A method for preparing medicated ink for preventing or treating thyroid nodules, a medicated ink formula and an application thereof

Abstract

The present invention discloses a preparation method, a formula and an application of medicated ink for preventing or treating thyroid nodules. The medicated ink comprises the following raw materials in parts by weight: concentrated powder of buffalo horn, antelope horn 270-290 parts, musk 210-230 parts, pearl, borneol, bufotoxin 130-150 parts, bezoar 13-15 parts, cinnabar, ox gallbladder, bear gallbladder, snake gallbladder, pig gallbladder, black carp gallbladder, lotus node, safflower, small thistle, large thistle, rhizoma lmperatae, selfheal spike, cortex moutan, clove, ligusticum wallichii. Experimental studies show that the medicated ink has obvious curative effects on preventing and treating thyroid nodules. The present invention provides an effective solution for the treatment or prevention of thyroid nodules.

Description

Technical Field

[0001] The present invention belongs to the field of pharmaceutical technology, and particularly relates to a preparation method, a formula and an application of medicated ink for preventing or treating thyroid nodules. Background Art

[0002] The thyroid gland is an important endocrine organ in the human body. The thyroid hormones secreted by it affect almost all organs and tissues of the human body, promoting metabolism, growth and development, and at the same time affecting reproduction, tissue differentiation and organ function. In childhood, thyroid hormones play an important role in growth and development and cognitive ability. If adults lack thyroid hormones, it may lead to hypothyroidism, with abnormalities in aspects such as mood, cognition, heart, muscle, bone and metabolism. A thyroid nodule is a common endocrine system disease caused by the abnormal local growth of thyroid cells, mainly manifested as thyroid enlargement and palpable masses. According to the etiology, thyroid nodules can be roughly divided into: hyperplastic nodular goiter, inflammatory thyroid nodules, thyroid cysts, thyroid cancer, among which thyroid cancer belongs to malignant thyroid nodules. Currently, there is a lack of effective drugs for treating thyroid nodules.

[0003] Babao Wudan Medicated Ink is a product developed and produced by the applicant Anhui Mo Pharmaceutical Co., Ltd. This product contains more than twenty traditional Chinese medicines such as concentrated powder of buffalo horn, antelope horn, musk, borneol, pearl, bufotalin, etc., and has a good therapeutic effect on various stubborn skin, oral and throat diseases that have not healed for many years. Patent document CN104383353B records its formula and preparation method. Through years of research and formula improvement, the applicant has found that Babao Wudan Medicated Ink also has obvious curative effects on preventing and treating thyroid nodules, so this application is proposed. Summary of the Invention

[0004] In view of the deficiencies of the prior art, the present invention provides a preparation method, a formula and an application of medicated ink for preventing or treating thyroid nodules.

[0005] The technical solution of the present invention is as follows:

[0006] A formula of medicated ink for preventing or treating thyroid nodules, the medicated ink comprising the following raw materials in parts by weight: concentrated powder of buffalo horn, antelope horn 270 - 290 parts, musk 210 - 230 parts, pearl, borneol, bufotalin 130 - 150 parts, bezoar 13 - 15 parts, cinnabar, ox gallbladder, bear gallbladder, snake gallbladder, pig gallbladder, black carp gallbladder, lotus root node, safflower, small thistle, large thistle, rhizoma imperatae, prunella vulgaris, cortex moutan, clove, rhizoma chuanxiong.

[0007] Further, the medicated ink comprises the following raw materials in parts by weight: 15 parts of concentrated buffalo horn powder, 290 parts of saiga horn, 230 parts of moschus, 120 parts of pearl, 100 parts of borneol, 150 parts of bufotalin, 15 parts of artificial bezoar, 24 parts of cinnabar, 55 parts of ox gallbladder, 210 parts of bear gallbladder, 33 parts of snake gallbladder, 108 parts of pig gallbladder, 70 parts of black carp gallbladder, 150 parts of lotus rhizome node, 70 parts of safflower, 150 parts of cirsium setosum, 150 parts of cirsium japonicum, 400 parts of rhizoma lmperatae, 200 parts of prunella vulgaris, 100 parts of cortex moutan, 70 parts of clove, 100 parts of rhizoma chuanxiong.

[0008] Further, the medicated ink comprises the following raw materials in parts by weight: 15 parts of concentrated buffalo horn powder, 270 parts of saiga horn, 210 parts of moschus, 120 parts of pearl, 100 parts of borneol, 130 parts of bufotalin, 13 parts of artificial bezoar, 24 parts of cinnabar, 55 parts of ox gallbladder, 210 parts of bear gallbladder, 33 parts of snake gallbladder, 108 parts of pig gallbladder, 70 parts of black carp gallbladder, 150 parts of lotus rhizome node, 70 parts of safflower, 150 parts of cirsium setosum, 150 parts of cirsium japonicum, 400 parts of rhizoma lmperatae, 200 parts of prunella vulgaris, 100 parts of cortex moutan, 70 parts of clove, 100 parts of rhizoma chuanxiong.

[0009] Further, the preparation method of the medicated ink comprises:

[0010] 1) Take rhizoma chuanxiong, safflower, lotus rhizome node, cirsium japonicum, prunella vulgaris, rhizoma lmperatae, clove, cortex moutan, add water, first perform ultrasonic extraction at room temperature, then apply pressure, and finally reduce pressure to concentrate the medicinal juice, and decoct to obtain a concentrated solution;

[0011] Or, take rhizoma chuanxiong, safflower, lotus rhizome node, cirsium japonicum, prunella vulgaris, rhizoma lmperatae, clove, cortex moutan, pulverize, add an aqueous solution of ethyl acetate, stir and extract at 50 ± 2 °C, filter, and concentrate the filtrate to remove the solvent to obtain a concentrated solution;

[0012] 2) Ultrafinely pulverize the remaining raw materials except the medicinal materials in step 1), and after sieving, mix them with the concentrated solution in step 1) to make the particle size reach the nanoscale;

[0013] 3) Take gelatin, steam and hydrate it with water, add water chestnut powder and the material obtained in step 2), mix well, filter, add tung oil soot ink, mix thoroughly, glue and shape, and air dry to obtain the finished product.

[0014] Further, by weight, the dosage of gelatin is 2000 parts, the dosage of water chestnut powder is 200 parts, and the dosage of tung oil soot ink is 2000 parts.

[0015] Further, the aqueous solution of ethyl acetate is an acidic aqueous solution of ethyl acetate.

[0016] Further, the pH of the aqueous solution of ethyl acetate is 3.5 ± 0.1, and the volume concentration of the aqueous solution of ethyl acetate is 75%.

[0017] Further, step 1) is:

[0018] Take Chuanxiong (Rhizoma Chuanxiong), Honghua (Flos Carthami), Oujie (Nodus Nelumbinis Rhizomatis), Daji (Herba Cirsii Japonici), Xiakucao (Spica Prunellae), Baimaogen (Rhizoma Imperatae), Dingxiang (Flos Caryophylli), and Mudanpi (Cortex Moutan). Add water according to the material-liquid ratio of 5 g / 100 mL. First, perform ultrasonic extraction at room temperature for 1 h, then control the temperature at 100 °C and pressurize to 0.5 Mpa, treat for 3 h, and finally reduce the pressure to 0.05 Mpa and control the temperature at 75 °C to concentrate the medicinal juice. Decoct three times, each time for 3 hours, to obtain the concentrated liquid.

[0019] Further, step 1) is as follows:

[0020] Take Chuanxiong (Rhizoma Chuanxiong), Honghua (Flos Carthami), Oujie (Nodus Nelumbinis Rhizomatis), Daji (Herba Cirsii Japonici), Xiakucao (Spica Prunellae), Baimaogen (Rhizoma Imperatae), Dingxiang (Flos Caryophylli), and Mudanpi (Cortex Moutan), pulverize them, add an aqueous solution of acidic ethyl acetate with a volume concentration of 75% according to an equal mass ratio, stir and extract at 50 ± 2 °C for 3 h, filter, and concentrate the filtrate to remove the solvent to obtain the concentrated liquid.

[0021] Use of the described medicinal ink formula or the described preparation method in the preparation of a drug for preventing or treating thyroid nodules.

[0022] Buffalo horn concentrated powder: A traditional Chinese medicine name, consisting of semi-concentrated powder of buffalo horn.

[0023] Antelope horn: The horn of the male of the saiga antelope (Saiga tatarica Linnaeus), an animal of the genus Saiga in the family Bovidae.

[0024] Musk: The dry secretion in the mature male glandular sac of animals of the Moschidae family. In the following examples and comparative examples of the present invention, artificial musk, a commercially available product, is selected, and its main component is musk.

[0025] Pearl: A pearl formed by the mantle being stimulated in the shells of animals such as Pinctada fucata, Pinctada margaritifera, Pinctada maxima, Pinctada chemnitzi in the genus Pinctada of the family Pteriidae, or Hyriopsis cumingii in the genus Hyriopsis, Cristaria plicata in the genus Cristaria, and Anodonta woodiana in the genus Anodonta of the family Unionidae.

[0026] Borneol: A processed product of the resin of Dryobalanops aromatica Gaertn.f., a plant of the genus Dryobalanops in the family Dipterocarpaceae, or a crystal obtained by distilling and cooling the chopped trunks and branches of Dryobalanops aromatica.

[0027] Venenum Bufonis: The white serous fluid secreted by the parotid gland and skin gland of animals such as Bufo gargarizans or Bufo melanostictus in the family Bufonidae, and processed and dried.

[0028] Calculus Bovis: The gallstone in the gallbladder of cattle, animals of the family Bovidae in the class Mammalia of the phylum Chordata. In the following examples and comparative examples of the present invention, artificial Calculus Bovis is selected, which is processed from bovine bile powder, cholic acid, hyodeoxycholic acid, taurine, bilirubin, cholesterol, trace elements, etc., and its composition is similar to that of natural Calculus Bovis, a commercially available product.

[0029] Cinnabar: It is cinnabar of the cinnabarite group of sulfide minerals, mainly containing mercuric sulfide (HgS).

[0030] Ox gallbladder: It is the gallbladder of Bos taurus domesticus Gmelin or Bubalus bubalis Linnaeus of the Bovidae family.

[0031] Bear gallbladder: It is the dried bile of Ursus arctos Linnaeus or Selenarctos thibetanus G. Cuvier of the Ursidae family. In the following examples and comparative examples of the present invention, artificial bear gallbladder is selected, and its main component is ursodeoxycholic acid, which is basically consistent with natural bear gallbladder in appearance, chemical composition, biological activity and curative effect.

[0032] Snake gallbladder: It is the gallbladder of Naja naja (Linnaeus) of the Naja genus of the Elapidae family, Bungarus fasciatus (Schneider) of the Bungarus genus, Zaocys dhumnades (Cantor) of the Zaocys genus of the Colubridae family, Ptyas korros (Schlegel) of the Ptyas genus, Agkistrodon halys (Pallas) of the Agkistrodon genus of the Viperidae family, etc.

[0033] Pig gallbladder: It is the dried product of the bile of Sus scrofa domestica Brisson of the Suidae family.

[0034] Black carp gallbladder: It is the gallbladder of Mylopharyngodon piceus (Richardson) of the Cyprinidae family.

[0035] Lotus rhizome node: It is the rhizome node of Nelumbo nucifera Gaertn. of the Nelumbo genus of the Nymphaeaceae family.

[0036] Safflower: It is the dried flower of Carthamus tinctorius L. of the Carthamus genus of the Asteraceae family.

[0037] Field thistle: It is the aerial part of Cirsium setosum (Willd.) MB. of the Cirsium genus of the Asteraceae family.

[0038] Japanese thistle: It is the aerial part of Cirsium japonicum DC. of the Cirsium genus of the Asteraceae family.

[0039] Lalang grass rhizome: It is the rhizome of Imperata cylindrica Beauv. var. major (Nees) C. E. Hubb. of the Imperata genus of the Poaceae family.

[0040] Prunella vulgaris: The dried spike of Prunella vulgaris L., a plant of the genus Prunella in the family Lamiaceae.

[0041] Moutan Cortex: The dried root bark of Paeonia suffruticosa Andr., a plant of the genus Paeonia in the family Paeoniaceae.

[0042] Clove: The dried flower buds of Eugenia caryophyllata Thunb., a plant of the genus Eugenia in the family Myrtaceae.

[0043] Chuanxiong Rhizoma: The dried rhizome of Ligusticum chuanxiong Hort., a plant of the genus Ligusticum in the family Umbelliferae.

[0044] Tung Oil Lampblack Ink: Ink made from the soot produced by burning tung oil.

[0045] Advantages of the present invention:

[0046] The present invention uses antelope horn, artificial musk, bufotalin, and bezoar, which have the effects of clearing heat and detoxifying, promoting qi and activating blood circulation in traditional Chinese medicine, as the main drugs, and uses five gallbladders as the ministerial drugs to enhance the effect of clearing heat and detoxifying. At the same time, it is supplemented with ingredients such as safflower, small thistle, and large thistle to reduce the toxic and side effects, making the whole formula cold but not cool. Using ink as a guide to harmonize various drugs.

[0047] The research results show that under specific ratio and preparation process conditions, the medicated ink of the present invention has obvious curative effects on the prevention and treatment of thyroid nodules. The present invention provides an effective solution for the treatment or prevention of thyroid nodules. Detailed implementation manners

[0048] In order to better understand the technical content of the present invention, specific examples are provided below to further illustrate the present invention.

[0049] The experimental methods used in the following examples are all conventional methods unless otherwise specified.

[0050] The materials, reagents, etc. used in the following examples can be obtained from commercial channels unless otherwise specified.

[0051] Example 1: Babao Wudan Medicated Ink with the Efficacy of Preventing or Treating Thyroid Nodules

[0052] The Babao Wudan Medicinal Ink comprises the following raw materials: 15 g of concentrated water buffalo horn powder, 290 g of saiga horn, 230 g of musk, 120 g of pearls, 100 g of borneol, 150 g of bufotalin, 15 g of bezoar, 24 g of cinnabar, 55 g of ox gallbladder, 210 g of bear gallbladder, 33 g of snake gallbladder, 108 g of pig gallbladder, 70 g of black carp gallbladder, 150 g of lotus rhizome node, 70 g of safflower, 150 g of common thistle, 150 g of Japanese thistle, 400 g of lanceolate hemostachys root, 200 g of common selfheal fruit-spike, 100 g of moutan bark, 70 g of clove, 100 g of chuanxiong rhizome.

[0053] Example 2: Babao Wudan Medicinal Ink with the efficacy of preventing or treating thyroid nodules

[0054] The Babao Wudan Medicinal Ink comprises the following raw materials: 15 g of concentrated water buffalo horn powder, 270 g of saiga horn, 210 g of musk, 120 g of pearls, 100 g of borneol, 130 g of bufotalin, 13 g of bezoar, 24 g of cinnabar, 55 g of ox gallbladder, 210 g of bear gallbladder, 33 g of snake gallbladder, 108 g of pig gallbladder, 70 g of black carp gallbladder, 150 g of lotus rhizome node, 70 g of safflower, 150 g of common thistle, 150 g of Japanese thistle, 400 g of lanceolate hemostachys root, 200 g of common selfheal fruit-spike, 100 g of moutan bark, 70 g of clove, 100 g of chuanxiong rhizome.

[0055] Comparative Example 1: Babao Wudan Medicinal Ink

[0056] The Babao Wudan Medicinal Ink comprises the following raw materials: 15 g of concentrated water buffalo horn powder, 200 g of saiga horn, 280 g of musk, 120 g of pearls, 100 g of borneol, 10 g of bufotalin, 100 g of bezoar, 24 g of cinnabar, 55 g of ox gallbladder, 210 g of bear gallbladder, 33 g of snake gallbladder, 108 g of pig gallbladder, 70 g of black carp gallbladder, 150 g of lotus rhizome node, 70 g of safflower, 150 g of common thistle, 150 g of Japanese thistle, 400 g of lanceolate hemostachys root, 200 g of common selfheal fruit-spike, 100 g of moutan bark, 70 g of clove, 100 g of chuanxiong rhizome.

[0057] Comparative Example 2: Babao Wudan Medicinal Ink

[0058] The Babao Wudan Medicinal Ink comprises the following raw materials: 15 g of concentrated water buffalo horn powder, 30 g of saiga horn, 100 g of musk, 120 g of pearls, 100 g of borneol, 15 g of bufotalin, 15 g of bezoar, 24 g of cinnabar, 55 g of ox gallbladder, 210 g of bear gallbladder, 33 g of snake gallbladder, 108 g of pig gallbladder, 70 g of black carp gallbladder, 150 g of lotus rhizome node, 70 g of safflower, 150 g of common thistle, 150 g of Japanese thistle, 400 g of lanceolate hemostachys root, 200 g of common selfheal fruit-spike, 100 g of moutan bark, 70 g of clove, 100 g of chuanxiong rhizome.

[0059] Comparative Example 3: Babao Wudan Medicinal Ink

[0060] Replace bezoar with other traditional Chinese medicines with the properties of clearing heat and detoxifying, promoting qi and activating blood circulation.

[0061] The Babao Wudan Yomozhi contains the following raw materials: 15 g of concentrated water buffalo horn powder, 290 g of saiga antelope horn, 230 g of musk, 120 g of pearl, 100 g of borneol, 150 g of bufotoxin, 15 g of coptis root, 24 g of cinnabar, 55 g of ox gallbladder, 210 g of bear gallbladder, 33 g of snake gallbladder, 108 g of pig gallbladder, 70 g of black carp gallbladder, 150 g of lotus rhizome node, 70 g of safflower, 150 g of small thistle, 150 g of large thistle, 400 g of lanceolate hemostachys root, 200 g of common selfheal fruit-spike, 100 g of tree peony bark, 70 g of clove, 100 g of chuanxiong rhizome.

[0062] Comparative Example 4: Babao Wudan Yomozhi

[0063] Replace bufotoxin with other traditional Chinese medicines with the properties of clearing heat and detoxifying, promoting qi and activating blood circulation.

[0064] The Babao Wudan Yomozhi contains the following raw materials: 15 g of concentrated water buffalo horn powder, 290 g of saiga antelope horn, 230 g of musk, 120 g of pearl, 100 g of borneol, Lithospermum erythrorhizon 150 g, 15 g of bezoar, 24 g of cinnabar, 55 g of ox gallbladder, 210 g of bear gallbladder, 33 g of snake gallbladder, 108 g of pig gallbladder, 70 g of black carp gallbladder, 150 g of lotus rhizome node, 70 g of safflower, 150 g of small thistle, 150 g of large thistle, 400 g of lanceolate hemostachys root, 200 g of common selfheal fruit-spike, 100 g of tree peony bark, 70 g of clove, 100 g of chuanxiong rhizome.

[0065] The preparation method of the Babao Wudan Yomozhi described in the above Examples 1-2 or Comparative Examples 1-4:

[0066] 1) Take chuanxiong rhizome, safflower, lotus rhizome node, large thistle, common selfheal fruit-spike, lanceolate hemostachys root, clove, and tree peony bark, add water according to the material-liquid ratio of 5 g / 100 mL, first extract ultrasonically at room temperature (ultrasonic power 80 W) for 1 h, then control the temperature at 100 °C and pressurize to 0.5 Mpa, process for 3 h, and finally reduce the pressure to 0.05 Mpa and control the temperature at 75 °C to concentrate the medicinal juice. Decoct three times, each time for 3 hours, to obtain the concentrated liquid;

[0067] 2) Ultrafinely crush the remaining raw materials except those in step 1), and after sieving, mix them with the concentrated liquid in step 1) to make the particle size reach the nanometer level;

[0068] 3) Take 2000 g of gelatin, add water and steam it, then add 200 g of water chestnut powder and the material obtained in step 2), mix well, filter, add 20,000 g of tung oil ink, mix fully, and glue and shape. Dry in the shade until it becomes a finished product, and then it is obtained.

[0069] The preparation method of the Babao Wudan Yomozhi with the efficacy of preventing or treating thyroid nodules in Example 3

[0070] Adopt the prescription of Example 1.

[0071] 1) Take Chuanxiong (Rhizoma Chuanxiong), Honghua (Flos Carthami), Oujie (Nodus Nelumbinis Rhizomatis), Daji (Herba Cirsii Japonici), Xiakucao (Spica Prunellae), Baimaogen (Rhizoma Imperatae), Dingxiang (Flos Caryophylli), and Mudanpi (Cortex Moutan), crush them, add an aqueous solution of ethyl acetate with a volume concentration of 75% (adjusted to 3.5 ± 0.1 with hydrochloric acid) according to an equal mass ratio, stir and extract at 50 ± 2 °C for 3 h, filter, and concentrate the filtrate to remove the solvent to obtain a concentrated solution;

[0072] 2) Ultrafinely crush the remaining raw materials other than the medicinal materials described in step 1), sieve them, and mix them evenly with the concentrated solution obtained in step 1) to make the particle size reach the nanoscale;

[0073] 3) Take 2000 g of gelatin, add water and steam it, then add 200 g of water chestnut powder and the material obtained in step 2), mix evenly, filter, add 2000 g of tung oil ink, mix well, and glue and shape. Dry it in the shade until it becomes a finished product, and that's it.

[0074] Preparation method of Babao Wudan Yaomo with the efficacy of preventing or treating thyroid nodules in Example 4

[0075] Adopt the prescription of Example 1.

[0076] 1) Take Chuanxiong (Rhizoma Chuanxiong), Honghua (Flos Carthami), Oujie (Nodus Nelumbinis Rhizomatis), Daji (Herba Cirsii Japonici), Xiakucao (Spica Prunellae), Baimaogen (Rhizoma Imperatae), Dingxiang (Flos Caryophylli), and Mudanpi (Cortex Moutan), crush them, add an aqueous solution of ethyl acetate with a volume concentration of 75% (pH 7.2) according to an equal mass ratio, stir and extract at 50 ± 2 °C for 3 h, filter, and concentrate the filtrate to remove the solvent to obtain a concentrated solution;

[0077] 2) Ultrafinely crush the remaining raw materials other than the medicinal materials described in step 1), sieve them, and mix them evenly with the concentrated solution obtained in step 1) to make the particle size reach the nanoscale;

[0078] 3) Take 2000 g of gelatin, add water and steam it, then add 200 g of water chestnut powder and the material obtained in step 2), mix evenly, filter, add 2000 g of tung oil ink, mix well, and glue and shape. Dry it in the shade until it becomes a finished product, and that's it.

[0079] Experimental Example 1

[0080] 1. Experimental materials

[0081] 1.1 Experimental animals

[0082] SPF - level SD male rats, with a body weight of 110 - 122 g.

[0083] 1.2 Experimental drugs

[0084] Propylthiouracil (PTU): Prepare a 0.1% PTU solution with physiological saline.

[0085] Levothyroxine sodium tablet liquid: Prepare a liquid of levothyroxine sodium tablets with distilled water.

[0086] Eight Treasures Five Gall Bladder Medicinal Ink Liquid (Product of Example 1): Prepare the liquid of Eight Treasures Five Gall Bladder Medicinal Ink with distilled water.

[0087] 2 Experimental Methods

[0088] 2.1 Animal Grouping and Administration

[0089] Randomly select 10 rats as the normal control group, and intragastrically administer normal saline at a dose of 1 mL / 100 g body weight. The remaining rats were all intragastrically administered PTU solution at a dose of 10 mL·kg -1 body weight once a day for 8 consecutive weeks. Then, perform thyroid palpation and color Doppler ultrasound on the rats to verify that the nodular goiter models are all successfully established. Randomly divide the successfully modeled rats into a model group and an experimental group (positive control group, low, medium, and high dose groups of Eight Treasures Five Gall Bladder Medicinal Ink), with 10 rats in each group.

[0090] The experimental group was intragastrically administered drugs at a dose of 1 mL / 100 g body weight. Positive control group: The rats were intragastrically administered a liquid medicine of levothyroxine sodium tablets at a concentration of 0.9 mg / L; The low, medium, and high dose groups of Eight Treasures Five Gall Bladder Medicinal Ink were intragastrically administered Eight Treasures Five Gall Bladder Medicinal Ink solutions at concentrations of 0.09, 0.18, and 0.36 g / L, respectively. The rats in the model group and the normal control group were intragastrically administered distilled water. Intragastrically administer once a day for 4 consecutive weeks.

[0091] 2.2 Detection of Experimental Indexes

[0092] After the administration and treatment, weigh the body weight of the rats. After anesthetizing the rats by intraperitoneal injection of phenobarbital, take a blood sample at the upper part of the thyroid cartilage of the rats. Then, separate the thyroid tissue of the rats, weigh the mass of the thyroid tissue, and perform pathological histological observation.

[0093] Detect the basic fibroblast growth factor (bFGF) in the serum of rats by ELISA method.

[0094] Detect the thyroid function (FT3, FT4, TSH) in the serum of rats by an electrochemiluminescence immunoassay analyzer.

[0095] 2.3 Experimental Results

[0096] Table 1

[0097] Group FT3 (ng / L) FT4 (ng / L) TSH (mU / L) bFGF (ng / L) Thyroid mass / mg Normal control group <![CDATA[3.59±0.16 # > <![CDATA[17.25±0.13 # > <![CDATA[1.33±0.07 # > <![CDATA[26.59±2.18 # > <![CDATA[32.82±4.12 # > Model group 1.29±0.05* 4.55±0.07* 3.36±0.12* 56.98±1.26* 174.26±6.59* Eight Treasures Five Gall Bladders Medicinal Ink - low dose group <![CDATA[2.06±0.11* # > <![CDATA[6.78±0.12* # > <![CDATA[2.22 ± 0.10* # > <![CDATA[44.58±2.03* # > <![CDATA[125.46±2.16* # > Eight Treasures Five Gall Bladders Medicinal Ink - medium dose group <![CDATA[2.83±0.09* # > <![CDATA[9.12±0.23* # > <![CDATA[1.60±0.16* # > 30.67±2.10*# <![CDATA[89.63±3.61* # > Eight Treasures Five Gall Bladders Medicinal Ink - high dose group <![CDATA[2.79±0.08* # > <![CDATA[10.66±0.34* # > <![CDATA[2.14±0.09* # > <![CDATA[36.95±2.26* # > <![CDATA[90.67±3.64* # > Positive control group <![CDATA[2.88±0.13* # > <![CDATA[13.26±0.56* # > <![CDATA[1.56±0.07* # > <![CDATA[46.65±3.56* # > <![CDATA[100.59±5.52* # >

[0098] Compared with the normal group, *P<0.05, compared with the model group, # P<0.05

[0099] Compared with the normal group, the thyroid mass of the rats in the model group was higher, the concentrations of TSH and bFGF in the serum were significantly increased, and FT3 and FT4 were significantly decreased; compared with the model group, the thyroid mass decreased in each dose group of Babao Wudan Yaomo, the concentrations of TSH and bFGF in the serum of the rats decreased, and FT3 and FT4 increased significantly; compared with the low-dose and high-dose groups, the serum FT3 of the rats in the medium-dose group was higher, and the concentrations of TSH and bFGF were significantly lower (P<0.05). The results showed that each dose of Babao Wudan Yaomo and the positive group had obvious therapeutic effects on nodular goiter.

[0100] Each example and comparative example of Babao Wudan Yaomo liquid medicine was administered according to the drug dosage of the medium-dose group, and the other experimental steps were the same as those in Experimental Example 1. The results are shown in Table 2.

[0101] Table 2

[0102] Group FT3 (ng / L) FT4 (ng / L) TSH (mU / L) bFGF (ng / L) Thyroid mass / mg Example 2 <![CDATA[2.74±0.16* # > <![CDATA[8.87±0.54* # > <![CDATA[1.68±0.13* # > <![CDATA[34.84±2.30* # > <![CDATA[95.46±2.47* # > Example 3 <![CDATA[3.53±0.36 # > <![CDATA[12.17±0.45* # > <![CDATA[1.24±0.20* # > <![CDATA[29.64±3.61* # > <![CDATA[53.94±4.00* # > Example 4 <![CDATA[2.89±0.20* # > <![CDATA[11.80±0.41* # > <![CDATA[1.40±0.18* # > <![CDATA[29.59±2.04* # > <![CDATA[75.94±2.14* # > Comparative example 1 <![CDATA[1.47±0.12* # > <![CDATA[6.26±0.37* # > <![CDATA[2.88±0.49* # > <![CDATA[47.58±0.28* # > <![CDATA[133.26±4.15* # > Comparative example 2 1.31±0.09* <![CDATA[5.12±0.23* # > <![CDATA[3.06±0.56* # > 54.26±1.97* <![CDATA[140.27±3.54* # > Comparative example 3 <![CDATA[1.54±0.17* # > <![CDATA[7.22±0.28* # > <![CDATA[2.26±0.79* # > <![CDATA[44.43±2.06* # > <![CDATA[155.42±3.59* # > Comparative example 4 <![CDATA[1.42±0.11* # > <![CDATA[6.19±0.34* # > <![CDATA[2.48±0.52* # > 52.26±2.99* <![CDATA[134.21±4.33* # >

[0103] It can be found that the therapeutic effect of the product obtained by extraction with acidic ethyl acetate aqueous solution in Example 3 group was the best, and it had a significant effect on preventing or treating thyroid nodules. Compared with Example 3 group, the effect of extraction with neutral ethyl acetate aqueous solution in Example 4 was weaker, and there were significant differences in other effect data except for the bEGF concentration. Compared with Example 1 in Table 1, after the main drug component dosage ratio was changed or replaced with a component with similar medicinal properties in the comparative example, significant changes occurred in each index, indicating that the components and ratio of the main drug had an important impact on whether Babao Wudan Yaomo could exert the anti-thyroid nodule effect, and must be strictly controlled.

[0104] The above are only some embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present invention shall fall within the protection scope of the present invention.

Claims

1. Use of a medicated ink formula in the preparation of a drug for preventing or treating thyroid nodules, wherein the medicated ink is composed of the following raw materials in parts by weight: 15 parts of concentrated powder of buffalo horn, 290 parts of antelope horn, 230 parts of musk, 120 parts of pearl, 100 parts of borneol, 150 parts of bufotalin, 15 parts of artificial bezoar, 24 parts of cinnabar, 55 parts of ox gallbladder, 210 parts of bear gallbladder, 33 parts of snake gallbladder, 108 parts of pig gallbladder, 70 parts of black carp gallbladder, 150 parts of lotus rhizome node, 70 parts of safflower, 150 parts of small thistle, 150 parts of large thistle, 400 parts of rhizoma imperatae, 200 parts of prunella vulgaris, 100 parts of cortex moutan, 70 parts of clove, 100 parts of ligusticum wallichii; Or 15 parts of concentrated powder of buffalo horn, 270 parts of antelope horn, 210 parts of musk, 120 parts of pearl, 100 parts of borneol, 130 parts of bufotalin, 13 parts of artificial bezoar, 24 parts of cinnabar, 55 parts of ox gallbladder, 210 parts of bear gallbladder, 33 parts of snake gallbladder, 108 parts of pig gallbladder, 70 parts of black carp gallbladder, 150 parts of lotus rhizome node, 70 parts of safflower, 150 parts of small thistle, 150 parts of large thistle, 400 parts of rhizoma imperatae, 200 parts of prunella vulgaris, 100 parts of cortex moutan, 70 parts of clove, 100 parts of ligusticum wallichii; The preparation method of the medicated ink includes: 1) Take ligusticum wallichii, safflower, lotus rhizome node, large thistle, prunella vulgaris, rhizoma imperatae, clove, cortex moutan, crush them, add acidic ethyl acetate aqueous solution, stir and extract at 50 ± 2 °C, filter, and concentrate the filtrate to remove the solvent to obtain a concentrated solution; 2) Ultrafinely crush the remaining raw materials except the medicinal materials in step 1), sieve them, and mix them with the concentrated solution in step 1) to make the particle size reach the nanometer level; 3) Take gelatin, steam and dissolve it in water, add water chestnut powder and the material obtained in step 2), mix well, filter, add tung oil soot ink, mix thoroughly, glue and shape, and air dry to obtain the finished product.

2. The application according to claim 1, characterized in that By weight, the dosage of gelatin is 2000 parts, the dosage of water chestnut powder is 200 parts, and the dosage of tung oil soot ink is 2000 parts.

3. The application according to claim 1, characterized in that The acidic ethyl acetate aqueous solution is an acidic ethyl acetate aqueous solution.

4. The application according to claim 1, characterized in that, The pH of the acidic ethyl acetate aqueous solution is 3.5 ± 0.1, and the volume concentration of the acidic ethyl acetate aqueous solution is 75%.

5. The application according to claim 1, wherein Step 1) is: Take ligusticum wallichii, safflower, lotus rhizome node, large thistle, prunella vulgaris, rhizoma imperatae, clove, cortex moutan, crush them, add acidic ethyl acetate aqueous solution with a volume concentration of 75% according to an equal mass ratio, stir and extract at 50 ± 2 °C for 3 h, filter, and concentrate the filtrate to remove the solvent to obtain a concentrated solution.