Pharmaceutical composition for treating glandular nodules and preparation method thereof

Abstract

The invention belongs to the technical field of preparation of pharmaceutical compositions, and particularly relates to a pharmaceutical composition for treating glandular nodules and a preparation method of the pharmaceutical composition. The pharmaceutical composition for treating glandular nodules comprises a traditional Chinese medicine combination part and a western medicine combination part, wherein the traditional Chinese medicine combination part comprises a curative effect component I, a curative effect component II and a curative effect component III, and the western medicine combination part comprises a functional component I, a functional component II and a functional component III. The preparation method of the pharmaceutical composition for treating glandular nodules comprises the following steps: weighing the functional component I, the functional component II and the functional component III, uniformly mixing the raw materials in the functional component I, the functional component II and the functional component III respectively to prepare capsules, and forming single-component capsule core-spun western medicine; weighing raw materials of the curative effect component I, the curative effect component II and the curative effect component III, and independently and uniformly mixing to prepare a gel medicine; and performing multi-layer coating on the gel medicine for the capsule. The glandular nodules are treated by combining traditional Chinese medicine components and western medicine components, medicines with different curative effects are dissolved in the stomach in different time periods by adopting multi-layer wrapping, and the problems that the treatment effect of a single kind of medicines is poor, and traditional Chinese medicine and western medicine combined medicines do not have a better combination mode are solved.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of medicine preparation, in particular to a medicine composition for treating adenoid nodules and a preparation method thereof. BACKGROUND

[0002] Adenoid nodules include thyroid-related nodules, breast-related nodules and other adenoid nodules, especially thyroid-related nodules and breast-related nodules have a high incidence, and there is no ideal treatment scheme at present. The treatment drugs for thyroid-related nodules and breast-related nodules are different.

[0003] The medicine composition for treating adenoid nodules includes traditional Chinese medicine composition and western medicine composition. The traditional Chinese medicine composition mainly has the effects of softening and resolving nodules, soothing the liver and regulating qi, promoting blood circulation and removing blood stasis, etc. If the composition is configured to have all the above effects, the composition contains many components and has a large side effect on the human body. If the composition is configured to have the effects of soothing the liver and regulating qi, promoting blood circulation and removing blood stasis in one period and the effect of softening and resolving nodules in another period, it is relatively troublesome to control the time nodes of the respective effects and the composition is easy to be missed. The effect of softening and resolving nodules is better after the effects of soothing the liver and regulating qi and promoting blood circulation and removing blood stasis are performed for a period of time, but it is difficult to control the time nodes of the respective effects.

[0004] The combination of traditional Chinese medicine and western medicine has a better effect on treating adenoid nodules, but the combination needs to control the time of taking the traditional Chinese medicine and the western medicine and needs to be taken according to the doctor's advice, which is relatively troublesome. The western medicine has a strong pertinence and a fast effect on treating adenoid nodules, but has a large side effect. The effect and safety of the western medicine are verified by large-scale clinical trials, the dose and use method are clear, no differentiation is needed, and the western medicine is suitable for patients who are unwilling to accept traditional Chinese medicine or have an acute condition. When the traditional Chinese medicine and the western medicine are taken at the same time, a larger side effect is caused and a larger damage is caused to the patient's body. There is no better medicine composition of the combination of traditional Chinese medicine and western medicine for treating adenoid nodules at present. SUMMARY

[0005] The application aims to provide a medicine composition for treating adenoid nodules and a preparation method thereof. The traditional Chinese medicine components and the western medicine components are combined to treat adenoid nodules, and the treatment effect is better. The medicine components with different effects are dissolved in the stomach at different time periods by using multi-layer wrapping, and the patient is treated, which solves the problems of the poor treatment effect of the single type of medicine, the large side effect of the multiple effect medicines and the lack of a better combination of traditional Chinese medicine and western medicine.

[0006] To solve the above technical problems, the application is implemented by the following technical scheme: A medicine composition for treating adenoid nodules includes a traditional Chinese medicine combination part and a western medicine combination part. The traditional Chinese medicine combination part includes a therapeutic effect component one, a therapeutic effect component two and a therapeutic effect component three. The western medicine combination part includes a functional component one, a functional component two and a functional component three. The curative component one is composed of 2-5 parts of Radix Bupleuri, 2-5 parts of Radix Anemarrhena, 5-10 parts of Rhizoma Cyperi, 5-10 parts of Pericarpium Citri Reticulatae, 3-5 parts of Rosa rugosa and 20-30 parts of gelatin by weight; The curative component two is composed of 5-8 parts of Rhizoma Sparganii, 3-5 parts of Curcuma zedoaria, 3-5 parts of Poria cocos, 5-8 parts of Rhizoma Atractylodis Macrocephalae and 20-30 parts of gelatin by weight; The curative component three is composed of 10-15 parts of Lingzhi, 5-10 parts of Fritillaria thunbergii Miq, 5-10 parts of and 20-30 parts of gelatin by weight; The functional component one is composed of 10-15 parts of methimazole or 10-15 parts of propylthiouracil, 20-30 parts of oil phase and 10-15 parts of surfactant by weight; The functional component two is composed of 10-15 parts of tamoxifen or 10-15 parts of toremifene, 20-30 parts of oil phase and 10-15 parts of surfactant by weight; The functional component three is composed of 10-15 parts of ibuprofen, 10-15 parts of diclofenac sodium or 10-15 parts of celecoxib, 20-30 parts of oil phase and 10-15 parts of surfactant by weight; The functional component one, the functional component two and the functional component three are mixed to form a core-sheathed western medicine; One, two or three of the curative component one, the curative component two and the curative component three are used to coat the core-sheathed western medicine layer by layer.

[0007] Further, at least one of the curative component one and the curative component two is used as an outer coating layer, and the curative component three is coated outside the core-sheathed western medicine; The curative component three is coated outside the core-sheathed western medicine, and the coating layer formed by the curative component one and / or the curative component two is coated outside the curative component three.

[0008] Further, a certain proportion of the curative component three is mixed in the curative component one and the curative component two, and the weight ratio of the curative component three in the curative component one and the curative component two is 20-40%.

[0009] Further, the oil phase is one or more of fish glue oil, soybean oil, olive oil, oleic acid, ethyl oleate and oleic acid polyethylene glycol glyceride, the surfactant is one or both of polyoxyethylene hydrogenated castor oil and Tween 20, and the oil phase component contains 10-15% of gelatin by weight.

[0010] Further, the pharmaceutical composition is a tablet-shaped capsule or a granular capsule.

[0011] A preparation method of a pharmaceutical composition for treating adenoid nodules, which is prepared by using the components of any of the above pharmaceutical compositions, and comprises the following steps: S1: weighing 10-15 parts of methimazole or 10-15 parts of propylthiouracil of functional component one, 20-30 parts of oil phase, and 10-15 parts of surfactant; weighing 10-15 parts of tamoxifen or 10-15 parts of toremifene of functional component two, 20-30 parts of oil phase, and 10-15 parts of surfactant; weighing 10-15 parts of one of ibuprofen, 10-15 parts of diclofenac sodium, or 10-15 parts of celecoxib of functional component three, 20-30 parts of oil phase, and 10-15 parts of surfactant; Mixing the raw materials in functional component one, functional component two, and functional component three respectively to make capsules, forming single-component capsule core western medicine; Mixing any two or three of functional component one, functional component two, and functional component three to make capsules, forming mixed-component capsule core western medicine; S2: shaping the single-component capsule core western medicine and the mixed-component capsule core western medicine in step S1 into oval capsules or round tablet type capsules by a shaping machine; S3: weighing 2-5 parts of bupleurum, 2-5 parts of yujin, 5-10 parts of cyperus, 5-10 parts of dried tangerine or orange peel, 3-5 parts of rose, and 20-30 parts of gelatin of curative component one; weighing 5-8 parts of sparganium, 3-5 parts of zedoary, 3-5 parts of poria, 5-8 parts of white atractylodes rhizome, and 20-30 parts of gelatin of curative component two; weighing 10-15 parts of five-ingredient fat, 5-10 parts of zhejiang fritillaria, and 5-10 parts of peony root, and 20-30 parts of gelatin of curative component three; Mixing the raw materials in curative component one, curative component two, and curative component three respectively to make gel medicine, using a coating machine to coat the oval capsules or round tablet type capsules with the gel medicine made from curative component three as the first layer, then using the coating machine to coat the capsules coated with the first layer with the gel medicine made from curative component one and curative component two as the second layer or / and the third layer, forming a wrapped capsule medicine; S4: after each layer of wrapping in step S3, the next layer of wrapping is carried out immediately, and after the last layer of wrapping, the wrapped capsule medicine is placed in a sterile environment for ventilation and drying.

[0012] Further, the raw material processing methods of functional component one, functional component two, and functional component three are the same, the oil phase raw materials are heated to 70-80℃ in a sterile tank while stirring, then the surfactant is slowly added to the oil phase for stirring and dissolving, after mixing uniformly, methimazole or propylthiouracil is dropped into the oil phase for preparing functional component one, tamoxifen or toremifene is dropped into the oil phase for preparing functional component two, ibuprofen, diclofenac sodium, or celecoxib is dropped into the oil phase for preparing functional component three, and they are uniformly dissolved, then the core western medicine gel liquid is prepared by a granulating device; Or, select one of methimazole or propylthiouracil, one of tamoxifen or toremifene, one of ibuprofen, diclofenac sodium or celecoxib, then, after mixing any two or three of the selected three drugs, add them to the oil phase to dissolve to prepare a mixed component core-coated western medicine gel liquid, and then granulate through the equipment.

[0013] Further, the raw materials in the therapeutic component one, the therapeutic component two and the therapeutic component three, except for gelatin, are crushed into powder, and then each raw material powder is added to sterile water, boiled and filtered, and the filter residue is added to sterile water for secondary boiling and filtering. The filtrates after two times of filtering are mixed to form a mixed filtrate. The mixed filtrates of each raw material in the therapeutic component one are mixed to form a total mixed filtrate one, and the mixed filtrates of each raw material in the therapeutic component two and the therapeutic component three are also mixed to form corresponding total mixed filtrates two and three. The total mixed filtrate one, the total mixed filtrate two and the total mixed filtrate three are respectively heated and concentrated, and gelatin is added during the heating and concentration process to prepare a gelatin medicine.

[0014] Further, pigments are added in the preparation process of the capsule core-coated western medicine according to the different components or different mixed components, so as to identify the type of the capsule core-coated western medicine.

[0015] Further, the wrapped capsule medicine is dried in the air after ventilation, and is wrapped with a layer of moisture-proof capsule shell outside.

[0016] The softening and knot-breaking medicine components are as follows: Five Lingzhi, also known as Lingzhi, Tanglingzhi, Lingzhi rice and Lingzhi block, is the dried excrement of Petaurista canus or Apodemus speciosus. Five Lingzhi tastes bitter and sweet, and is warm in nature. It has the effects of activating blood and dispersing blood stasis, resolving blood stasis and stopping bleeding, and eliminating accumulation and detoxifying. It is mainly used to treat abdominal blood stasis pain, amenorrhea in women, postpartum abdominal pain due to blood stasis, metrorrhagia, infantile malnutrition and snake, scorpion and centipede bites.

[0017] Zhebeimu is the dried bulb of Fritillaria thunbergii Miq. of Liliaceae. It tastes bitter and sweet, and is cold in nature, and belongs to the lung and heart channels. Zhebeimu is a commonly used heat-clearing and phlegm-resolving drug in traditional Chinese medicine, and its core effect focuses on clearing heat, resolving phlegm and resolving knots.

[0018] Mudanpi is the dried root bark of Paeonia suffruticosa Andr. of Ranunculaceae. It tastes bitter and acrid, and is cold in nature, and belongs to the heart, liver and kidney channels. Mudanpi is a commonly used heat-clearing and blood-activating and blood-stasis-resolving drug in traditional Chinese medicine, and its core effect focuses on clearing heat, cooling blood and resolving blood stasis. It is widely used in blood heat syndrome, blood stasis syndrome and heat-toxicity accumulation syndrome, and has an important auxiliary effect on nodules and lumps.

[0019] The liver-soothing and qi-regulating medicine components are as follows: Bupleurum has the effects of relieving exterior syndromes and reducing fever, soothing the liver and relieving depression, and raising yang qi. Relieving exterior syndromes and reducing fever: Bupleurum is slightly cold in nature and bitter in taste. It is good at relieving exterior syndromes and reducing fever, and dispersing the lesser yang, thus dispelling pathogenic factors in the half-exterior, half-interior region. It can be used for fever symptoms in patients with external febrile diseases. Bupleurum enters the liver meridian and has the effect of soothing the liver and relieving depression. Bupleurum contains saikosaponins, which can lower plasma cholesterol, reduce liver damage, and promote bile secretion. The efficacy of Bupleurum is based on the dual verification of traditional Chinese medicine theory and modern pharmacological research, and it is widely used, especially in cases of glandular nodules and emotional disorders.

[0020] Turmeric has the effect of soothing the liver and relieving depression, complementing Bupleurum, and focusing on "regulating qi and promoting blood circulation". Compared with Bupleurum's "pure liver-soothing" effect, turmeric adds the effect of "promoting blood circulation", making it suitable for nodules that are hard, fixed (characteristic of blood stasis), or accompanied by significant pain. It is applicable to glandular nodules of the liver qi stagnation type, liver qi stagnation and blood stasis type, and phlegm and blood stasis type.

[0021] Cyperus rotundus is used to regulate the Qi of the liver meridian, resolve "liver Qi stagnation" (the most common symptom of glandular nodules), and improve Qi stagnation caused by Qi stagnation. Compared with Bupleurum chinense, which is "more ascending and dispersing," and Curcuma longa, which "also invigorates blood," Cyperus rotundus has a gentler and more focused effect on soothing the liver, and does not have the disadvantage of depleting Qi or damaging Yin. It is suitable for long-term conditioning, especially for nodular distending pain caused by emotional fluctuations.

[0022] Dried tangerine peel is a classic Chinese medicine for "regulating qi and strengthening the spleen, drying dampness and resolving phlegm". It has a mild medicinal property and a wide range of applications. It is especially suitable for the syndrome of "liver stagnation and spleen deficiency with internal generation of phlegm and dampness" accompanying glandular nodules (breast, thyroid). Its medicinal effect takes into account both regulating qi and spleen and stomach function, and it is a "core medicine for harmonizing" nodules for long-term treatment.

[0023] Rose petals are a mild medicinal herb in Traditional Chinese Medicine (TCM) for "soothing the liver and regulating qi, promoting blood circulation and regulating menstruation." Its medicinal properties are mild and gentle, without the drawbacks of being overly drying or harsh. It is particularly suitable for mild qi stagnation and emotional imbalance associated with glandular nodules (breast, thyroid), making it a "safe choice" for daily conditioning. Compared to the "strong qi-regulating" properties of Bupleurum and Cyperus, rose petals are more gentle and suitable for long-term, small-dose conditioning (such as brewing tea). They are especially suitable for patients with yin deficiency, those who cannot tolerate pungent and warm qi-regulating herbs, or as a daily ingredient for nodule prevention and conditioning.

[0024] The components of the blood-activating and stasis-removing drugs are as follows: San Leng is a potent herb in Traditional Chinese Medicine that "breaks up blood stasis, promotes qi circulation, eliminates stagnation, and relieves pain." Its core efficacy lies in breaking up blood stasis, softening hard masses, and dispersing nodules. It is especially suitable for the "phlegm and blood stasis" syndrome of glandular nodules (thyroid and breast) with a long course of disease and hard texture. It is a key herb for "attacking and dispersing nodules" in the treatment of nodules. Its efficacy combines the depth of traditional theory with the support of modern pharmacology.

[0025] Radix Curcumae is a core harsh medicinal material of traditional Chinese medicine (TCM) for breaking blood and promoting qi, resolving accumulation and resolving stasis, and has similar effects to Rhizoma Sparganii but focuses on different aspects, and the core effects are concentrated in strong blood stasis breaking, soft and hard mass resolving, and qi movement and pain stopping, and is especially suitable for the "phlegm and blood stasis mutual accumulation" syndrome type of long duration, hard texture, and adhesion of gland nodules (thyroid and breast), and is a key drug (often used with Rhizoma Sparganii) for "breaking hard mass and resolving stasis" in the regulation of nodules, and the effects of the drug are supported by both traditional theory and modern pharmacology.

[0026] Poria cocos is a classic medicinal material of traditional Chinese medicine (TCM) for promoting water excretion and dampness, and invigorating the spleen and calming the heart, and has mild medicinal properties and a very wide range of applications, and is especially suitable for the "liver depression and spleen deficiency, and internal production of phlegm and dampness" syndrome type of gland nodules (thyroid and breast), and is a core regulating drug for "invigorating the spleen, eliminating dampness, and regulating medicinal properties" in the regulation of nodules, and the effects of the drug are supported by both traditional theory and modern pharmacology.

[0027] Rhizoma Atractylodis Macrocephalae is a core medicinal material of traditional Chinese medicine (TCM) for invigorating the spleen and benefiting qi, drying dampness and promoting water excretion, and has mild and thick medicinal properties, and is especially suitable for the "liver depression and spleen deficiency, and internal production of phlegm and dampness" syndrome type of gland nodules (thyroid and breast), and is a key drug for "building a solid foundation of the spleen and stomach, and regulating medicinal properties" in the regulation of nodules, and the effects of the drug are supported by both traditional theory and modern pharmacology.

[0028] Western medicine for thyroid nodules with functional abnormalities: methimazole and propylthiouracil. It is suitable for thyroid nodules combined with hyperthyroidism (such as toxic nodular goiter), can inhibit the synthesis of thyroid hormones, control the symptoms of hyperthyroidism, and indirectly alleviate the hyperplasia of nodules caused by abnormal hormones.

[0029] Western medicine related to breast nodules: tamoxifen and toremifene. It is suitable for breast hyperplasia nodules and hormone-dependent fibroadenoma, can antagonize the effect of estrogen, reduce the hyperplasia of breast tissue, relieve the swelling pain of nodules, and reduce the volume of nodules.

[0030] Non-steroidal anti-inflammatory drugs: ibuprofen, diclofenac sodium, and celecoxib. It is suitable for acute thyroiditis and breast hyperplasia with obvious inflammatory swelling and pain, can quickly anti-inflammatory and analgesic, and relieve the pain symptoms caused by nodules.

[0031] Compared with the prior art, the present application has the following beneficial effects: 1. The present application divides the ingredients of the traditional Chinese medicine composition into three treatment directions according to soft and hard mass resolving, liver regulating and blood activating and stasis removing, and divides the traditional Chinese medicine ingredient raw materials into three groups, each group has different treatment effects, the outermost layer of the therapeutic effect component is together to the liver regulating and blood activating and stasis removing, so that the body is comfortable and ventilated, after the outermost layer is dissolved, the function component two of blood activating and stasis removing is opened, and the function component three of soft and hard mass resolving is opened, the treatment process is processed in stages, the side effects are small, the treatment process makes the patient more comfortable, and the treatment effect is better.

[0032] 2. This invention places the Western medicine components within a coating layer. The traditional Chinese medicine portion is largely dissolved by stomach acid, at which point the traditional Chinese medicine portion exerts its optimal efficacy, while the Western medicine portion begins to dissolve, slowly releasing the Western medicine. The efficacy of the traditional Chinese medicine and Western medicine does not dissolve in the stomach at the same time, and their effects are released at different times, preventing interaction. After the efficacy of the traditional Chinese medicine takes effect, the nodules will be weakened, and the Western medicine will exert a greater effect. By eating before taking the medication (eating before taking the medication; if the effect is strong, millet porridge or similar foods can be consumed to dilute stomach acid and slow down the dissolution rate of the capsule, thereby reducing the dissolution rate of the gelatin and oil phases and controlling the diffusion rate of the drug components), the stomach acid is diluted. The degree of dilution determines the dissolution rate of the capsule, allowing the efficacy to be tailored to the patient's condition. This differs from traditional tablets and coated medications, which, once dissolved, rapidly exert their effects, leading to concentrated efficacy, excessively strong effects, and significant side effects.

[0033] Of course, any product implementing this invention does not necessarily need to achieve all of the advantages described above at the same time. Detailed Implementation

[0034] The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0035] A pharmaceutical composition for treating glandular nodules includes a traditional Chinese medicine component and a Western medicine component; wherein the traditional Chinese medicine component includes therapeutic component one, therapeutic component two, and therapeutic component three, and the Western medicine component includes functional component one, functional component two, and functional component three; The therapeutic component one, by weight, consists of 2-5 parts Bupleurum, 2-5 parts Curcuma, 5-10 parts Cyperus, 5-10 parts Tangerine Peel, 3-5 parts Rose, and 20-30 parts Gelatin. The therapeutic component consists of two parts by weight: 5-8 parts of Sparganium rhizome, 3-5 parts of Curcuma rhizome, 3-5 parts of Poria cocos, 5-8 parts of Atractylodes macrocephala rhizome, and 20-30 parts of gelatin. The therapeutic components are divided into three parts by weight: 10-15 parts of Wulingzhi, 5-10 parts of Zhebeimu, 5-10 parts of Mudanpi, and 20-30 parts of Gelatin. Functional component one, by weight, consists of 10-15 parts of methimazole or 10-15 parts of propylthiouracil, 20-30 parts of oil phase, and 10-15 parts of surfactant. Functional component two, by weight, consists of 10-15 parts of tamoxifen or 10-15 parts of toremifene, 20-30 parts of oil phase, and 10-15 parts of surfactant; Functional component three is composed of one of ibuprofen 10-15 parts, diclofenac sodium 10-15 parts or celecoxib 10-15 parts, oil phase 20-30 parts and surfactant 10-15 parts by weight fraction; The oil phase is one or more of fish gelatin oil, soybean oil, olive oil, oleic acid, ethyl oleate and oleic acid polyethylene glycol glyceride, the surfactant is one or both of polyoxyethylene hydrogenated castor oil or Tween 20, and the oil phase component contains 10-15% by weight of gelatin.

[0036] Example one Functional component one is composed of methimazole 10-15 parts, oil phase 20-30 parts and surfactant 10-15 parts by weight fraction; wherein the oil phase is a mixed oil of fish gelatin oil, soybean oil and olive oil, and the surfactant is polyoxyethylene hydrogenated castor oil.

[0037] The fish gelatin oil, soybean oil and olive oil are added to a sterile tank for heating, the heating temperature is 70-80℃ while stirring, then the polyoxyethylene hydrogenated castor oil is added to the oil phase for stirring and dissolving, after mixing uniformly, the methimazole is dropped in and uniformly dissolved, then the gelatin 10-15 parts is added, after stirring for a period of time, it is cooled to 30-45℃, then a core tablet granulator is used to make the core tablet of western medicine gelatin granules; The efficacy component one is composed of Radix Bupleuri 2-5 parts, Radix Curcumae 2-5 parts, Rhizoma Cyperi 5-10 parts, Pericarpium Citri Reticulatae 5-10 parts, Rosa rugosa 3-5 parts and gelatin 20-30 parts by weight fraction; the efficacy component two is composed of Rhizoma Polygoni 5-8 parts, Curcuma zedoary 3-5 parts, Poria cocos 3-5 parts, Rhizoma Atractylodis 5-8 parts and gelatin 20-30 parts by weight fraction; the efficacy component three is composed of five Lingzhi 10-15 parts, Fritillaria 5-10 parts, Radix Paeoniae 5-10 parts and gelatin 20-30 parts by weight fraction; All the raw materials of the efficacy components are independently ground and powdered, then each kind of raw material powder is added to sterile water and boiled for 2-3h, then filtered, the filter residue is added to sterile water and boiled for 2-3h again, then filtered, the filtrates of the two times of filtration are mixed to form a mixed filtrate; The mixed filtrate of all the raw materials of the efficacy component one except gelatin is mixed and concentrated, the gelatin is added during the mixing and heating concentration, and the gelatin medicine one is prepared when the concentration reaches a viscous state, and cooled to 30-45℃ for use; The raw materials of the efficacy component two and the efficacy component three are treated in the same way as the efficacy component one, and the gelatin medicine two and the gelatin medicine three are prepared respectively.

[0038] The core western medicine gel granule pill is coated with gel medicine three for the first layer, then coated with gel medicine two for the second layer, and finally coated with gel medicine one for the third layer. After the coating is completed, it is dried in a sterile environment, and then placed in a capsule shell (similar to the shell of a capsule medicine) to produce the medicine of Example One. It is mainly used for the treatment of thyroid nodules.

[0039] Example Two Half of the weight of methimazole in the core western medicine gel granule pill is removed, and then divided into three parts and added to therapeutic component one, therapeutic component two, and therapeutic component three, respectively. When heating and concentrating, methimazole and gelatin are added to prepare corresponding gel medicine one, gel medicine two, and gel medicine three.

[0040] The core western medicine gel granule pill with half the amount of methimazole is coated with three layers, using the same coating method as Example One. After the coating is completed, it is dried in a sterile environment, and then placed in a capsule shell to produce the medicine of Example Two. It is mainly used for the treatment of thyroid nodules.

[0041] Example Three The mixed filtrate of all raw materials in therapeutic component one, therapeutic component two, and therapeutic component three is mixed and concentrated to produce a total gel medicine.

[0042] The core western medicine gel granule pill is coated with one layer of total gel medicine, and the one-layer coated pill is dried in a sterile environment, and then placed in a capsule shell to produce the medicine of Example Three. It is mainly used for the treatment of thyroid nodules.

[0043] Example Four Fish gel oil, soybean oil, and olive oil are added to a sterile tank and heated to 70-80°C while stirring. Then, polyoxyethylene hydrogenated castor oil is added to the oil phase and stirred to dissolve. After mixing evenly, the western medicine mixture formed by adding methimazole is added, and the mixture is kept at 70-80°C for use.

[0044] The mixed filtrate of all raw materials in therapeutic component one, therapeutic component two, and therapeutic component three is mixed, and the western medicine mixture is added to the concentrated solution (three-layer coating concentrated solution) for concentration. Gelatin is added during concentration. After concentration is completed, the pill is cooled and produced as the medicine of Example Four. It is mainly used for the treatment of thyroid nodules.

[0045] Example Five Replace methimazole in Example One with propylthiouracil, and the other raw materials and preparation steps remain the same to produce the medicine of Example Five.

[0046] The use methods of the medicines of Example One, Example Two, Example Three, Example Four, and Example Five are the same: The drugs prepared in Examples 1 to 5 are selected for patients with similar conditions of thyroid nodules, taken orally, once a day, according to the standard patient weight of 80-150 pounds, 2 pills at a time, 150-200 pounds, 3 pills at a time, and 200 pounds or more, 4 pills at a time.

[0047] 10 days is a course of treatment, and after the end of a course of treatment, it needs to be interval 0-3 days, and then continue the next course of treatment.

[0048] Example 6 Replace the methimazole in Example 1 with tamoxifen, and the other raw materials and preparation steps remain unchanged to make the drug of Example 6. It is mainly used for the treatment of breast nodules.

[0049] Example 7 Replace the methimazole in Example 2 with tamoxifen, and the other raw materials and preparation steps remain unchanged to make the drug of Example 7. It is mainly used for the treatment of breast nodules.

[0050] Example 8 Replace the methimazole in Example 3 with tamoxifen, and the other raw materials and preparation steps remain unchanged to make the drug of Example 8. It is mainly used for the treatment of breast nodules.

[0051] Example 9 Replace the methimazole in Example 4 with tamoxifen, and the other raw materials and preparation steps remain unchanged to make the drug of Example 9. It is mainly used for the treatment of breast nodules.

[0052] Example 10 Replace the tamoxifen in Example 6 with toremifene, and the other raw materials and preparation steps remain unchanged to make the drug of Example 10. It is mainly used for the treatment of breast nodules.

[0053] The use methods of the drugs of Examples 6, 7, 8, 9 and 10 are the same: The drugs prepared in Examples 6 to 10 are selected for patients with similar conditions of breast nodules, taken orally, once a day, according to the standard patient weight of 80-150 pounds, 2 pills at a time, 150-200 pounds, 3 pills at a time, and 200 pounds or more, 4 pills at a time.

[0054] Example 11 Add the same amount of tamoxifen to the methimazole in Example 1, and the other raw materials and preparation steps remain unchanged to make the drug of Example 11. It is used for the simultaneous treatment of thyroid nodules and breast nodules.

[0055] Example 12 In the methimazole of Example Two, add the same amount of tamoxifen, and the other raw materials and preparation steps remain unchanged, to make the medicine of Example Twelve. Used for simultaneous treatment of thyroid nodules and breast nodules.

[0056] Example Thirteen In the methimazole of Example Three, add the same amount of tamoxifen, and the other raw materials and preparation steps remain unchanged, to make the medicine of Example Thirteen. Used for simultaneous treatment of thyroid nodules and breast nodules.

[0057] Example Fourteen In the methimazole of Example Four, add the same amount of tamoxifen, and the other raw materials and preparation steps remain unchanged, to make the medicine of Example Fourteen. Used for simultaneous treatment of thyroid nodules and breast nodules.

[0058] Example Fifteen In the methimazole of Example One, add the same amount of toremifene, and the other raw materials and preparation steps remain unchanged, to make the medicine of Example Fifteen. Used for simultaneous treatment of thyroid nodules and breast nodules.

[0059] The medicines of Example Eleven, Example Twelve, Example Thirteen, Example Fourteen and Example Fifteen are used in the same way: The medicines prepared in Example Eleven to Fifteen are all orally taken by patients who are simultaneously suffering from thyroid nodules and breast nodules in the same way. For patients with a body weight of 80-150 kg, take 2 pills at a time; for patients with a body weight of 150-200 kg, take 3 pills at a time; for patients with a body weight of more than 200 kg, take 4 pills at a time.

[0060] 10 days is a course of treatment, and after the end of a course of treatment, an interval of 0-3 days is needed before the next course of treatment is continued.

[0061] Example Sixteen In the methimazole of Example One, replace it with ibuprofen, and the other raw materials and preparation steps remain unchanged, to make the medicine of Example Sixteen. Used for treatment of acute thyroiditis, breast hyperplasia, etc.

[0062] Example Seventeen In the methimazole of Example Two, replace it with ibuprofen, and the other raw materials and preparation steps remain unchanged, to make the medicine of Example Seventeen. Used for treatment of acute thyroiditis, breast hyperplasia, etc.

[0063] Example Eighteen In the methimazole of Example Three, replace it with ibuprofen, and the other raw materials and preparation steps remain unchanged, to make the medicine of Example Eighteen. Used for treatment of acute thyroiditis, breast hyperplasia, etc.

[0064] Example Nineteen The methimazole in Example Four is replaced by ibuprofen, and other raw materials and preparation steps are unchanged to prepare the medicine of Example Nineteen. It is used for treating acute thyroiditis, breast hyperplasia, etc.

[0065] Example Twenty The methimazole in Example One is replaced by diclofenac sodium, and other raw materials and preparation steps are unchanged to prepare the medicine of Example Twenty. It is used for treating acute thyroiditis, breast hyperplasia, etc.

[0066] Example Twenty-one The methimazole in Example One is replaced by celecoxib, and other raw materials and preparation steps are unchanged to prepare the medicine of Example Twenty-one. It is used for treating acute thyroiditis, breast hyperplasia, etc.

[0067] The medicines of Example Sixteen, Example Seventeen, Example Eighteen, Example Nineteen, Example Twenty and Example Twenty-one are used in the same way: The medicines prepared in Example Sixteen to Example Twenty-one are all selected for patients with similar conditions of acute thyroiditis, breast hyperplasia, etc. at the same time. They are taken orally, once a day, and one time takes 2 pills for patients with a standard weight of 80-150 pounds, 3 pills for patients with a standard weight of 150-200 pounds, and 4 pills for patients with a standard weight of more than 200 pounds.

[0068] 10 days are a course of treatment, and after the end of a course of treatment, the next course of treatment is continued after an interval of 0-3 days.

[0069] Example Twenty-two to Example Thirty-three The methimazole in Example One is replaced by one of methimazole or propylthiouracil, one of tamoxifen or toremifene, and one of ibuprofen, diclofenac sodium or celecoxib to form 12 kinds of mixed medicines, and other raw materials and preparation steps are unchanged from Example One to prepare the medicines of Example Twenty-two to Example Thirty-three.

[0070] The medicines prepared in Example Twenty-two to Example Thirty-three are all selected for patients with multiple adenoid nodules and serious conditions. They are taken orally, once a day, and one time takes 2 pills for patients with a standard weight of 80-150 pounds, 3 pills for patients with a standard weight of 150-200 pounds, and 4 pills for patients with a standard weight of more than 200 pounds.

[0071] 10 days are a course of treatment, and after the end of a course of treatment, the next course of treatment is continued after an interval of 0-3 days.

[0072] In the embodiment one to embodiment thirty-three, the oil phase (fish gelatin oil, soybean oil, olive oil, oleic acid, ethyl oleate and oleic acid polyethylene glycol glycerol ester one or more) and surfactant (polyoxyethylene hydrogenated castor oil or tween 20 one or two) are selected, the drug efficacy is basically not affected, only the dissolution rate of gastric acid is affected, but the difference is not big, according to the needs of selection and replacement.

[0073] When the drug efficacy test is carried out (embodiment one to embodiment thirty-three), the capsule core western medicine does not need to add pigment in the preparation process.

[0074] Test result analysis (treatment of thyroid nodule, embodiment one to embodiment five): In the embodiment one to embodiment five of treating thyroid nodule, the drug efficacy will have a big gap, especially the side effect of drug efficacy is very different, the effect is better. But the side effect of embodiment one and embodiment two is small, the treatment process will appear to soothe the liver and regulate qi, promote blood circulation and remove blood stasis, the body is comfortable, then appear soft and dispel knot, finally, the effect of western medicine will appear obvious, the effect of mutual influence of traditional Chinese medicine and western medicine is not big. But a small amount of western medicine will appear in the early stage of embodiment two, when the traditional Chinese medicine drug efficacy plays a role, a small amount of western medicine will play a role to assist treatment, the effect of embodiment one and embodiment five is not big (since the western medicine effect of methimazole and propylthiouracil is basically the same, the curative effect is not big). But the curative effect of embodiment three is concentrated in the first, second and third curative effect components, the traditional Chinese medicine drug efficacy will be concentrated and burst, which has a greater impact on the body. Embodiment three starts to soften and disperse knot without the phenomenon of soothing the liver and regulating qi, promoting blood circulation and removing blood stasis, the effect of softening and dispersing knot is not good, and the side effect of traditional Chinese medicine is greater than that of embodiment one and embodiment two.

[0075] In embodiment four, traditional Chinese medicine and western medicine will play a role together, the side effect is big, the damage to the body is big, sometimes the phenomenon of poor drug efficacy caused by the mutual influence of traditional Chinese medicine and western medicine will occur, and the treatment effect may be not as good as embodiment one, embodiment two and embodiment five due to the reasons such as the patient can not effectively absorb or the side effect is big.

[0076] Test result analysis (treatment of breast nodule, embodiment six to embodiment ten): The drug treatment effects of Examples Six, Seven and Ten all appear the phenomena of soothing the liver and regulating Qi, promoting blood circulation and removing blood stasis, the body is comfortable, then appears the phenomena of softening and resolving hard masses, and finally appears the relatively obvious effects of western medicine. Since it is adopted the multi-layer coating structure, and the structure layers corresponding to Examples One, Two and Five are the same, it shows that the structure layer design is to realize the different time period effects of the Chinese medicine components, and the effects of the mixed multiple Chinese medicine raw materials will be reduced, and the side effects will be greater, but according to the treatment effects of soothing the liver and regulating Qi, promoting blood circulation and removing blood stasis and softening and resolving hard masses, the Chinese medicine is divided into three groups of components, and three layers of coating layers are formed, therefore, the side effects of the layered coating are small, the effects are better, the influence of the interaction between the Chinese medicine and the western medicine is reduced, and the effects of Examples Six, Seven and Ten in treating breast nodules are better.

[0077] Test result analysis (treatment of thyroid nodules and breast nodules, Examples Eleven to Fifteen): The Chinese medicine of Examples Eleven, Twelve and Fifteen all appear the phenomena of soothing the liver and regulating Qi, promoting blood circulation and removing blood stasis, the body is comfortable, then appears the phenomena of softening and resolving hard masses, and finally appears the relatively obvious effects of western medicine, but since the western medicine is a double-component drug (the corresponding western medicine main drugs are provided for thyroid nodules and breast nodules), therefore the effects of the western medicine are greater (than the effects of the western medicine of Examples One, Two and Five and Examples Six, Seven and Ten), but the side effects of Examples Eleven, Twelve and Fifteen are smaller than those of Examples Thirteen and Fourteen.

[0078] Test result analysis (treatment of acute thyroiditis, breast hyperplasia, etc., Examples Sixteen to Twenty-one): The effects of the western medicine part are stronger than those of the drugs for treating thyroid nodules and breast nodules (Examples Eleven to Fifteen), but the effects of the Chinese medicine part of Examples Sixteen, Seventeen, Twenty and Twenty-one are relatively moderate, and also appear the phenomena of soothing the liver and regulating Qi, promoting blood circulation and removing blood stasis, the body is comfortable, then appears the phenomena of softening and resolving hard masses, and finally appears the relatively obvious effects of western medicine.

[0079] Test result shows (mainly for patients with complicated multiple sites of glandular nodules and serious conditions, Examples Twenty-two to Thirty-three): It is not recommended to combine Chinese medicine and western medicine, and the selection of drugs should be based on the patient's condition, the side effects of western medicine are large, and it is recommended to take Chinese medicine and western medicine separately, and it needs to be taken according to the doctor's advice, the side effects of western medicine are relatively obvious during the test process, but the Chinese medicine also appears the phenomena of soothing the liver and regulating Qi, promoting blood circulation and removing blood stasis in the early stage of playing a role, the body is comfortable, then appears the phenomena of softening and resolving hard masses, and finally appears the relatively obvious effects of western medicine, but when the western medicine plays a role, the effects of the Chinese medicine have not dissipated, and will be superimposed on the western medicine, the side effects on the patient will be superimposed, and if the patient's condition is serious, it is not recommended to use coating.

[0080] In the description of the application, references to "one embodiment", "an example", "certain examples" etc. mean that a particular feature, structure, material or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the application. The appearances of the phrases "in one embodiment", "an example" or "in certain examples" in various places in the specification are not necessarily referring to the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics can be combined in any suitable manner in one or more embodiments or examples.

[0081] The preferred embodiments of the application disclosed above are only to help explain the application. The preferred embodiments do not describe all of the details of the application and limit the application to the specific embodiments described. Obviously, many modifications and variations of the application can be made in light of the teachings above. The embodiments are chosen and described in order to best explain the principles of the application and its practical application and to enable others skilled in the art to best utilize the application. The application is limited only by the claims and their full scope and equivalents.

Claims

1. A pharmaceutical composition for treating adenoid nodules, characterized by comprising a mixture of a drug for treating adenoid nodules and a drug for treating bronchial asthma. The medicine composition comprises a traditional Chinese medicine combination part and a western medicine combination part; wherein the traditional Chinese medicine combination part comprises a curative effect component one, a curative effect component two and a curative effect component three, and the western medicine combination part comprises a functional component one, a functional component two and a functional component three; The curative effect component one is composed of 2-5 parts of Chaihu, 2-5 parts of Yujin, 5-10 parts of Xiangfu, 5-10 parts of Chenpi, 3-5 parts of Meigui and 20-30 parts of gelatin by weight; The curative effect component two is composed of 5-8 parts of Sanleng, 3-5 parts of E'zhu, 3-5 parts of Fuling, 5-8 parts of Baishu and 20-30 parts of gelatin by weight; The curative effect component three is composed of 10-15 parts of Wulingzhi, 5-10 parts of Zhebeimu, 5-10 parts of Mudanpi and 20-30 parts of gelatin by weight; The functional component one is composed of 10-15 parts of methimazole or 10-15 parts of propylthiouracil, 20-30 parts of oil phase and 10-15 parts of surfactant by weight; The functional component two is composed of 10-15 parts of tamoxifen or 10-15 parts of toremifene, 20-30 parts of oil phase and 10-15 parts of surfactant by weight; The functional component three is composed of one of 10-15 parts of ibuprofen, 10-15 parts of diclofenac sodium or 10-15 parts of celecoxib, 20-30 parts of oil phase and 10-15 parts of surfactant by weight; The functional component one, the functional component two and the functional component three are mixed to form a core-sheathed western medicine; One, two or three of the curative effect component one, the curative effect component two and the curative effect component three are used to coat the core-sheathed western medicine layer by layer.

2. The pharmaceutical composition for treating adenoid nodules according to claim 1, wherein At least one of the curative effect component one and the curative effect component two is used as an outer coating, and the curative effect component three is coated outside the core-sheathed western medicine; The curative effect component three is coated outside the core-sheathed western medicine, and the coating layer formed by the curative effect component one and / or the curative effect component two is coated outside the curative effect component three.

3. The pharmaceutical composition for treating adenoid nodules according to claim 2, wherein A certain proportion of the curative effect component three is mixed in the curative effect component one and the curative effect component two, and the weight ratio of the curative effect component three in the curative effect component one and the curative effect component two is 20-40%.

4. The pharmaceutical composition for treating adenoid nodules according to claim 1, wherein The oil phase is one or more of fish glue oil, soybean oil, olive oil, oleic acid, ethyl oleate and oleic acid polyethylene glycol glyceride, the surfactant is one or both of polyoxyethylene hydrogenated castor oil and Tween 20, and the oil phase component contains 10-15% of gelatin by weight.

5. The pharmaceutical composition for treating adenoid nodules according to claim 1, wherein The medicine composition is a tablet-shaped capsule or a granular capsule.

6. A method of preparing a pharmaceutical composition for treating adenoid nodules, characterized by, The components of the medicine composition of any one of claims 1-5 are prepared by the following steps: S1: weigh 10-15 parts of methimazole or 10-15 parts of propylthiouracil of the functional component one, 20-30 parts of oil phase and 10-15 parts of surfactant; weigh 10-15 parts of tamoxifen or 10-15 parts of toremifene of the functional component two, 20-30 parts of oil phase and 10-15 parts of surfactant; weigh one of 10-15 parts of ibuprofen, 10-15 parts of diclofenac sodium or 10-15 parts of celecoxib of the functional component three, 20-30 parts of oil phase and 10-15 parts of surfactant; The raw materials in the functional component one, the functional component two and the functional component three are mixed respectively to make capsules, forming single-component capsule core western medicine; Any two or three of the functional component one, the functional component two and the functional component three are mixed to make capsules, forming mixed-component capsule core western medicine; S2: The single-component capsule core western medicine and the mixed-component capsule core western medicine in step S1 are made into oval capsules or round tablet type capsules by a shaping machine; S3: Take 2-5 parts of Bupleurum falcatum, 2-5 parts of Curcuma zedoary, 5-10 parts of Cyperus rotundus, 5-10 parts of Citrus reticulata, 3-5 parts of Rosa rugosa and 20-30 parts of gelatin for the curative component one; 5-8 parts of Rhizoma Sparganii, 3-5 parts of Curcuma zedoary, 3-5 parts of Poria cocos, 5-8 parts of Atractylodes macrocephala and 20-30 parts of gelatin for the curative component two; 10-15 parts of Arisaema amurense, 5-10 parts of Fritillaria thunbergii, 5-10 parts of Paeonia suffruticosa and 20-30 parts of gelatin for the curative component three; The raw materials in the curative component one, the curative component two and the curative component three are mixed respectively to make gel medicine, and the gel medicine made from the curative component three is used to coat the oval capsules or round tablet type capsules to form a first layer of coating, and then the gel medicine made from the curative component one and the curative component two is used to coat the capsules with the first layer of coating to form a second layer or / and a third layer of coating, forming a coated capsule medicine; S4: After each layer of coating in step S3, the next layer of coating is carried out immediately, and after the last layer of coating, the coated capsule medicine is placed in a sterile environment for ventilation and drying.

7. The method of claim 6, wherein the method is for preparing a pharmaceutical composition for treating adenoid tonsillar nodules. The raw materials in the functional component one, the functional component two and the functional component three are processed by the same method, the oil phase raw materials are heated to 70-80℃ in a sterile tank while stirring, then the surfactant is slowly added to the oil phase for stirring and dissolution, after mixing, methylthiouracil or propylthiouracil is added dropwise for the preparation of the functional component one, tamoxifen or toremifene is added dropwise for the preparation of the functional component two, and ibuprofen, diclofenac sodium or celecoxib is added dropwise for the preparation of the functional component three, and they are uniformly dissolved, then the core western medicine gel liquid is prepared by the equipment; Alternatively, one of methylthiouracil or propylthiouracil, one of tamoxifen or toremifene, one of ibuprofen, diclofenac sodium or celecoxib is selected, then any two or three of the selected three kinds of drugs are mixed and added to the oil phase for dissolution to prepare a mixed-component core western medicine gel liquid, which is then granulated by the equipment.

8. The method of claim 6, wherein the method is for preparing a pharmaceutical composition for treating adenoid nodules. The raw materials in the curative component one, the curative component two and the curative component three are crushed into powder, then each kind of raw material powder is added to sterile water and boiled, then filtered, the residue is added to sterile water for secondary boiling and filtering, the filtrates after two times of filtering are mixed to form a mixed filtrate, the mixed filtrate of each raw material in the curative component one is concentrated to form a total mixed filtrate one, and the mixed filtrate of each raw material in the curative component two and the curative component three is also concentrated to form a corresponding total mixed filtrate two and a total mixed filtrate three; The total mixed filtrate one, the total mixed filtrate two and the total mixed filtrate three are heated and concentrated, and gelatin is added for gelatin medicine making during the heating and concentrating process to prepare gel medicine.

9. The method of claim 6, wherein the preparation method of the pharmaceutical composition for treating adenoid nodules is characterized by, The capsule core western medicine adds pigment according to different components or different mixed components in the preparation process, so as to identify the medicinal effect type of the capsule core western medicine.

10. The method of claim 6, wherein the preparation method of the pharmaceutical composition for treating adenoid nodules is characterized by, The wrapped capsule medicine is wrapped with a moisture-proof capsule shell after ventilation and air drying.