Processing and preparing method of essence-adding hemeletic pill

Abstract

The invention provides a processing and preparing method of sperm-adding hemeletic pills. The processing and preparing method comprises the following steps: S1, treating raw materials; the preparation method comprises the following steps: drying and crushing ginseng, Chinese yam, dogwood pulp, radix ophiopogonis, semen cuscutae, cistanche, prepared rehmannia root, morinda officinalis, schisandra chinensis, semen boitae and cinnamon in a prescription to obtain a medicinal powder component; s2, preparing a glue solution: performing glue melting treatment on deer-horn glue, tortoise-plastron glue and swimming bladder in the prescription to obtain a glue solution component; s3, mixing and pelleting: mixing the medicinal powder component with the glue solution component to prepare pellets; s4, post-treatment: drying and sterilizing the pills to obtain the sperm-increasing hemeletic pill, and the processing and preparation method of the sperm-increasing hemeletic pill can be researched and developed, so that the problems that due to the fact that glue medicinal materials are high in viscosity, the glue medicinal materials are difficult to uniformly mix with dozens of times of medicine powder in amount in a traditional method, effective components in the pill are easily distributed unevenly, and the quality of the pill is influenced are solved. The quality fluctuation among different batches is large, the stability of the curative effect is influenced, and the uniformity and the stability of medicinal materials are improved.

Description

Technical Field

[0001] This invention relates to the field of preparation technology of Tianjing Sixu Pills, and specifically to a processing and preparation method for Tianjing Sixu Pills. Background Technology

[0002] Tianjing Sixu Wan originates from "Bianzheng Lu" written by Chen Shiduo, a famous physician of the Qing Dynasty. It is a classic prescription for treating male infertility with low sperm count. The whole formula consists of 15 medicinal materials, including ginseng, deer antler glue, tortoise shell glue, prepared rehmannia root, wolfberry, and morinda root. It has remarkable effects of tonifying the kidney and replenishing essence, nourishing yin and assisting yang, and replenishing qi and blood. It aims to fundamentally improve the quantity and quality of reproductive sperm.

[0003] However, the traditional preparation method of this formula is briefly recorded, only stating "grind each ingredient into powder, dissolve the glue and alcohol in it, and make pills." This traditional process, which relies on manual operation, has many inherent defects, severely restricting its modern application and clinical promotion. This is because gelatinous medicinal materials (deer antler glue, tortoise shell glue, fish swim bladder) are highly viscous, and the traditional "alcohol-melting" method makes it difficult to mix them evenly with dozens of times the amount of medicinal powder. This easily leads to uneven distribution of the effective ingredients in the pills, large quality fluctuations between different batches, and affects the stability of the therapeutic effect, resulting in poor uniformity and stability of the medicinal materials. Summary of the Invention

[0004] In view of this, the present invention provides a processing and preparation method for Tianjing Sixu Pills. By developing a processing and preparation method for Tianjing Sixu Pills, the problem of uneven distribution of effective ingredients in the pills, large quality fluctuations between different batches, and poor stability of efficacy caused by the high viscosity of gelatinous medicinal materials (deer antler glue, tortoise shell glue, fish maw) and the difficulty in uniformly mixing them with dozens of times the amount of medicinal powder using the traditional "alcohol melting" method can be solved. This results in the instability of the active ingredients in the pills and the poor uniformity and stability of the medicinal materials.

[0005] To solve the above-mentioned technical problems, the present invention provides a method for processing and preparing Tianjing Sixu Pill, comprising the following steps: S1. Raw material processing: The eleven medicinal materials in the prescription, namely ginseng, yam, cornus officinalis, ophiopogon japonicus, dodder seed, cistanche deserticola, prepared rehmannia root, morinda officinalis, schisandra chinensis, arborvitae seed, and cinnamon, are dried in a forced-air drying environment at 60℃±5℃ until the moisture content is less than or equal to 8%. Then, they are put into a universal pulverizer and pulverized into fine powder that passes through a 100-mesh sieve. The powder is then mixed evenly to obtain medicinal powder A. S2. Preparation of the adhesive solution: Crush the deer antler glue and tortoise shell glue in the prescription into small pieces, and place them together with the stir-fried fish maw in a dissolving tank with a jacketed heating function. Add 0.3-0.5 times the amount of rice wine and 0.2-0.3 times the amount of purified water in the prescription, and stir at low speed at 60℃±2℃ until they are completely dissolved to obtain a preliminary mixed adhesive solution. Transfer the preliminary mixed adhesive solution to a colloid mill for circulating grinding, and then homogenize it 2-3 times under a high pressure homogenizer at 25-35MPa to obtain a uniform and fine adhesive solution B. S3. Mixing and pelleting: The powdered medicinal components and the adhesive components are mixed to form pellets. Powder A is added to a three-dimensional motion mixer. While stirring, adhesive B is slowly and evenly sprayed in, along with an appropriate amount of 70% ethanol as a wetting agent, until a soft material C that can be formed by "forming a ball when squeezed but crumbling easily when pressed" is produced. The soft material C is then fed into an intelligent traditional Chinese medicine pelleting machine to form spherical pellets with a diameter of 6mm. The pellets are then placed in a mesh belt dryer and dried using a gradient temperature process: the first stage is drying at 40℃ for 2 hours, and the second stage is drying at 55℃ for 4 hours, until the moisture content of the pellets is less than or equal to 10%. S4. Post-processing: The pills are dried and sterilized to obtain the Tianjing Sixu pills. The dried pills are placed on the conveyor belt of a linked microwave ultraviolet sterilizer and pass through the microwave sterilization zone and the ultraviolet irradiation zone for terminal sterilization. After cooling, they can be packaged in aluminum-plastic blister packs.

[0006] The preparation steps of the adhesive in S2 include: heating and melting deer antler glue, tortoise shell glue and fish swim bladder in the presence of solvent, followed by homogenization treatment.

[0007] The solvent is rice wine and / or purified water. The amount of rice wine added is 0.3-0.5 times the total weight of the gelatinous medicinal materials; the amount of purified water added is 0.2-0.3 times the total weight of the gelatinous medicinal materials.

[0008] The homogenization process includes homogenization using a high-pressure homogenizer at a pressure of 20-40 MPa; the heating and melting temperature is 50-70℃.

[0009] The drying process in S1 employs a two-stage gradient drying method, which involves drying at 35-45℃ for 1-3 hours first, and then drying at 50-60℃ for 3-5 hours.

[0010] The sterilization process includes at least one of microwave sterilization, ultraviolet sterilization, or irradiation sterilization.

[0011] In the preparation step of the adhesive in S1, a pharmaceutically acceptable dispersant is also added; the dispersant includes at least one of nano-silica, microcrystalline cellulose, or magnesium stearate.

[0012] In the raw material processing step S1, the wolfberry in the prescription is extracted and dried separately to obtain wolfberry extract, which is then mixed with the medicinal powder components.

[0013] The preparation method of Tianjing Sixu Pill: The formula of Tianjing Sixu Pill is as follows: 223.8g each of ginseng, deer antler glue, tortoise shell glue, yam, and wolfberry; 186.5g each of cornus officinalis, ophiopogon japonicus, dodder seed, and cistanche deserticola; 298.4g each of prepared rehmannia root, fish maw (fried), and morinda officinalis; 37.3g of schisandra chinensis; 111.9g of arborvitae seed; and 37.3g of cinnamon.

[0014] In summary, compared with the prior art, this application includes at least one of the following beneficial technical effects: 1. Significantly improved dissolution rate of active ingredients and enhanced efficacy: This invention greatly improves the polysaccharide extraction rate by extracting and concentrating wolfberry alone through water extraction, and greatly improves the dissolution rate of ginsenoside Rg1 by pulverizing 11 medicinal materials into 100-mesh powder and homogenizing with gelatin solution, thus greatly improving the overall utilization rate of active ingredients; in clinical practice, the improvement in sperm density and motility is 40%-50% higher than that of traditional pills, achieving "doubled efficacy" and solving the problem of low dissolution rate in traditional methods.

[0015] 2. High uniformity of the gel and stable efficacy of the pills: This invention can melt the gel at 60℃, grind it with a colloid mill, and homogenize it under high pressure at 30MPa. Combined with dispersion of nano-silica, the gel particle size is small, and the difference in collagen content per pill is reduced from 20% to less than 8%; the difference in ginsenoside Rg1 content between batches is less than or equal to 5%, which solves the problem of efficacy fluctuation caused by uneven dispersion of traditional gels and meets the "quality controllable" requirements of modern pharmaceuticals.

[0016] 3. Stable pill quality and long shelf life: This invention uses gradient temperature drying to avoid excessive moisture gradients inside and outside the pills, greatly reducing the cracking rate and controlling the moisture content at 8%-10%; microwave and ultraviolet combined sterilization achieves a microbial kill rate of greater than or equal to 99.9%, and the shelf life of sealed storage at room temperature reaches 24 months, solving the problems of easy cracking and mold growth of traditional pills and improving product stability.

[0017] 4. Significantly improved production efficiency: This invention uses standardized equipment to replace traditional manual operation, realizing continuous and large-scale production, which greatly improves production efficiency and is suitable for large-scale industrial production.

[0018] 5. Significantly improved bioavailability: This invention increases the specific surface area of ​​medicinal materials through ultrafine pulverization, and high-pressure homogenization makes the colloidal components easier to absorb. The dual effects significantly improve the dissolution rate and absorption degree of active ingredients. Attached Figure Description

[0019] Figure 1 This is a flowchart illustrating the processing and preparation process of the Tianjing Sixu Pill of the present invention. Detailed Implementation

[0020] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. All other embodiments obtained by those skilled in the art based on the described embodiments of the present invention are within the scope of protection of the present invention.

[0021] like Figure 1 As shown: This embodiment provides a method for processing and preparing Tianjing Sixu Pill, including the following steps, S1. Raw material processing: The eleven medicinal materials in the prescription—ginseng, yam, cornus officinalis, ophiopogon japonicus, dodder seed, cistanche deserticola, rehmannia glutinosa, morinda officinalis, schisandra chinensis, arborvitae seed, and cinnamon—are dried in a forced-air drying environment at 60℃±5℃ until the moisture content is less than or equal to 8%. Then, they are put into a universal pulverizer and pulverized into fine powder that passes through a 100-mesh sieve. The powder is then transferred to a three-dimensional motion mixer and mixed evenly to obtain medicinal powder A. Specifically, the manufacturer of the forced-air drying oven is Shanghai Yiheng Scientific Instruments Co., Ltd., model DHG-9240A; the manufacturer of the universal pulverizer is Jinan Dawei Machinery Co., Ltd., model XDW-6; the 100-mesh sieve is a sieve produced by Xinxiang Screen Factory; and the manufacturer of the three-dimensional motion mixer is Changzhou Lima Drying Engineering Co., Ltd., model SYH-50. S2. Preparation of the adhesive solution: Crush the deer antler glue and tortoise shell glue in the prescription into small pieces, and place them together with the stir-fried fish maw in a dissolving tank with a jacketed heating function. Add 0.3-0.5 times the amount of rice wine and 0.2-0.3 times the amount of purified water in the prescription. Stir at low speed at 60℃±2℃ until completely dissolved to obtain a preliminary mixed adhesive solution. Transfer the preliminary mixed adhesive solution to a colloid mill for circulating grinding, and then homogenize it 2-3 times under a high pressure homogenizer at 25-35MPa to obtain a uniform and fine adhesive solution B. Specifically, the dissolving tank is manufactured by Jiangsu Yangyang Chemical Equipment Manufacturing Co., Ltd., model YY-HJG-50; the colloid mill is manufactured by Shanghai Fluke Fluid Machinery Manufacturing Co., Ltd., model JM-80; and the high pressure homogenizer is manufactured by Shanghai Fluke, model FH100. S3. Mixing and pelleting: The powdered medicinal components and the adhesive components are mixed to form pellets. Powder A is added to a three-dimensional motion mixer. While stirring, adhesive B is slowly and evenly sprayed in through a spray gun. At the same time, an appropriate amount of 70% ethanol is sprayed in as a wetting agent until a soft material C that can be formed into a ball when squeezed but crumbles easily when pressed is formed. The soft material C is then added to an intelligent Chinese medicine pelleting machine to form spherical pellets with a diameter of 6mm. The pellets are then placed in a mesh belt dryer and dried using a gradient temperature process: the first stage is drying at 40℃ for 2 hours, and the second stage is drying at 55℃ for 4 hours, until the moisture content of the pellets is less than or equal to 10%. Specifically, the model of the three-dimensional motion mixer is SYH-1000, manufactured by Jiangsu Changhong Drying Equipment Co., Ltd.; the manufacturer of the intelligent Chinese medicine pelleting machine is Beijing Hanlin Hangyu Technology Development Co., Ltd., model HJY-2000; and the manufacturer of the mesh belt dryer is Changzhou Lima Drying Engineering Co., Ltd., model LM-80. S4. Post-processing: The pills are dried and sterilized to obtain the Tianjing Sixu pills. The dried pills are placed on the conveyor belt of a linked microwave ultraviolet sterilizer and pass through the microwave sterilization zone and the ultraviolet irradiation zone for terminal sterilization. After cooling, they can be packaged in aluminum-plastic blister packs. Specifically, the manufacturer of the linked microwave ultraviolet sterilizer is Guangzhou Weigu Microwave Equipment Co., Ltd., model WG-MU-200, and the manufacturer of the aluminum-plastic blister pack machine is Shanghai Zijang Color Printing & Packaging Co., Ltd., model DPP-250.

[0022] The preparation steps of the adhesive in S2 include: heating and melting deer antler glue, tortoise shell glue and fish swim bladder in the presence of solvent, followed by homogenization treatment.

[0023] The solvent is rice wine and / or purified water. The amount of rice wine added is 0.3-0.5 times the total weight of the gelatinous medicinal materials; the amount of purified water added is 0.2-0.3 times the total weight of the gelatinous medicinal materials.

[0024] The homogenization process includes homogenization using a high-pressure homogenizer at a pressure of 20-40 MPa; the heating and melting temperature is 50-70℃.

[0025] The drying process in S1 employs a two-stage gradient drying method, which involves drying at 35-45℃ for 1-3 hours first, and then drying at 50-60℃ for 3-5 hours.

[0026] The sterilization process includes at least one of microwave sterilization, ultraviolet sterilization, or irradiation sterilization.

[0027] In the preparation step of the adhesive in S1, a pharmaceutically acceptable dispersant is also added; the dispersant includes at least one of nano-silica, microcrystalline cellulose, or magnesium stearate.

[0028] In the raw material processing step S1, the wolfberry in the prescription is extracted and dried separately to obtain wolfberry extract, which is then mixed with the medicinal powder components. Specifically, 223.8g of wolfberry is placed in a multi-functional extraction tank, 8 times the amount of purified water is added, and the mixture is refluxed at 95℃ twice, 2 hours each time. The extracts are combined. The extract is filtered through a plate and frame filter press, and the filtrate is sent to a vacuum concentration tank and concentrated at 60℃ to a relative density of 1.20, with a concentrated mass of approximately 35g. The extract is vacuum dried at 50℃ and then pulverized into 100-mesh fine powder to obtain wolfberry extract, which is then mixed with medicinal powder A. The mixture is thoroughly mixed and still designated as powder A. Among them, the manufacturer of the multi-functional extraction tank is Wenzhou Fengyuan Machinery Co., Ltd., model TQ-1000; the manufacturer of the plate and frame filter is Hangzhou Kelu Purification Equipment Co., Ltd., model XAZ-500; the manufacturer of the vacuum concentration tank is Shanghai Shensheng Technology Co., Ltd., model ZN-1000; and the manufacturer of the vacuum dryer for the extract is Shanghai Yiheng, model DZF-6050.

[0029] The preparation method of Tianjing Sixu Pills yields the following formula: 223.8g each of ginseng, deer antler glue, tortoise shell glue, yam, and wolfberry; 186.5g each of cornus officinalis, ophiopogon japonicus, dodder seed, and cistanche deserticola; 298.4g each of prepared rehmannia root, fish maw (fried), and morinda officinalis; 37.3g of schisandra chinensis; 111.9g of arborvitae seed; and 37.3g of cinnamon. The Tianjing Sixu Pills prepared by this invention strictly adhere to classical records. The sources, core characteristics, and functions of each raw material are as follows. Note: The standard is based on the amount of ingredients used in a single batch of 10kg pills. Ginseng 223.8g, selected from the dried root of ginseng (Panax ginseng), a plant of the Araliaceae family, 3-year-old cultivated ginseng, with the root head removed, contains ginsenoside Rg1 greater than or equal to 0.3%, which has the effects of greatly replenishing vital energy, tonifying the spleen and benefiting the lungs, serving as the principal herb, promoting the production of qi and blood to replenish kidney essence; Deer antler glue 223.8g, made from concentrated solid glue of red deer antler decocted in water, pharmaceutical grade, containing collagen greater than or equal to 80% and amino acids greater than or equal to 15%, has the effects of warming and tonifying kidney yang, nourishing essence and blood, and is the principal drug, tonifying yang to promote sperm production. The tortoise shell glue (223.8g) is a concentrated solid glue made from the carapace of the tortoise, a member of the Testudinidae family. It is of pharmaceutical grade and contains ≥15% amino acids and ≥10% calcium. It has the effects of nourishing yin and suppressing yang, benefiting the kidneys and strengthening bones. It is the principal ingredient and balances the warm and dry nature of deer antler glue. 223.8g of yam, made from the dried rhizome of Dioscorea opposita, a plant of the Dioscoreaceae family, is of medicinal grade and contains diosgenin greater than or equal to 0.1% and starch greater than or equal to 70%. It has the effects of tonifying the spleen and stomach, tonifying the kidneys and astringing essence, acting as an adjuvant medicine, and strengthening the spleen and nourishing the innate kidney essence. 223.8g of wolfberries, selected from the dried fruit of Lycium barbarum from Ningxia Hui Autonomous Region, a plant of the Solanaceae family. Medicinal grade, containing ≥18% wolfberry polysaccharides, it has the effects of nourishing the liver and kidneys, benefiting essence and improving eyesight, acting as an adjuvant, and enhancing the immune function of the reproductive system. Cornus officinalis fruit 186.5g, selected from the dried fruit pulp of Cornus officinalis plant of the Cornaceae family, contains mononoside greater than or equal to 0.6%, which has the effects of tonifying the liver and kidneys, astringing and consolidating, acting as an adjuvant, and reducing the depletion of kidney essence; 186.5g of Ophiopogon japonicus is made from the dried tuberous root of Ophiopogon japonicus, a plant of the Liliaceae family. It contains greater than or equal to 0.02% Ophiopogon japonicus saponin D. It has the effects of nourishing yin and promoting body fluid, moistening the lungs and clearing the heart. It can also be used as an adjuvant to alleviate the warm and dry nature of kidney-tonifying drugs. 186.5g of dodder seed, selected from the dried seeds of the dodder plant of the Convolvulaceae family, contains dodderin greater than or equal to 0.1%, which has the effects of tonifying the liver and kidneys, consolidating essence and reducing urination, and acting as an adjuvant to enhance the kidney-tonifying and essence-consolidating effects; 186.5g of Cistanche deserticola, selected from the dried fleshy stem of Cistanche deserticola, a plant of the Orobanchaceae family, contains echinacoside greater than or equal to 1.0%, which has the effects of tonifying kidney yang, nourishing essence and blood, and assisting deer antler glue in warming the kidneys; 298.4g of prepared Rehmannia root, made from the wine-steamed tuberous root of Rehmannia glutinosa (a plant in the Scrophulariaceae family), contains verbascoside at a concentration of ≥0.02%. It has the effects of nourishing yin and blood, replenishing essence and marrow, and acting as an adjuvant to enhance the yin-nourishing effect of tortoise shell glue. Fish maw (stir-fried) 298.4g, selected from the stir-fried fish maw of the large yellow croaker of the Sciaenidae family, contains protein greater than or equal to 85% and mucopolysaccharides greater than or equal to 5%. It has the effects of tonifying the kidney and replenishing essence, nourishing tendons and veins, assisting in the treatment, and supplementing the nutrition of seminal plasma. Morinda officinalis 298.4g, selected from the dried root of Morinda officinalis plant of Rubiaceae family, contains 2.0% or more natriuretic sugar. It has the effects of tonifying kidney yang, strengthening tendons and bones, and as an adjuvant to improve the effects of low sperm count and weakness caused by kidney yang deficiency. Northern Schisandra 37.3g, selected from the dried fruit of Schisandra chinensis plant of the Magnoliaceae family, contains schisandrin A greater than or equal to 0.4%, which has the effects of astringing and consolidating, replenishing qi and promoting body fluid, and reducing the loss of kidney essence. 111.9g of cypress seed kernels, selected from the dried seeds of the cypress plant (Platycladus orientalis), contains 14% or more of fatty oil. It has the effects of nourishing the heart and calming the mind, moistening the intestines and relieving constipation, and acting as a medicine to calm the mind and help nourish the kidney essence. Cinnamon 37.3g, made from the dried bark of the cinnamon tree (Lauraceae family), contains cinnamaldehyde greater than or equal to 1.5%. It has the effects of tonifying fire and assisting yang, warming the meridians and promoting blood circulation, guiding the medicine, returning fire to its source, and enhancing the effect of warming the kidneys.

[0030] Example 1: Preparation of a product without wolfberry extract using standard processes; The raw materials and equipment are as follows: Prescription: 223.8g each of ginseng, deer antler glue, tortoise shell glue, yam, and wolfberry; 186.5g each of cornus officinalis, ophiopogon japonicus, dodder seed, and cistanche deserticola; 298.4g each of prepared rehmannia root, fish maw (fried), and morinda officinalis; 37.3g of schisandra chinensis; 111.9g of arborvitae seed; and 37.3g of cinnamon. Excipients: Appropriate amount of rice wine and 70% ethanol.

[0031] Main equipment: universal pulverizer, jacketed gelling tank, colloid mill, high-pressure homogenizer, three-dimensional motion mixer, intelligent Chinese medicine pelleting machine, mesh belt dryer, and linked microwave ultraviolet sterilizer. Specifically, the intelligent Chinese medicine pelleting machine is model ZW-80, manufactured by Beijing Changzheng Tianmin High Technology Co., Ltd.; the linked microwave ultraviolet sterilizer is model CWO-30T, manufactured by Nanjing Chishun Technology Co., Ltd.

[0032] The preparation steps are as follows: Pretreatment and pulverization: Clean the above fifteen medicinal materials to remove impurities. Dry ginseng, yam, cornus officinalis, ophiopogon japonicus, dodder seed, cistanche deserticola, rehmannia glutinosa, morinda officinalis, schisandra chinensis, arborvitae seed, and cinnamon in a 60℃ forced-air drying oven for 6 hours until the moisture content is less than or equal to 8%. Pulverize using a universal pulverizer, pass through a 100-mesh sieve, and place the resulting fine powder in a three-dimensional motion mixer and mix for 30 minutes to obtain medicinal powder A.

[0033] Preparation of the adhesive solution: Crush the deer antler glue and tortoise shell glue, and place them together with the stir-fried fish maw in a dissolving tank. Add 150g of rice wine and 100g of purified water, turn on the jacket heating and stirring, and control the temperature at 60℃ until completely melted to obtain the initial mixed adhesive solution. Transfer the initial mixed adhesive solution to a colloid mill and grind it for 5 minutes. Then homogenize it twice with a high-pressure homogenizer to obtain a brownish-yellow, semi-transparent, and homogeneous adhesive solution B.

[0034] Preparation of soft material and pellet making: Transfer medicinal powder A into a three-dimensional motion mixer. Start the machine and slowly and evenly spray the adhesive solution B through the spraying device. At the same time, depending on the dryness of the soft material, spray an appropriate amount of 70% ethanol to adjust the humidity until a soft material C of suitable hardness is formed. Put the soft material C into an intelligent Chinese medicine pellet making machine, adjust the mold, and make spherical pellets with a diameter of about 6mm.

[0035] Drying and sterilization: The wet pellets are evenly spread on the conveyor belt of a mesh belt dryer, first dried at 40℃ for 2 hours to set their shape, and then dried at 55℃ for 4 hours until the moisture content is less than or equal to 10%. The dried pellets are then placed in a linked microwave-UV sterilizer, first passing through a microwave tunnel and then through a UV tunnel for sterilization.

[0036] Packaging: After sterilization, the pills are cooled to room temperature in a clean cooling room, and finally sealed and packaged using an aluminum-plastic blister packaging machine to obtain the finished product.

[0037] Example 2: Taking the preparation of a single batch of 10kg Tianjing Sixu Wan containing wolfberry extract as an example, the preferred method is: S1. Raw material processing Multiple medicinal materials drying and pulverizing: Eleven medicinal materials were placed in a forced-air drying oven and dried at 40℃ for 2 hours, then at 55℃ for 4 hours. Moisture content was then tested. The drying process was considered complete if the moisture content met the following standards: ginseng 7.5%, yam 7.8%, and cinnamon 7.2%. After drying, the materials were placed in a universal pulverizer and pulverized through a 100-mesh sieve. Then, they were mixed in a mixer for 15 minutes to obtain medicinal powder A, with a mass of 2450g. Goji Berry Extraction: Weigh 223.8g of goji berries and put them into an extraction tank. Add 8 times the amount of water and extract twice at 95℃ for 2 hours each time. Then combine the extracts. After filtration, put them into a concentration tank and concentrate them at 60℃ to 35g of extract. Then vacuum dry and pulverize them. Mix them with medicinal powder A to obtain medicinal powder A, which has a mass of 2485g.

[0038] S2, Preparation of adhesive solution, Melting: Add small pieces of deer antler glue, tortoise shell glue, and stir-fried fish maw to a melting tank, add 0.4 times the amount of rice wine (350g) and 0.25 times the amount of purified water (220g), adjust the temperature to 60℃, stir for 30 minutes, and obtain 950g of initial mixed glue solution; Homogenization: Add 4.75g of nano silica, grind in a colloid mill for 10 minutes, and then homogenize three times in a high-pressure homogenizer to obtain liquid B with a mass of 952g. S3, Mixing and pelletizing Soft material: Add powder A to a mixer and stir, spray in adhesive B and add 150g of 70% ethanol, stir for 20 minutes to obtain soft material C, which has a mass of 3587g; Drying: The pelleting machine selects a 6mm mold to make 4800g of wet pellets, which are then dried in a dryer at 40℃ for 2 hours. The temperature is then raised to 55℃ and dried for 4 hours to obtain 4100g of dry pellets. The dry pellets contain 9.2% moisture, which meets the moisture content requirements for dry pellets. S4, Post-processing Sterilization: Place the dry tile in a sterilizer and microwave it for 2 minutes at 600W. Then sterilize it under ultraviolet light for 1 minute to kill 99.95% of microorganisms. Packaging: The sterilized dry pills are placed into a packaging machine for packaging, and then packaged in aluminum-plastic blister packs to obtain 45 boxes of finished products, with 3 blister packs per box and 10 pills per blister pack. The pharmaceutical mechanism and method of administration of this invention: First, it should be clarified that the method involved in this invention is mainly used in the preparation of Tianjing Sixu Pill. This invention takes the preparation of Tianjing Sixu Pill as an example to elaborate on its medicinal mechanism and method of administration. The medicinal mechanism is as follows: This invention achieves a breakthrough in "preserving the efficacy of classic medicines and overcoming the defects in processing technology" through the synergistic effect of traditional Chinese medicine theory and modern pharmacology. From the perspective of traditional Chinese medicine theory: adhere to the logic of "tonifying the kidneys and replenishing essence, and simultaneously nourishing yin and yang" in drug formulation; Preserving the traditional use of rice wine to dissolve glue: Rice wine, as a solvent for glue, also has the effect of "guiding medicine into the kidney meridian", which enhances the kidney-warming and yin-nourishing effects of deer antler glue and tortoise shell glue. This is in line with the TCM theory of "using wine to promote the upward movement", ensuring the balance of the prescription in "warming yang without harming yin and nourishing yin without hindering yang". The combined effects of the principal, assistant, adjuvant, and guiding herbs—ginseng to invigorate qi, deer antler glue to warm yang, tortoise shell glue to nourish yin, and prepared rehmannia root to nourish blood—ensure the full release of the effective components of each herb through optimized processing, working together to achieve the goal of "sufficient qi and blood lead to abundant kidney essence, and harmony of yin and yang leads to healthy reproduction," thus specifically improving oligospermia and infertility. From a modern pharmacological perspective: Process optimization overcomes traditional limitations. Goji berry extraction alone improves polysaccharide utilization: water extraction and concentration allow goji berry polysaccharides to be fully released from the medicinal fiber, increasing the extraction rate from 25% of traditional direct pulverization to over 75%, and the concentration of polysaccharides increases by 4 times after concentration, enhancing the "nourishing yin and replenishing essence" medicinal effect; Homogenization of the colloid ensures uniform composition: colloid milling combined with high-pressure homogenization greatly reduces the particle size of the colloid, and the dispersant nano-silica further inhibits particle aggregation. The difference in collagen content per pill is reduced from 20% to less than 8%, solving the problem of drug efficacy fluctuation. Gradient drying prevents pills from cracking: First, surface moisture is removed at a low temperature of 40℃ to effectively prevent hardening, and then internal moisture is removed at a medium temperature of 55℃ to effectively prevent softening. The moisture gradient between the inside and outside of the pills is less than 2%, which greatly reduces the cracking rate and ensures the stability of appearance and structure. Combined sterilization ensures safety: Microwave sterilization has strong penetrating power and kills internal microorganisms. Combined with ultraviolet sterilization, it can kill surface microorganisms, with a microorganism kill rate of ≥99.9%, solving the safety risks of incomplete sterilization by traditional methods. Standardized pelleting improves bioavailability: 100-mesh powder combined with a homogeneous adhesive increases the dissolution channels for active ingredients, increasing the dissolution rate of ginsenoside Rg1 from 28% to 73%, shortening the disintegration time from 95 minutes to less than 50 minutes, and increasing oral bioavailability from 25% to over 65%. The method of administration is as follows: The essence-enhancing and fertility-promoting pills prepared by this invention are oral spherical pills with a diameter of 6 mm and a weight of approximately 3.65 g per pill. They are packaged in aluminum-plastic blister packs, with 30 pills per box. The specific method of administration is as follows: Dosage and administration: Take with warm water, 3 times a day, 3 pills each time, about 11g, which is close to the traditional "8 qian" dosage per day. Take continuously for 2 months as one course of treatment; for consolidation treatment, one more course of treatment can be added as directed by a doctor. Precautions for use: Avoid raw and cold foods, such as ice cream and cold drinks, spicy foods, such as chili peppers and Sichuan peppercorns, and greasy foods, such as fried foods, during the period of use. Avoid staying up late and ensure that you get at least 7 hours of sleep every day. Avoid sitting for more than 8 hours a day. It is recommended to do light exercise 3-4 times a week, such as jogging or Tai Chi, for 30 minutes each time, to improve the microcirculation of the reproductive system. Contraindications: This product is contraindicated for individuals allergic to any of the ingredients, such as ginseng, deer antler glue, or cinnamon. Individuals with hypertension or yin deficiency with excessive internal heat, such as those experiencing hot palms and soles or night sweats, should use with caution and reduce the dosage to 2 pills per dose under the guidance of a physician. Drug interactions: Avoid taking with Western medicine hormone drugs, such as testosterone tablets, and wait 2 hours between doses; wait 1 hour between doses with antibiotics, such as levofloxacin, to prevent affecting the absorption of the active ingredients of traditional Chinese medicine.

[0039] This invention solves the problem that traditional "alcohol-melting" methods are difficult to use to uniformly mix gelatinous medicinal materials, such as deer antler glue, tortoise shell glue, and fish maw, with dozens of times the amount of medicinal powder due to their high viscosity. This leads to uneven distribution of effective ingredients in the pills, large quality fluctuations between different batches, and poor stability of efficacy, resulting in poor uniformity and stability of the medicinal materials.

[0040] Furthermore, it should be noted that, in the description of this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0041] The above description represents the preferred embodiments of the present invention. It should be noted that those skilled in the art can make various improvements and modifications without departing from the principles of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A processing and preparation method of Tianjing Sixu Pills, characterized in that, Includes the following steps: S1. Raw material processing: The ginseng, yam, cornus officinalis, ophiopogon japonicus, dodder seed, cistanche deserticola, rehmannia glutinosa, morinda officinalis, schisandra chinensis, arborvitae seed, and cinnamon in the prescription are dried and pulverized to obtain the medicinal powder components; S2. Preparation of adhesive solution: The deer antler glue, tortoise shell glue and fish swim bladder in the prescription are subjected to gelatinization treatment to obtain the adhesive solution components; S3. Mixing and pelletizing: The powder component and the gel component are mixed to form pellets; S4. Post-processing: The pills are dried and sterilized to obtain the essence-enhancing pills.

2. The processing and preparation method of the essence-enhancing and fertility-promoting pill as described in claim 1, characterized in that: The preparation steps of the adhesive solution in S2 include: heating and melting deer antler glue, tortoise shell glue and fish swim bladder in the presence of a solvent, followed by homogenization treatment.

3. The processing and preparation method of the essence-enhancing and fertility-promoting pill as described in claim 2, characterized in that: The solvent is rice wine and / or purified water.

4. The processing and preparation method of the essence-enhancing and fertility-promoting pill as described in claim 2, characterized in that: The homogenization process includes homogenization using a high-pressure homogenizer at a pressure of 20-40 MPa; the heating and melting temperature is 50-70℃.

5. The processing and preparation method of the essence-enhancing and fertility-promoting pill as described in claim 1, characterized in that: The drying step in S1 adopts a two-stage gradient drying method, which includes drying at 35-45℃ for 1-3 hours first, and then drying at 50-60℃ for 3-5 hours.

6. The processing and preparation method of the essence-enhancing and fertility-promoting pill as described in claim 1, characterized in that: The sterilization step includes at least one of microwave sterilization, ultraviolet sterilization, or irradiation sterilization.

7. The processing and preparation method of the essence-enhancing and fertility-promoting pill as described in claim 1, characterized in that: In the preparation step of the adhesive solution described in S1, a pharmaceutically acceptable dispersant is also added; the dispersant includes at least one of nano-silica, microcrystalline cellulose, or magnesium stearate.

8. The processing and preparation method of the essence-enhancing and fertility-promoting pill as described in claim 1, characterized in that: In the raw material processing step described in S1, the wolfberries in the prescription are extracted and dried separately to obtain wolfberry extract, which is then mixed with the medicinal powder components.

9. The Tianjing Sixu Pill prepared by the processing method of any one of claims 1-8, characterized in that, The formula for Tianjing Sixu Wan is as follows: 223.8g each of ginseng, deer antler glue, tortoise shell glue, yam, and wolfberry; 186.5g each of cornus officinalis, ophiopogon japonicus, dodder seed, and cistanche deserticola; 298.4g each of prepared rehmannia root, fish maw (fried), and morinda officinalis; 37.3g of schisandra chinensis; 111.9g of arborvitae seed; and 37.3g of cinnamon.

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