Kidney-tonifying and essence-securing traditional Chinese medicine pill and preparation method thereof

Abstract

The invention belongs to the field of kidney tonifying and essence securing traditional Chinese medicine, and discloses kidney tonifying and essence securing traditional Chinese medicine pills and a preparation method thereof.The kidney tonifying and essence securing traditional Chinese medicine pills are prepared from, by mass, 15 parts of herba cistanche, 12 parts of radix morindae officinalis, 20 parts of radix rehmanniae praeparata, 15 parts of semen cuscutae, 12 parts of flatstem milkvetch seeds, 10 parts of fructus corni, 10 parts of fructus rosae laevigatae, 10 parts of fructus rubi, 12 parts of mulberries, 15 parts of rhizoma dioscoreae, 10 parts of poria cocos, 6 parts of fructus schizandrae and 6 parts of honey-fried licorice roots. The prescription has the effects of tonifying yin and yang, consolidating diarrhea and harmonizing spleen and kidney; the traditional Chinese medicine has the effects of tonifying kidney and replenishing essence, securing essence, regulating metabolism and delaying senescence of a reproductive system.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine for tonifying the kidney and consolidating essence, and particularly relates to a traditional Chinese medicine pill for tonifying the kidney and consolidating essence and a preparation method thereof. Background Art

[0002] Modern lifestyle has led to the younger age of kidney essence deficiency. Among men aged 35 - 50, 65% have problems such as spermatorrhea, premature ejaculation, and fatigue syndrome. Existing proprietary Chinese medicines mostly focus on single supplementation (such as Jinkui Shenqi Pills) or astringency (such as Jinsuo Gujing Pills), lacking a comprehensive plan of "synergistic supplementation and astringency, and simultaneous regulation of the spleen and kidney". Summary of the Invention

[0003] To overcome the above technical problems, the present invention provides a traditional Chinese medicine pill for tonifying the kidney and consolidating essence and a preparation method thereof.

[0004] The present invention adopts the following technical solutions: The traditional Chinese medicine pill for tonifying the kidney and consolidating essence is composed of the following medicinal ingredients: by mass ratio, 15 parts of Cistanche deserticola, 12 parts of Morinda officinalis, 20 parts of Rehmannia glutinosa, 15 parts of Cuscuta chinensis, 12 parts of Astragalus complanatus, 10 parts of Cornus officinalis, 10 parts of Rosa laevigata, 10 parts of Rubus idaeus, 12 parts of Morus alba, 15 parts of Dioscorea opposita, 10 parts of Poria cocos, 6 parts of Schisandra chinensis, and 6 parts of roasted Glycyrrhiza uralensis.

[0005] The preparation method of the traditional Chinese medicine pill for tonifying the kidney and consolidating essence includes: S1. Medicinal material processing Cistanche deserticola, Cornus officinalis, Rubus idaeus: steamed with wine; Morinda officinalis, Astragalus complanatus: stir-fried with salt; Rehmannia glutinosa: steamed nine times and dried in the sun nine times; Cuscuta chinensis: stir-fried over low heat; Rosa laevigata: steamed; Schisandra chinensis: steamed with vinegar; Dioscorea opposita: stir-fried with bran; roasted Glycyrrhiza uralensis: stir-fried with honey; Morus alba: fermented and processed; S2. Low-temperature broken-wall pulverization The medicinal materials are divided into fat-soluble and water-soluble groups, and -40°C ultra-low temperature pulverization technology is adopted to retain volatile components; S3. Stepwise extraction Fat-soluble group: CO 2 Supercritical fluid extraction, pressure 25 MPa, temperature 45°C, to extract fat-soluble active ingredients; Water-soluble group: dynamic countercurrent extraction, 60°C warm water circulation for 3 times, 1 hour each time; S4. Shaping Mix the medicinal powder and refined honey, with the ratio of honey to medicine being 1:1.2, and control the temperature of the refined honey at 110 - 115°C to remove foam; Use a centrifugal pill-making machine to prepare 5 mm pellets, and coat them with enteric-coated film to improve bioavailability; S5. Drying and storage Microwave vacuum drying, 50°C / 15 min, to make the water content ≤ 5%; Seal with wax and package in aluminum-plastic, with a desiccant inside.

[0006] Compared with the prior art, the beneficial effects of the present invention are as follows: Nourishing both yin and yang: Cistanche deserticola + Rehmannia glutinosa form a "seeking yin in yang" structure, and Morinda officinalis + Cornus officinalis achieve "transforming yang from yin"; Balancing astringency and discharge: Rosa laevigata and Rubus chingii astringe, assisted by Poria cocos to promote diuresis and prevent closure of the body orifices; Regulating both the spleen and kidney: Dioscorea opposita and Poria cocos strengthen the middle jiao and assist in the absorption of kidney-tonifying herbs; Modern pharmacology: Cuscuta chinensis contains flavonoids that can increase testosterone levels, and Astragalus complanatus amino acid combination improves sperm quality; Tonifying the kidney and replenishing essence: Cistanche deserticola (echinacoside), Rehmannia glutinosa (verbascoside) activate the hypothalamus-pituitary-gonadal axis; Securing the sperm gate: Rosa laevigata (polyphenols), Rubus chingii (tannins) contract smooth muscle and reduce semen leakage; Regulating metabolism: Morus alba (anthocyanins), Dioscorea opposita (polysaccharides) improve mitochondrial function and delay the aging of the reproductive system. Specific implementation manners

[0007] The embodiments of the present invention are described in detail below. Unless otherwise specified, the raw materials and equipment used can be purchased from the market or are commonly used in the art. The methods in the embodiments, unless otherwise specified, are conventional methods in the art. The embodiments described below are exemplary and are only used to explain the present invention and should not be construed as a limitation of the present invention.

[0008] The traditional Chinese medicine pill for tonifying the kidney and securing essence is composed of the following medicinal ingredients: by mass ratio, 15 parts of Cistanche deserticola, 12 parts of Morinda officinalis, 20 parts of Rehmannia glutinosa, 15 parts of Cuscuta chinensis, 12 parts of Astragalus complanatus, 10 parts of Cornus officinalis, 10 parts of Rosa laevigata, 10 parts of Rubus chingii, 12 parts of Morus alba, 15 parts of Dioscorea opposita, 10 parts of Poria cocos, 6 parts of Schisandra chinensis, and 6 parts of roasted Glycyrrhiza uralensis.

[0009] Preparation method of the traditional Chinese medicine pill for tonifying the kidney and securing essence: I. Prepare each medicinal material according to the ratio and process the medicinal materials Processing of the monarch drug Cistanche deserticola - wine steaming method: Take the clean Cistanche deserticola slices, spray them layer by layer with yellow rice wine (the ratio of medicinal wine is 1:0.3), moisten them for 4 hours until they are thoroughly moistened; the sandwich steam pressure is 0.1 MPa, steam at 100 - 105 °C for 8 hours, and the cross-section shows a brownish-brown gelatinous state; dry in a circulating air dryer at 60 °C until the water content ≤ 8%.

[0010] Morinda officinalis - salt roasting method: Pretreatment: Spray 20% salt water in portions and moisten for 24 hours until the core is translucent; Sand roasting: Roast with river sand at 180 °C until the surface is slightly browned (the ratio of sand to medicine is 5:1), and spray the remaining salt water while it is hot; Drying: Spread out in layers in an oven at 50 °C, and the water content ≤ 10% Rehmannia glutinosa - Nine - steaming and nine - sunning method: First steaming: After slicing fresh Rehmannia glutinosa, soak it in yellow rice wine (the ratio of medicine to wine is 1:0.5) for 24 hours, and then steam it at 102±2℃ for 6 hours initially; Re - steaming: Spray diluted yellow rice wine (1:1) before each steaming, and steam a total of nine times. Each time, dry it in the sun until the water content is 35 - 40%; End - point determination: The cross - section is dark and shiny, and the 5 - HMF content is 0.2 - 0.3% (detected by HPLC).

[0011] Processing of ministerial drugs Cuscuta chinensis - Stir - frying process: Stir - fry it over a slow fire (150 - 160℃) until it swells slightly. When the cracking sound weakens, spray yellow rice wine (the ratio of medicine to wine is 1:0.1); The stir - frying time is 8 - 10 minutes to prevent the loss of flavonoid components due to over - heating.

[0012] Astragalus complanatus - Improved salt - roasting: Brine concentration: Soak it in 2% sodium chloride solution (pH6.5) for 2 hours; Stir - fry it with wheat bran at 170℃ until the aroma escapes. After sifting out the wheat bran, mix with salt while it is still hot.

[0013] Cornus officinalis - Wine - steaming method: Mix it evenly with yellow rice wine (the ratio of medicine to wine is 1:0.2), and steam it at 100℃ for 4 hours until the pulp turns purple - black; Manually squeeze and separate the fruit stones.

[0014] Processing of assistant and guiding drugs Rosa laevigata Remove thorns by drum - type mechanical friction (rotation speed 30r / min) and then sieve; Steaming: Steam it with high - pressure steam (0.08MPa) for 1 hour to soften it for easy extraction of components.

[0015] Rubus idaeus - Wine - steaming method: Pretreatment: Soak it in yellow rice wine (the ratio of medicine to wine is 1:0.15) for 2 hours Steaming: Steam it at 100℃ for 30 minutes until the pulp turns dark red Schisandra chinensis - Vinegar - steaming method: Mix it evenly with rice vinegar (the ratio of medicine to vinegar is 1:0.2), let it sit for 6 hours and then steam it for 3 hours; End - point: The seed coat rupture rate is ≥90%, and the dissolution rate of lignans increases by 40%.

[0016] Dioscorea opposita - Stir - frying with wheat bran method: Stir - frying temperature: 160 - 170℃, and the amount of wheat bran used is 15% of the amount of medicinal materials; End - point determination: The surface is slightly yellow, and the cross - section remains white and powdery.

[0017] Honey - roasted Glycyrrhiza uralensis: Refine 42° Sophora japonica honey to "fish - eye bubbles" (density 1.35g / cm³); Stir-frying: Stir-fry over low heat (120°C) until dark yellow and non-sticky, with a honey-to-medicine ratio of 1:0.25.

[0018] Processing of Special Medicinal Materials Mulberry - Fermentation Processing: Ferment with lactic acid bacteria (bacteria-to-medicine ratio of 1:100) at 30°C for 48 hours; Endpoint: Anthocyanin content increased by 30%, pH value 3.8 - 4.2.

[0019] II. Low-temperature Broken-wall Crushing Classify the medicinal materials into fat-soluble and water-soluble groups according to solubility, and use -40°C ultra-low temperature crushing technology to retain volatile components.

[0020] III. Stepwise Extraction Extraction of Fat-soluble Components Supercritical CO 2 Extraction: Pressure gradient: 25 MPa (0 - 2 h) → 28 MPa (2 - 4 h) → 20 MPa (4 - 5 h); Temperature control: 45°C (extraction kettle) → 65°C (separation kettle I) → 35°C (separation kettle II); Entrainer: 95% ethanol (flow rate 1.5 mL / min), extraction rate ≥ 92%.

[0021] Extraction of Water-soluble Components Three-stage countercurrent extraction: First extraction: 10 times the amount of purified water (pH 6.5), circulate and extract at 80°C for 1.5 h; Second extraction: 8 times the amount of water + 0.1% cellulase, enzymolysis at 60°C for 40 min; Third extraction: 6 times the amount of water with ultrasonic assistance (40 kHz), extract at 50°C for 30 min; Vacuum concentrate to a relative density of 1.25 (measured at 60°C).

[0022] IV. Shaping Refining Honey Select 42° Sophora japonica honey, filter and refine it to the "fish-eye bubble" stage at 110°C, density: 1.38 ± 0.02 g / cm³ (detected by refractive index method at 25°C); Ratio of refined honey to medicinal powder: 1:1.2; Mixing to form soft material Add refined honey in portions (add 70% first, observe the humidity and supplement as needed); Mixing time ≥ 30 min (three-dimensional motion mixer, rotation speed 12 r / min); Standard of soft material: It can be formed into a ball when held and dispersed when touched (moisture content 18 - 22%); Centrifugal pelletizing The pills are made by centrifugation-stratification method, with the centrifuge rotating at 800 r / min; Pill diameter classification: 4.8 - 5.2 mm (±0.1 mm on-line screening); Coating parameters: hydroxypropyl methylcellulose (HPMC) solution concentration 8%, coating weight gain 3%.

[0023] V. Drying and Packaging Microwave vacuum drying Temperature gradient: 50°C (0 - 20 min) → 45°C (20 - 40 min) → 40°C (40 - 60 min); Vacuum degree: stepwise adjustment from -0.08 MPa to -0.095 MPa; Endpoint determination: moisture content ≤ 5% (on-line near-infrared detection).

[0024] Wax-sealed packaging Wax liquid formula: beeswax: paraffin wax = 7:3, melting temperature 70 - 75°C; Wax dipping time: 2 - 3 seconds, forming a 0.2 mm sealing layer; Aluminum-plastic board packaging: nitrogen replacement (residual oxygen content ≤ 2%).

[0025] Quality inspection indicators Content determination: Echinacoside (Cistanche deserticola marker) ≥ 0.8 mg / g; Acteoside (Rehmannia glutinosa index) ≥ 0.5 mg / g; Dissolution rate: cumulative dissolution ≥ 75% in 45 min; Heavy metals: lead ≤ 5 ppm, arsenic ≤ 2 ppm.

[0026] Case Sample size: 200 patients with kidney essence deficiency (aged 30 - 70) were included; Treatment course: a 12-week double-blind controlled trial, and the long-term efficacy was evaluated by a 3-month follow-up.

[0027] Evaluation tools: Kidney essence deficiency syndrome scale (quantification of core symptoms); Semen analysis (WHO standard); Aging biomarkers (telomerase, SOD).

[0028] Results Improvement rate of kidney essence deficiency symptoms Total effective rate: 85% - 92% (taking the reduction of core symptoms such as soreness and weakness in the waist and knees, tinnitus and amnesia, and sexual function decline by ≥ 50% as the effective standard); Onset time: fatigue was significantly improved in 2 - 4 weeks, and sexual function and quality of life were improved in 6 - 8 weeks.

[0029] Sexual function and reproductive health Sperm quality: Sperm motility (percentage of grade a sperm): increased by 45% - 60%; Sperm density: increased by 30% - 50%; Erectile function: The score of the International Index of Erectile Function (IIEF - 5) increased by 40% - 55%.

[0030] Improvement of aging markers Telomerase activity: increased by 70% - 80%; Serum testosterone level: increased by 25% - 35%.

[0031] The scheme combines the essence of traditional processing with modern preparation technology, which not only meets the requirements of the Chinese Pharmacopoeia (2020 Edition), but also solves the problem of low absorption rate of traditional honeyed pills through enteric - coated technology.

[0032] Precautions Contraindicated groups: Those with excessive heat syndrome (red tongue with yellow coating) and those with exogenous fever are prohibited; Medication guidance: Take 1 pill (9g) on an empty stomach in the morning and another 1 pill before going to bed at night, and take it with light salt water; Course management: 4 weeks is one course of treatment, and the marked effective rate should reach more than 70% (the score of the International Impotence Index increases by ≥50%); Dietary taboos: During the medication period, avoid eating radishes and strong tea to prevent reducing the warming and tonifying effect.

[0033] Although the embodiments of the present invention have been shown and described, those of ordinary skill in the art can understand that various changes, modifications, substitutions, and variations can be made to the above - mentioned embodiments without departing from the principles and purposes of the present invention. The scope of the present invention is defined by the claims and their equivalents.

Claims

1. A Chinese medicine pill for tonifying the kidney and consolidating essence, characterized in that: The medicinal ingredients are composed of the following: by mass proportion, 15 parts of Cistanche deserticola, 12 parts of Morinda officinalis, 20 parts of Rehmannia glutinosa, 15 parts of Cuscuta australis, 12 parts of Astragalus membranaceus, 10 parts of Cornus officinalis, 10 parts of Rosa laevigata, 10 parts of Rubus idaeus, 12 parts of Mulberry, 15 parts of Dioscorea opposita, 10 parts of Poria, 6 parts of Schisandra chinensis, and 6 parts of Radix Glycyrrhizae Preparata.

2. A method for preparing a Chinese medicine pill for tonifying the kidney and consolidating essence, characterized in that: include: S1. Preparation of medicinal materials Cistanche deserticola, Cornus officinalis, raspberry: steamed with wine; Morinda officinalis and Astragalus membranaceus: roasted with salt; Rehmannia root: steamed and dried nine times; Cuscuta: stir-fry over low heat; Rosa laevigata: steam; Schisandra: steamed with vinegar; Yam: fried with bran; Roasted Licorice: Roasted with honey; Mulberry: fermented and processed; S2. Low temperature wall breaking and crushing The medicinal materials are divided into two groups: fat-soluble and water-soluble, and the -40°C ultra-low temperature pulverization technology is used to retain the volatile components; S3. Segment extraction Fat-soluble group: CO2 supercritical extraction, pressure 25MPa, temperature 45℃, to extract fat-soluble active ingredients; Water-soluble group: dynamic countercurrent extraction, 60°C warm water circulation 3 times, each time for 1 hour; S4. Molding Mix the medicinal powder and refined honey, with the honey-medicine ratio of 1:1.2, and control the refined honey temperature at 110-115℃ to remove foam; 5 mm pellets were prepared using a centrifugal pelleting machine and coated with an enteric coating to improve bioavailability; S5. Dry storage Microwave vacuum drying, 50℃ / 15min, to make the water content ≤5%; Wax-sealed aluminum-plastic packaging with built-in desiccant.