CN106668431B - A Chinese medicinal composition with effects of warming kidney and invigorating qi, and its preparation method and application - Google Patents
A Chinese medicinal composition with effects of warming kidney and invigorating qi, and its preparation method and application Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition with the curative effects of warming kidney, tonifying qi and the like, and a preparation method and application thereof. The invention adds two medicinal materials of eucommia bark and psoralea fruit on the basis of the formula of the existing Shenkangning capsule, and simultaneously reduces the using amount of other medicinal materials, thereby obtaining a brand-new traditional Chinese medicine composition with the curative effects of warming kidney, tonifying qi, invigorating blood circulation, excreting dampness and the like. In addition, the invention adopts a dynamic warm-immersion extraction method combined with a steam reflux method to extract the raw material medicine, compared with the traditional decocting method, the content of the danshensu is improved by 2.36-2.92 times, and the content is stable and lasts for more than three years, thereby solving the technical problems of low content and instability of the danshensu in the existing Shenkangning capsule compound preparation.
Description
Technical Field
The invention relates to a traditional Chinese medicine composition and a preparation method thereof, in particular to a traditional Chinese medicine composition with the curative effects of warming kidney, tonifying qi and the like, a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine research.
Background
The traditional Chinese medicine considers that the kidney is the congenital foundation of the human body, the kidney qi is derived from the function of steaming kidney water by the fire of the Mingmen, and the qi circulates the triple energizer cloth to be applied to the exterior, interior and exterior of the whole body, the internal organs and the channels and collaterals, so as to maintain the metabolism function of the human body life network. The term "kidney qi" refers to qi transformed by kidney essence, which reflects the functional activities of the kidney and is especially important for the vital activities of the human body. If kidney qi is insufficient, not only premature senility but also life can be damaged, but also various diseases can be caused, such as soreness and pain of waist and legs, mental fatigue and hypodynamia, insomnia and dreamful sleep, dizziness, fullness of brain, hyperhidrosis, alopecia and tooth loss, memory decline and other symptoms, which are extremely unfavorable for health. According to medical indications and statistics, 52% of men over 35 years old have different degrees of kidney deficiency, 66% between 45 and 55 years old and up to 78% between 55 and 65 years old, and the kidney deficiency becomes a common symptom. The chronic glomerulonephritis is called chronic nephritis for short, and refers to proteinuria, hematuria, hypertension and edema which are basic clinical manifestations, the onset modes are different, the disease state is prolonged, the pathological changes are slow to progress, renal hypofunction can be reduced to different degrees, and finally, a group of glomerulonephritis with chronic renal failure is developed. The main clinical manifestations are different due to different pathological types and disease stages of the disease, and the disease manifestations are diversified. The traditional Chinese medicine considers that the pathogenesis of chronic nephritis (CGN) is mainly based on spleen and kidney deficiency, particularly yang deficiency, and the symptoms of water dampness, damp-heat and blood stasis are taken as pathological changes. Therefore, the main therapeutic principles are strengthening healthy qi to eliminate pathogenic factors, i.e. protecting kidney qi, regulating yin and yang, excreting dampness and purging turbid. Because the disease is complicated, the pathogenesis is variable, the course of the disease is lingering, the disease condition is complicated due to the inclusion of deficiency and excess in the later period of the disease, and the disease condition is easy to repeat, thereby bringing certain difficulty to clinical treatment. Because the traditional Chinese medicine has the characteristics of reliable curative effect, comprehensive action, safe clinical medication and the like, the traditional Chinese medicine is highly popular with patients.
Shenkangning capsule (Chinese medicine standard Z20090980) is a classic Chinese patent medicine with the curative effects of warming kidney, tonifying qi, invigorating blood circulation, excreting dampness and the like, and is used for treating diseases such as waist soreness, fatigue, intolerance of cold, nocturia and the like caused by chronic nephritis, kidney qi deficiency and renal insufficiency. The formula of the traditional Chinese medicine comprises eight medicines of astragalus, salvia miltiorrhiza, poria cocos, rhizoma alismatis, motherwort herb, radix aconiti lateralis preparata, cynomorium songaricum and Chinese yam, wherein the dosage of each raw material medicine is as follows: 360g of astragalus, 300g of salvia miltiorrhiza, 300g of poria cocos, 180g of rhizoma alismatis, 450g of motherwort, 180g of radix aconiti lateralis preparata, 300g of cynomorium songaricum and 50g of Chinese yam. The preparation process comprises the following steps: pulverizing rhizoma Dioscoreae into fine powder; decocting radix astragali, Saviae Miltiorrhizae radix, Poria, Alismatis rhizoma, herba Leonuri, radix Aconiti lateralis Preparata, and herba Cynomorii in water twice, decocting with 10 times of water for 2 hr for the first time, decocting with 8 times of water for 1 hr for the second time, mixing decoctions, filtering, concentrating the filtrate to obtain soft extract, adding rhizoma Dioscoreae fine powder, mixing, drying, pulverizing, adding appropriate amount of adjuvants such as starch, mixing, granulating, and drying. However, it has the following technical problems:
1. the Shenkangning capsule comprises eight medicinal materials of astragalus root, salvia root, poria, alisma tuber, leonurus, aconite accessory piece, cynomorium songaricum and Chinese yam, and the existing preparation method is the traditional decocting method, and has low extraction rate and long extraction time.
2. The danshensu as the main active ingredient in the Shenkangning capsule has poor stability and is easy to be oxidized, so that the content of the danshensu in the Shenkangning capsule can not meet the requirement in the quality guarantee period and the quality of the danshensu is unstable.
Therefore, there is an urgent need to provide a new Chinese medicinal composition with effects of warming kidney, invigorating qi, promoting blood circulation, and eliminating dampness, and a preparation method capable of improving the stability of danshensu.
Disclosure of Invention
The invention aims to solve the technical problem of unstable quality of Shenkangning capsules and provides a novel traditional Chinese medicine composition with the curative effects of warming kidney, tonifying qi, activating blood, excreting dampness and the like, and a preparation method and application thereof.
In order to achieve the purpose, the invention adopts the following technical means:
the invention relates to a traditional Chinese medicine composition with the effects of warming kidney and tonifying qi, which is prepared from the following raw material medicines in parts by weight: 400 parts of astragalus mongholicus, 300 parts of salvia miltiorrhiza, 300 parts of poria cocos, 145 parts of rhizoma alismatis, 450 parts of leonurus, 110 parts of aconitum lateralis preparata, 130 parts of cynomorium songaricum, 300 parts of cynomorium songaricum, 40-60 parts of Chinese yam, 40-60 parts of eucommia ulmoides and 40-60 parts of fructus psoraleae.
Preferably, the traditional Chinese medicine composition consists of the following raw material medicines in parts by weight: 350 parts of astragalus membranaceus, 275 parts of salvia miltiorrhiza, 275 parts of poria cocos, 150 parts of rhizoma alismatis, 400 parts of motherwort, 120 parts of radix aconiti lateralis preparata, 275 parts of cynomorium songaricum, 50 parts of Chinese yam, 50 parts of eucommia ulmoides and 50 parts of fructus psoraleae.
Wherein, the salvia miltiorrhiza is preferably the salvia miltiorrhiza medicinal material harvested in 10 months in Anhui province.
The Chinese medicinal composition can be added with pharmaceutically acceptable auxiliary materials to prepare various clinically suitable Chinese medicinal preparations with the functions of warming the kidney and tonifying qi according to a conventional method. Preferably, the preparation comprises powder, granules, tablets, oral liquid or capsules.
Further, the invention also provides a method for preparing the traditional Chinese medicine composition, which comprises the following steps:
(1) weighing the raw materials according to the weight parts;
(2) pulverizing rhizoma Dioscoreae into fine powder;
(3) extracting Saviae Miltiorrhizae radix with deionized purified water 8-12 times the weight of Saviae Miltiorrhizae radix under sealed reflux at 100 deg.C for 4-7 hr, and concentrating the extractive solution at 75-85 deg.C to obtain soft extract;
(4) mixing radix astragali, Poria, Alismatis rhizoma, herba Leonuri, radix Aconiti lateralis Preparata, herba Cynomorii, Eucommiae cortex and fructus Psoraleae, adding 2-4 times of water into the mixture to moisten the medicinal materials, loading into a dynamic extraction tank, adding 2-4 times of water to adjust the temperature of solvent to 90 + -5 deg.C, extracting twice, respectively for 1.5 hr for the first time and 1 hr for the second time, mixing the extractive solutions, filtering, and concentrating the filtrate to obtain soft extract;
(5) mixing
And (4) mixing the thick paste obtained in the step (3) with the thick paste obtained in the step (4), adding the fine powder of the Chinese yam, uniformly mixing, drying and crushing to obtain the traditional Chinese medicine composition.
Wherein, the salvia miltiorrhiza is preferably the salvia miltiorrhiza medicinal material harvested in 10 months in Anhui province.
Wherein, the preferable method also comprises the steps of adding a proper amount of auxiliary materials into the obtained traditional Chinese medicine composition, adding pharmaceutically acceptable auxiliary materials and preparing various clinically suitable preparations according to a conventional method.
Furthermore, the invention also provides application of the traditional Chinese medicine composition in preparing medicines with the functions of warming kidney, tonifying qi, activating blood and excreting dampness.
Compared with the prior art, the invention has the beneficial effects that:
1. the invention firstly tries to add two medicinal materials of eucommia bark and psoralea fruit on the basis of the existing Shenkangning capsule prescription and simultaneously reduces the using amount of other medicinal materials, thereby obtaining a brand-new traditional Chinese medicine composition with the curative effects of warming kidney, tonifying qi, activating blood, excreting dampness and the like;
2. the invention utilizes the dynamic warm-leaching extraction method and combines the steam reflux method to extract the bulk drug, and compared with the traditional decocting method, the dynamic warm-leaching method has the characteristics of low leaching temperature, large contact surface area with the medicinal material, short leaching time, less solute loss and the like. Meanwhile, the salvia miltiorrhiza bunge is extracted by adopting an independent steam reflux method, which is different from the conventional common extraction method, and a plurality of technological preparation parameters are synchronously optimized, so that the content of the tanshinol in the composition after the salvia miltiorrhiza bunge is extracted independently is increased by 2.36-2.92 times compared with the composition prepared by a conventional decoction extraction method. The content is stable and lasts for more than three years, and the technical problems of low content and instability of the danshensu in the existing Shenkangning capsule compound preparation are solved.
Drawings
FIG. 1 is a schematic diagram of a dynamic warm leaching process.
Wherein, 1, a dynamic warm immersion tank; 2. a heater; 3. a pump; 4. a solvent storage tank; 5. a condenser; 6. a cooler; 7. a solvent intermediate tank.
Detailed Description
The invention will be further described with reference to specific embodiments, and the advantages and features of the invention will become apparent as the description proceeds. These examples are illustrative only and do not limit the scope of the present invention in any way. It will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention, and that such changes and modifications may be made without departing from the spirit and scope of the invention.
EXAMPLE 1 preparation of the Chinese medicinal composition
(1) Weighing the following raw materials by weight:
350g of astragalus, 275g of salvia miltiorrhiza, 275g of poria cocos, 150g of rhizoma alismatis, 400g of motherwort, 120g of radix aconiti lateralis preparata, 275g of cynomorium songaricum, 50g of Chinese yam, 50g of eucommia ulmoides and 50g of fructus psoraleae;
(2) pulverizing rhizoma Dioscoreae into fine powder;
(3) adding 10 times of deionized purified water into Saviae Miltiorrhizae radix (harvested 10 months in Anhui province), extracting with 100 deg.C steam under sealed reflux for 5 hr, concentrating the extractive solution at 80 deg.C for 8 hr, and obtaining an extract rate of about 16%.
(4) Mixing radix astragali, Poria, Alismatis rhizoma, herba Leonuri, radix Aconiti lateralis Preparata, herba Cynomorii, Eucommiae cortex and fructus Psoraleae, adding 3 times of water to the mixture to soak the medicinal materials, placing into a dynamic extraction tank, adding 3 times of water to adjust the temperature of solvent to 90 deg.C, extracting twice, 1.5 hr for the first time and 1 hr for the second time, mixing the extractive solutions, filtering, and concentrating the filtrate to obtain soft extract;
(5) mixing:
and (4) mixing the thick paste obtained in the step (3) with the thick paste obtained in the step (4), adding the fine powder of the Chinese yam, uniformly mixing, drying and crushing to obtain the Chinese yam powder.
And adding appropriate amount of starch and other adjuvants into the obtained Chinese medicinal composition, mixing, granulating, drying, and making into various clinically suitable preparations according to conventional preparation method of Chinese medicinal preparation.
EXAMPLE 2 preparation of the Chinese medicinal composition
(1) Weighing the following raw materials by weight:
360g of astragalus, 300g of salvia miltiorrhiza, 300g of poria cocos, 180g of rhizoma alismatis, 450g of motherwort, 180g of radix aconiti lateralis preparata, 300g of cynomorium songaricum, 50g of Chinese yam, 50g of eucommia ulmoides and 50g of fructus psoraleae;
(2) pulverizing rhizoma Dioscoreae into fine powder;
(3) adding 12 times of deionized purified water into Saviae Miltiorrhizae radix (harvested in 10 months in Anhui province), extracting with 100 deg.C steam under sealed reflux for 6 hr, concentrating the extractive solution at 80 deg.C for 8 hr, and obtaining extract with a yield of about 16%;
(4) mixing radix astragali, Poria, Alismatis rhizoma, herba Leonuri, radix Aconiti lateralis Preparata, herba Cynomorii, Eucommiae cortex and fructus Psoraleae, adding 3 times of water to the mixture to soak the medicinal materials, placing into a dynamic extraction tank, adding 3 times of water to adjust the temperature of solvent to 95 deg.C, extracting twice, 1.5 hr for the first time and 1 hr for the second time, mixing the extractive solutions, filtering, and concentrating the filtrate to obtain soft extract;
(5) mixing:
and (4) mixing the thick paste obtained in the step (3) with the thick paste obtained in the step (4), adding the fine powder of the Chinese yam, uniformly mixing, drying and crushing to obtain the Chinese yam powder.
And adding appropriate amount of starch and other adjuvants into the obtained Chinese medicinal composition, mixing, granulating, drying, and making into various clinically suitable preparations according to conventional preparation method of Chinese medicinal preparation.
EXAMPLE 3 preparation of the Chinese medicinal composition
(1) Weighing the following raw materials by weight:
330g of astragalus, 280g of salvia miltiorrhiza, 280g of poria cocos, 150g of rhizoma alismatis, 400g of motherwort, 120g of radix aconiti lateralis preparata, 280g of cynomorium songaricum, 55g of Chinese yam, 55g of eucommia ulmoides and 50g of fructus psoraleae;
(2) pulverizing rhizoma Dioscoreae into fine powder;
(3) adding 8 times of deionized purified water into Saviae Miltiorrhizae radix (harvested in 10 months in Anhui province), extracting with 100 deg.C steam under sealed reflux for 4 hr, concentrating the extractive solution at 80 deg.C for 8 hr, and obtaining extract with a yield of about 16%;
(4) mixing radix astragali, Poria, Alismatis rhizoma, herba Leonuri, radix Aconiti lateralis Preparata, herba Cynomorii, Eucommiae cortex and fructus Psoraleae, adding 3 times of water to the mixture to soak the medicinal materials, placing into a dynamic extraction tank, adding 3 times of water to adjust the temperature of solvent to 85 deg.C, extracting twice, 1.5 hr for the first time and 1 hr for the second time, mixing the extractive solutions, filtering, and concentrating the filtrate to obtain soft extract;
(5) mixing:
and (4) mixing the thick paste obtained in the step (3) with the thick paste obtained in the step (4), adding the fine powder of the Chinese yam, uniformly mixing, drying and crushing to obtain the Chinese yam powder.
And adding appropriate amount of starch and other adjuvants into the obtained Chinese medicinal composition, mixing, granulating, drying, and making into various clinically suitable preparations according to conventional preparation method of Chinese medicinal preparation.
Experimental example 1 determination of the origin of Salvia miltiorrhiza
The danshensu is derived from salvianolic acid B by hydrolysis and transformation, and the determination of radix Salviae Miltiorrhizae ensures the content of danshensu. Therefore, the invention selects 5 producing areas of red sage root as raw material medicine, and the 5 producing areas of red sage root are extracted by the following method: adding 10 times of deionized purified water into Saviae Miltiorrhizae radix, extracting with 100 deg.C steam under sealed reflux for 5 hr, and concentrating the extractive solution at 80 deg.C to obtain soft extract. The contents of tanshinone IIA and salvianolic acid B were measured, respectively, and the results are shown in Table 1.
TABLE 1
According to the results in table 1, the salvia miltiorrhiza medicinal material harvested in Anhui producing area for 10 months is selected in the invention.
Experimental example 2 determination of extraction Process flow
1. Determination of extraction procedure
The invention respectively adopts the following three extraction processes, and the contents of the tanshinol and the astragaloside obtained by the different extraction processes are measured, and the results are shown in table 2.
1) The water decoction method comprises the following steps: 350g of astragalus, 275g of poria, 275g of salvia miltiorrhiza (collected in 10 months in Anhui province), 150g of rhizoma alismatis, 400g of motherwort, 120g of radix aconiti lateralis preparata, 275g of cynomorium songaricum, 50g of eucommia and 50g of fructus psoraleae are respectively weighed, water is added for twice, 10 times of water is added for 2 hours for the first time, 8 times of water is added for 1 hour for the second time, decoction liquid is combined, the decoction liquid is filtered, the filtrate is concentrated into thick paste, yam fine powder is added into the concentrated paste, the mixture is uniformly mixed, dried and crushed, and the content of danshensu and astragaloside is measured.
2) Dynamic warm leaching extraction method: 350g of astragalus, 275g of poria, 275g of salvia miltiorrhiza (harvested in 10 months from Anhui province), 150g of rhizoma alismatis, 400g of motherwort, 120g of radix aconiti lateralis preparata, 275g of cynomorium songaricum, 50g of eucommia and 50g of fructus psoraleae are respectively weighed, 3 times of water by weight of the medicinal materials is added to soak the medicinal materials, the medicinal materials are put into a dynamic extraction tank, then 3 times of water by weight of the medicinal materials is added to adjust the temperature of a solvent to be 90 ℃, the medicinal materials are respectively extracted twice, for the first time for 1.5 hours and for the second time for 1 hour, the extracting solutions are combined and filtered, the extracting solution is concentrated into thick paste at the temperature of 80 ℃, Chinese yam fine powder is added into the concentrated paste, the mixture is.
3) Dynamic warm-dipping extraction method and steam reflux method are combined
Adding 275g of Saviae Miltiorrhizae radix (harvested 10 months in Anhui province), 10 times of deionized purified water, extracting with 100 deg.C steam under sealed reflux for 5 hr, and concentrating the extractive solution at 80 deg.C for 8 hr to obtain soft extract; 350g of astragalus, 275g of poria cocos, 150g of rhizoma alismatis, 400g of leonurus, 120g of radix aconiti lateralis preparata, 275g of cynomorium songaricum, 50g of eucommia ulmoides and 50g of fructus psoraleae are respectively weighed, 3 times of water is added to soak the medicinal materials, the medicinal materials are placed into a dynamic extraction tank, then 3 times of water is added to the medicinal materials to adjust the temperature of a solvent to be 90 ℃, the medicinal materials are respectively extracted twice, the first time lasts for 1.5 hours and the second time lasts for 1 hour, the extracting solution is combined and filtered, the extracting solution is concentrated into thick paste at the temperature of 80 ℃, Chinese yam fine powder is added into the concentrated paste, the mixture is uniformly mixed, dried and crushed, and.
TABLE 2 extraction methods comparative test results
Alignment by three extraction methods: the contents of astragaloside IV and tanshinol are higher than those of other two methods by a dynamic warm-soaking extraction method and a salvia miltiorrhiza steam reflux method, so the method is selected.
2. Screening of extraction temperature by dynamic warm-leaching extraction method
Weighing 350g of astragalus, 275g of poria cocos, 150g of rhizoma alismatis, 400g of leonurus, 120g of radix aconiti lateralis preparata, 275g of cynomorium songaricum, 50g of eucommia ulmoides and 50g of fructus psoraleae, adding 3 times of water to soak the medicinal materials, putting the medicinal materials into a dynamic extraction tank, adding 3 times of water to adjust the temperature of a solvent to be 50 ℃, 70 ℃ and 90 ℃, extracting for 2 times, 1.5 hours for the 1 st time and 1 hour for the 2 nd time respectively, collecting an extracting solution, filtering and concentrating. The astragaloside content was determined and the results are shown in table 3.
TABLE 3 extraction temperature screening test results
The test results show that: the extraction temperature at 90 ℃ is superior to other temperatures, and the optimal extraction temperature is selected as 90 ℃.
3. Screening of extraction time by dynamic warm-immersion extraction method
Weighing 350g of astragalus, 275g of poria cocos, 150g of rhizoma alismatis, 400g of leonurus, 120g of radix aconiti lateralis preparata, 275g of cynomorium songaricum, 50g of eucommia ulmoides and 50g of fructus psoraleae, adding 3 times of water to soak the medicinal materials, putting the medicinal materials into a dynamic extraction tank, adding 3 times of water to adjust the temperature of a solvent to 90 ℃, and extracting for 2 times respectively, wherein the extraction time is as follows: 1) 1 st time for 1.0h and 2 nd time for 1.0 h; 2) 1 st time for 1.5h and 2 nd time for 1.0 h; 3) collecting extractive solution for 1 time 2.5 hr and 2 times 1.0 hr, filtering, and concentrating. The astragaloside content was determined and the results are shown in table 4.
TABLE 4 extraction temperature screening test results
The test result shows that the result of 2.0h is superior to other results, so the extraction is selected to be 2.0 h.
4. Screening of solvent dosage by dynamic warm-dipping extraction method
Weighing 350g of astragalus membranaceus, 275g of poria cocos, 150g of rhizoma alismatis, 400g of leonurus, 120g of radix aconiti lateralis preparata, 275g of cynomorium songaricum, 50g of eucommia ulmoides and 50g of fructus psoraleae, adding water 2 times, 3 times or 4 times of the medicinal materials to soak the medicinal materials, putting the medicinal materials into a dynamic extraction tank, adding water 2 times, 3 times or 4 times of the medicinal materials to adjust the solvent temperature to 90 ℃, extracting for 2 times respectively, wherein the extraction time is 1.5 hours at the 1 st time and 1.0 hour at the 2 nd time, collecting the extracting solution, filtering and concentrating. The astragaloside content was determined and the results are shown in Table 5.
TABLE 5 extraction temperature screening test results
Test results show that when the dosage of the solvent is 6 times, the content of the astragaloside is optimal.
Experimental example 3 comparison of astragaloside IV and danshensu content in compositions prepared by different preparation methods
In order to show the contents of astragaloside and danshensu in the compositions prepared by different preparation methods by comparison, the invention carries out the following experiments:
experimental group 1: (1) weighing the following raw materials by weight: 350g of astragalus membranaceus, 275g of salvia miltiorrhiza (collected in 10 months in Anhui province), 275g of poria cocos, 150g of rhizoma alismatis, 400g of leonurus, 120g of radix aconiti lateralis preparata, 275g of cynomorium songaricum, 50g of Chinese yam, 50g of eucommia ulmoides and 50g of fructus psoraleae; (2) extraction: pulverizing rhizoma Dioscoreae into fine powder; decocting radix astragali, Saviae Miltiorrhizae radix, Poria, Alismatis rhizoma, herba Leonuri, radix Aconiti lateralis Preparata, herba Cynomorii, Eucommiae cortex, and fructus Psoraleae with water twice, adding 10 times of water for 2 hr for the first time, adding 8 times of water for 1 hr for the second time, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract; (3) mixing: adding rhizoma Dioscoreae fine powder into the concentrated extract, mixing, drying, pulverizing, adding appropriate amount of adjuvants such as starch, mixing, granulating, and drying.
Experimental group 2: (1) weighing the following raw materials by weight: 350g of astragalus membranaceus, 275g of salvia miltiorrhiza (collected in 10 months in Anhui province), 275g of poria cocos, 150g of rhizoma alismatis, 400g of leonurus, 120g of radix aconiti lateralis preparata, 275g of cynomorium songaricum, 50g of Chinese yam, 50g of eucommia ulmoides and 50g of fructus psoraleae; (2) extraction: extracting Saviae Miltiorrhizae radix with 10 times of water under reflux at 100 deg.C for 7 hr, filtering, and concentrating the filtrate to obtain Saviae Miltiorrhizae radix extract; pulverizing rhizoma Dioscoreae into fine powder; decocting radix astragali, Poria, Alismatis rhizoma, herba Leonuri, radix Aconiti lateralis Preparata, and herba Cynomorii in water twice, adding 10 times of water for 2 hr for the first time, adding 8 times of water for 1 hr for the second time, mixing decoctions, filtering, and concentrating the filtrate to obtain soft extract; (3) mixing: adding rhizoma Dioscoreae fine powder into the Saviae Miltiorrhizae radix extract and other medicinal materials soft extract, mixing, drying, pulverizing, adding appropriate amount of adjuvants such as starch, mixing, granulating, and drying.
Experimental group 3: (1) weighing the following raw materials by weight: 350g of astragalus membranaceus, 275g of salvia miltiorrhiza (collected in 10 months in Anhui province), 275g of poria cocos, 150g of rhizoma alismatis, 400g of leonurus, 120g of radix aconiti lateralis preparata, 275g of cynomorium songaricum, 50g of Chinese yam, 50g of eucommia ulmoides and 50g of fructus psoraleae; (2) extraction: decocting Saviae Miltiorrhizae radix at 100 deg.C for 2 times, adding 10 times of water for the first time, decocting for 2 hr, adding 8 times of water for the second time, decocting for 1 hr, mixing decoctions, filtering, and concentrating the filtrate to obtain Saviae Miltiorrhizae radix soft extract; pulverizing rhizoma Dioscoreae into fine powder; mixing astragalus, poria cocos, rhizoma alismatis, leonurus, radix aconiti lateralis preparata, cynomorium songaricum, eucommia ulmoides and fructus psoraleae, adding water 3 times the weight of medicinal materials into the mixture to soak the medicinal materials, loading the mixture into a dynamic extraction tank, then adding water 3 times the weight of the medicinal materials to adjust the temperature of a solvent to 90 ℃, extracting twice respectively for 1.5 hours for the first time and 1 hour for the 2 nd time, combining the extracting solutions, filtering, concentrating the filtrate into thick paste, and (3) mixing: adding rhizoma Dioscoreae fine powder into the Saviae Miltiorrhizae radix extract and other medicinal materials soft extract, mixing, drying, pulverizing, adding appropriate amount of adjuvants such as starch, mixing, granulating, and drying.
Experimental group 4: (1) weighing the following raw materials by weight: 350g of astragalus membranaceus, 275g of salvia miltiorrhiza (collected in 10 months in Anhui province), 275g of poria cocos, 150g of rhizoma alismatis, 400g of leonurus, 120g of radix aconiti lateralis preparata, 275g of cynomorium songaricum, 50g of Chinese yam, 50g of eucommia ulmoides and 50g of fructus psoraleae; (2) pulverizing rhizoma Dioscoreae into fine powder; (3) adding 10 times of deionized purified water into Saviae Miltiorrhizae radix, extracting with 100 deg.C steam under sealed reflux for 5 hr, and concentrating the extractive solution at 80 deg.C for 8 hr. (4) Mixing radix astragali, Poria, Alismatis rhizoma, herba Leonuri, radix Aconiti lateralis Preparata, herba Cynomorii, Eucommiae cortex and fructus Psoraleae, adding 3 times of water to the mixture to soak the medicinal materials, placing into a dynamic extraction tank, adding 3 times of water to adjust the temperature of solvent to 90 deg.C, extracting twice, 1.5 hr for the first time and 1 hr for the second time, mixing the extractive solutions, filtering, and concentrating the filtrate to obtain soft extract; (5) mixing: and (4) mixing the thick paste obtained in the step (3) with the thick paste obtained in the step (4), adding the fine powder of the Chinese yam, uniformly mixing, drying and crushing to obtain the Chinese yam powder.
Experimental group 5: experimental example 5 is different from experimental example 4 in that 10 times of tap water by weight of Salvia miltiorrhiza Bunge (collected in Anhui province of China for 10 months) is added, and steam is sealed and refluxed at 100 ℃ for extraction for 7 hours. The rest steps are the same.
Experimental group 6: (1) weighing the following raw materials by weight: 350g of astragalus membranaceus, 275g of salvia miltiorrhiza (collected in 10 months in Anhui province), 275g of poria cocos, 150g of rhizoma alismatis, 400g of leonurus, 120g of radix aconiti lateralis preparata, 275g of cynomorium songaricum, 50g of Chinese yam, 50g of eucommia ulmoides and 50g of fructus psoraleae; (2) extraction: pulverizing rhizoma Dioscoreae into fine powder; mixing radix astragali, radix Salviae Miltiorrhizae, Poria, rhizoma Alismatis, herba Leonuri, radix Aconiti lateralis Preparata, herba Cynomorii, cortex Eucommiae, and fructus Psoraleae, adding 3 times of water to the mixture to soak the medicinal materials, loading into a dynamic extraction tank, adding 3 times of water to adjust the temperature of the solvent to 90 deg.C, extracting twice, 1.5 hr for the first time and 1 hr for the second time, mixing the extractive solutions, filtering, and concentrating the filtrate to obtain soft extract. (3) Mixing: adding rhizoma Dioscoreae fine powder into the soft extract, mixing, drying, and pulverizing.
The contents of astragaloside and tanshinol in the pharmaceutical compositions obtained in experimental groups 1-6 were determined, and the results are shown in table 6 below.
TABLE 6 determination of astragaloside IV and tanshinol content in the pharmaceutical compositions obtained in experimental groups 1-6
The experimental results show that experimental group 4 is the optimal process.
Experimental example 4 pharmacodynamic study of the pharmaceutical composition of the present invention
1. Study of pharmacodynamics
1.1 Experimental materials:
pharmaceutical composition 1 (shenkangning capsule): the preparation method comprises the following steps: (1) weighing the following raw materials by weight: 360g of astragalus mongholicus, 300g of salvia miltiorrhiza (harvested in 10 months in Anhui producing areas), 300g of poria cocos, 180g of rhizoma alismatis, 450g of leonurus, 180g of radix aconiti lateralis preparata, 300g of cynomorium songaricum and 50g of Chinese yam. (2) Pulverizing rhizoma Dioscoreae into fine powder; (3) decocting radix astragali, Saviae Miltiorrhizae radix, Poria, Alismatis rhizoma, herba Leonuri, radix Aconiti lateralis Preparata, and herba Cynomorii in water twice, adding 10 times of water for 2 hr for the first time, adding 8 times of water for 1 hr for the second time, mixing decoctions, filtering, concentrating the filtrate into soft extract, adding rhizoma Dioscoreae fine powder, mixing, drying, and pulverizing.
Pharmaceutical composition 2: prepared according to the method of example 1.
Pharmaceutical composition 3: the preparation method comprises the following steps: (1) weighing the following raw materials by weight: 350g of astragalus mongholicus, 275g of salvia miltiorrhiza (harvested in 10 months from Anhui province), 275g of poria cocos, 150g of rhizoma alismatis, 400g of leonurus, 120g of monkshood, 275g of cynomorium songaricum, 50g of Chinese yam and 50g of eucommia ulmoides. (2) Pulverizing rhizoma Dioscoreae into fine powder; (3) extracting Saviae Miltiorrhizae radix with 10 times of deionized purified water under sealed reflux at 100 deg.C for 5 hr, and concentrating the filtrate to obtain Saviae Miltiorrhizae radix soft extract; (4) mixing radix astragali, Poria, Alismatis rhizoma, herba Leonuri, radix Aconiti lateralis Preparata, herba Cynomorii and Eucommiae cortex, adding 3 times of water to the mixture to soak the medicinal materials, placing into a dynamic extraction tank, adding 3 times of water to adjust the solvent temperature to 90 deg.C, extracting twice, respectively for 1.5 hr for the first time and 1 hr for the second time, mixing the extractive solutions, filtering, and concentrating the filtrate to obtain soft extract. (5) Mixing: adding rhizoma Dioscoreae fine powder into the Saviae Miltiorrhizae radix extract and other medicinal materials soft extract, mixing, drying, pulverizing, adding appropriate amount of adjuvants such as starch, mixing, granulating, and drying.
Preparation of pharmaceutical composition 4: (1) weighing the following raw materials by weight: 350g of astragalus mongholicus, 275g of salvia miltiorrhiza (harvested in 10 months from Anhui province), 275g of poria cocos, 150g of rhizoma alismatis, 400g of leonurus, 120g of monkshood, 275g of cynomorium songaricum, 50g of Chinese yam and 50g of fructus psoraleae. (2) Pulverizing rhizoma Dioscoreae into fine powder; (3) extracting Saviae Miltiorrhizae radix with 10 times of deionized purified water under sealed reflux at 100 deg.C for 5 hr, and concentrating the filtrate to obtain Saviae Miltiorrhizae radix soft extract; (4) mixing radix astragali, Poria, Alismatis rhizoma, herba Leonuri, radix Aconiti lateralis Preparata, herba Cynomorii and fructus Psoraleae, adding 3 times of water to the mixture to soak the medicinal materials, placing into a dynamic extraction tank, adding 3 times of water to adjust the solvent temperature to 90 deg.C, extracting twice, respectively for 1.5 hr for the first time and 1 hr for the second time, mixing the extractive solutions, filtering, and concentrating the filtrate to obtain soft extract. (5) Mixing: adding rhizoma Dioscoreae fine powder into the concentrated extract, mixing, drying, pulverizing, adding appropriate amount of adjuvants such as starch, mixing, granulating, and drying.
1.2 subjects:
SD rats, body weight (200. + -. 10 g), male and female halves. After the rats were normally kept for 7 days, 60 rats with good health were selected. Can be used for freely drinking and eating.
1.3 test methods:
60 healthy rats, half male and half female, were randomly divided into 6 groups, i.e.: blank control group, acute kidney injury model group, medicine composition 1 group, medicine composition 2 group, medicine composition 3 group and medicine composition 4 group. The pharmaceutical composition group was gavaged to the corresponding pharmaceutical composition according to body weight, and administered daily for 4 weeks, during which gentamicin hydrochloride was subcutaneously injected daily from day 15 for 7 days. Blank control group, acute kidney injury model group: the same volume of water is drenched every day for four weeks continuously, during which the acute kidney injury model group is injected with gentamicin hydrochloride subcutaneously every day from day 15 for 7 days, and after each group is administered for 2 hours in the last time, urine and blood are respectively taken for urine biochemical index determination and rat kidney organ influence for appearance inspection. The urine test adopts visual eight-joint test paper to semi-quantitatively measure the total protein amount, urine sugar, ketone body, glucose and urine pH value.
1.4 test results:
the results show that the drug combination groups 1-4 can obviously reduce the total amount of protein, urine sugar and ketone bodies in rats with acute kidney injury caused by gentamicin hydrochloride and restore the pH value of urine. There was no significant difference from the control group. Indicating that the test result of the pharmaceutical composition 2 is better than that of other pharmaceutical composition groups. The results of the medicinal compositions 3 and 4 are superior to those of the medicinal composition 1, so that the effect of adding eucommia bark and fructus psoraleae is better, and the test result has obvious curative effect compared with the model group. The results are shown in Table 7.
TABLE 7 Effect of pharmaceutical compositions on urine biochemical indicators of rats with renal injury models
Note: comparison with control group (P <0.01), comparison with model group △△ (P <0.01), comparison with composition 4 ▲ (P <0.05)
2. Visual examination of the Effect of the composition on rat Kidney organs
Renal hypertrophy is the earliest pathological feature of chronic nephritis and is an important sign of treatment effect. The results of the comparison of the appearance of the rat kidney organs are as follows: the rats in the blank control group had normal kidney size and shape, smooth surface, dark red color, no adhesion of capsule, easy peeling, clear cleaning, and no exudate. The kidney of the rat in the model group is relatively hypertrophied, blood exudation occurs to different degrees, erythema exists on the surface, the drug combination groups 1-4 are all improved, the phenomenon of the model group is hardly seen in the drug combination 2, and the improvement degrees of the drug combinations 3 and 4 are better than the drug combination 1.
Experimental example 5 clinical efficacy of the pharmaceutical composition of the present invention
1. Clinical data and methods
1.1 clinical data and grouping
120 patients with nephropathy mainly caused by spleen-kidney deficiency, particularly yang deficiency are selected from 3 months to 2016 years and 9 months in 2015, the patients are randomly divided into 4 groups, 30 patients in each group have the disease course of more than 1 month, and the clinical detection result is obtained after the patients take the medicine.
1.2 inclusion criteria: clinically, edema caused by spleen-kidney yang deficiency and blood stasis and damp obstruction is manifested by edema, hypodynamia, cold pain of waist and knees; chronic nephritis, etc.
1.3 diagnostic criteria: and (3) complete alleviation: after the medicine is taken for 8 weeks, the clinical symptoms disappear completely, all indexes return to the normal range, the urine protein amount is less than 0.15g/24h, and the plasma protein is more than 3.5 g/dl. The effect is shown: the clinical symptoms disappear, all indexes recover to a normal range, the urine protein amount is less than 0.15g/24h, and the plasma protein is obviously increased. The method has the following advantages: clinical symptoms disappeared, 24h urine protein volume pay decreased by more than 50%, but >1.5g/24h, plasma protein <3.0 g/dl. And (4) invalidation: no improvement or worsening of clinical symptoms.
1.4 medicine: the capsules of the pharmaceutical compositions 1 to 4 are 1000 capsules, namely, the pharmaceutical compositions 1 to 4 prepared by the method of the experimental example 4 are respectively added with a proper amount of starch and other auxiliary materials.
1.5 methods of treatment: 120 patients were randomly divided into 4 groups, drug combination 1 group was a control group, and drug combinations 2-4 were observation groups 1, 2, and 3, respectively. 5 pills each time, 3 times a day, 8 weeks as a treatment course, and clinical indicators during the observation period.
1.6 observation indexes: plasma albumin: bromocresol green end point method; protein quantification at 24 hours: an end-point method; and (3) measuring blood creatinine and urea nitrogen by a conventional method.
2. Results
The clinical efficacy analysis results are shown in tables 8 and 9 below.
Comparison of clinical efficacy of the compositions of Table 84 groups
| Group of | Number of examples | Complete relief | Show effect | Is effective | Invalidation | Total effective rate (%) |
| Control group | 30 | 7 | 7 | 11 | 5 | 83.3 |
| Observation of 1 group | 30 | 9 | 11 | 8 | 2 | 93.3 |
| Observation of 2 groups | 30 | 8 | 6 | 12 | 4 | 86.6 |
| Observation of 3 groups | 30 | 8 | 7 | 12 | 3 | 90.0 |
TABLE 94 Change in mean renal function and urine protein before and after treatment
△ P <0.05 in comparison with the treatment of the group, and P <0.05 in comparison with the control group
The experimental results show that the curative effect of the group 1 is better than that of the other group 3, the Ccr and urine protein results are most obvious, the curative effect control groups of the groups 2 and 3 are observed, the curative effect of the single composition added with the eucommia ulmoides or the fructus psoraleae and the curative effect of the composition added with the eucommia ulmoides and the fructus psoraleae are better than that of the original prescription composition, and the experimental data show that the curative effect of the composition added with the eucommia ulmoides and the fructus psoraleae is obviously improved compared with that of the original prescription composition.
Claims (7)
1. A traditional Chinese medicine composition with effects of warming kidney and tonifying qi is characterized by being prepared by the following steps:
(1) weighing the following raw materials in parts by weight:
350 parts of astragalus membranaceus, 275 parts of salvia miltiorrhiza, 275 parts of poria cocos, 150 parts of rhizoma alismatis, 400 parts of motherwort, 120 parts of radix aconiti lateralis preparata, 275 parts of cynomorium songaricum, 50 parts of Chinese yam, 50 parts of eucommia ulmoides and 50 parts of fructus psoraleae;
(2) pulverizing rhizoma Dioscoreae into fine powder;
(3) adding 10 times of deionized purified water into Saviae Miltiorrhizae radix, extracting with 100 deg.C steam under sealed reflux for 5 hr, and concentrating the extractive solution at 75-85 deg.C to obtain soft extract;
(4) mixing radix astragali, Poria, Alismatis rhizoma, herba Leonuri, radix Aconiti lateralis Preparata, herba Cynomorii, Eucommiae cortex and fructus Psoraleae, adding 3 times of water to the mixture to soak the medicinal materials, placing into a dynamic extraction tank, adding 3 times of water to adjust the temperature of solvent to 90 + -5 deg.C, extracting twice, 1.5 hr for the first time and 1 hr for the second time, mixing extractive solutions, filtering, and concentrating the filtrate to obtain soft extract;
(5) mixing
And (4) mixing the thick paste obtained in the step (3) with the thick paste obtained in the step (4), adding the fine powder of the Chinese yam, uniformly mixing, drying and crushing to obtain the traditional Chinese medicine composition.
2. The traditional Chinese medicine composition of claim 1, wherein the salvia miltiorrhiza is a salvia miltiorrhiza medicinal material harvested in Anhui province within 10 months.
3. A traditional Chinese medicine preparation with effects of warming kidney and tonifying qi is characterized in that pharmaceutically acceptable auxiliary materials are added into the traditional Chinese medicine composition of claim 1 or 2, and various clinically suitable preparations are prepared according to a conventional method.
4. The Chinese medicinal preparation of claim 3, wherein the preparation comprises powder, granules, tablets, oral liquid or capsules.
5. A method of preparing the traditional Chinese medicine composition of claim 1, comprising the steps of:
(1) weighing the following raw materials in parts by weight:
350 parts of astragalus membranaceus, 275 parts of salvia miltiorrhiza, 275 parts of poria cocos, 150 parts of rhizoma alismatis, 400 parts of motherwort, 120 parts of radix aconiti lateralis preparata, 275 parts of cynomorium songaricum, 50 parts of Chinese yam, 50 parts of eucommia ulmoides and 50 parts of fructus psoraleae;
(2) pulverizing rhizoma Dioscoreae into fine powder;
(3) adding 10 times of deionized purified water into Saviae Miltiorrhizae radix, extracting with 100 deg.C steam under sealed reflux for 5 hr, and concentrating the extractive solution at 75-85 deg.C to obtain soft extract;
(4) mixing radix astragali, Poria, Alismatis rhizoma, herba Leonuri, radix Aconiti lateralis Preparata, herba Cynomorii, Eucommiae cortex and fructus Psoraleae, adding 3 times of water to the mixture to soak the medicinal materials, placing into a dynamic extraction tank, adding 3 times of water to adjust the temperature of solvent to 90 + -5 deg.C, extracting twice, 1.5 hr for the first time and 1 hr for the second time, mixing extractive solutions, filtering, and concentrating the filtrate to obtain soft extract;
(5) mixing
Mixing the thick paste obtained in the step (3) with the thick paste obtained in the step (4), adding the fine powder of Chinese yam, uniformly mixing, drying and crushing to obtain the traditional Chinese medicine composition of claim 1.
6. The method of claim 5, wherein the Danshen is Danshen harvested at 10 months of Anhui province.
7. Use of the Chinese medicinal composition of claim 1 or 2 in the preparation of a medicament having the effects of warming kidney, invigorating qi, promoting blood circulation, and eliminating dampness.
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