A medicinal ink for preventing or treating lung nodules, its preparation method and application

Abstract

The present invention provides a medicated ink for preventing or treating pulmonary nodules, a preparation method thereof, and an application thereof. Preparation method of the medicated ink: S1. Chuanxiong (Rhizoma Chuanxiong), lotus node, safflower, small thistle, large thistle, Imperata cylindrica Beauv., Prunella vulgaris L., Cortex Moutan, and cloves are pulverized, soaked in water and then subjected to steam distillation, and the filtrate is collected. The filter residue is fermented with a complex enzyme, the enzyme is inactivated, and percolation extraction is carried out. The percolate is combined with the filtrate, mixed with β-glucan, and concentrated into a thick paste A; S2. Cornu Saigae Tataricae, artificial musk, borneol, pearl, bufotoxin, artificial bezoar, and cinnabar are pulverized, soaked in ethanol and subjected to ultrasonic extraction, filtered, the filter residue is added with ethanol for ultrasonic extraction, the filtrates are combined, and concentrated into a thick paste B; S3. Ox bile, artificial bear bile, snake bile, pig bile, and black carp bile are broken to obtain a mixed bile, mixed with α-glucanase and alginate, centrifuged, and the supernatant is freeze-dried to obtain bile powder; S4. The thick paste A, thick paste B, and bile powder are stirred and mixed with concentrated powder of buffalo horn, xanthan gum, and tung oil fume, and pressed into shape to obtain the medicated ink.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and particularly relates to a medicated ink for preventing or treating pulmonary nodules, a preparation method thereof, and an application thereof. Background Art

[0002] Due to reasons such as environmental pollution in living environment and irregular living patterns, the qi mechanism of the human body is disordered, or the lungs are damaged due to excessive smoking and drinking, etc. Moisture accumulates into phlegm, qi and blood are blocked, and they coagulate into stasis, staying in the lung collaterals, thus forming "lung accumulation" (pulmonary nodules or small tumors). Pulmonary nodules are focal, round, solid or subsolid pulmonary shadows with increased density and a diameter ≤ 3 cm that appear during CT scans. Modern research believes that pulmonary nodules are mostly chronic inflammatory granulomas, tumor-like hyperplasia, or lung tumors, etc., and are closely related to lung cancer. In recent years, the mortality rate of lung cancer has risen rapidly and ranks first among the causes of death from various cancers. After the discovery of pulmonary nodules, early intervention can, to a certain extent, maintain or reduce the size of benign pulmonary nodules, eliminate and control the development of pulmonary nodule disease, and has a positive significance for reducing or preventing the occurrence or malignancy of lung tumors. Currently, for some drugs used to regulate or treat pulmonary nodules, the treatment measures of Western medicine for pulmonary nodules are limited, and patients often cannot receive effective treatment, and it is easy to form a vicious cycle in the later stage. Traditional Chinese medicine treats pulmonary nodules through multiple channels and multiple targets, but there are still some problems in the current traditional Chinese medicine treatment, such as large loss of active ingredients, unstable drug efficacy, slow onset, short shelf life, and unsatisfactory effect, which limit its development. Medicated ink is composed of ingredients such as concentrated powder of buffalo horn, antelope horn, musk, borneol, etc., and has a long history of use. It has the effects of promoting blood circulation to relieve pain, cooling blood to stop bleeding, antiseptic and astringent, etc., and also has the effect of inhibiting inflammatory factors. There is no report on using medicated ink for preventing or treating pulmonary nodules. Summary of the Invention

[0003] In view of this, the present invention provides a medicated ink for preventing or treating pulmonary nodules, a preparation method thereof, and an application thereof. The medicated ink of the present invention can better retain the active ingredients in the raw materials, has high stability, a relatively fast onset, and a good effect. [[ID=IS]]

[0004] The technical solution of the present invention is realized as follows:

[0005] A preparation method of a medicated ink for preventing or treating pulmonary nodules, comprising the following steps:

[0006] S1. Crush Chuanxiong, lotus node, safflower, small thistle, large thistle, Imperata cylindrica, Prunella vulgaris, Cortex Moutan, and cloves into a mixed powder A, add water to soak, then perform steam distillation, filter, collect the filtrate, add a complex enzyme to the filter residue for fermentation, inactivate the enzyme, perform percolation extraction, combine the percolate with the filtrate, add β-glucan and stir evenly to obtain a mixed liquid A, and concentrate it into a thick paste A;

[0007] S2. Grind antelope horn, artificial musk, borneol, pearl, bufotoxin, artificial bezoar, and cinnabar into a mixed powder B, then add an ethanol solution for soaking, ultrasonic extraction, filtration. Take the filter residue and add an ethanol solution for ultrasonic extraction again. Combine all the filtrates and concentrate them into a thick paste B.

[0008] S3. After breaking the gallbladders of ox bile, artificial bear bile, snake bile, pig bile, and black carp bile respectively, collect the bile and mix them to obtain a mixed bile. Add α-glucanase and alginate to the mixed bile, stir and mix, centrifuge, and take the supernatant for freeze-drying to obtain bile powder.

[0009] S4. Stir and mix the thick paste A, thick paste B, and bile powder obtained above with concentrated water buffalo horn powder, xanthan gum, and tung oil fume, and press them into shape to obtain the medicated ink for preventing or treating lung nodules.

[0010] Further, in step S1, the particle size of the mixed powder A is 40 - 60 mesh; the ratio of the mixed powder A to the water-based liquid is 1:5 - 6 g / mL; the soaking temperature is 40 - 50 °C and the time is 2 - 4 h; the composite enzyme includes cellulase, papain, and pectinase with a mass ratio of (3 - 4):(0.5 - 1):(1 - 2); the addition amount of β-glucan is 4 - 6% of the mass of the mixed liquid A.

[0011] Further, in step S1, the steam distillation is carried out at 80 - 100 °C for 5 - 8 h; the fermentation conditions are at a temperature of 40 - 50 °C and a pH of 4 - 7 for fermentation for 30 - 60 min; the percolation extraction speed is 4 - 6 ml / min; the thick paste A is obtained by concentrating the mixed liquid A at 40 - 60 °C into a paste with a relative density of 1.2 - 1.5.

[0012] Further, in step S2, the particle size of the mixed powder B is 40 - 60 mesh; the ethanol solution concentration is 70 - 80% v / v, and the addition amount is 2 - 4 times the mass of the mixed powder B; the soaking is carried out at a temperature of 40 - 60 °C for 18 - 24 h; the ultrasonic extraction conditions are at a temperature of 40 - 60 °C and a power of 300 - 500 W for ultrasonic extraction for 60 - 90 min; the thick paste B is obtained by concentrating the filtrate at 40 - 60 °C into a paste with a relative density of 1.2 - 1.5.

[0013] Further, in step S3, the addition amount of α-glucanase is 2 - 3% of the mass of the mixed bile, and the alginate is 2 - 5% of the mass of the mixed bile; the centrifugation is carried out at a rate of 12000 - 14000 r / min for 10 - 15 min.

[0014] Further, in step S3, the lyophilization is carried out by pre-freezing the supernatant at -40~-30°C for 2~3 h, drying it at -30~-20°C for 10~15 h, and then drying it at -20~-10°C until the water content is 10~20%.

[0015] The medicated ink for preventing or treating lung nodules, by weight: 20~30 parts of concentrated buffalo horn powder, 18~25 parts of saiga horn powder, 18~24 parts of artificial musk, 10~14 parts of borneol, 5~9 parts of pearls, 1~6 parts of bufotalin, 7~15 parts of artificial bezoar, 0.5~2 parts of cinnabar, 3~7 parts of ox bile, 0.5~5 parts of artificial bear bile, 1~3 parts of snake bile, 1~3 parts of pig bile, 0.1~3 parts of black carp bile, 6~10 parts of chuanxiong rhizome, 4~10 parts of lotus rhizome node, 18~22 parts of safflower, 3~6 parts of herba cirsii, 3~6 parts of herba cirsii japonici, 5~8 parts of rhizoma lmperatae, 5~9 parts of prunella vulgaris, 13~17 parts of cortex moutan, 8~12 parts of cloves, 15~20 parts of xanthan gum, 80~100 parts of tung oil fume.

[0016] Further, the medicated ink, by weight: 28 parts of concentrated buffalo horn powder, 23 parts of saiga horn powder, 20 parts of artificial musk, 13 parts of borneol, 6 parts of pearls, 3 parts of bufotalin, 10 parts of artificial bezoar, 1 part of cinnabar, 5 parts of ox bile, 3 parts of artificial bear bile, 1 part of snake bile, 3 parts of pig bile, 1 part of black carp bile, 9 parts of chuanxiong rhizome, 8 parts of lotus rhizome node, 19 parts of safflower, 4 parts of herba cirsii, 5 parts of herba cirsii japonici, 6 parts of rhizoma lmperatae, 5 parts of prunella vulgaris, 15 parts of cortex moutan, 10 parts of cloves, 20 parts of xanthan gum, 90 parts of tung oil fume.

[0017] The medicated ink prepared by the preparation method of the medicated ink for preventing or treating lung nodules, and the application of the medicated ink in the preparation of drugs for preventing or treating lung nodules.

[0018] Further, the medicated ink of the present invention can be in the form of tablets or pills.

[0019] Compared with the prior art, the beneficial effects of the present invention are:

[0020] Through a reasonable preparation process, the present invention can relatively highly retain the active ingredients in the target medicated ink, effectively reduce the loss of active ingredients, and can improve the stability of the target medicated ink, with a relatively fast onset of action. It can act on the lesion site of lung nodules, inhibit the occurrence of lung inflammation, and achieve the purpose of delaying or treating lung nodules.

[0021] In the process of preparing the target medicated ink of the present invention, through a specific method of steam distillation, combined enzyme fermentation and percolation extraction with chuanxiong rhizome, lotus rhizome node, safflower, herba cirsii, herba cirsii japonici, rhizoma lmperatae, prunella vulgaris, cortex moutan, cloves, the active ingredients in the raw materials can be released more efficiently, the content of active ingredients in the target medicated ink can be increased, and thus its action effect can be improved.

[0022] The present invention adopts different extraction methods for different raw materials, which can effectively extract active ingredients, and at the same time can ensure the stability of the finally prepared medicated ink, with a relatively fast onset of action and a long shelf life.

[0023] Through reasonable raw material ratios and their preparation processes, the present invention enables each raw material component to synergistically play a synergistic effect, achieving functions such as clearing heat and detoxifying, soothing the liver and regulating qi, resolving phlegm and dissipating nodules, reducing swelling and relieving pain, promoting blood circulation and removing blood stasis, removing phlegm and dampness, and clearing the lungs, thereby effectively preventing or treating pulmonary nodules. Specific Embodiments

[0024] To better understand the technical content of the present invention, specific embodiments are provided below to further illustrate the present invention.

[0025] Unless otherwise specified, the experimental methods used in the embodiments of the present invention are all conventional methods.

[0026] Unless otherwise specified, the materials, reagents, etc. used in the embodiments of the present invention can all be obtained from commercial channels.

[0027] Example 1

[0028] The medicated ink for preventing or treating pulmonary nodules in this embodiment, by weight: 20 parts of concentrated buffalo horn powder, 18 parts of antelope horn powder, 18 parts of artificial musk, 10 parts of borneol, 5 parts of pearls, 1 part of bufotalin, 7 parts of artificial bezoar, 0.5 part of cinnabar, 3 parts of ox bile, 0.5 part of artificial bear bile, 1 part of snake bile, 1 part of pig bile, 0.1 part of black carp bile, 6 parts of chuanxiong rhizome, 4 parts of lotus rhizome node, 18 parts of safflower, 3 parts of small thistle, 3 parts of large thistle, 5 parts of lanceolate hedyotis root, 5 parts of selfheal fruit-spike, 13 parts of moutan bark, 8 parts of clove, 15 parts of xanthan gum, 80 parts of tung oil fume.

[0029] The preparation method of the medicated ink for preventing or treating pulmonary nodules in this embodiment includes the following steps:

[0030] S / 1, Chuanxiong rhizome, lotus rhizome node, safflower, small thistle, large thistle, lanceolate hedyotis root, selfheal fruit-spike, moutan bark, and clove are crushed into a mixed powder A with a particle size of 40 mesh, added with water (the material-liquid ratio of the mixed powder A to water is 1:5 g / mL), soaked at 40 °C for 2 h, and then subjected to steam distillation at 80 °C for 5 h, filtered, and the filtrate is collected. The filter residue is added with a composite enzyme composed of cellulase, papain, and pectin in a mass ratio of 3:0.5:1, fermented at 40 °C and pH 4 for 30 min, inactivated, and subjected to percolation extraction at a percolation extraction rate of 4 ml / min. The percolate is combined with the filtrate, and 4% of β-glucan based on the mass of the mixed solution A is added and stirred evenly to obtain a mixed solution A, which is concentrated into a thick paste A with a relative density of 1.2 at 40 °C;

[0031] S2. Grind antelope horn, artificial musk, borneol, pearl, bufotoxin, artificial bezoar, and cinnabar into a 40-mesh mixed powder B. Then add an ethanol solution with a concentration of 70% v / v that is twice its mass, soak at a temperature of 40°C for 18 h, and then perform ultrasonic extraction for 60 min at a temperature of 40°C and a power of 300 W. Filter, take the filter residue, add an ethanol solution with a concentration of 70% v / v that is twice its mass, and perform ultrasonic extraction for 60 min at a temperature of 40°C and a power of 300 W. Combine all the filtrates, and then concentrate to a thick paste B with a relative density of 1.2 at 40°C.

[0032] S3. After breaking the gallbladders of ox bile, artificial bear bile, snake bile, pig bile, and black carp bile respectively, mix the obtained bile to get mixed bile. Add 2% of its mass of α-glucanase and 2% of its mass of alginate to the mixed bile, stir and mix, centrifuge at a rate of 12000 r / min for 10 min, take the supernatant, pre-freeze at -40°C for 2 h, then dry at -30°C for 10 h, and then dry at -20°C until the water content is 10% to obtain bile powder.

[0033] S4. Stir and mix the thick paste A, thick paste B, and bile powder obtained above with concentrated buffalo horn powder, xanthan gum, and tung oil fume, and press into shape to obtain the medicated ink for preventing or treating lung nodules.

[0034] Example 2

[0035] The medicated ink for preventing or treating lung nodules in this example, by weight: 30 parts of concentrated buffalo horn powder, 25 parts of antelope horn powder, 24 parts of artificial musk, 14 parts of borneol, 9 parts of pearl, 6 parts of bufotoxin, 15 parts of artificial bezoar, 2 parts of cinnabar, 7 parts of ox bile, 5 parts of artificial bear bile, 3 parts of snake bile, 3 parts of pig bile, 3 parts of black carp bile, 10 parts of chuanxiong rhizome, 10 parts of lotus node, 22 parts of safflower, 6 parts of small thistle, 6 parts of large thistle, 8 parts of lanceolate hemostachys rhizome, 9 parts of selfheal fruit-spike, 17 parts of moutan bark, 12 parts of clove, 20 parts of xanthan gum, 100 parts of tung oil fume.

[0036] The preparation method of the medicated ink for preventing or treating lung nodules in this example includes the following steps:

[0037] S1. Crush Chuanxiong (Rhizoma Chuanxiong), Lotus Rhizome Node, Safflower (Flos Carthami), Cirsium Setosum, Cirsium japonicum Fisch., Imperata Cylindrica Beauv., Prunella Vulgaris L., Cortex Moutan, and Clove into a mixed powder A with a particle size of 60 mesh. Add water (the ratio of the mixed powder A to water is 1:6 g / mL), soak at 50°C for 4 h, then perform steam distillation at 100°C for 8 h. Filter and collect the filtrate. Add the filter residue to a composite enzyme composed of cellulase, papain, and pectinase with a mass ratio of 4:1:2, ferment at 50°C and pH 7 for 60 min, inactivate the enzyme, and perform percolation extraction at a speed of 6 mL / min. Combine the percolate and the filtrate, add 6% of β-glucan based on the mass of the mixed solution A, stir well to obtain the mixed solution A, and concentrate it into a thick paste A with a relative density of 1.5 at 60°C.

[0038] S2. Crush Cornu Saigae Tataricae, Artificial Moschus, Borneol, Pearl, Venenum Bufonis, Artificial Calculus Bovis, and Cinnabaris into a mixed powder B with a particle size of 60 mesh. Then add an ethanol solution with a concentration of 80% v / v, which is 4 times its mass, soak at 60°C for 24 h, and then perform ultrasonic extraction at 60°C and a power of 500 W for 90 min. Filter, and add the filter residue to an ethanol solution with a concentration of 80% v / v, which is 4 times its mass, and perform ultrasonic extraction at 60°C and a power of 500 W for 90 min. Combine all the filtrates, and then concentrate them into a thick paste B with a relative density of 1.5 at 60°C.

[0039] S3. After breaking the gallbladders of Ox Bile, Artificial Bear Gall, Snake Gall, Pig Gall, and Black Carp Gall respectively, mix the obtained bile to get a mixed bile. Add 3% of α-glucanase and 5% of alginate based on its mass, stir and mix, centrifuge at a speed of 14000 r / min for 15 min, take the supernatant, pre-freeze it at -30°C for 3 h, then dry it at -20°C for 15 h, and then dry it at -10°C until the water content is 20% to obtain bile powder.

[0040] S4. Stir and mix the above-obtained thick paste A, thick paste B, bile powder with concentrated powder of Cornu Bubali, xanthan gum, and tung oil fume, and press them into shape to obtain the medicated ink for preventing or treating lung nodules.

[0041] Example 3

[0042] For the medicated ink for preventing or treating lung nodules in this example, by weight: 25 parts of concentrated powder of Cornu Bubali, 20 parts of Cornu Saigae Tataricae powder, 22 parts of Artificial Moschus, 12 parts of Borneol, 8 parts of Pearl, 5 parts of Venenum Bufonis, 12 parts of Artificial Calculus Bovis, 2 parts of Cinnabaris, 6 parts of Ox Bile, 5 parts of Artificial Bear Gall, 2 parts of Snake Gall, 1 part of Pig Gall, 2 parts of Black Carp Gall, 8 parts of Chuanxiong (Rhizoma Chuanxiong), 6 parts of Lotus Rhizome Node, 20 parts of Safflower (Flos Carthami), 5 parts of Cirsium Setosum, 3 parts of Cirsium japonicum Fisch., 7 parts of Imperata Cylindrica Beauv., 8 parts of Prunella Vulgaris L., 14 parts of Cortex Moutan, 9 parts of Clove, 16 parts of xanthan gum, 85 parts of tung oil fume.

[0043] The preparation method of medicated ink for preventing or treating lung nodules in this embodiment includes the following steps:

[0044] S1. Crush Chuanxiong (Rhizoma Chuanxiong), lotus node, safflower, small thistle, large thistle, Imperata cylindrica Beauv., Prunella vulgaris L., Cortex Moutan, and cloves into a mixed powder A with a particle size of 50 mesh. Add water (the material-liquid ratio of the mixed powder A to water is 1:5 g / mL), soak at 50°C for 3 h, then perform steam distillation at 90°C for 7 h, filter, and collect the filtrate. Add the filter residue to a composite enzyme composed of cellulase, papain, and pectinase with a mass ratio of 3:0.8:2, ferment at 50°C and pH 6 for 40 min, inactivate the enzyme, and perform percolation extraction at a speed of 5 mL / min. Take the percolate and combine it with the filtrate, add 5% of β-glucan based on the mass of the mixed solution A, stir and mix evenly to obtain mixed solution A, and concentrate it into a thick paste A with a relative density of 1.3 at 50°C;

[0045] S2. Crush antelope horn, artificial musk, borneol, pearl, bufotalin, artificial bezoar, and cinnabar into a mixed powder B with a mesh size of 60. Then add an ethanol solution with a concentration of 75% v / v that is 3 times its mass, soak at 60°C for 20 h, then perform ultrasonic extraction at 60°C and a power of 400 W for 80 min, filter, take the filter residue and add an ethanol solution with a concentration of 75% v / v that is 3 times its mass, perform ultrasonic extraction at 60°C and a power of 400 W for 70 min, combine all the filtrates, and then concentrate them into a thick paste B with a relative density of 1.3 at 60°C;

[0046] S3. After breaking the gallbladders of ox bile, artificial bear bile, snake bile, pig bile, and black carp bile respectively, take the mixed bile, add 2% of α-glucanase and 4% of alginate based on its mass, stir and mix, centrifuge at a rate of 13000 r / min for 12 min, take the supernatant, pre-freeze it at -30°C for 2 h, then dry it at -30°C for 12 h, and then dry it at -18°C until the water content is 16% to obtain bile powder;

[0047] S4. Stir and mix the obtained thick paste A, thick paste B, bile powder with concentrated water buffalo horn powder, xanthan gum, and tung oil fume, and press them into shape to obtain the medicated ink for preventing or treating lung nodules.

[0048] Example 4

[0049] The medicated ink for preventing or treating lung nodules in this embodiment, by weight: 28 parts of concentrated buffalo horn powder, 23 parts of saiga horn powder, 20 parts of artificial musk, 13 parts of borneol, 6 parts of pearls, 3 parts of bufotalin, 10 parts of artificial bezoar, 1 part of cinnabar, 5 parts of ox bile, 3 parts of artificial bear bile, 1 part of snake bile, 3 parts of pig bile, 1 part of black carp bile, 9 parts of chuanxiong rhizome, 8 parts of lotus node, 19 parts of safflower, 4 parts of small thistle, 5 parts of large thistle, 6 parts of lanceolate hedyotis root, 5 parts of selfheal fruit-spike, 15 parts of moutan bark, 10 parts of clove, 20 parts of xanthan gum, 90 parts of tung oil smoke.

[0050] The preparation method of the medicated ink for preventing or treating lung nodules in this embodiment includes the following steps:

[0051] S1. Crush chuanxiong rhizome, lotus node, safflower, small thistle, large thistle, lanceolate hedyotis root, selfheal fruit-spike, moutan bark, and clove into a mixed powder A with a particle size of 60 mesh, add water (the liquid ratio of the mixed powder A to water is 1:6 g / mL), soak at 40 °C for 4 h, then perform steam distillation at 100 °C for 6 h, filter, collect the filtrate, add the filter residue to a composite enzyme composed of cellulase, papain, and pectin with a mass ratio of 4:1:1.5, ferment at 40 °C and pH 5 for 50 min, inactivate the enzyme, perform percolation extraction, the percolation extraction rate is 6 ml / min, take the percolate and combine it with the filtrate, add 4% of β-glucan based on the mass of the mixed solution A and stir evenly to obtain the mixed solution A, and concentrate it into a thick paste A with a relative density of 1.4 at 40 °C;

[0052] S2. Crush saiga horn, artificial musk, borneol, pearls, bufotalin, artificial bezoar, and cinnabar into a mixed powder B with a particle size of 50 mesh, then add an ethanol solution with a concentration of 80% v / v that is 4 times its mass, soak at 50 °C for 22 h, then perform ultrasonic extraction at 50 °C and a power of 500 W for 70 min, filter, take the filter residue and add an ethanol solution with a concentration of 80% v / v that is 2 times its mass, perform ultrasonic extraction at 50 °C and a power of 500 W for 80 min, combine all the filtrates, and then concentrate them into a thick paste B with a relative density of 1.4 at 50 °C;

[0053] S3. After breaking the gallbladders of ox bile, artificial bear bile, snake bile, pig bile, and black carp bile respectively, collect the mixed bile, add 3% of a-glucanase and 2% of alginate based on its mass, stir and mix, centrifuge at a rate of 14,000 r / min for 10 min, take the supernatant, pre-freeze it at -35 °C for 3 h, then dry it at -25 °C for 14 h, and then dry it at -15 °C until the water content is 12% to obtain bile powder;

[0054] S4. Stir and mix the obtained thick paste A, thick paste B, and bile powder with concentrated buffalo horn powder, xanthan gum, and tung oil smoke, and press them into shape to obtain the medicated ink for preventing or treating lung nodules.

[0055] Comparative Example 1

[0056] Compared with Example 4, the raw material ratio of the medicated ink for preventing or treating lung nodules in this comparative example is different.

[0057] The medicated ink for preventing or treating lung nodules in this comparative example, by weight: 10 parts of concentrated buffalo horn powder, 10 parts of antelope horn powder, 12 parts of artificial musk, 25 parts of borneol, 15 parts of pearl, 10 parts of bufotalin, 3 parts of artificial bezoar, 5 parts of cinnabar, 9 parts of ox bile, 8 parts of artificial bear bile, 0.5 part of snake bile, 0.1 part of pig bile, 5 parts of black carp bile, 20 parts of chuanxiong rhizome, 23 parts of lotus node, 5 parts of safflower, 12 parts of small thistle, 1 part of large thistle, 2 parts of lanceolate hedyotis root, 3 parts of selfheal fruit-spike, 2 parts of moutan bark, 18 parts of clove, 20 parts of xanthan gum, 90 parts of tung oil fume.

[0058] Comparative Example 2

[0059] Compared with Example 4, the preparation steps of S1 are different.

[0060] The process of step S1 in this comparative example is as follows: Chuanxiong rhizome, lotus node, safflower, small thistle, large thistle, lanceolate hedyotis root, selfheal fruit-spike, moutan bark, and clove are crushed into a mixed powder A with a particle size of 60 mesh, water is added (the material-liquid ratio of the mixed powder A to water is 1:6 g / mL), soaked at 40°C for 4 h, then subjected to steam distillation at 100°C for 6 h, filtered, the filtrate is collected, the filter residue is added with water again (the material-liquid ratio of the mixed powder A to water is 1:6 g / mL), soaked at 40°C for 4 h, then subjected to steam distillation at 100°C for 6 h, filtered, all the filtrates are combined, and concentrated into a thick paste A with a relative density of 1.4 at 40°C.

[0061] Comparative Example 3

[0062] Compared with Example 4, the preparation steps of S2 are different.

[0063] The process of step S2 in this comparative example is as follows: Antelope horn, artificial musk, borneol, pearl, bufotalin, artificial bezoar, and cinnabar are crushed into a mixed powder B with a particle size of 50 mesh, then 4 times its mass of a 50% v / v ethanol solution is added, and ultrasonic extraction is carried out at 80°C and a power of 100 W for 120 min, filtered, and the filtrate is concentrated into a thick paste B with a relative density of 1.4 at 50°C.

[0064] Comparative Example 4

[0065] Compared with Example 4, the preparation steps of S3 are different.

[0066] The process of step S3 in this comparative example is as follows: After breaking the gallbladders of bovine bile, artificial bear bile, snake bile, pig bile, and black carp bile respectively, the bile is taken and mixed to obtain mixed bile. Then, 3% of α-glucanase and 2% of alginate based on the mass of the mixed bile are added and stirred. Filtration is carried out under 0.097 Mpa, and then it is placed at -15°C for freeze-drying until the water content is 12% to obtain bile powder.

[0067] Comparative Example 5

[0068] Compared with Example 4, in step S3 of this comparative example, α-glucanase and alginate are not added.

[0069] The process of step S3 in this comparative example is as follows: After breaking the gallbladders of bovine bile, artificial bear bile, snake bile, pig bile, and black carp bile respectively, the bile is taken and mixed to obtain mixed bile. Centrifugation is carried out at a rate of 14000 r / min for 10 min, and the supernatant is taken and pre-frozen at -35°C for 3 h, then dried at -25°C for 14 h, and then dried at -15°C until the water content is 12% to obtain bile powder.

[0070] Experimental situation of medicated ink

[0071] 88 SPF male rats at 9 weeks old with a body weight of 180 - 220 g are selected and randomly divided into 11 groups, with 8 rats in each group. The first group is the healthy rat negative control group, the second group is the positive control group, and the third to eleventh groups are the groups of Example 1 - 4 and Comparative Example 1 - 5 respectively. Among them, the first group is healthy rats and no treatment is done. The second to eleventh groups are subjected to modeling treatment, and the modeling process is as follows: After one week of adaptive feeding of the rats, the rats are anesthetized. After anesthesia, a bleomycin solution with a mass concentration of 0.9% is dropped into the trachea of the rats at a dose of 0.005 g / kg. Two days after modeling, the rats in the third to eleventh groups are respectively given the medicated ink prepared in Example 1 - 4 and Comparative Example 1 - 5 at a dose of 0.1 g / kg every morning. The first group is gavaged with the same amount of distilled water, and the second positive control group is gavaged with the same amount of sodium chloride injection with a mass concentration of 0.9%. After 25 days, the rats in the first to eleventh groups are sacrificed by cervical dislocation, and the lung tissues of the rats are taken out, washed with water, weighed, and the right lung tissue of each group of rats and normal saline are mixed at a ratio of 1:9 g / mL, and then tissue homogenization is carried out on ice. After centrifugation at a speed of 12000 r / min and a temperature of 4°C for 20 min, the supernatant is taken. According to the operation instructions of the ELISA kit, the contents of TNF-α, IL-10, and INF-γ in the right lung tissues of each group are measured, and the experimental results are shown in Table 2 below.

[0072] In addition, the left lung tissue slices of the rats in each of the above-mentioned groups 1-11 were fixed in 4% paraformaldehyde, embedded and sectioned by conventional pathological methods. The pathological sections were stained with HE and subjected to subsequent microscopic examination and analysis. The alveolar inflammation was scored according to the following criteria, and the scores of each group were statistically analyzed. The results are shown in Table 3 below. The alveolar inflammation scoring criteria are shown in Table 1 below.

[0073] Table 1 Alveolar Inflammation Scoring Criteria

[0074]

[0075] Table 2 Contents of TNF-α, IL-10, and INF-γ in the lung tissues of each group

[0076]

[0077] The above results show that the medicated ink prepared in Examples 1-4 of the present invention can play an anti-inflammatory role to varying degrees, can reduce the contents of inflammatory factors TNF-α, IL-10, and INF-γ in the lung nodule tissue, thereby reducing the inflammatory response of the lung nodules, and thus achieving the purpose of preventing or treating lung nodules. The raw material ratio of the medicated ink for preventing or treating lung nodules in Comparative Example 1 is different, so that the active ingredients in the prepared medicated ink cannot play a synergistic effect well. Compared with Example 4, in the preparation step of S1 in Comparative Example 2, only 2 times of steam distillation is carried out, without enzymatic hydrolysis and percolation; in the preparation step of S2 in Comparative Example 3, only one ultrasonic treatment is carried out, and the ultrasonic power is different; in Comparative Example 4, after the mixed bile is stirred and mixed with a-glucanase and alginate, it is directly pressure-filtered, and at the same time, temperature-changing drying treatment is not carried out; in step S3 of Comparative Example 5, a-glucanase and alginate are not added. The treatment methods in Comparative Examples 2-4 result in a large loss of active ingredients in the medicated ink raw materials, the synergistic effect among the various raw materials is weakened, and the effect is reduced.

[0078] Table 3 Alveolar Inflammation Score of Each Group

[0079]

[0080] The above results show that when slicing the left lung slices, obvious thickening of the alveolar wall, congestion, edema of the pulmonary interstitial capillaries, inflammatory exudation, and severe inflammatory reactions can be observed in the positive control group. In Comparative Examples 1-5, individual cases with relatively severe pulmonary edema and more exudative inflammation showed milder inflammatory reactions than the positive control group. In the rats of Examples 1-4, it was observed that the alveolar wall was thinner, the alveolar structure was relatively clear, the congestion and edema of the pulmonary interstitium were not obvious, there was a small amount of inflammatory exudation, and the inflammatory reaction was small. Thus, it can be seen that the medicated ink prepared in Examples 1-4 of the present invention can achieve a better anti-inflammatory effect compared to Comparative Examples 1-5, thereby achieving a better purpose of delaying or treating pulmonary nodules.

[0081] The above is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.

Claims

1. A preparation method of medicated ink for preventing or treating pulmonary nodules, characterized in that, It includes the following steps: S1. Crush Chuanxiong (Rhizoma Chuanxiong), Lotus Rhizome Node, Safflower (Flos Carthami), Small Thistle (Herba Cirsii Setosi), Big Thistle (Herba Cirsii Japonici), Imperata Rhizome (Rhizoma Imperatae), Prunella Spike (Spica Prunellae), Moutan Bark (Cortex Moutan), and Cloves into a mixed powder A. Add water to soak it, then perform steam distillation, filter, and collect the filtrate. Add a complex enzyme to the filter residue for fermentation, inactivate the enzyme, perform percolation extraction, combine the percolate with the filtrate, add β-glucan and stir evenly to obtain a mixed solution A, and concentrate it into a thick paste A. The percolation extraction speed is 4 - 6 ml / min; S2. Crush Cornu Saigae Tataricae, Artificial Musk, Borneol, Pearl, Venenum Bufonis, Artificial Calculus Bovis, and Cinnabar into a mixed powder B, then add an ethanol solution to soak it, and perform ultrasonic extraction at a temperature of 40 - 60°C and a power of 300 - 500 W for 60 - 90 min. Filter, add the ethanol solution to the filter residue for ultrasonic extraction again, combine all the filtrates, and concentrate them into a thick paste B; S3. After breaking the gallbladders of Ox Bile, Artificial Bear Gall, Snake Gall, Pig Gall, and Black Carp Gall respectively, take the bile and mix them to obtain a mixed bile. Add α-glucanase and alginate to the mixed bile, stir and mix, centrifuge, take the supernatant, pre-freeze it at -40 - -30°C for 2 - 3 h, freeze-dry it at -30 - -20°C for 10 - 15 h, and then freeze-dry it at -20 - -10°C until the water content is 10 - 20% to obtain bile powder; S4. Stir and mix the above-obtained thick paste A, thick paste B, bile powder with Cornu Bubali Concentrate Powder, xanthan gum, and tung oil fume evenly, and press them into shape to obtain the medicated ink for preventing or treating pulmonary nodules; The medicated ink is prepared from the following raw materials in parts by weight: 20 - 30 parts of Cornu Bubali Concentrate Powder, 18 - 25 parts of Cornu Saigae Tataricae, 18 - 24 parts of Artificial Musk, 10 - 14 parts of Borneol, 5 - 9 parts of Pearl, 1 - 6 parts of Venenum Bufonis, 7 - 15 parts of Artificial Calculus Bovis, 0.5 - 2 parts of Cinnabar, 3 - 7 parts of Ox Bile, 0.5 - 5 parts of Artificial Bear Gall, 1 - 3 parts of Snake Gall, 1 - 3 parts of Pig Gall, 0.1 - 3 parts of Black Carp Gall, 6 - 10 parts of Chuanxiong (Rhizoma Chuanxiong), 4 - 10 parts of Lotus Rhizome Node, 18 - 22 parts of Safflower (Flos Carthami), 3 - 6 parts of Small Thistle (Herba Cirsii Setosi), 3 - 6 parts of Big Thistle (Herba Cirsii Japonici), 5 - 8 parts of Imperata Rhizome (Rhizoma Imperatae), 5 - 9 parts of Prunella Spike (Spica Prunellae), 13 - 17 parts of Moutan Bark (Cortex Moutan), 8 - 12 parts of Cloves, 15 - 20 parts of xanthan gum, 80 - 100 parts of tung oil fume.

2. The preparation method of the medicated ink for preventing or treating pulmonary nodules according to claim 1, characterized in that, In step S1, the particle size of the mixed powder A is 40 - 60 mesh; the ratio of the mixed powder A to the water material liquid is 1:5 - 6 g / mL; the soaking temperature is 40 - 50°C and the time is 2 - 4 h; the complex enzyme includes cellulase, papain, and pectinase with a mass ratio of (3 - 4):(0.5 - 1):(1 - 2); the addition amount of β-glucan is 4 - 6% of the mass of the mixed solution A.

3. The preparation method of the medicated ink for preventing or treating pulmonary nodules according to claim 1, characterized in that, In step S1, the steam distillation is carried out at 80 - 100°C for 5 - 8 h; the fermentation conditions are fermentation at a temperature of 40 - 50°C and a pH of 4 - 7 for 30 - 60 min; the thick paste A is obtained by concentrating the mixed solution A at 40 - 60°C into a paste with a relative density of 1.2 - 1.

5.

4. The preparation method of the medicated ink for preventing or treating pulmonary nodules according to claim 1, characterized in that, In step S2, the particle size of the mixed powder B is 40 - 60 mesh; the concentration of the ethanol solution is 70 - 80% v / v, and the addition amount is 2 - 4 times the mass of the mixed powder B; the soaking is carried out at a temperature of 40 - 60 °C for 18 - 24 h; the thick paste B is obtained by concentrating the filtrate at 40 - 60 °C into a paste with a relative density of 1.2 - 1.

5.

5. The preparation method of the medicated ink for preventing or treating pulmonary nodules according to claim 1, characterized in that, In step S3, the addition amount of α - glucanase is 2 - 3% of the mass of the mixed bile, and the addition amount of alginate is 2 - 5% of the mass of the mixed bile; the centrifugation is carried out at a rate of 12000 - 14000 r / min for 10 - 15 min.

6. The preparation method of the medicated ink for preventing or treating pulmonary nodules according to claim 1, characterized in that, The medicated ink is prepared from the following raw materials in parts by weight: 28 parts of concentrated water buffalo horn powder, 23 parts of saiga antelope horn, 20 parts of artificial musk, 13 parts of borneol, 6 parts of pearl, 3 parts of toad venom, 10 parts of artificial bezoar, 1 part of cinnabar, 5 parts of ox bile, 3 parts of artificial bear bile, 1 part of snake bile, 3 parts of pig bile, 1 part of black carp bile, 9 parts of chuanxiong rhizome, 8 parts of lotus node, 19 parts of safflower, 4 parts of cat's ear herb, 5 parts of thistle, 6 parts of lanceolate galangal rhizome, 5 parts of self - henbane, 15 parts of moutan bark, 10 parts of clove, 20 parts of xanthan gum, 90 parts of tung oil fume.

7. Use of the medicated ink prepared by the preparation method according to any one of claims 1 - 5 in the preparation of a drug for preventing or treating pulmonary nodules.

Images