Traditional Chinese medicine nano-tablet for targeting pleural tumor and preparation process of traditional Chinese medicine nano-tablet
By combining traditional Chinese medicine ingredients with nanotechnology, we have developed traditional Chinese medicine nanoparticles that target pleural tumors. This has solved the problems of low drug utilization and poor targeting in the treatment of pleural tumors using traditional Chinese medicine preparations. It has achieved specific enrichment of drugs in the pleural region and multi-target anti-tumor effects, thus improving the therapeutic effect.
Patent Information
- Application Number
- CN202511743297.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-11-25
- Publication Date
- 2026-01-23
AI Technical Summary
Traditional Chinese medicine preparations suffer from problems such as low drug utilization, poor targeting, and unstable efficacy when treating pleural tumors, making it difficult to effectively penetrate the lesion area.
Combining traditional Chinese medicine ingredients with nanotechnology, a traditional Chinese medicine nanoparticle targeting pleural tumors was developed. The nanoparticle uses a PLGA and NLC composite nanocarrier, combined with succinyl chitosan, a tumor microenvironment responsive material, to achieve targeted drug delivery through the EPR effect of nanoparticles, and utilizes the guiding effect of the guiding drug to enhance the accumulation of the drug in the pleural region.
It achieves specific enrichment of drugs in the pleura, increases local drug concentration, enhances bioavailability, and inhibits tumor cell proliferation and metastasis through multi-target action, regulates the tumor immune microenvironment, and improves treatment efficacy.
Smart Images
Figure CN121371099A_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine nanoparticle targeting pleural tumors and its preparation process. Background Technology
[0002] Pleural tumors are malignant tumors originating in or metastasizing to the pleura, with malignant pleural mesothelioma (MPM) being the most common. Pleural mesothelioma is difficult to diagnose, and most patients are already at an advanced stage at initial diagnosis, resulting in limited treatment options and unsatisfactory clinical outcomes. Current conventional treatments include surgical resection, radiotherapy, and chemotherapy, but the effects are not ideal. The efficacy of pemetrexed combined with platinum-based chemotherapy as a first-line treatment has limitations; the "dual immunotherapy" approved in recent years has also failed to achieve significant breakthroughs. One important reason is that MPM has a complex tumor immune microenvironment, exhibiting a "cold tumor" immune state, and the physical barrier formed by pleural thickening makes it difficult for drugs to effectively penetrate the lesion area.
[0003] Traditional Chinese medicine (TCM) possesses unique advantages in cancer treatment, particularly in its significant effects on overall regulation, reducing toxicity, and enhancing efficacy. However, traditional TCM formulas suffer from drawbacks such as low dissolution rate of active ingredients, low bioavailability, lack of targeted delivery, and large dosages. Furthermore, traditional decoctions or pill / powder formulations struggle to achieve targeted drug delivery to the pleura, resulting in insufficient drug concentrations at the lesion site and impacting therapeutic efficacy.
[0004] In recent years, the development of nanotechnology has provided new ideas for the modernization of traditional Chinese medicine. Studies have shown that nanocarrier systems can improve drug solubility and stability, enhance bioavailability, and achieve targeted delivery by enhancing penetration and retention effects. Particularly in the treatment of pleural mesothelioma, research has reported that selenium nanomaterials can enhance NK cell-mediated cytotoxicity and inhibit pleural mesothelioma cell growth through the TrxR1-pSTAT3 signaling pathway. Furthermore, novel nanofluidic technologies have also opened up possibilities for targeted drug delivery to internal organs.
[0005] Based on the above background, this invention combines traditional Chinese medicine theory with modern nanotechnology to develop a Chinese medicine nanoparticle with targeted function. Summary of the Invention
[0006] The purpose of this invention is to provide a traditional Chinese medicine nanoparticle targeting pleural tumors and its preparation process, thereby solving the problems of low drug utilization, poor targeting, and unstable efficacy of traditional Chinese medicine preparations in the treatment of pleural tumors.
[0007] The above-mentioned technical objective of the present invention is achieved through the following technical solution: A traditional Chinese medicine nanoparticle targeting pleural tumors, the traditional Chinese medicine nanoparticle comprising the following components: Agrimonia pilosa, Asparagus cochinchinensis, Hedyotis diffusa, Scutellaria barbata, Astragalus membranaceus, Panax notoginseng, Prunella vulgaris, Scrophularia ningpoensis, Lithospermum erythrorhizon, Trichosanthes kirilowii, Eupolyphaga sinensis, Glycyrrhiza uralensis, Sparganium stoloniferum, Curcuma zedoaria, Eupolyphaga sinensis, Scolopendra subspinipes, and Bungarus fasciatus.
[0008] More preferably, the traditional Chinese medicine nanoparticles comprise the following components: Agrimonia pilosa 15-25 parts, Asparagus cochinchinensis 15-25 parts, Hedyotis diffusa 25-35 parts, Scutellaria barbata 25-35 parts, Astragalus membranaceus 25-35 parts, Panax notoginseng 12-18 parts, Pheretima aspergillum 12-18 parts, Prunella vulgaris 15-25 parts, Scrophularia ningpoensis 15-25 parts, Lithospermum erythrorhizon 12-18 parts, Trichosanthes kirilowii 8-12 parts, Eupolyphaga sinensis 7-11 parts, Glycyrrhiza uralensis 4-8 parts, Sparganium stoloniferum 8-12 parts, Curcuma zedoaria 8-12 parts, Eupolyphaga sinensis 8-12 parts, Scolopendra subspinipes 3-9 parts, and Bungarus fasciatus 3-9 parts.
[0009] More preferably, the traditional Chinese medicine nanoparticles comprise the following components: 20 parts Agrimonia pilosa, 20 parts Asparagus cochinchinensis, 30 parts Hedyotis diffusa, 30 parts Scutellaria barbata, 30 parts Astragalus membranaceus, 15 parts Poria cocos, 15 parts Pheretima aspergillum, 20 parts Prunella vulgaris, 20 parts Scrophularia ningpoensis, 15 parts Lithospermum erythrorhizon, 10 parts Trichosanthes kirilowii, 9 parts Eupolyphaga sinensis, 6 parts Glycyrrhiza uralensis, 10 parts Sparganium stoloniferum, 10 parts Curcuma zedoaria, 10 parts Eupolyphaga sinensis, 6 parts Scolopendra subspinipes, and 6 parts Bungarus fasciatus.
[0010] More preferably, the traditional Chinese medicine nanotablets further include a nanocarrier material, which is a composite system of polylactic acid-glycolic acid copolymer (PLGA) and nanostructured lipid carrier (NLC), with a weight ratio of PLGA:NLC = 1:2-1:4.
[0011] More preferably, the traditional Chinese medicine nanotablets also contain tumor microenvironment responsive materials, wherein the tumor microenvironment responsive material is succinyl chitosan, and its content in the tablets is 3%-5% (w / w).
[0012] This invention also provides a preparation process for traditional Chinese medicine nanoparticles targeting pleural tumors, comprising the following steps: S1. Extraction of Traditional Chinese Medicine Composition: Weigh each medicinal material according to the formula ratio and clean it to remove impurities. Crush the plant-based medicinal materials into coarse powder and pass through a 20-mesh sieve; crush the animal-based medicinal materials separately into fine powder and pass through an 80-mesh sieve. Use a graded extraction process. First, steam distill the volatile oil from the plant-based medicinal materials containing volatile components. The remaining residue is then extracted together with other plant-based medicinal materials using an alcohol-water double extraction method. After concentration, a traditional Chinese medicine extract is obtained. Add the fine powder of the animal-based medicinal materials to an acidic aqueous solution and extract at 90°C for 2 hours. Filter and collect the extract. Add 4 times the amount of water to the residue and extract for 1 hour. Combine the two extracts and concentrate to 1 / 5 of the original volume. S2. Construction of nano-drug delivery system: Extracts of traditional Chinese medicine and nano-carrier materials were prepared into nanoparticles by thin film ultrasonic-high pressure homogenization method, with the particle size controlled at 100-200 nanometers. S3. Targeted modification of guiding herbs: Nine-fragrant insects and moxa pearls were used to prepare guiding herb extracts, and then processed by nanoemulsification technology to obtain guiding herb nanoemulsions. S4. Formulation: The above nanoparticles are mixed with the guiding drug nanoemulsion and appropriate excipients, and tablets are made using dry granulation and tableting technology; the above targeted nanoparticles are further processed into enteric-coated tablets, lyophilized powder injections or enteric-coated microcapsules.
[0013] More preferably, step S2 includes the following steps: S2.1 Preparation of nanocarrier materials: Polylactic acid-glycolic acid copolymer (PLGA) and nanostructured lipid carrier (NLC) are mixed in a weight ratio, and an appropriate amount of dichloromethane is added to dissolve them as the oil phase; S2.2 Preparation of aqueous phase: Combine the above alcohol extract, water extract and animal drug extract, add 0.5% (w / v) of poloxamer 188 as emulsifier, and ultrasonically disperse evenly to form the aqueous phase; S2.3, Initial emulsion formation: Under ice bath conditions, the oil phase is slowly added dropwise to the aqueous phase (water phase to oil phase volume ratio 3:1), and emulsified for 3 minutes at 10,000 rpm using a high-speed shear emulsifier to form an initial emulsion; S2.4 High-pressure homogenization: The colostrum is passed through a high-pressure homogenizer and circulated 5 times at a pressure of 800 bar to obtain nanoemulsion with a particle size distribution of 100-200 nanometers; S2.5, Encapsulation of volatile oil: The volatile oil collected in the first step is encapsulated with α-cyclodextrin in a ratio of 1:8 to form an inclusion complex, which is then mixed with the above nanoemulsion.
[0014] More preferably, the tablet in S4 has a multi-layer structure, with the inner layer being a mixture of nanoparticles and transdermal drug nanoemulsion, and the outer layer being a pH-sensitive coating material to ensure drug release in a specific pH environment in the intestine.
[0015] More preferably, step S4 includes the following steps: S4.1, Preparation of excipients: Take 25% microcrystalline cellulose, 5% croscarmellose sodium cellulose, and 1% silica as fillers and disintegrants; S4.2 Mixing: The nanopowder obtained by spray drying of the nano-drug delivery system is mixed evenly with the guiding drug nanoemulsion and excipients in an equal incremental manner; S4.3 Granulation: The mixed powder is pressed into dense flakes using a dry granulator, and then crushed and granulated to obtain 20-40 mesh particles; S4.4 Tableting: Add 0.5% magnesium stearate as a lubricant to the granules, mix evenly, and compress into tablet cores using a rotary tablet press; S4.5 Coating: The tablet core is coated with pH-sensitive coating material (Utec L100-55), and the coating weight gain is 3% of the tablet core weight.
[0016] In summary, the present invention has the following beneficial effects: Firstly, this invention has strong targeting: through the guiding effect of the drug and the EPR effect of nanoparticles, the drug is specifically enriched in the pleura, thereby increasing the local drug concentration.
[0017] Secondly, the present invention has high bioavailability: the nano-formulation improves the solubility and stability of poorly soluble drugs and promotes gastrointestinal absorption.
[0018] Thirdly, this invention has an immunomodulatory effect: the active ingredients in the formula can regulate the tumor immune microenvironment, transforming "cold tumors" into "hot tumors" and enhancing the effect of immunotherapy.
[0019] Fourth, this invention can fight tumors through multiple pathways: by the multi-target action of various active ingredients, it can simultaneously inhibit tumor cell proliferation, invasion and metastasis, and induce tumor cell apoptosis. Attached Figure Description
[0020] Figure 1 This is a flowchart of the preparation process in this invention. Detailed Implementation
[0021] The present invention will be further described in detail below with reference to the accompanying drawings.
[0022] Example 1: A traditional Chinese medicine nanoparticle targeting pleural tumors, the traditional Chinese medicine nanoparticle comprising the following components: 15 parts Agrimonia pilosa, 15 parts Asparagus cochinchinensis, 25 parts Hedyotis diffusa, 25 parts Scutellaria barbata, 25 parts Astragalus membranaceus, 12 parts Poria cocos, 12 parts Pheretima aspergillum, 15 parts Prunella vulgaris, 15 parts Scrophularia ningpoensis, 12 parts Lithospermum erythrorhizon, 8 parts Trichosanthes kirilowii, 7 parts Eupolyphaga sinensis, 4 parts Glycyrrhiza uralensis, 8 parts Sparganium stoloniferum, 8 parts Curcuma zedoaria, 8 parts Eupolyphaga sinensis, 3 parts Scolopendra subspinipes, and 3 parts Bungarus fasciatus.
[0023] Among them, the traditional Chinese medicine nanotablets also include nanocarrier materials, which are composite systems of polylactic acid-glycolic acid copolymer (PLGA) and nanostructured lipid carrier (NLC) with a weight ratio of PLGA:NLC=1:2.
[0024] Tumor microenvironment responsive material, wherein the tumor microenvironment responsive material is succinyl chitosan, and its content in the tablet is 3% (w / w).
[0025] A preparation process for a traditional Chinese medicine nanoparticle targeting pleural tumors, such as... Figure 1 As shown, it includes the following steps: S1. Extraction of Traditional Chinese Medicine Composition: Weigh each medicinal material according to the formula ratio and clean it to remove impurities. Crush the plant-based medicinal materials into coarse powder and pass through a 20-mesh sieve; crush the animal-based medicinal materials separately into fine powder and pass through an 80-mesh sieve. Use a graded extraction process. First, steam distill the volatile oil from the plant-based medicinal materials containing volatile components. The remaining residue is then extracted together with other plant-based medicinal materials using an alcohol-water double extraction method. After concentration, a traditional Chinese medicine extract is obtained. Add the fine powder of the animal-based medicinal materials to an acidic aqueous solution and extract at 90°C for 2 hours. Filter and collect the extract. Add 4 times the amount of water to the residue and extract for 1 hour. Combine the two extracts and concentrate to 1 / 5 of the original volume. Among them, volatile oil extraction involves placing medicinal materials containing volatile components in a multi-functional extraction tank, adding 10 times the amount of water, and extracting volatile oil using steam distillation for 4 hours, then collecting the volatile oil for later use.
[0026] The alcohol extraction process involves mixing the residue after extracting the volatile oil with herbs such as Agrimonia pilosa, Asparagus cochinchinensis, Scrophularia ningpoensis, and Astragalus membranaceus, adding 8 times the amount of 70% ethanol, heating and refluxing twice for 1.5 hours each time, combining the ethanol extracts, recovering the ethanol under reduced pressure, and concentrating to an extract with a relative density of 1.15-1.20 (60℃).
[0027] The water extraction process involves adding 10 times the amount of water to the residue after alcohol extraction, decocting it twice, 1.5 hours each time, combining the decoctions, filtering, and concentrating it to an extract with a relative density of 1.10-1.15 (60℃).
[0028] S2. Construction of nano-drug delivery system: Extracts of traditional Chinese medicine and nano-carrier materials were prepared into nanoparticles by thin film ultrasonic-high pressure homogenization method, with the particle size controlled at 100-200 nanometers.
[0029] S2.1 Preparation of nanocarrier materials: Polylactic acid-glycolic acid copolymer (PLGA) and nanostructured lipid carrier (NLC) are mixed in a weight ratio, and an appropriate amount of dichloromethane is added to dissolve them as the oil phase.
[0030] S2.2 Preparation of aqueous phase: Combine the above alcohol extract, water extract and animal drug extract, add 0.5% (w / v) of poloxamer 188 as an emulsifier, and ultrasonically disperse evenly to form the aqueous phase.
[0031] S2.3, Initial Emulsion Formation: Under ice bath conditions, the oil phase is slowly added dropwise to the aqueous phase (water phase to oil phase volume ratio 3:1), and emulsified for 3 minutes at 10,000 rpm using a high-speed shear emulsifier to form the initial emulsion.
[0032] S2.4 High-pressure homogenization: The colostrum is passed through a high-pressure homogenizer and circulated 5 times at a pressure of 800 bar to obtain nanoemulsion with a particle size distribution of 100-200 nanometers.
[0033] S2.5, Encapsulation of volatile oil: The volatile oil collected in the first step is encapsulated with α-cyclodextrin in a ratio of 1:8 to form an inclusion complex, which is then mixed with the above nanoemulsion.
[0034] S3. Targeted modification of guiding herbs: Nine-fragrant insects and moxa pearls were used to prepare guiding herb extracts, and then processed by nanoemulsification technology to obtain guiding herb nanoemulsions. S4. Formulation: The above nanoparticles are mixed with the guiding drug nanoemulsion and appropriate excipients, and tablets are made using dry granulation and tableting technology; the above targeted nanoparticles are further processed into enteric-coated tablets, lyophilized powder injections or enteric-coated microcapsules.
[0035] The tablets in S4 have a multi-layer structure, with an inner layer consisting of a mixture of nanoparticles and a transdermal drug nanoemulsion, and an outer layer consisting of a pH-sensitive coating material to ensure drug release in a specific pH environment in the intestine.
[0036] S4.1 Preparation of excipients: Take 25% microcrystalline cellulose, 5% croscarmellose sodium cellulose, and 1% silica as fillers and disintegrants.
[0037] S4.2 Mixing: The nanopowder obtained by spray drying of the nano-drug delivery system is mixed evenly with the guiding drug nanoemulsion and excipients in an equal incremental manner.
[0038] S4.3 Granulation: The mixed powder is pressed into dense flakes using a dry granulator, and then crushed and granulated to obtain 20-40 mesh particles.
[0039] S4.4 Tableting: Add 0.5% magnesium stearate as a lubricant to the granules, mix evenly, and compress into tablet cores using a rotary tablet press.
[0040] S4.5 Coating: The tablet core is coated with pH-sensitive coating material (Utec L100-55), and the coating weight gain is 3% of the tablet core weight.
[0041] Example 2: The parts that are the same as in the previous example will not be repeated. The difference is that the traditional Chinese medicine nano-tablets include the following components: Agrimonia pilosa 20 parts, Asparagus cochinchinensis 20 parts, Hedyotis diffusa 30 parts, Scutellaria barbata 30 parts, Astragalus membranaceus 30 parts, Panax notoginseng 15 parts, Pheretima aspergillum 15 parts, Prunella vulgaris 20 parts, Scrophularia ningpoensis 20 parts, Lithospermum erythrorhizon 15 parts, Trichosanthes kirilowii 10 parts, Eupolyphaga sinensis 9 parts, Glycyrrhiza uralensis 6 parts, Sparganium stoloniferum 10 parts, Curcuma zedoaria 10 parts, Eupolyphaga sinensis 10 parts, Scolopendra subspinipes 6 parts, and Bungarus fasciatus 6 parts.
[0042] The weight ratio of the composite system of polylactic acid-glycolic acid copolymer (PLGA) and nanostructured lipid carrier (NLC) is PLGA:NLC=1:3.
[0043] The content of succinyl chitosan in the tablets is 4% (w / w).
[0044] Example 3: The parts that are the same as in the previous examples will not be repeated. The difference is that the traditional Chinese medicine nano-tablets include the following components: Agrimonia pilosa 25 parts, Asparagus cochinchinensis 25 parts, Hedyotis diffusa 35 parts, Scutellaria barbata 35 parts, Astragalus membranaceus 35 parts, Panax notoginseng 18 parts, Pheretima aspergillum 18 parts, Prunella vulgaris 25 parts, Scrophularia ningpoensis 25 parts, Lithospermum erythrorhizon 18 parts, Trichosanthes kirilowii 12 parts, Eupolyphaga sinensis 11 parts, Glycyrrhiza uralensis 8 parts, Sparganium stoloniferum 12 parts, Curcuma zedoaria 12 parts, Eupolyphaga sinensis 12 parts, Scolopendra subspinipes 9 parts, and Bungarus fasciatus 9 parts.
[0045] The weight ratio of the composite system of polylactic acid-glycolic acid copolymer (PLGA) and nanostructured lipid carrier (NLC) is PLGA:NLC=1:4.
[0046] The content of succinyl chitosan in the tablets is 5% (w / w).
[0047] Example 4: Effect Verification To verify the efficacy of this invention, in vitro and in vivo experimental studies were conducted: In vitro experiments: The human pleural mesothelioma cell line NCI-H2052 was used for MTT assay. The results showed that the IC50 value of the extract of the traditional Chinese medicine nanoparticles of this invention was 125 μg / mL at 48 hours, which was significantly lower than that of the traditional decoction extract (IC50 value of 285 μg / mL).
[0048] In vivo experiments: A mouse model of pleural mesothelioma was established, and mice were randomly divided into a model group, a traditional decoction group, and a nanoparticle group of this invention. The results showed that the nanoparticle group exhibited a 68.5% inhibition rate of pleural tumor weight, significantly higher than the traditional decoction group (42.3%). In vivo small animal imaging further confirmed that the drug concentration in the pleura of the nanoparticle group was 3.2 times that of the traditional decoction group.
[0049] The above experimental results show that the traditional Chinese medicine nanoparticles provided by this invention have significant targeting and anti-pleural tumor activity.
[0050] This specific embodiment is merely an explanation of the present invention and is not intended to limit the invention. After reading this specification, those skilled in the art can make modifications to this embodiment without contributing any inventive step, but such modifications are protected by patent law as long as they are within the scope of the claims of the present invention.
Claims
1. A traditional Chinese medicine nanoparticle targeting pleural tumors, characterized in that, The traditional Chinese medicine nanoparticles comprise the following components: Agrimonia pilosa, Asparagus cochinchinensis, Hedyotis diffusa, Scutellaria barbata, Astragalus membranaceus, Panax notoginseng, Prunella vulgaris, Scrophularia ningpoensis, Lithospermum erythrorhizon, Trichosanthes kirilowii, Eupolyphaga sinensis, Glycyrrhiza uralensis, Sparganium stoloniferum, Curcuma zedoaria, Eupolyphaga sinensis, Scolopendra subspinipes, and Bungarus fasciatus.
2. The traditional Chinese medicine nanoparticle targeting pleural tumors according to claim 1, characterized in that, The traditional Chinese medicine nanoparticles comprise the following components: Agrimonia pilosa 15-25 parts, Asparagus cochinchinensis 15-25 parts, Hedyotis diffusa 25-35 parts, Scutellaria barbata 25-35 parts, Astragalus membranaceus 25-35 parts, Panax quinquefolius 12-18 parts, Pheretima aspergillum 12-18 parts, Prunella vulgaris 15-25 parts, Scrophularia ningpoensis 15-25 parts, Lithospermum erythrorhizon 12-18 parts, Trichosanthes kirilowii 8-12 parts, Eupolyphaga sinensis 7-11 parts, Glycyrrhiza uralensis 4-8 parts, Sparganium stoloniferum 8-12 parts, Curcuma zedoaria 8-12 parts, Eupolyphaga sinensis 8-12 parts, Scolopendra subspinipes 3-9 parts, and Bungarus fasciatus 3-9 parts.
3. The traditional Chinese medicine nanoparticles targeting pleural tumors according to claim 2, characterized in that, The traditional Chinese medicine nano-tablets comprise the following components: 20 parts Agrimonia pilosa, 20 parts Asparagus cochinchinensis, 30 parts Hedyotis diffusa, 30 parts Scutellaria barbata, 30 parts Astragalus membranaceus, 15 parts Poria cocos, 15 parts Pheretima aspergillum, 20 parts Prunella vulgaris, 20 parts Scrophularia ningpoensis, 15 parts Lithospermum erythrorhizon, 10 parts Trichosanthes kirilowii, 9 parts Eupolyphaga sinensis, 6 parts Glycyrrhiza uralensis, 10 parts Sparganium stoloniferum, 10 parts Curcuma zedoaria, 10 parts Eupolyphaga sinensis, 6 parts Scolopendra subspinipes, and 6 parts Bungarus fasciatus.
4. The traditional Chinese medicine nanoparticle for targeting pleural tumors according to claim 3, characterized in that, The traditional Chinese medicine nanotablets also include nanocarrier materials, which are composite systems of polylactic acid-glycolic acid copolymer (PLGA) and nanostructured lipid carrier (NLC), with a weight ratio of PLGA:NLC = 1:2-1:
4.
5. The traditional Chinese medicine nanoparticle for targeting pleural tumors according to claim 4, characterized in that, The traditional Chinese medicine nanoparticles also contain tumor microenvironment responsive materials, namely succinyl chitosan, which has a content of 3%-5% (w / w) in the tablets.
6. The preparation process of a traditional Chinese medicine nanoparticle targeting pleural tumors according to claim 5, characterized in that, Includes the following steps: S1. Extraction of Traditional Chinese Medicine Composition: Weigh each medicinal material according to the formula ratio and clean it to remove impurities. Crush the plant-based medicinal materials into coarse powder and pass through a 20-mesh sieve; crush the animal-based medicinal materials separately into fine powder and pass through an 80-mesh sieve. Use a graded extraction process. First, use steam distillation to extract the volatile oil from the plant-based medicinal materials containing volatile components. The remaining residue is then extracted together with other plant-based medicinal materials using a double extraction method with alcohol and water. After concentration, a traditional Chinese medicine extract is obtained. Add the fine powder of the animal-based medicinal materials to an acidic aqueous solution and extract at 90°C for 2 hours. Filter and collect the extract. Add 4 times the amount of water to the residue and extract for 1 hour. Combine the two extracts and concentrate to 1 / 5 of the original volume. S2. Construction of nano-drug delivery system: Extracts of traditional Chinese medicine and nano-carrier materials were prepared into nanoparticles by thin film ultrasonic-high pressure homogenization method, with the particle size controlled at 100-200 nanometers. S3. Targeted modification of guiding herbs: Nine-fragrant insects and moxa pearls were used to prepare guiding herb extracts, and then processed by nanoemulsification technology to obtain guiding herb nanoemulsions. S4. Formulation: The above nanoparticles are mixed with the guiding drug nanoemulsion and appropriate excipients, and tablets are made using dry granulation and tableting technology; the above targeted nanoparticles are further processed into enteric-coated tablets, lyophilized powder injections or enteric-coated microcapsules.
7. The preparation process of a traditional Chinese medicine nanoparticle targeting pleural tumors according to claim 6, characterized in that, S2 includes the following steps: S2.1 Preparation of nanocarrier materials: Polylactic acid-glycolic acid copolymer (PLGA) and nanostructured lipid carrier (NLC) are mixed in a weight ratio, and an appropriate amount of dichloromethane is added to dissolve them as the oil phase; S2.2 Preparation of aqueous phase: Combine the above alcohol extract, water extract and animal drug extract, add 0.5% (w / v) of poloxamer 188 as emulsifier, and ultrasonically disperse evenly to form the aqueous phase; S2.3, Initial emulsion formation: Under ice bath conditions, the oil phase is slowly added dropwise to the aqueous phase (water phase to oil phase volume ratio 3:1), and emulsified for 3 minutes at 10,000 rpm using a high-speed shear emulsifier to form an initial emulsion; S2.4 High-pressure homogenization: The colostrum is passed through a high-pressure homogenizer and circulated 5 times at a pressure of 800 bar to obtain nanoemulsion with a particle size distribution of 100-200 nanometers; S2.5, Encapsulation of volatile oil: The volatile oil collected in the first step is encapsulated with α-cyclodextrin in a ratio of 1:8 to form an inclusion complex, which is then mixed with the above nanoemulsion.
8. The preparation process of a traditional Chinese medicine nanoparticle targeting pleural tumors according to claim 7, characterized in that: The tablets in S4 have a multi-layer structure, with an inner layer consisting of a mixture of nanoparticles and a transdermal drug nanoemulsion, and an outer layer consisting of a pH-sensitive coating material to ensure drug release in a specific pH environment in the intestine.
9. The preparation process of a traditional Chinese medicine nanoparticle targeting pleural tumors according to claim 8, characterized in that, S4 includes the following steps S4.1 Preparation of excipients: Take 25% microcrystalline cellulose, 5% croscarmellose sodium cellulose, and 1% silica as fillers and disintegrants; S4.2 Mixing: The nanopowder obtained by spray drying of the nano-drug delivery system is mixed evenly with the guiding drug nanoemulsion and excipients in an equal incremental manner; S4.3 Granulation: The mixed powder is pressed into dense flakes using a dry granulator, and then crushed and granulated to obtain 20-40 mesh particles; S4.4 Tableting: Add 0.5% magnesium stearate as a lubricant to the granules, mix evenly, and compress into tablet cores using a rotary tablet press; S4.5 Coating: The tablet core is coated with pH-sensitive coating material (Utec L100-55), and the coating weight gain is 3% of the tablet core weight.