CN114177244A - Traditional Chinese medicine composition for treating thyroid cancer and preparation method thereof - Google Patents
Traditional Chinese medicine composition for treating thyroid cancer and preparation method thereof Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/481—Astragalus (milkvetch)
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- A61K36/06—Fungi, e.g. yeasts
- A61K36/07—Basidiomycota, e.g. Cryptococcus
- A61K36/076—Poria
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/284—Atractylodes
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/536—Prunella or Brunella (selfheal)
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/65—Paeoniaceae (Peony family), e.g. Chinese peony
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/888—Araceae (Arum family), e.g. caladium, calla lily or skunk cabbage
- A61K36/8884—Arisaema, e.g. Jack in the pulpit
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- A61K36/88—Liliopsida (monocotyledons)
- A61K36/888—Araceae (Arum family), e.g. caladium, calla lily or skunk cabbage
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- A61K36/88—Liliopsida (monocotyledons)
- A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
- A61K36/8966—Fritillaria, e.g. checker lily or mission bells
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- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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- A61K2236/30—Extraction of the material
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- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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- A61K2236/50—Methods involving additional extraction steps
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
Abstract
The invention belongs to the field of traditional Chinese medicines, and particularly discloses a traditional Chinese medicine composition for treating thyroid cancer and a preparation method thereof. The traditional Chinese medicine composition is prepared from 9 raw medicinal materials of astragalus, bighead atractylodes rhizome, poria cocos, white paeony root, rhizoma arisaematis preparata, thunberg fritillary bulb, pinellia ternate, oroxylum indicum and selfheal, and has the effects of strengthening spleen, tonifying qi, eliminating dampness, reducing phlegm, softening hardness and dissipating stagnation. The pharmacodynamics experiment results show that the traditional Chinese medicine composition can obviously inhibit the growth of human thyroid cancer tumor in a tumor-bearing nude mouse, obviously inhibit the proliferation of thyroid cancer cells in vitro, has exact treatment effect on thyroid cancer, and provides a new clinical medication selection for patients.
Description
Technical Field
The invention relates to a traditional Chinese medicine composition and a preparation method thereof, in particular to a traditional Chinese medicine composition for treating thyroid cancer and a preparation method thereof, and belongs to the field of traditional Chinese medicines.
Background
Thyroid cancer is the most common malignant tumor of thyroid gland, and the incidence rate of thyroid cancer is obviously increased in recent years, especially in coastal cities. The young and middle-aged people are high-incidence population of thyroid cancer, and women are more than men, and the ratio of men to women is 1: 3. Thyroid cancer is characterized by the appearance of more women and fewer men and is related to the physiological function of the thyroid gland.
Thyroid cancer does not have obvious symptoms at the initial stage, and the lump appears only in the thyroid tissue, is usually gradually enlarged, has uneven surface and hard texture, and reduces the up-down movement degree of the lump when being swallowed; in the late stage, compression symptoms and distant metastasis may occur, such as compression of the recurrent laryngeal nerve and trachea, hoarseness and dyspnea may occur, and compression of the sympathetic ganglion of the neck may produce Horner syndrome. Most thyroid cancers originate from follicular epithelial cells, including papillary cancers, follicular adenocarcinoma, undifferentiated cancers and medullary cancers from parachlorofollicular cells, and have relatively good prognosis, mostly occur in young people and survival rate of over 90 percent; the follicular adenocarcinoma tumor grows faster, belongs to moderate malignancy and is easy to transfer by blood circulation; undifferentiated carcinoma had a poor prognosis with an average survival time of 3-6 months.
At present, the clinical treatment of thyroid cancer is mainly performed by operation treatment, is matched with auxiliary chemotherapy, is cancer differentiation feasible radiotherapy, is normalized in target treatment, has better overall prognosis when being used for treating various types of thyroid cancers by a simple western medicine, still has higher recurrence rate, and is easy to cause symptoms such as recurrent laryngeal nerve injury, postoperative chylomicron fistula, hemorrhage, trachea collapse and the like after the operation. The chemotherapy drugs have high toxicity, and can kill tumor cells without selectively killing human autoimmune cells such as leucocytes, lymphocytes and the like, so that patients often have great adverse reactions due to infection caused by low autoimmune capability, long treatment course and high cost, and have great limitations in clinical use.
In recent years, the clinical experience of traditional Chinese medicine for treating thyroid cancer is continuously abundant, and certain clinical effects have been achieved. Thyroid cancer belongs to the category of 'goiter and tumor' in traditional Chinese medicine, emotional internal injury and improper diet are two main causes of thyroid cancer, and qi stagnation, phlegm coagulation, blood stasis and congestion before neck are basic causes and pathogenesis of goiter. In the early stage of this disease, stagnation of qi activity, accumulation of phlegm and fluid, accumulation of phlegm and qi in the front of the neck may cause blood stasis. The traditional Chinese medicine can integrally regulate the physique of a patient while treating the primary morbidity, and has the advantages of comprehensive curative effect, less adverse reaction and less contraindication. The traditional Chinese medicine has important functions in the aspects of relieving adverse reactions of thyroid cancer radiotherapy and operative treatment, improving the living quality of patients and comprehensively treating.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine composition for treating thyroid cancer, which is prepared from 9 raw medicinal materials including astragalus membranaceus, bighead atractylodes rhizome, poria cocos, radix paeoniae alba, rhizoma arisaematis preparata, thunberg fritillary bulb, pinellia ternate, oroxylum indicum and selfheal, has the effects of strengthening spleen and tonifying qi, eliminating dampness and phlegm, softening hardness and dissipating stagnation, can be used for treating thyroid cancer, and has an obvious effect.
A traditional Chinese medicine composition for treating thyroid cancer is prepared from the following traditional Chinese medicine components in parts by weight:
10-20 parts of astragalus membranaceus, 5-15 parts of bighead atractylodes rhizome and 5-15 parts of poria cocos
5-15 parts of white peony root, 5-15 parts of prepared arisaema tuber, 5-15 parts of thunberg fritillary bulb
5-15 parts of pinellia ternate, 3-9 parts of oroxylum indicum and 5-15 parts of selfheal.
Preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine components in parts by weight:
15 parts of astragalus membranaceus, 9 parts of bighead atractylodes rhizome and 9 parts of poria cocos
9 parts of white peony root, 9 parts of prepared arisaema tuber, 9 parts of thunberg fritillary bulb
9 parts of pinellia ternate, 9 parts of oroxylum indicum and 9 parts of selfheal.
In the formula, the astragalus root is sweet in taste and slightly warm, and has the effects of tonifying qi and invigorating yang, tonifying defensive qi and consolidating superficial resistance, and inducing diuresis and relieving swelling; the white atractylodes rhizome is bitter in taste, sweet and warm in nature, and can tonify qi, invigorate spleen, eliminate dampness and promote diuresis; the astragalus and the bighead atractylodes rhizome have synergistic effect, and the effects of strengthening spleen and replenishing qi, and promoting diuresis and excreting dampness are enhanced, and the astragalus and the bighead atractylodes rhizome are combined as monarch drugs. Pinellia tuber, pungent and warm in property, can dry dampness and resolve phlegm, relieve distension and fullness and dissipate stagnation; the processed rhizoma arisaematis is bitter in nature and cool in taste, and can clear and resolve heat phlegm, dispel wind and stop spasm; zhejiang fritillaria is bitter and cold in taste, enters lung and heart channels, and can clear heat, reduce phlegm, dissipate stagnation and cure carbuncle; the 3 medicines are mutually reinforced to play the roles of eliminating dampness and phlegm and softening hardness and dissipating stagnation together, and are used as ministerial medicines together. Poria has sweet taste and neutral nature, and has effects in promoting diuresis, eliminating dampness, invigorating spleen and stomach, calming heart and tranquilizing mind; the white peony root is sweet and pungent in flavor and warm in nature, enters liver, spleen and kidney channels, and has the effects of nourishing blood, astringing yin, relieving spasm and relieving pain; the composition can be used together with Poria for nourishing blood, softening liver, eliminating dampness, and invigorating spleen. The selfheal is bitter, pungent and cold in taste and has the effects of dispersing stagnation and detoxifying; the oroxylum indicum is bitter, sweet and cool in taste, enters lung, liver and stomach channels, and can clear heat, relieve sore throat and reduce phlegm; the 2 medicines are combined to clear lung and relieve sore throat, soothe liver and harmonize stomach, and are guiding medicines.
The 9 traditional Chinese medicines such as the astragalus, the bighead atractylodes rhizome and the like are combined according to the compatibility theory of monarch, minister, assistant and guide in traditional Chinese medicine, the medicines are combined and synergized, the effects of strengthening spleen and tonifying qi, eliminating dampness and phlegm, softening hardness and dissipating stagnation, and nourishing yin and clearing heat are achieved, and the traditional Chinese medicine is used for treating thyroid cancer and has multiple good effects.
The invention also aims to provide a traditional Chinese medicine oral medicinal preparation containing the traditional Chinese medicine composition and a preparation method thereof, wherein the traditional Chinese medicine oral medicinal preparation is one of oral liquid, mixture, granules, microcapsules, capsules, pills and tablets.
The preparation method of the traditional Chinese medicine oral pharmaceutical preparation comprises the following steps:
A. 9 raw material medicines of astragalus, bighead atractylodes rhizome, poria cocos, white paeony root, prepared arisaema consanguineum schott, thunberg fritillary bulb, pinellia ternate, oroxylum indicum and selfheal are taken, wherein the astragalus, the bighead atractylodes rhizome, the poria cocos, the white paeony root and the prepared arisaema consanguineum schott are cleaned and then sliced, the thunberg fritillary bulb and the pinellia ternate are coarsely crushed, the selfheal is cut into segments, and the oroxylum indicum is cleaned and selected for later use;
B. weighing the raw material medicinal slices in the step A according to the formula amount, uniformly mixing, adding 6-10 times of water, decocting for 2-3 times, each time for 1-3h, filtering decoction, and concentrating under reduced pressure to obtain an extract I for later use;
C. adding ethanol into the extract I obtained in the step B, standing, performing cold precipitation, filtering, recovering ethanol from the filtrate, and concentrating to obtain an extract II for later use;
D. and (4) adding pharmaceutically acceptable auxiliary materials into the extract II obtained in the step C according to a conventional process to prepare an oral medicinal preparation.
Preferably, the water is added in the step B for decoction for 2 times, 8-10 times of the water is added for decoction for 2-3 hours in the first time, and 6-8 times of the water is added for decoction for 1-2 hours in the second time.
Preferably, the decoction in the step B is concentrated under reduced pressure to extract I with the relative density of 1.12-1.18 at 50-60 ℃.
Preferably, the extract II with the relative density of 1.20-1.30 at 50-60 ℃ is obtained by concentrating the extract C under reduced pressure.
Preferably, ethanol is added in the step C to ensure that the alcohol content reaches 50-70%, and the mixture is kept stand and subjected to cold precipitation for 24-48 h.
The conventional process of step C includes, but is not limited to, water precipitation, filtration, concentration, drying, pulverization, sieving and the like.
Preferably, the acceptable excipient comprises one or more of a filler, a lubricant, a preservative, a flavoring agent, a disintegrating agent, a binder, a coloring agent and a dispersing agent.
Preferably, the pharmaceutically acceptable excipients include, but are not limited to, lactose, starch, dextrin, sugar powder, magnesium stearate, maltose, citric acid, tartaric acid, sodium hydroxide, aspartame, stevioside, sodium cyclamate, aspartame, potassium acesulfame, aspartame, sucralose, sodium benzoate, and the like.
The traditional Chinese medicine composition is used for preparing a medicine for treating thyroid cancer diseases.
The invention provides the application of a traditional Chinese medicine composition in preparing a medicine for treating thyroid cancer, and pharmacodynamic experiment results show that the traditional Chinese medicine composition can obviously inhibit the growth of human thyroid cancer tumors in nude mice with tumor and obviously inhibit the proliferation of thyroid cancer cells in vitro, has exact treatment effect on thyroid cancer, provides a new clinical medicine selection for patients, and provides a new direction for developing and utilizing traditional Chinese medicine resources in China.
Detailed Description
The present invention is further illustrated below by specific examples in order to provide those skilled in the art with a full understanding of the present invention, but it should be understood by those skilled in the art that the examples of the present invention are not to be construed as limiting the present invention in any way.
EXAMPLE 1 preparation of oral liquid
Astragalus root 1.5kg Atractylodis rhizoma 0.9kg Poria 0.9kg
0.9kg of white peony root, 0.9kg of arisaema cum bile, 0.9kg of thunberg fritillary bulb
Pinellia ternata 0.9kg semen oroxyli 0.9kg Prunellae Spica 0.9kg
A. 9 raw material medicines of astragalus, bighead atractylodes rhizome, poria cocos, white paeony root, prepared arisaema consanguineum schott, thunberg fritillary bulb, pinellia ternate, oroxylum indicum and selfheal are taken, wherein the astragalus, the bighead atractylodes rhizome, the poria cocos, the white paeony root and the prepared arisaema consanguineum schott are cleaned and then sliced, the thunberg fritillary bulb and the pinellia ternate are coarsely crushed, the selfheal is cut into segments, and the oroxylum indicum is cleaned and selected for later use;
B. weighing the raw material medicinal slices in the step A according to the formula amount, uniformly mixing, decocting for 2 times, adding 8 times of water for decocting for 3 hours for the first time, adding 6 times of water for decocting for 2 hours for the second time, combining the decoction, filtering, and concentrating under reduced pressure to obtain an extract I with the relative density of 1.12 at 50-60 ℃ for later use;
C. adding ethanol into the extract I obtained in the step B to enable the ethanol content to reach 70%, standing, performing cold precipitation for 24 hours, filtering, recovering ethanol from the filtrate, and concentrating to obtain an extract II with the relative density of 1.20 at 50-60 ℃ for later use;
D. and C, taking the extract II obtained in the step C, adding cane sugar for flavoring, adding purified water to the total preparation amount, filtering until the clarity is qualified, filling, sterilizing and packaging to obtain the oral liquid.
Example 2 preparation of the composition
Astragalus root 2.0kg Atractylodis rhizoma 0.5kg Poria 1.5kg
0.5kg of white peony root, 1.5kg of arisaema cum bile and 0.5kg of thunberg fritillary bulb
Pinellia ternata 1.5kg semen Oroxyli 0.6kg Prunellae Spica 1.5kg
A. 9 raw material medicines of astragalus, bighead atractylodes rhizome, poria cocos, white paeony root, prepared arisaema consanguineum schott, thunberg fritillary bulb, pinellia ternate, oroxylum indicum and selfheal are taken, wherein the astragalus, the bighead atractylodes rhizome, the poria cocos, the white paeony root and the prepared arisaema consanguineum schott are cleaned and then sliced, the thunberg fritillary bulb and the pinellia ternate are coarsely crushed, the selfheal is cut into segments, and the oroxylum indicum is cleaned and selected for later use;
B. weighing the raw material medicinal slices in the step A according to the formula amount, uniformly mixing, decocting for 2 times, adding 10 times of water for decocting for 2 hours for the first time, adding 8 times of water for decocting for 1 hour for the second time, combining the decoction, filtering, and concentrating under reduced pressure to obtain an extract I with the relative density of 1.15 at 50-60 ℃ for later use;
C. adding ethanol into the extract I obtained in the step B to enable the alcohol content to reach 60%, standing, performing cold precipitation for 24 hours, filtering, recovering ethanol from the filtrate, and concentrating to obtain an extract II with the relative density of 1.28 at 50-60 ℃ for later use;
D. and C, adding sodium benzoate into the extract II obtained in the step C, adding purified water to the total preparation amount, filtering until the clarity is qualified, filling, sterilizing and packaging to obtain a mixture.
EXAMPLE 3 preparation of granules
Astragalus root 1.5kg Atractylodis rhizoma 0.9kg Poria 0.9kg
0.9kg of white peony root, 0.9kg of arisaema cum bile, 0.9kg of thunberg fritillary bulb
Pinellia ternata 0.9kg semen oroxyli 0.9kg Prunellae Spica 0.9kg
A. 9 raw material medicines of astragalus, bighead atractylodes rhizome, poria cocos, white paeony root, prepared arisaema consanguineum schott, thunberg fritillary bulb, pinellia ternate, oroxylum indicum and selfheal are taken, wherein the astragalus, the bighead atractylodes rhizome, the poria cocos, the white paeony root and the prepared arisaema consanguineum schott are cleaned and then sliced, the thunberg fritillary bulb and the pinellia ternate are coarsely crushed, the selfheal is cut into segments, and the oroxylum indicum is cleaned and selected for later use;
B. weighing the raw material medicinal slices in the step A according to the formula amount, uniformly mixing, decocting for 2 times, adding 10 times of water for decocting for 3 hours for the first time, adding 8 times of water for decocting for 1 hour for the second time, combining the decoction, filtering, and concentrating under reduced pressure until the relative density is 1.18 extract I at 50-60 ℃ for later use;
C. adding ethanol into the extract I obtained in the step B to enable the ethanol content to reach 60%, standing, performing cold precipitation for 48 hours, filtering, recovering ethanol from the filtrate, and concentrating to obtain an extract II with the relative density of 1.30 at 50-60 ℃ for later use;
D. and (3) taking the extract II in the step (C), carrying out vacuum drying under the conditions of vacuum degree of-0.09 MPa to-0.10 MPa and 60 ℃, crushing into fine powder, sieving, adding sucrose powder, dextrin and mannitol (weight ratio of 3: 1) according to the formula amount, uniformly mixing, preparing a soft material by using 95% ethanol, granulating, drying, and finishing granules to obtain the granules.
EXAMPLE 4 preparation of granules
Astragalus root 1.0kg Atractylodis rhizoma 1.5kg Poria 0.5kg
White peony root 1.5kg processed arisaema tuber 0.5kg Zhejiang fritillaria 1.5kg
0.5kg of pinellia tuber, 0.5kg of oroxylum indicum, 0.5kg of selfheal
A. 9 raw material medicines of astragalus, bighead atractylodes rhizome, poria cocos, white paeony root, prepared arisaema consanguineum schott, thunberg fritillary bulb, pinellia ternate, oroxylum indicum and selfheal are taken, wherein the astragalus, the bighead atractylodes rhizome, the poria cocos, the white paeony root and the prepared arisaema consanguineum schott are cleaned and then sliced, the thunberg fritillary bulb and the pinellia ternate are coarsely crushed, the selfheal is cut into segments, and the oroxylum indicum is cleaned and selected for later use;
B. weighing the raw material medicinal slices in the step A according to the formula amount, uniformly mixing, decocting for 2 times, adding 8 times of water for decocting for 2 hours for the first time, adding 6 times of water for decocting for 2 hours for the second time, combining the decoction, filtering, and concentrating under reduced pressure until the relative density is 1.15 extract I at 50-60 ℃ for later use;
C. adding ethanol into the extract I obtained in the step B to enable the ethanol content to reach 50%, standing, performing cold precipitation for 48 hours, filtering, recovering ethanol from the filtrate, and concentrating to obtain an extract II with the relative density of 1.28 at 50-60 ℃ for later use;
D. and C, drying the extract II in the step C under normal pressure at 60 ℃, crushing into fine powder, sieving, adding the dextrin and 0.2% of aspartame according to the formula amount, uniformly mixing, granulating, drying, and finishing granules to obtain the granules.
Example 5 preparation of microcapsules
Astragalus root 1.4kg Atractylodis rhizoma 1.0kg Poria 0.8kg
White peony root 1.0kg processed arisaema tuber 0.8kg Zhejiang fritillaria 1.0kg
Pinellia ternata 0.8kg semen oroxyli 0.7kg selfheal 0.8kg
A. 9 raw material medicines of astragalus, bighead atractylodes rhizome, poria cocos, white paeony root, prepared arisaema consanguineum schott, thunberg fritillary bulb, pinellia ternate, oroxylum indicum and selfheal are taken, wherein the astragalus, the bighead atractylodes rhizome, the poria cocos, the white paeony root and the prepared arisaema consanguineum schott are cleaned and then sliced, the thunberg fritillary bulb and the pinellia ternate are coarsely crushed, the selfheal is cut into segments, and the oroxylum indicum is cleaned and selected for later use;
B. weighing the raw material medicinal slices in the step A according to the formula amount, uniformly mixing, decocting for 3 times, adding 10 times of water for decocting for 2 hours for the first time, adding 8 times of water for decocting for 2 hours for the second time, adding 6 times of water for decocting for 1 hour for the third time, combining the decoction, filtering, and concentrating under reduced pressure until the relative density is 1.12 extract I at 50-60 ℃ for later use;
C. adding ethanol into the extract I obtained in the step B to enable the ethanol content to reach 60%, standing, performing cold precipitation for 48 hours, filtering, recovering ethanol from the filtrate, and concentrating to obtain an extract II with the relative density of 1.25 at 50-60 ℃ for later use;
D. and (3) taking the extract II obtained in the step (C), carrying out vacuum drying under the conditions of vacuum degree of-0.09 Mpa to-0.10 Mpa and 60 ℃, and crushing into fine powder, wherein the mass ratio of the sodium chelatin: the mixture of maltodextrin 3: 2 is taken as a capsule wall material, and the weight ratio of octadecanol: titanium dioxide is 3: 1 as an anti-sticking agent, and the mass ratio of polyethylene glycol: adding the capsule wall material, the anti-sticking agent and the plasticizer into purified water, heating and stirring at 55 ℃ to dissolve the capsule wall material, the anti-sticking agent and the plasticizer to prepare a capsule wall material solution with the mass fraction of 34%, cooling to room temperature, adding the fine extract powder under stirring, and adding 1.1% of sucrose fatty acid ester in the total amount of the preparation formula: homogenizing and emulsifying soybean phospholipid 8: 5 composite emulsifier to obtain emulsion;
E. and D, carrying out spray drying on the emulsion in the step D under the conditions of air inlet temperature of 162 ℃, spray pressure of 0.45MPa and feeding speed of 22.5mL/min, collecting the microcapsules, and cooling to obtain the microcapsule.
EXAMPLE 6 preparation of tablets
Astragalus root 1.8kg Atractylodis rhizoma 0.8kg Poria 1.2kg
0.8kg of white peony root, 1.3kg of arisaema cum bile, 0.8kg of thunberg fritillary bulb
Pinellia ternate 1.2kg semen oroxyli 0.8kg selfheal 1.2kg
A. 9 raw material medicines of astragalus, bighead atractylodes rhizome, poria cocos, white paeony root, prepared arisaema consanguineum schott, thunberg fritillary bulb, pinellia ternate, oroxylum indicum and selfheal are taken, wherein the astragalus, the bighead atractylodes rhizome, the poria cocos, the white paeony root and the prepared arisaema consanguineum schott are cleaned and then sliced, the thunberg fritillary bulb and the pinellia ternate are coarsely crushed, the selfheal is cut into segments, and the oroxylum indicum is cleaned and selected for later use;
B. weighing the raw material medicinal slices in the step A according to the formula amount, uniformly mixing, decocting for 2 times, adding 8 times of water for decocting for 3 hours for the first time, adding 6 times of water for decocting for 2 hours for the second time, combining the decoction, filtering, and concentrating under reduced pressure until the relative density is 1.18 extract I at 50-60 ℃ for later use;
C. adding ethanol into the extract I obtained in the step B to enable the ethanol content to reach 70%, standing, performing cold precipitation for 24 hours, filtering, recovering ethanol from the filtrate, and concentrating to obtain an extract II with the relative density of 1.30 at 50-60 ℃ for later use;
D. and (3) taking the extract II in the step (C), carrying out vacuum drying under the conditions of vacuum degree of-0.09 MPa to-0.10 MPa and 60 ℃, crushing into fine powder, sieving, adding a proper amount of starch, mixing uniformly, adding a 90% ethanol solution to prepare a soft material, granulating, drying, granulating, adding a proper amount of magnesium stearate, mixing, and tabletting to obtain tablets.
EXAMPLE 7 preparation of capsules
Astragalus root 1.6kg Atractylodis rhizoma 0.8kg Poria 1.2kg
0.7kg of white peony root, 1.0kg of arisaema cum bile, 0.7kg of thunberg fritillary bulb
Pinellia ternata 1.0kg semen Oroxyli 0.7kg Prunellae Spica 1.0kg
A. 9 raw material medicines of astragalus, bighead atractylodes rhizome, poria cocos, white paeony root, prepared arisaema consanguineum schott, thunberg fritillary bulb, pinellia ternate, oroxylum indicum and selfheal are taken, wherein the astragalus, the bighead atractylodes rhizome, the poria cocos, the white paeony root and the prepared arisaema consanguineum schott are cleaned and then sliced, the thunberg fritillary bulb and the pinellia ternate are coarsely crushed, the selfheal is cut into segments, and the oroxylum indicum is cleaned and selected for later use;
B. weighing the raw material medicinal slices in the step A according to the formula amount, uniformly mixing, decocting for 3 times, adding 9 times of water for decocting for 2 hours for the first time, adding 8 times of water for decocting for 1 hour for the second time, adding 7 times of water for decocting for 1 hour for the third time, combining the decoctions, filtering, and concentrating under reduced pressure until the relative density is 1.15 extract I at 50-60 ℃ for later use;
C. adding ethanol into the extract I obtained in the step B to enable the alcohol content to reach 60%, standing, performing cold precipitation for 24 hours, filtering, recovering ethanol from the filtrate, and concentrating to obtain an extract II with the relative density of 1.25 at 50-60 ℃ for later use;
D. and (3) taking the extract II in the step (C), carrying out vacuum drying under the conditions of vacuum degree of-0.09 MPa to-0.10 MPa and 60 ℃, crushing into fine powder, sieving, adding the starch, the silica gel micropowder and the low-substituted hydroxypropyl cellulose (the weight ratio is 2: 1) in formula ratio, uniformly mixing, granulating, drying, grading, filling, polishing in a polishing machine, and removing damaged capsules to obtain the traditional Chinese medicine composition.
EXAMPLE 8 preparation of capsules
Astragalus root 1.5kg Atractylodis rhizoma 0.9kg Poria 0.9kg
0.9kg of white peony root, 0.9kg of arisaema cum bile, 0.9kg of thunberg fritillary bulb
Pinellia ternata 0.9kg semen oroxyli 0.4kg Prunellae Spica 0.9kg
A. 9 raw material medicines of astragalus, bighead atractylodes rhizome, poria cocos, white paeony root, prepared arisaema consanguineum schott, thunberg fritillary bulb, pinellia ternate, oroxylum indicum and selfheal are taken, wherein the astragalus, the bighead atractylodes rhizome, the poria cocos, the white paeony root and the prepared arisaema consanguineum schott are cleaned and then sliced, the thunberg fritillary bulb and the pinellia ternate are coarsely crushed, the selfheal is cut into segments, and the oroxylum indicum is cleaned and selected for later use;
B. weighing the raw material medicinal slices in the step A according to the formula amount, uniformly mixing, decocting for 2 times, adding 9 times of water for decocting for 3 hours for the first time, adding 7 times of water for decocting for 2 hours for the second time, combining the decoction, filtering, and concentrating under reduced pressure until the relative density is 1.18 extract I at 50-60 ℃ for later use;
C. adding ethanol into the extract I obtained in the step B to enable the ethanol content to reach 50%, standing, performing cold precipitation for 48 hours, filtering, recovering ethanol from the filtrate, and concentrating to obtain an extract II with the relative density of 1.30 at 50-60 ℃ for later use;
D. and (3) performing belt vacuum drying on the extract II obtained in the step (C) under the conditions of vacuum degree of-0.09 MPa to-0.10 MPa and 60 ℃, crushing into fine powder, sieving, adding the starch and the microcrystalline cellulose in a formula ratio of 5: 1, uniformly mixing, granulating, drying, granulating, filling, polishing in a polishing machine, and removing damaged capsules to obtain the extract.
EXAMPLE 9 preparation of granules
Astragalus root 1.5kg Atractylodis rhizoma 0.9kg Poria 0.9kg
0.9kg of white peony root, 0.9kg of arisaema cum bile, 0.9kg of thunberg fritillary bulb
Pinellia ternata 0.9kg semen oroxyli 0.3kg Prunellae Spica 0.9kg
A. 9 raw material medicines of astragalus, bighead atractylodes rhizome, poria cocos, white paeony root, prepared arisaema consanguineum schott, thunberg fritillary bulb, pinellia ternate, oroxylum indicum and selfheal are taken, wherein the astragalus, the bighead atractylodes rhizome, the poria cocos, the white paeony root and the prepared arisaema consanguineum schott are cleaned and then sliced, the thunberg fritillary bulb and the pinellia ternate are coarsely crushed, the selfheal is cut into segments, and the oroxylum indicum is cleaned and selected for later use;
B. weighing the raw material medicinal slices in the step A according to the formula amount, uniformly mixing, decocting for 2 times, adding 10 times of water for decocting for 3 hours for the first time, adding 8 times of water for decocting for 1 hour for the second time, combining the decoction, filtering, and concentrating under reduced pressure until the relative density is 1.18 extract I at 50-60 ℃ for later use;
C. adding ethanol into the extract I obtained in the step B to enable the ethanol content to reach 60%, standing, performing cold precipitation for 48 hours, filtering, recovering ethanol from the filtrate, and concentrating to obtain an extract II with the relative density of 1.30 at 50-60 ℃ for later use;
D. and (3) taking the extract II in the step (C), carrying out vacuum drying under the conditions of vacuum degree of-0.09 MPa to-0.10 MPa and 60 ℃, crushing into fine powder, sieving, adding sucrose powder, dextrin and mannitol (weight ratio of 3: 1) according to the formula amount, uniformly mixing, preparing a soft material by using 95% ethanol, granulating, drying, and finishing granules to obtain the granules.
EXAMPLE 10 preparation of pellets
Astragalus root 1.20kg Atractylodis rhizoma 0.8kg Poria 1.2kg
0.8kg of white peony root, 1.2kg of arisaema tuber, 0.8kg of thunberg fritillary bulb
Pinellia ternata 1.2kg oroxylum seed 0.8kg prunella vulgaris 0.8kg
A. 9 raw material medicines of astragalus, bighead atractylodes rhizome, poria, white paeony root, thunberg fritillary bulb, pinellia tuber, oroxylum indicum and selfheal are taken, wherein the astragalus, the bighead atractylodes rhizome, the poria, the white paeony root and the prepared arisaema are cleaned and then sliced, the thunberg fritillary bulb and the pinellia tuber are coarsely crushed, the selfheal is cut into segments, and the oroxylum indicum is cleaned and selected for later use;
B. weighing the raw material medicinal slices in the step A according to the formula amount, uniformly mixing, decocting for 3 times, adding 8 times of water for decocting for 3 hours for the first time, adding 6 times of water for decocting for 2 hours for the second time, adding 6 times of water for decocting for 1 hour for the third time, combining the decoction, filtering, and concentrating under reduced pressure until the relative density is 1.18 extract I at 50-60 ℃ for later use;
C. adding ethanol into the extract I obtained in the step B to enable the ethanol content to reach 70%, standing, performing cold precipitation for 48 hours, filtering, recovering ethanol from the filtrate, and concentrating to obtain an extract II with the relative density of 1.26 at 50-60 ℃ for later use;
D. and (4) taking the extract II in the step (C), carrying out vacuum drying under the conditions of vacuum degree of-0.09 MPa to-0.10 MPa and 60 ℃, crushing into fine powder, sieving, adding dextrin, mixing uniformly, making pills, drying, coating and polishing to obtain the pills.
Test example 1 in vivo Effect study on thyroid cancer
In order to verify the efficacy of the traditional Chinese medicine composition for treating thyroid cancer, the inventor carries out abundant pharmacodynamic research. It should be noted that the drug selected for the pharmacodynamic test of the present invention is a representative drug obtained from the formulation and the preparation method thereof, and the test and the result related to the other formulations and the drugs obtained from the preparation method thereof included in the present invention are not limited to the space and are not exhaustive.
1 materials of the experiment
1.1 experimental animals and cellular BALB/c nude mice, male, 6-8 weeks old, weight 18-20g, purchased from Beijing Wintonlihua laboratory animals technologies, Inc., license number: SYXK (Kd) 2019-0025. Human thyroid cancer cells (TT cells) were purchased from shanghai institute of cell biology, china academy of sciences.
1.2 Instrument, reagent and drug AG285 model electronic analytical balance, Mettler-Toledo, Switzerland; model-550 automatic microplate reader, Bio-Rad, USA; clean bench, Suzhou clean plant, Inc. (model SW-CJ-IFD); CO2 incubator, SANYO (model XD-101); the test drug was a sample of granules prepared according to the formulation and method of example 3; doxorubicin (Specification: 10 mg/lot: 16002713), produced by Haizingli pharmaceuticals, Inc.; f12 medium (containing 10% fetal bovine serum), manufactured by Gibco, USA.
2 method of experiment
2.1 cell culture
TT cells were cultured with F12 containing 10% fetal calf serum at 37 ℃ with saturation humidity and 5% CO2Culturing in an incubator. Culturing for 4 days, subculturing, collecting the cells in good log phase after recovery culture, centrifuging, and preparing into 1 × 10 with physiological saline7Cell suspension per mL.
2.2 thyroid cancer tumor-bearing mouse modeling
50 BALB/c nude mice were selected and randomly divided into a model group, a control group and a test group (low dose, medium dose and high dose), 10 mice in each group were used0.1mL (about 1X 10) of TT cell suspension of thyroid cancer was injected subcutaneously6One), the growth of the subcutaneous transplanted tumor of the nude mice is observed every day, and the tumor volume is up to 80mm3The relevant experiments were performed.
2.3 administration by groups
The clinical dosage of the tested drug for the human is 1.45g crude drug/kg, and the rats in the high, medium and low dose groups are respectively administrated with 4.50g/kg, 8.99g crude drug/kg and 17.98g/kg for intragastric administration, which are respectively equal to 2, 1 and 1/2 times of the crude drug dosage of the equivalent traditional Chinese medicine composition commonly used in the clinical of adults; the tail vein injection of the control group is 20mg/kg of adriamycin, the tail vein injection of the model group is 100 mu L of 0.9% physiological saline, and the drug intervention is carried out 1 time every 2 days, and the continuous intervention lasts for 20 days.
2.4 tumor growth status
During the drug intervention period, the vernier caliper is used every day to measure the short diameter (A) and the long diameter (B) of the tumor body, and the tumor volume is B multiplied by A2And/2, calculating the tumor volume ratio as the tumor volume after intervention/the tumor volume before intervention.
2.5 splenic lymphocyte proliferation assay
After the end of the priming, the spleens of the mice were aseptically removed, accurately weighed, and the Spleen Index (SI) was calculated as spleen weight (mg)/body weight (g), the spleens were weighed and prepared into lymphocyte single cell suspensions (strictly aseptic), and the number of the lymphocytes was counted at 1 × 10 per well4The cells are inoculated in a 96-well plate, a tested drug is used as a stimulus source, an MTT experiment is carried out after 48 hours, and the proliferation level of the mouse spleen T, B lymphocytes is detected by a microplate reader.
3 results of the experiment
3.1 Effect on tumor growth in thyroid carcinoma tumor-bearing mice
Compared with the model group, the tumor volume ratio of the experimental group and the control group is reduced on the 7 th, 14 th and 21 th days of intervention (P is less than 0.05); compared with the control group, the tumor volume ratio of the test and the high-dose group at 7 th, 14 th and 21 th days is not statistically different (P > 0.05), which is shown in Table 1.
TABLE 1 tumor growth in groups of thyroid cancer bearing mice (n ═ 10)
Note: compared to the model set: p < 0.05 is denoted by "+"; compared with the control group: p < 0.05 for "▲"means.
3.2 Effect on proliferation of splenic lymphocytes from thyroid cancer tumor-bearing mice
Compared with a thyroid cancer tumor-bearing mouse model group, the SI (spleen index) of a control group mouse is reduced (P is less than 0.05), and the SI of a test group mouse is increased and is dose-dependent (P is less than 0.05); compared with the model group, the proliferation activity of the T cells and the B cells of the control group mice is reduced (P < 0.05), and the proliferation activity of the T cells and the B cells of the test group mice is enhanced and is in dose dependence (P < 0.05), and the proliferation activity is shown in the table 2.
TABLE 2 level of splenic lymphocyte proliferation in thyroid cancer tumor-bearing mice (n ═ 10)
Note: compared to the model set: p < 0.05 is denoted by "+"; compared with the control group: p < 0.05 for "▲"means.
Test example 2 in vitro test on the Effect of antithyroid cancer
1 materials of the experiment
1.1 test cells
TT cells, purchased from Shanghai institute of cell biology, Chinese academy of sciences.
1.2 instruments, reagents and drugs
Clean bench, Suzhou clean plant, Inc. (model SW-CJ-IFD); CO22Incubator, SANYO (model XD-101); model-550 automatic microplate reader, Bio-Rad, USA; DMSO (dimethyl sulfoxide, gauge: 100ml), Sigma Inc. of USA; the test drug was a sample of granules prepared according to the formulation and method of example 3; doxorubicin (Specification: 10 mg/lot: 16002713), produced by Haizingli pharmaceuticals, Inc.; f12 medium (containing 10% fetal bovine serum), manufactured by Gibco, USA.
2 method of experiment
Preparation of example 3 of the invention by modified MTT methodThe prepared granules are subjected to in vitro anti-human thyroid cancer cell experiments: TT cells are prepared to have a concentration of 5 × 104one/mL cell suspension, 100. mu.L cell suspension was added to a 96-well plate, and the plate was placed at 37 ℃ and 5% CO2Culturing for 24h in an incubator; diluting the drug with incomplete medium to different gradient concentrations, adding 100 μ L of corresponding culture solution containing the test drug (the test drug is from the granule prepared in example 3, the crude drug content in the low, medium and high dose groups is 0.14g/mL, 0.28g/mL, 0.56g/mL respectively), setting blank control group (100 μ L without incomplete medium) and solvent group (100 μ L10% DMSO), placing 96-well plate at 37 deg.C and 5% CO2Culturing for 72h in an incubator. Then 20. mu.L of MTT (5mg/mL) was added to each well, the incubation was continued for 4h, the medium was terminated, the medium was discarded, 150. mu.L of DMSO was added to each well for dissolution, and the mixture was gently mixed by shaking for 10 minutes. The absorbance, i.e., the OD value, of each well was measured by a microplate reader, and the average value of each duplicate well was used as the OD value of the group of cells to calculate the inhibition rate of each drug.
3 results of the experiment
Compared with a blank control group and a solvent group, each group has stronger inhibiting effect on TT cells, and each dosage group presents better dose-effect relationship.
TABLE 3 in vitro anti-human thyroid cancer cell assay results
The experimental results show that the traditional Chinese medicine composition provided by the invention can obviously inhibit the growth of human thyroid cancer tumor in a tumor-bearing nude mouse and obviously inhibit the proliferation of thyroid cancer cells in vitro, and the traditional Chinese medicine composition has very strong thyroid cancer resisting effect in vivo and in vitro and can be used for treating thyroid cancer.
Claims (10)
1. A traditional Chinese medicine composition for treating thyroid cancer is characterized by being prepared from the following traditional Chinese medicine components: astragalus root, white atractylodes rhizome, poria, white peony root, arisaema tuber, thunberg fritillary bulb, pinellia tuber, oroxylum indicum and selfheal.
2. The traditional Chinese medicine composition according to claim 1, which is prepared from the following traditional Chinese medicine components in parts by weight:
10-20 parts of astragalus membranaceus, 5-15 parts of bighead atractylodes rhizome and 5-15 parts of poria cocos
5-15 parts of white peony root, 5-15 parts of prepared arisaema tuber, 5-15 parts of thunberg fritillary bulb
5-15 parts of pinellia ternate, 3-9 parts of oroxylum indicum and 5-15 parts of selfheal.
3. The traditional Chinese medicine composition according to claim 2, which is prepared from the following traditional Chinese medicine components in parts by weight:
15 parts of astragalus membranaceus, 9 parts of bighead atractylodes rhizome and 9 parts of poria cocos
9 parts of white peony root, 9 parts of prepared arisaema tuber, 9 parts of thunberg fritillary bulb
9 parts of pinellia ternate, 9 parts of oroxylum indicum and 9 parts of selfheal.
4. An oral pharmaceutical preparation comprising the traditional Chinese medicine composition of any one of claims 1 to 3, wherein the oral pharmaceutical preparation is one of oral liquid, mixture, granules, microcapsules, capsules, pills or tablets.
5. A method of preparing the oral pharmaceutical formulation of claim 4, comprising the steps of:
A. weighing 9 raw material medicines of astragalus, bighead atractylodes rhizome, poria cocos, white paeony root, prepared arisaema consanguineum schott, thunberg fritillary bulb, pinellia ternate, oroxylum indicum and selfheal, wherein the astragalus, the bighead atractylodes rhizome, the poria cocos, the white paeony root and the prepared arisaema consanguineum schott are cleaned and then sliced, the thunberg fritillary bulb and the pinellia ternate are coarsely crushed, the selfheal is cut into segments, and the oroxylum indicum is cleaned and selected for later use;
B. mixing the decoction pieces of the raw material medicine in the step A, adding 6-10 times of water, decocting for 2-3 times, each time for 1-3h, filtering the decoction, and concentrating under reduced pressure to obtain an extract I for later use;
C. adding ethanol into the extract I obtained in the step B, standing, performing cold precipitation, filtering, recovering ethanol from the filtrate, and concentrating to obtain an extract II for later use;
D. and (4) adding pharmaceutically acceptable auxiliary materials into the extract II obtained in the step C according to a conventional process to prepare an oral medicinal preparation.
6. The preparation method according to claim 5, wherein the step B is decocted in water for 2 times, the first time is decocted in water with an amount of 8-10 times that of the decoction for 2-3 hours, and the second time is decocted in water with an amount of 6-8 times that of the decoction for 1-2 hours.
7. The preparation method according to claim 5, wherein the decoction in the step B is concentrated under reduced pressure to obtain extract I with a relative density of 1.12-1.18 at 50-60 ℃.
8. The preparation method according to claim 5, wherein the extract II with the relative density of 1.20-1.30 is obtained by concentrating the extract II in the step C under reduced pressure at 50-60 ℃.
9. The preparation method according to claim 5, wherein ethanol is added in the step C to make the alcohol content reach 50% -70%, and the mixture is left for 24-48h of cold precipitation.
10. The use of the Chinese medicinal composition of claim 1 in the preparation of a medicament for the treatment of thyroid cancer.
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| CN102058744A (en) * | 2010-11-25 | 2011-05-18 | 代龙 | Chinese medicinal composition for treating malignant tumor and preparation method thereof |
| CN104491291A (en) * | 2014-12-17 | 2015-04-08 | 崔合芳 | Traditional Chinese medicine composition for treating liver-yang hyperactivity type thyroid adenoma |
| CN110327389A (en) * | 2019-07-10 | 2019-10-15 | 浙江省肿瘤医院 | Application of the total glucoside in preparation treatment thyroid cancer and raising tumor radiotherapy synergism medicine |
| CN110464801A (en) * | 2019-09-24 | 2019-11-19 | 长春中医药大学 | A kind of Chinese medicine composition and its preparation method and application for treating advanced breast cancer |
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| CN103656388B (en) * | 2013-11-20 | 2016-08-17 | 田博 | A kind of Chinese medicine composition treating thyroid cancer |
| CN105521255A (en) * | 2015-12-28 | 2016-04-27 | 黄维清 | A traditional Chinese medicine prescription for treating thyroid cancer |
| CN114177244B (en) * | 2021-12-16 | 2022-09-23 | 浙江省人民医院 | Traditional Chinese medicine composition for treating thyroid cancer and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101288759A (en) * | 2008-05-15 | 2008-10-22 | 天科仁祥技术（北京）有限责任公司 | Chinese medicinal composition for treating benign thyroid tumor and its preparation method |
| CN102058744A (en) * | 2010-11-25 | 2011-05-18 | 代龙 | Chinese medicinal composition for treating malignant tumor and preparation method thereof |
| CN104491291A (en) * | 2014-12-17 | 2015-04-08 | 崔合芳 | Traditional Chinese medicine composition for treating liver-yang hyperactivity type thyroid adenoma |
| CN110327389A (en) * | 2019-07-10 | 2019-10-15 | 浙江省肿瘤医院 | Application of the total glucoside in preparation treatment thyroid cancer and raising tumor radiotherapy synergism medicine |
| CN110464801A (en) * | 2019-09-24 | 2019-11-19 | 长春中医药大学 | A kind of Chinese medicine composition and its preparation method and application for treating advanced breast cancer |
| CN112618679A (en) * | 2020-12-24 | 2021-04-09 | 梧州市华夏医药科技有限公司 | Xiajujin Jiekang oral liquid and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2023109574A1 (en) * | 2021-12-16 | 2023-06-22 | 浙江省人民医院 | Traditional chinese medicine composition for treating thyroid cancer and preparation method therefor |
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Inventor after: Ge Minghua Inventor after: Tan Zhuo Inventor after: Li Qinglin Inventor after: Huang Ping Inventor after: Pan Zongfu Inventor after: Xu Jiajie Inventor after: Liu Yujia Inventor before: Ge Minghua Inventor before: Tan Zhuo Inventor before: Li Qinglin Inventor before: Huang Ping Inventor before: Pan Zongfu Inventor before: Xu Jiajie Inventor before: Liu Yujia |