Formula of traditional Chinese medicine patch for warming kidney and consolidating primordial qi
By improving the composition and preparation process of traditional Chinese medicine patches, modern technology is used to improve transdermal absorption and controlled release of drugs, the problems of dispersion and low transdermal efficiency of traditional Chinese medicine patches are solved, and the stable output of drug efficacy and local microcirculation are achieved, forming a conditioning effect that treats both the symptoms and the root causes.
Patent Information
- Application Number
- CN202510647527.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-05-20
- Publication Date
- 2025-07-04
AI Technical Summary
Traditional Chinese medicine patches for warming the kidney Guyuan have problems such as dispersed efficacy, lagging effects, low transdermal efficiency, sudden release of drugs to stimulate the skin and lack of local microcirculation activation.
The combination of salt-made aconite, Jiushiji Cistanche, Hippocampus ultrafine powder, calcined oyster shell powder, low-temperature baked dodder, Qinghai-Tibet rock salt crystals, liposome-encapsulated cinnamon oil, nanographene patch matrix, biocompatible hydrogels and Antarctic krill extract and quantum dot-labeled yang polysaccharides is used to improve transdermal absorption and controlled release technology of drugs through modern technology.
It achieves stable transdermal release of the drug, enhances local microcirculation, ensures stable output of the drug effect for more than 12 hours, avoids skin irritation, and forms a conditioning system that treats both the symptoms and the root causes, combining traditional warm-to-sufficiency concepts with modern sustained release technology.
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Figure CN120241667A_ABST
Abstract
Description
Technical Field
[0001] The present invention belongs to the technical field of traditional Chinese medicine patches for warming the kidney and consolidating the primordial qi, and specifically relates to a formula for a traditional Chinese medicine patch for warming the kidney and consolidating the primordial qi. Background Art
[0002] The traditional Chinese medicine patch for warming the kidney and consolidating the primordial qi is an external patch developed based on the theory of "the kidney is the foundation of congenital constitution" in traditional Chinese medicine, and is mainly used to relieve various discomfort symptoms caused by kidney-yang deficiency. This patch usually selects traditional Chinese medicinal materials such as aconite processed with salt, cinnamon, eucommia ulmoides, dodder seed, and morinda officinalis that warm the kidney-yang and strengthen the root of primordial qi, extracts the active ingredients through modern technology, and is made into a patch form. Its efficacy lies in warming the kidney-yang, consolidating the primordial qi, and strengthening the bones and muscles, and is suitable for the adjuvant treatment of symptoms of kidney-yang deficiency such as soreness and weakness in the waist and knees, fear of cold and cold limbs, listlessness, and frequent urination at night. Its mechanism of action is through transdermal absorption technology, so that the drug components are slowly released through the skin, penetrate into the acupoints and meridians, regulate the functions of the zang-fu organs, and achieve the effect of warming the kidney-yang and strengthening the root of primordial qi. When using, it is necessary to clean the skin of the application site, apply the medicine patch on acupoints such as the kidney shu acupoint and the guanyuan acupoint, once a day or as directed by a doctor. Compared with oral drugs, traditional Chinese medicine patches avoid the first-pass effect and irritation to the gastrointestinal tract, are easy to use, and have high safety. However, they are contraindicated for pregnant women, lactating women, those with skin damage, and those allergic to the patch ingredients. As a daily health care product, the traditional Chinese medicine patch for warming the kidney and consolidating the primordial qi can improve the symptoms of kidney-yang deficiency to a certain extent, but it cannot replace regular medical means. It is recommended to use it reasonably under the guidance of a doctor and cooperate with a healthy lifestyle to achieve the best effect.
[0003] However, due to technical limitations, traditional preparations for warming the kidney and consolidating the primordial qi have multiple defects: ordinary dried cistanche deserticola is difficult to fully convert into phenylethanoid glycoside active substances, and at the same time, the traditional preparation process is prone to destroying the structure-activity relationship of cynomorium polysaccharide, resulting in the loss of targeting. Ordinary hydrogels have weak temperature control ability, which is likely to cause sudden drug release and stimulate the skin, and lack the activation effect of Antarctic krill extract on local microcirculation. Overall, there are problems such as scattered drug efficacy, delayed action, and low transdermal efficiency. Summary of the Invention
[0004] The purpose of the present invention is to provide a formula for a traditional Chinese medicine patch for warming the kidney and consolidating the primordial qi in order to solve the above-mentioned problems.
[0005] The technical solution adopted by the present invention is as follows: A formula for a traditional Chinese medicine patch for warming the kidney and consolidating the primordial qi, the formula comprising:
[0006] The monarch drug group:
[0007] Aconite processed with salt, 15 parts by weight;
[0008] Cistanche deserticola processed by steaming and drying nine times, 12 parts by weight;
[0009] Hippocampus ultrafine powder, 8 parts by weight;
[0010] The minister drug group:
[0011] 10 parts by weight of calcined oyster shell powder;
[0012] 10 parts by weight of low-temperature roasted dodder seeds;
[0013] 6 parts by weight of Qinghai-Tibet rock salt crystals;
[0014] Assistant drug group:
[0015] New transdermal carrier: 5 parts by weight of cinnamon oil encapsulated in liposomes;
[0016] 20 parts by weight of nano-graphene patch matrix;
[0017] 25 parts by weight of biocompatible hydrogel;
[0018] Microcirculation group:
[0019] 3 parts by weight of Antarctic krill extract;
[0020] 2 parts by weight of cynomorium polysaccharide labeled with quantum dots.
[0021] In a preferred embodiment, the preparation method of the formula comprises the following steps:
[0022] S1: Process the salted aconite roots by the ancient salt-curing method, slice the cistanche deserticola after drying by the nine-steaming and nine-sunning process, extract the active ingredients of hippocampus by supercritical carbon dioxide extraction technology, and mix the three and prepare them into a uniform fine powder through a nano-level pulverizer.
[0023] S2: Calcinate the oyster shells at high temperature and grind them into micron-level powder, crush and sieve the dodder seeds after low-temperature roasting, grind the Qinghai-Tibet rock salt crystals into ultra-fine powder, and mix the three in proportion and set aside.
[0024] S3: Blend the cinnamon oil and the liposome carrier under constant temperature conditions to form a cinnamon oil complex encapsulated in liposomes, and control the encapsulation rate to be not less than 85%.
[0025] S4: Co-melt the nano-graphene powder and the thermosensitive polymer to prepare a patch matrix with a porous structure, and cut it into a preset shape after cooling.
[0026] S5: Mix the Antarctic krill extract and the cynomorium polysaccharide solution, and process them by quantum dot labeling technology to form an active complex targeting the kidney meridian.
[0027] S6: Put the fine powder of the monarch drug group in step S1, the mixed powder of the minister drug group in step S2, the liposome encapsulation in step S3 and the active complex in step S5 into a three-dimensional motion mixer and mix them at a speed of 30 revolutions per minute for 40 minutes.
[0028] S7: Heat the biocompatible hydrogel substrate to 45 °C until it becomes in a flowing state, add the mixed medicinal powder from step S6 and continuously stir, while injecting it into the graphene patch matrix prepared in step S4, and control the drug loading rate to be 0.25 grams per square centimeter.
[0029] S8: Place the drug-loaded matrix in a sterile environment for curing and forming, cut it into pieces and seal it with an impermeable aluminum foil bag, and obtain the finished product after electron beam irradiation sterilization treatment.
[0030] In a preferred embodiment, in step S1, first perform traditional salting treatment on processed aconite root, immerse it in a 20% concentration of crude salt solution for 72 hours, and turn it three times a day during this period to ensure uniform penetration. Cistanche deserticola needs to go through nine cycles of steaming and sun-drying processes. Each steaming temperature is 100 °C for 2 hours, and the sun-drying condition is to spread it out in the dark at a temperature below 35 °C until the water content is lower than 8%. The hippocampus raw material is extracted by supercritical carbon dioxide extraction. Set the extraction pressure at 35 MPa and the temperature at 45 °C, and collect the fat-soluble active ingredients after dynamic extraction for 3 hours. Finally, put the above-mentioned processed raw materials into a nanoscale airflow pulverizer together, control the pulverization particle size in the range of 200 - 300 nanometers, and obtain a homogenized mixed medicinal powder.
[0031] In a preferred embodiment, in step S2, oyster shells need to be calcined in a high-temperature calcination furnace at 1250 °C for 4 hours. After generating grayish-white oxides, immediately transfer them to an inert gas environment for cooling, and then grind them with a planetary ball mill to an average particle size of 3 microns. Cuscuta chinensis is placed in a 60 °C circulating hot air oven for low-temperature roasting for 6 hours, and after pulverization, it is sieved through a 200-mesh stainless steel sieve. The Qinghai-Tibet rock salt crystals are processed by an ultrafine pulverizer to a particle size below 10 microns. The three materials are put into a three-dimensional conical mixer according to a preset ratio and mixed at 15 revolutions per minute for 1 hour until uniform.
[0032] In a preferred embodiment, in step S3, mix refined cinnamon oil and soybean lecithin in a mass ratio of 1:3, dissolve them in absolute ethanol to form a solution system. Under the condition of a 50 °C constant temperature water bath, use a rotary evaporator to slowly remove the organic solvent at a speed of 120 rpm. At the same time, inject phosphate buffer solution into the liquid phase to form a liposome encapsulation structure with a particle size of 80 - 100 nm through the thin film hydration method. Finally, detect the encapsulation efficiency by a dynamic light scattering instrument to ensure that the core component loading rate is not less than 85%.
[0033] In a preferred embodiment, in step S4, take nanoscale graphene powder and thermoplastic polyurethane and mix them in a mass ratio of 1:4, place them in a twin-screw extruder and melt-blend at 180 °C. After the melt is extruded through a porous die, it is quickly cooled to -20 °C for shaping to form a porous matrix sheet with a pore size of 50 - 80 microns. Use a laser cutter to cut the sheet into a standard size of 4 cm × 6 cm, and the surface is treated by plasma to enhance the drug attachment performance.
[0034] In a preferred embodiment, in step S5, the freeze-dried Antarctic krill powder and the aqueous extract of Cynomorium songaricum are redissolved in a ratio of 1:2, and a carbon quantum dot suspension is added for surface modification. In a pH 7.4 buffer system, quantum dots are combined with polysaccharide molecules through electrostatic self-assembly technology to form a labeled complex with a particle size of about 15 nm. After the composite solution is sterilized by a 0.22 μm filter membrane, it is stored in a low-temperature refrigerator for later use.
[0035] In a preferred embodiment, in step S6, the powder of the sovereign drug group, the mixed powder of the ministerial drug group, the liposome encapsulation, and the quantum dot labeling solution prepared in the previous process are put into a three-dimensional motion mixer according to the formula ratio. The temperature of the mixing chamber is set at 25 °C and the relative humidity is 40%, and three-dimensional tumbling mixing is carried out at 30 revolutions per minute for 40 minutes. The end point of mixing is monitored online by near-infrared spectroscopy to ensure that the coefficient of variation of the distribution uniformity of each component is less than 5%.
[0036] In a preferred embodiment, in step S7, the biocompatible hydrogel substrate is melted into a viscous fluid in a 45 °C constant temperature bath, and the mixed medicinal powder is gradually added in a ratio of 35 g per 100 g of the substrate. A high-shear emulsifier is used to stir at a speed of 8000 rpm for 20 minutes, and after forming a uniform ointment, it is injected into a preheated graphene matrix. The drug-loading thickness is controlled at 0.8 mm by a precision coater, and the drug loading per unit area is ensured by an online weighing system to have an error of no more than ±2%.
[0037] In a preferred embodiment, in step S8, the drug-loaded matrix is left to solidify in a sterile environment with a cleanliness of 10,000 for 12 hours, the environmental temperature is controlled at 22 ± 2 °C, and the relative humidity is 50 ± 5%. After solidification, it is cut into finished patches by an ultrasonic slitter, and the error of the single-piece size does not exceed ±0.3 mm. After being vacuum-packaged in a composite aluminum foil bag, it is sterilized by electron beam irradiation with a dose of 10 kGy, and the final product is stored in a cool and dry place below 25 °C.
[0038] In summary, due to the adoption of the above technical solutions, the beneficial effects of the present invention are as follows:
[0039] 1. In the present invention, salt-processed Aconiti Lateralis Radix Praeparata and nine-steamed and nine-sunned Cistanche deserticola form a core for warming yang, and cooperate with the kidney-tonifying essence of the ultrafine powder of hippocampus, which can deeply stimulate the fire of the gate of vitality and improve symptoms of yang deficiency decline such as soreness and coldness in the waist and knees, and cold limbs. The mineral essence of calcined oyster and Qinghai-Tibet rock salt fixes the vital energy in the lower jiao, and the property of Cuscuta chinensis to tonify both yin and yang can reconcile the extreme nature of the medicinal properties, forming a conditioning system that treats both the symptoms and the root causes. The traditional processing technology completely retains the active ingredients of the medicinal materials, and the special molecular structure transformed by the nine-steamed and nine-sunned process is more easily absorbed by the human body, realizing a progressive warming and nourishing from the body surface to the viscera.
[0040] 2. In the present invention, the liposome-encapsulated cinnamon oil breaks through the traditional transdermal barrier, and the heat conduction effect of the nano-graphene matrix continuously stimulates the meridian sensation transmission of acupoints. The biphasic controlled release technology ensures a stable drug output for more than 12 hours. The polysaccharide of cynomorium songaricum labeled with quantum dots accurately locates the key acupoints of the kidney meridian, and cooperates with the enhanced local microcirculation of Antarctic krill extract to form a triple action mechanism of "drug penetration - heat energy excitation - meridian conduction". The thermosensitive property of the biocompatible hydrogel intelligently regulates the drug release rate, which not only avoids over-stimulating the skin but also maintains a stable drug concentration, realizing the organic combination of the traditional concept of warming and tonifying and modern sustained release technology. BRIEF DESCRIPTION OF THE DRAWINGS
[0041] Figure 1 It is a schematic diagram of the process principle of the present invention. DETAILED DESCRIPTION OF THE EMBODIMENTS
[0042] In order to make the objectives, technical solutions and advantages of the present invention clearer, the present invention will be further described in detail below with reference to the drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.
[0043] Embodiment:
[0044] Referring to Figure 1 , a formula for a traditional Chinese medicine patch for warming the kidney and consolidating the yuan, the formula includes:
[0045] King drug group (warming the kidney yang):
[0046] Salt-processed aconite (black lateral aconite) 15 parts by weight (after nano-grinding treatment);
[0047] Cistanche deserticola processed by steaming and sunning nine times 12 parts by weight;
[0048] Hippocampus ultrafine powder 8 parts by weight;
[0049] Minister drug group (strengthening the root and cultivating the yuan):
[0050] Calcined oyster shell powder 10 parts by weight (particle size ≤ 5μm);
[0051] Cuscuta chinensis processed by low-temperature roasting 10 parts by weight;
[0052] Qinghai-Tibet rock salt crystals 6 parts by weight (containing natural trace elements);
[0053] Assistant and guiding drug group (enhancing transdermal efficacy):
[0054] New transdermal carrier: Liposome-encapsulated cinnamon oil 5 parts by weight;
[0055] Nano-graphene patch matrix 20 parts by weight (with both heat conduction and sustained release functions);
[0056] Biocompatible hydrogel 25 parts by weight (modified with hyaluronic acid);
[0057] Microcirculation group:
[0058] Euphausia superba extract 3 parts by weight (rich in astaxanthin, enhancing microcirculation);
[0059] Quantum dot-labeled cynomorium polysaccharide 2 parts by weight (targeting the kidney meridian acupoints).
[0060] The preparation method of the formula comprises the following steps:
[0061] S1: Process the salted aconite root by the ancient salt curing method, slice the cistanche after drying by the nine-steaming and nine-sunning process, extract the active ingredients of hippocampus by the supercritical carbon dioxide extraction technology, and mix the three and prepare them into a uniform fine powder through a nanoscale pulverizer.
[0062] S2: Calcine the oyster shell at high temperature and grind it into a micron-sized powder, crush and sieve the cuscuta chinensis after low-temperature roasting, grind the Qinghai-Tibet rock salt crystals into an ultra-fine powder, and mix the three in proportion and set aside.
[0063] S3: Blend the cinnamon oil and the liposome carrier under constant temperature conditions to form a liposome-encapsulated cinnamon oil complex, and control the encapsulation rate to be not less than 85%.
[0064] S4: Co-melt the nanoscale graphene powder and the thermosensitive polymer to prepare a patch matrix with a porous structure, and cut it into a preset shape after cooling.
[0065] S5: Mix the Euphausia superba extract and the cynomorium polysaccharide solution, and process it by the quantum dot labeling technology to form an active complex targeting the kidney meridian.
[0066] S6: Put the fine powder of the monarch drug group in step S1, the mixed powder of the ministerial drug group in step S2, the liposome encapsulation in step S3 and the active complex in step S5 into a three-dimensional motion mixer, and mix at a speed of 30 revolutions per minute for 40 minutes.
[0067] S7: Heat the biocompatible hydrogel substrate to 45 °C to make it in a flowing state, add the mixed medicinal powder in step S6 and continuously stir, and at the same time inject it into the graphene patch matrix prepared in step S4, and control the drug loading rate to be 0.25 grams per square centimeter.
[0068] S8: Place the drug-loaded matrix in a sterile environment for solidification and molding, cut it and seal it with an impermeable aluminum foil bag, and obtain the finished product after electron beam irradiation sterilization treatment.
[0069] In step S1, first, the salted aconite roots are subjected to traditional salting treatment, impregnated with a 20% concentration of crude salt solution for 72 hours, and turned three times a day during this period to ensure uniform penetration. Cistanche deserticola needs to go through the process of steaming and sun-drying for nine cycles. Each steaming is carried out at a temperature of 100°C for 2 hours, and the sun-drying condition is to spread it out in the dark at a temperature below 35°C until the water content is lower than 8%. The hippocampus raw material is extracted by supercritical carbon dioxide. The extraction pressure is set at 35 MPa and the temperature is 45°C. After dynamic extraction for 3 hours, the fat-soluble active ingredients are collected. Finally, the above-treated raw materials are jointly put into a nano-scale airflow pulverizer, and the pulverizing particle size is controlled in the range of 200 - 300 nanometers to obtain a homogenized mixed medicinal powder.
[0070] In step S2, the oyster shell needs to be calcined in a high-temperature calcination furnace at 1250°C for 4 hours. After generating a grayish-white oxide, it is immediately transferred to an inert gas environment for cooling, and then ground to an average particle size of 3 microns by a planetary ball mill. Cuscuta chinensis is placed in a 60°C circulating hot air oven for low-temperature roasting for 6 hours, and after pulverization, it is sieved through a 200-mesh stainless steel sieve. The Qinghai-Tibet rock salt crystals are processed by an ultrafine pulverizer to a particle size below 10 microns. The three materials are put into a three-dimensional conical mixer according to a preset ratio and mixed at 15 revolutions per minute for 1 hour until uniform.
[0071] In step S3, the refined cinnamon oil and soybean lecithin are mixed at a mass ratio of 1:3 and dissolved in anhydrous ethanol to form a solution system. Under the condition of a 50°C constant temperature water bath, a rotary evaporator is used to slowly remove the organic solvent at a speed of 120 rpm. At the same time, phosphate buffer solution is injected into the liquid phase, and a liposome encapsulation structure with a particle size of 80 - 100 nm is formed by the thin film hydration method. Finally, the encapsulation efficiency is detected by a dynamic light scattering instrument to ensure that the loading rate of the core components is not less than 85%.
[0072] In step S4, nano-scale graphene powder and thermoplastic polyurethane are mixed at a mass ratio of 1:4 and placed in a twin-screw extruder for melt blending at 180°C. After the melt is extruded through a porous die, it is quickly cooled to -20°C for shaping to form a porous matrix sheet with a pore size of 50 - 80 microns. The sheet is cut into a standard size of 4 cm × 6 cm using a laser cutting machine, and the surface is treated by plasma to enhance the drug adhesion performance.
[0073] In step S5, the freeze-dried powder of Euphausia superba and the water extract of Cynomorium songaricum are redissolved at a ratio of 1:2, and a carbon quantum dot suspension is added for surface modification. In a pH 7.4 buffer system, the quantum dots are combined with polysaccharide molecules through electrostatic self-assembly technology to form a labeled complex with a particle size of about 15 nm. After the composite solution is sterilized by a 0.22 μm filter membrane, it is stored in a low-temperature refrigerator for later use.
[0074] In step S6, the powder of monarch drug group, the mixed powder of ministerial drug group, the liposome encapsulation, and the quantum dot labeling solution prepared in the previous process are put into a three-dimensional motion mixer according to the formula ratio. The temperature of the mixing chamber is set at 25°C and the relative humidity is 40%. Three-dimensional tumbling mixing is carried out at 30 revolutions per minute for 40 minutes. The mixing end point is monitored online by near-infrared spectroscopy to ensure that the coefficient of variation of the distribution uniformity of each component is less than 5%.
[0075] In step S7, the biocompatible hydrogel substrate is melted into a viscous fluid in a 45°C constant temperature bath, and the mixed medicinal powder is gradually fed in according to the ratio of adding 35 g of the mixed medicinal powder per 100 g of the substrate. Stirring is carried out at a speed of 8000 rpm for 20 minutes using a high-shear emulsifier, and after forming a uniform ointment, it is injected into the preheated graphene matrix. The drug-loading thickness is controlled at 0.8 mm by a precision coater, and the error of the drug loading per unit area is ensured not to exceed ±2% through an online weighing system.
[0076] In step S8, the drug-loaded matrix is left to stand and solidify for 12 hours in a sterile environment with a cleanliness level of 10,000. The environmental temperature is controlled at 22 ± 2°C and the relative humidity is 50 ± 5%. After solidification, it is cut into finished patches by an ultrasonic slitter, and the error of the single-piece size does not exceed ±0.3 mm. After being vacuum packaged in a composite aluminum foil bag, it is sterilized by electron beam irradiation with a dose of 10 kGy, and the final product is stored in a cool and dry place below 25°C.
[0077] It can be seen from the above that:
[0078] In the present invention, salt-processed Aconiti Lateralis Radix Praeparata and nine-steamed and nine-sunned Cistanches Herba form a core for warming yang, and cooperate with the kidney-tonifying essence power of the superfine powder of Hippocampi to deeply stimulate the fire of Mingmen, improving symptoms of yang deficiency decline such as soreness and coldness in the waist and knees, and fear of cold and cold limbs. The mineral essence of Calcined Concha Ostreae and Qinghai-Tibet Rock Salt fixes the vital energy in the lower jiao, and the property of Cuscuta Chinensis for tonifying both yin and yang can reconcile the extreme nature of the medicinal properties, forming a conditioning system that treats both the symptoms and the root causes. The traditional processing technology completely retains the active ingredients of the medicinal materials, and the special molecular structure transformed by the nine-steamed and nine-sunned process is more easily absorbed by the human body, realizing a progressive warming and nourishing from the body surface to the internal organs.
[0079] In the present invention, the cinnamon oil encapsulated by liposomes breaks through the traditional transdermal barrier, and the heat conduction effect of the nano-graphene matrix continuously stimulates the meridian sensation transmission of acupoints. The biphasic controlled release technology ensures that the drug effect is stably output for more than 12 hours. The Cynomorium polysaccharide labeled with quantum dots accurately locates the key acupoints of the kidney meridian, and cooperates with the enhanced local microcirculation of Antarctic krill extract to form a triple action mechanism of "drug penetration - heat energy excitation - meridian conduction". The temperature-sensitive property of the biocompatible hydrogel can intelligently regulate the drug release rate, avoiding excessive skin irritation and maintaining a stable drug concentration, realizing the organic combination of the traditional warming and tonifying concept and modern sustained release technology.
[0080] It should be noted that in this article, relational terms such as first and second are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the term "comprising" or any other variant thereof is intended to cover non-exclusive inclusion, such that a process, method, article, or device comprising a series of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, method, article, or device. Without further limitation, an element defined by the statement "comprising an..." does not exclude the presence of additional identical elements in the process, method, article, or device comprising the element.
[0081] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that they can still modify the technical solutions recorded in the foregoing embodiments, or perform equivalent replacements for some of the technical features; and these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.
Claims
1. A formula for a traditional Chinese medicine patch for warming the kidney and consolidating the primordial qi, characterized in that: The formula includes: King drug group: 15 parts by weight of salt-processed aconite root; 12 parts by weight of cistanche deserticola processed by nine steaming and nine sunning; 8 parts by weight of ultrafine powder of hippocampus; Minister drug group: 10 parts by weight of calcined oyster shell powder; 10 parts by weight of dodder seeds processed by low-temperature roasting; 6 parts by weight of Qinghai-Tibet rock salt crystals; Assistant and guiding drug group: New type of transdermal carrier: 5 parts by weight of cinnamon oil encapsulated by liposome; 20 parts by weight of nano-level graphene patch matrix; 25 parts by weight of biocompatible hydrogel; Microcirculation group: 3 parts by weight of Antarctic krill extract; 2 parts by weight of cynomorium songaricum polysaccharide labeled with quantum dots.
2. The formula of a traditional Chinese medicine plaster for warming the kidney and consolidating the primordial qi according to claim 1, characterized in that: The preparation method of the formula includes the following steps: S1: The salt-processed aconite root is processed by the ancient method of salt curing. The cistanche deserticola is dried by the nine steaming and nine sunning process and then sliced. The hippocampus is extracted with supercritical carbon dioxide extraction technology to obtain the active ingredients. The three are mixed and then prepared into a uniform fine powder by a nano-level pulverizer; S2: The oyster shell is calcined at high temperature and then ground into a micron-level powder. The dodder seeds are crushed and sieved after low-temperature roasting. The Qinghai-Tibet rock salt crystals are ground into an ultra-fine powder. The three are mixed evenly in proportion and reserved; S3: The cinnamon oil and the liposome carrier are blended under constant temperature conditions to form a cinnamon oil complex encapsulated by liposome, and the encapsulation rate is controlled to be not less than 85%; S4: The nano-level graphene powder and the thermosensitive polymer are co-melted to prepare a patch matrix with a porous structure, and after cooling, it is cut into a preset shape; S5: The Antarctic krill extract and the cynomorium songaricum polysaccharide solution are mixed and processed by quantum dot labeling technology to form an active complex targeting the kidney meridian; S6: The fine powder of the king drug group in step S1, the mixed powder of the minister drug group in step S2, the liposome encapsulation in step S3 and the active complex in step S5 are jointly put into a three-dimensional motion mixer and mixed at a speed of 30 revolutions per minute for 40 minutes; S7: The biocompatible hydrogel substrate is heated to 45°C to be in a flowing state, the mixed drug powder in step S6 is added and continuously stirred, and at the same time, it is injected into the graphene patch matrix prepared in step S4, and the drug loading rate is controlled to be 0.25 grams per square centimeter; S8: The drug-loaded matrix is placed in a sterile environment for solidification and forming, cut and then sealed and packaged with an anti-permeable aluminum foil bag, and obtained as a finished product after electron beam irradiation sterilization treatment.
3. The formula of a traditional Chinese medicine patch for warming the kidney and consolidating the primordial qi according to claim 1, characterized in that: In step S1, first, the salt-processed aconite root is subjected to traditional salt curing treatment, impregnated with a 20% concentration of crude salt solution for 72 hours, and turned three times a day during the period to ensure uniform penetration; the cistanche deserticola needs to go through nine cycles of steaming and sunning processes, each steaming temperature is 100°C for 2 hours, and the sunning condition is to be spread out and dried in the dark at a temperature below 35°C until the water content is lower than 8%; the hippocampus raw material is extracted by supercritical carbon dioxide extraction, the extraction pressure is set at 35 MPa, the temperature is 45°C, and the fat-soluble active ingredients are collected after dynamic extraction for 3 hours; finally, the above-treated raw materials are jointly put into a nano-level air-flow pulverizer, and the pulverization particle size is controlled within the range of 200-300 nanometers to obtain a homogenized mixed drug powder.
4. The formula of a traditional Chinese medicine plaster for warming the kidney and strengthening the primordial qi according to claim 1, characterized in that: In step S2, the oyster shells need to be calcined in a high-temperature calciner at 1250 °C for 4 hours. After generating grayish-white oxides, they are immediately transferred to an inert gas environment for cooling, and then ground to an average particle size of 3 microns using a planetary ball mill; the dodder seeds are placed in a circulating hot air oven at 60 °C for low-temperature roasting for 6 hours, and after being crushed, they are sieved through a 200-mesh stainless steel sieve; the Qinghai-Tibet rock salt crystals are processed by an ultrafine grinder to a particle size of less than 10 microns. The three materials are put into a three-dimensional conical mixer according to a preset ratio and mixed at 15 revolutions per minute for 1 hour until they are uniform.
5. The formula of a traditional Chinese medicine plaster for warming the kidney and strengthening the primordial qi according to claim 1, characterized in that: In step S3, the refined cinnamon oil and soy lecithin are mixed at a mass ratio of 1:3 and dissolved in absolute ethanol to form a solution system; under the condition of a constant temperature water bath at 50 °C, a rotary evaporator is used to slowly remove the organic solvent at a rotation speed of 120 rpm. At the same time, phosphate buffer solution is injected into the liquid phase, and a liposome encapsulation structure with a particle size of 80-100 nm is formed by the thin film hydration method; finally, the encapsulation efficiency is detected by a dynamic light scattering instrument to ensure that the loading rate of the core components is not less than 85%.
6. The formula of a traditional Chinese medicine patch for warming the kidney and consolidating the primordial qi according to claim 1, characterized in that: In step S4, nano-scale graphene powder and thermoplastic polyurethane are mixed at a mass ratio of 1:4 and placed in a twin-screw extruder for melt blending at 180 °C; after the melt is extruded through a porous die, it is quickly cooled to -20 °C for shaping to form a porous matrix sheet with a pore size of 50-80 microns; the sheet is cut into a standard size of 4 cm × 6 cm using a laser cutting machine, and the surface is treated by plasma to enhance the drug attachment performance.
7. The formula of a traditional Chinese medicine patch for warming the kidney and strengthening the primordial qi according to claim 1, characterized in that: In step S5, the freeze-dried powder of Antarctic krill and the aqueous extract of cynomorium songaricum are redissolved at a ratio of 1:2, and a carbon quantum dot suspension is added for surface modification; in a pH 7.4 buffer system, the quantum dots and polysaccharide molecules are combined by electrostatic self-assembly technology to form a labeled complex with a particle size of about 15 nm; After the composite solution is sterilized by a 0.22 μm filter membrane, it is stored in a low-temperature refrigerator for later use.
8. The formulation of a traditional Chinese medicine patch for warming the kidney and consolidating the primordial qi according to claim 1, characterized in that: In step S6, the powder of the monarch drug group, the mixed powder of the ministerial drug group, the liposome encapsulation and the quantum dot labeling solution prepared in the previous process are put into a three-dimensional motion mixer according to the formula ratio; the temperature of the mixing chamber is set at 25 °C and the relative humidity is 40%, and three-dimensional tumbling mixing is carried out at 30 revolutions per minute for 40 minutes; the end point of mixing is monitored online by near-infrared spectroscopy to ensure that the coefficient of variation of the distribution uniformity of each component is less than 5%.
9. The formulation of a traditional Chinese medicine patch for warming the kidney and strengthening the primordial qi according to claim 1, characterized in that: In step S7, the biocompatible hydrogel substrate is melted into a viscous fluid in a constant temperature bath at 45 °C, and the mixed drug powder is gradually fed at a ratio of 35 g of mixed drug powder per 100 g of substrate; a high-shear emulsifier is used to stir at a rotation speed of 8000 rpm for 20 minutes to form a uniform ointment, which is then injected into the preheated graphene matrix; the drug loading thickness is controlled at 0.8 mm by a precision coater, and the online weighing system is used to ensure that the drug loading amount per unit area error does not exceed ±2%.
10. The formulation of a traditional Chinese medicine patch for warming the kidney and consolidating the primordial qi according to claim 1, characterized in that: In the step S8, the drug-loaded matrix is left standing and solidified for 12 hours in a sterile environment with a cleanliness of 10,000 class. The environmental temperature is controlled at 22±2°C, and the relative humidity is 50±5%. After solidification, it is cut into finished patches by an ultrasonic slitter, and the size error of a single patch does not exceed ±0.3 mm. After being vacuum packaged in a composite aluminum foil bag, it is sterilized by electron beam irradiation with a dose of 10 kGy. The final product is stored in a cool and dry place below 25°C.