wherein the traditional Chinese medicine composition is prepared from the following raw materials: 45 parts of astragalus membranaceus, 30 parts of salvia miltiorrhiza, 6 parts of leech, 20 parts of radix saposhnikoviae, 15 parts of stiff silkworm, 15 parts of cicada slough, 10 parts of aconite, 20 parts of rehmannia, 20 parts of dogwood, 20 parts of cherokee rose, 30 parts of raspberry, 30 parts of rheum officinale, 30 parts of achyranthes bidentata, 20 parts of Chinese yam, 20 parts of red paeony root and 20 parts of dendrobium;
or 41 parts of astragalus membranaceus, 35 parts of salvia miltiorrhiza, 5 parts of leech, 23 parts of radix sileris, 13 parts of stiff silkworm, 17 parts of cicada slough, 8.5 parts of aconite, 23 parts of rehmannia, 18 parts of dogwood, 23 parts of cherokee rose fruit, 25 parts of raspberry, 35 parts of rheum officinale, 25 parts of achyranthes bidentata, 18 parts of Chinese yam, 17 parts of radix paeoniae rubra and 24 parts of dendrobium;
Or 52 parts of astragalus membranaceus, 27 parts of salvia miltiorrhiza, 7 parts of leech, 18 parts of radix saposhnikoviae, 17 parts of stiff silkworm, 13 parts of cicada slough, 11 parts of aconite, 18 parts of rehmannia, 23 parts of dogwood, 18 parts of cherokee rose fruit, 37 parts of raspberry, 25 parts of rheum officinale, 37 parts of achyranthes bidentata, 23 parts of Chinese yam, 25 parts of red paeony root and 17 parts of dendrobium nobile.
5. The Chinese medicinal composition according to any one of claims 1 to 4, wherein the Chinese medicinal composition is prepared by pulverizing the above raw materials respectively and mixing; or the composition is obtained by mixing the raw materials and crushing the mixture; or mixing the above raw materials, extracting by conventional extraction method to obtain extract, and refining and purifying to obtain effective part, or further preparing the above extract and effective part into conventional oral dosage form by conventional preparation process.
6. The traditional Chinese medicine composition for treating chronic kidney disease is characterized by being prepared from the following raw materials: 20-80 parts of astragalus extract, 15-60 parts of red sage root extract, 2-10 parts of leech extract, 10-40 parts of divaricate saposhnikovia root extract, 7-28 parts of stiff silkworm extract, 7-28 parts of cicada slough extract, 5-20 parts of aconite extract, 10-40 parts of rehmannia root extract, 10-40 parts of dogwood extract, 10-40 parts of cherokee rose fruit extract, 15-60 parts of raspberry extract, 15-60 parts of rheum officinale extract, 15-60 parts of achyranthes root extract, 10-40 parts of Chinese yam extract, 10-40 parts of red paeony root extract and 10-40 parts of dendrobium extract;
Or, the traditional Chinese medicine composition is prepared from the following raw materials: 26-69 parts of astragalus extract, 18-50 parts of red sage root extract, 3-8.4 parts of leech extract, 12-32 parts of divaricate saposhnikovia root extract, 9-23 parts of stiff silkworm extract, 9-23 parts of cicada slough extract, 6-16 parts of aconite extract, 12-32 parts of rehmannia root extract, 12-32 parts of dogwood extract, 12-32 parts of cherokee rose fruit extract, 18-50 parts of raspberry extract, 18-50 parts of rheum officinale extract, 18-50 parts of achyranthes root extract, 12-32 parts of Chinese yam extract, 12-32 parts of red paeony root extract and 12-32 parts of dendrobium extract;
or, the traditional Chinese medicine composition is prepared from the following raw materials: 35-60 parts of astragalus extract, 23-41 parts of red sage root extract, 4-7.5 parts of leech extract, 15-27 parts of divaricate saposhnikovia root extract, 11-20 parts of stiff silkworm extract, 11-20 parts of cicada slough extract, 7.5-13 parts of aconite extract, 15-27 parts of rehmannia root extract, 15-27 parts of dogwood extract, 15-27 parts of cherokee rose fruit extract, 23-41 parts of raspberry extract, 23-41 parts of rheum officinale extract, 23-41 parts of achyranthes root extract, 15-27 parts of Chinese yam extract, 15-27 parts of red paeony root extract and 15-27 parts of dendrobium stem extract;
Wherein the extracts are water extracts of the raw materials respectively.
7. The traditional Chinese medicine composition according to claim 6, wherein the traditional Chinese medicine composition is prepared from the following raw materials: 45 parts of astragalus extract, 30 parts of red sage root extract, 6 parts of leech extract, 20 parts of divaricate saposhnikovia root extract, 15 parts of stiff silkworm extract, 15 parts of cicada slough extract, 10 parts of aconite extract, 20 parts of rehmannia root extract, 20 parts of dogwood extract, 20 parts of cherokee rose fruit extract, 30 parts of raspberry extract, 30 parts of rheum officinale extract, 30 parts of achyranthes root extract, 20 parts of Chinese yam extract, 20 parts of red paeony root extract and 20 parts of dendrobium extract.
8. The traditional Chinese medicine composition for treating chronic kidney disease is characterized by being prepared from the following raw materials: 20-80 parts of astragalus membranaceus particles, 15-60 parts of red sage root particles, 2-10 parts of leech particles, 10-40 parts of radix saposhnikoviae particles, 7-28 parts of stiff silkworm particles, 7-28 parts of cicada slough particles, 5-20 parts of aconite particles, 10-40 parts of rehmannia root particles, 10-40 parts of dogwood particles, 10-40 parts of cherokee rose fruits, 15-60 parts of raspberry particles, 15-60 parts of rheum officinale particles, 15-60 parts of achyranthes roots, 10-40 parts of Chinese yam particles, 10-40 parts of red paeony root particles and 10-40 parts of dendrobium;
Or, the traditional Chinese medicine composition is prepared from the following raw materials: 26-69 parts of astragalus membranaceus particles, 18-50 parts of red sage root particles, 3-8.4 parts of leech particles, 12-32 parts of divaricate saposhnikovia root particles, 9-23 parts of stiff silkworm particles, 9-23 parts of cicada slough particles, 6-16 parts of aconite particles, 12-32 parts of rehmannia root particles, 12-32 parts of dogwood particles, 12-32 parts of cherokee rose fruits, 18-50 parts of raspberry particles, 18-50 parts of rheum officinale particles, 18-50 parts of achyranthes roots, 12-32 parts of Chinese yam particles, 12-32 parts of red paeony root particles and 12-32 parts of dendrobium nobile particles;
or, the traditional Chinese medicine composition is prepared from the following raw materials: 35-60 parts of astragalus membranaceus particles, 23-41 parts of red sage root particles, 4-7.5 parts of leech particles, 15-27 parts of divaricate saposhnikovia root particles, 11-20 parts of stiff silkworm particles, 11-20 parts of cicada slough particles, 7.5-13 parts of aconite particles, 15-27 parts of rehmannia root particles, 15-27 parts of dogwood particles, 15-27 parts of cherokee rose fruits, 23-41 parts of raspberry particles, 23-41 parts of rheum officinale particles, 23-41 parts of achyranthes bidentata particles, 15-27 parts of Chinese yam particles, 15-27 parts of red paeony root particles and 15-27 parts of dendrobium nobile particles.
9. The traditional Chinese medicine composition according to claim 8, wherein the traditional Chinese medicine composition is prepared from the following raw materials: 45 parts of astragalus membranaceus particles, 30 parts of salvia miltiorrhiza particles, 6 parts of leech particles, 20 parts of radix sileris particles, 15 parts of stiff silkworm particles, 15 parts of cicada slough particles, 10 parts of aconite particles, 20 parts of rehmannia particles, 20 parts of dogwood particles, 20 parts of cherokee rose fruits, 30 parts of raspberry particles, 30 parts of rheum officinale particles, 30 parts of achyranthes bidentata particles, 20 parts of Chinese yam particles, 20 parts of red paeony root particles and 20 parts of dendrobium nobile particles.
10. Use of a Chinese medicinal composition according to any one of claims 1-4, 6-9 in the manufacture of a medicament for the treatment of chronic kidney disease.
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