WO2018090849A1 - 一种补元消磨的中药颗粒剂 - Google Patents

一种补元消磨的中药颗粒剂 Download PDF

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WO2018090849A1
WO2018090849A1 PCT/CN2017/109619 CN2017109619W WO2018090849A1 WO 2018090849 A1 WO2018090849 A1 WO 2018090849A1 CN 2017109619 W CN2017109619 W CN 2017109619W WO 2018090849 A1 WO2018090849 A1 WO 2018090849A1
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granule
chinese medicine
traditional chinese
ethanol
ginseng
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French (fr)
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谢海青
杨安平
冯志刚
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佛山科学技术学院
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    • A—HUMAN NECESSITIES
    • 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)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/24—Mucus; Mucous glands; Bursa; Synovial fluid; Arthral fluid; Excreta; Spinal fluid
    • A—HUMAN NECESSITIES
    • 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)
    • A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
    • A61K36/258—Panax (ginseng)
    • A—HUMAN NECESSITIES
    • 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)
    • A61K36/40—Cornaceae (Dogwood family)
    • A—HUMAN NECESSITIES
    • 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)
    • A61K36/61—Myrtaceae (Myrtle family), e.g. teatree or eucalyptus
    • A—HUMAN NECESSITIES
    • 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)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
    • A61K36/9066—Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • 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
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • 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
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization

Definitions

  • the invention relates to the field of medicine, in particular to a traditional Chinese medicine granule for supplementing the mass.
  • Tumors are new organisms formed by the body's cells under the action of various tumorigenic factors, which lose the normal regulation of their growth at the genetic level and lead to abnormal proliferation and differentiation. Once a new organism is formed, it will not stop growing due to the elimination of the cause. His growth is not regulated by the normal body, but the normal tissues and organs are destroyed. This is especially true in malignant tumors. Compared with benign tumors, malignant tumors grow fast, invasive growth, prone to bleeding, necrosis, ulcers, etc., and often have distant metastasis, causing body weight loss, weakness, anemia, loss of appetite, fever and severe organs. Impaired function, etc., eventually causing death. Generally speaking, “cancer” is used to refer to all malignant tumors.
  • the existing methods for treating cancer are mainly surgery, radiotherapy or chemotherapy.
  • various advanced cancers are rapidly losing weight, lack of energy, and rapidly deteriorating.
  • Most of them are caused by surgery, radiotherapy, recurrence after chemotherapy or further development of the disease.
  • the yin and evil of cancer rapidly expanded, and most patients died in a short period of time. At this time, the virtual and the real are mixed, with the main being virtual, dying, and no real attack.
  • the technical problem to be solved by the invention is to provide a traditional Chinese medicine granule for replenishing the element, the medicine composition is simple, the dosage of the medicine is small, the time is fast, the effect is obvious, and the invention can effectively treat the rapid weight loss, breath sputum and disease condition of the advanced cancer patient. Rapid deterioration and other symptoms, to gain more time for future survival treatment.
  • the present invention provides a Chinese medicine granule for replenishing the granules, and the formula of the medicinal granules is:
  • the traditional Chinese medicine granules are prepared by the following methods: weighing each raw material according to the formula, pulverizing and mixing uniformly; adding water to immerse the medicinal material, heating and boiling, separating the decoction liquid, filtering, evaporating the water boiling liquid, adding after cooling 1-2 times the amount of ethanol, put The precipitate is taken, the supernatant is taken, the precipitate is washed with ethanol, the washing liquid is combined with the filtrate, the ethanol is recovered under reduced pressure, filtered, and the filtrate is evaporated to a thick paste at a low temperature to obtain an extract; the extract is mixed with the auxiliary material. After that, the wetting agent is added into a soft material; the soft material is made into a granule form by a pellet machine, and the package is sealed.
  • the formulation of the traditional Chinese medicine granule is:
  • the formulation of the traditional Chinese medicine granule is:
  • Astragalus 120g ginseng 30g, hawthorn 60g, Wulingzhi 30g, clove 10g, turmeric 10g.
  • the water boiling liquid is evaporated to a concentration specific gravity of 1:1.14.
  • the adjuvant is starch, dextrin and/or sucrose.
  • the temperature of the low temperature evaporation is 60 to 70 °C.
  • the wetting agent is 75-85% ethanol.
  • the step of forming the soft material into a granule form by using a granule machine comprises:
  • the soft material is made into a wet granule by a granule machine, and the moisture content of the wet granule is 7-10%;
  • the wet granules are dried into a granule form by a dryer, and the drying temperature of the dryer is 70-80 °C.
  • the medicine of the invention has simple composition, low cost and can be universally applied, and adopts a large dose of astragalus, ginseng and hawthorn, plus a pair of aphrodisiac (Ginseng 20-40g and Wulingzhi 20-40g, clove 5-15g and turmeric) 5-15g), to treat patients with advanced cancer, rapid weight loss, breath, and rapid deterioration of the disease.
  • the amount of jaundice is 110-130g, which is the best for lungs and enhances the yang of one body.
  • the dosage of ginseng is 20-40g, and the big qi is returned to the spleen to protect the stomach and qi, which is the medicine for emergency treatment.
  • hawthorn is 50-70g, which is a big tonifying kidney, and its acid-converging nature can prevent jaundice from rising.
  • Wulingzhi and ginseng, tonic and phlegm and pain kill cancer without hurting.
  • Clove and turmeric warming in the air to open the stagnation, the best treatment of cancer caused by abdominal distension, indigestion. It is also compatible with the ginseng, and the opposite is the opposite, preventing the use of large doses of ginseng and phlegm.
  • the invention generally has 5-7 doses effective, and strives for more time for cancer patients to take treatment for disease in the future. In general, a cancer patient can extend the life expectancy by 1-7 years after taking the traditional Chinese medicine composition of the present invention.
  • the present invention has obvious therapeutic effects on many cancers, especially lung cancer, liver cancer, prostate cancer, breast cancer, cervical cancer, stomach cancer, and colorectal cancer.
  • the invention provides a Chinese medicine granule for replenishing the granules, and the formula of the medicinal granules is:
  • the traditional Chinese medicine granules are prepared by the following methods: weighing each raw material according to the formula, pulverizing and mixing uniformly; adding water to immerse the medicinal material, heating and boiling, separating the decoction liquid, filtering, evaporating the water boiling liquid, adding after cooling 1-2 times the amount of ethanol, place the precipitate, take the supernatant, the precipitate is washed with ethanol, the washing liquid and the filtrate are combined, the ethanol is recovered under reduced pressure, filtered, and the filtrate is evaporated to a thick paste at a low temperature to obtain an extract; After mixing the extract and the auxiliary material, the wetting agent is added to make the soft material; the soft material is made into a granule type by a pellet machine, and the package is sealed.
  • the formulation of the traditional Chinese medicine granules is preferably:
  • the formula of the traditional Chinese medicine granule is:
  • Astragalus 120g ginseng 30g, hawthorn 60g, Wulingzhi 30g, clove 10g, turmeric 10g.
  • Astragalus also known as Mian
  • Astragalus has enhanced immune function, liver protection, diuresis, anti-aging, anti-stress, antihypertensive and a wide range of antibacterial effects.
  • the facts of evil spirits, qi stagnation and dampness, food stagnation, sputum at the beginning or after the collapse of the hot poison Shangsheng and other evidence, as well as yin deficiency and impotence, must be banned.
  • Ginseng sweet and bitter, warm, the main complement to the five internal organs, the spirit of peace, the soul of the soul, stop the horror, in addition to evil, eyesight, happy puzzle. Long service, light and long.
  • Hawthorn a strong astringent medicine, has the effect of nourishing liver and kidney.
  • Wulingzhi can be used for blood stasis internal resistance, blood does not return to the bleeding, such as women with more bleeding, more color purple, less abdominal pain.
  • Clove can treat stomach diseases, abdominal pain, vomiting, neuralgia, toothache and other diseases.
  • Yujin has the functions of promoting blood circulation and relieving pain, relieving qi and relieving depression, clearing heart and cooling blood, and reducing the effect of biliary and yellowing. It is used for thoracic tingling, chest pain, heart pain, menstrual dysmenorrhea, breast pain, fever, dizziness, epilepsy, blood heat Spitting, jaundice and urinary redness.
  • the invention adopts large doses of astragalus, ginseng and hawthorn, plus a pair of aphrodisiac (Ginseng 20-40g and Wulingzhi 20-40g, clove 5-15g and turmeric 5-15g) to treat patients with advanced cancer rapidly. Symptoms such as weight loss, breathlessness, and rapid deterioration of the condition. Among them, the amount of jaundice is 110-130g, which is the best for lungs and enhances the yang of one body. Ginseng dosage 20-40g, Dabu Yuanqi to the spleen, protect the stomach, for the treatment of critical illness.
  • hawthorn is 50-70g, which is a big tonifying kidney, and its acid-converging nature can prevent jaundice from rising.
  • Wulingzhi and ginseng, tonic and phlegm and pain kill cancer without hurting.
  • Clove and turmeric warming in the air to open the stagnation, the best treatment of cancer caused by abdominal distension, indigestion. It is also compatible with the ginseng, and the opposite is the opposite, preventing the use of large doses of ginseng and phlegm.
  • the invention generally has 5-7 doses effective, and strives for more time for the patient to take treatment for the disease in the future.
  • the water decoction liquid is evaporated to a concentration specific gravity of 1:1.14, which is beneficial to maintaining the efficacy and ensuring the therapeutic effect.
  • the adjuvant is starch, dextrin and/or sucrose, but is not limited thereto. It should be noted that the auxiliary material may also be selected according to the prior art, and the scope of implementation thereof is not limited to the embodiment of the present invention.
  • the low temperature evaporation temperature is 60-70 ° C, and the wetting agent is 75-85% ethanol, which is beneficial to improving the utilization rate of the traditional Chinese medicine, maintaining the drug effect, and being easy to absorb.
  • the step of forming the soft material into a granule form by using a granule machine comprises:
  • the soft material is made into a wet granule by a granule machine, and the moisture content of the wet granule is 7-10%;
  • the wet granules are dried into a granule form by a dryer, and the drying temperature of the dryer is 70-80 °C.
  • the utilization rate of the traditional Chinese medicine material can be improved, the dosage of the product is accurate, the absorption is convenient, and the effect is fast.
  • the present invention is further produced by specific embodiments below.
  • the filtrate is evaporated to a thick paste at low temperature, the temperature of low temperature evaporation is 60 ° C, the specific gravity of the thick paste is generally 1.30-1.40, which is obtained by heat measurement (80-90 ° C), and the extract is mixed;
  • the wetting agent is made into a soft material; the soft material is made into a wet granule by a granule machine, and the moisture content of the wet granule is 7%; the wet granule is dried into a granule type by a dryer, and the drying temperature of the dryer is 70 ° C, and the package is sealed. .
  • the filtrate is evaporated to a thick paste at a low temperature, the temperature of low temperature evaporation is 65 ° C, the specific gravity of the thick paste is generally 1.30-1.40, which is obtained by heat measurement (80-90 ° C), and the extract is mixed;
  • the wetting agent is made into a soft material; the soft material is made into a wet granule by a granule machine, and the moisture content of the wet granule is 8%; the wet granule is dried into a granule form by a dryer, and the drying temperature of the dryer is 72 ° C, and the package is sealed. .
  • the filtrate is evaporated to a thick paste at low temperature, the temperature of low temperature evaporation is 60 ° C, the specific gravity of the thick paste is generally 1.30-1.40, which is obtained by heat measurement (80-90 ° C), and the extract is mixed;
  • the wetting agent is made into a soft material; the soft material is made into a wet granule by a granule machine, and the moisture content of the wet granule is 9%; the wet granule is dried into a granule type by a dryer, and the drying temperature of the dryer is 75 ° C, and the package is sealed. .
  • the filtrate is evaporated to a thick paste at low temperature, the temperature of low temperature evaporation is 70 ° C, the specific gravity of the thick paste is generally 1.30-1.40, which is obtained by heat measurement (80-90 ° C), and the extract is mixed;
  • the wetting agent is made into a soft material; the soft material is made into a wet granule by a granule machine, and the moisture content of the wet granule is 10%; the wet granule is dried into a granule form by a dryer, and the drying temperature of the dryer is 80 ° C, and the package is sealed. .
  • the patient is treated with the traditional Chinese medicine composition of the invention, as follows:
  • the remaining life distribution is as follows:
  • the traditional Chinese medicine composition according to any one of embodiments 1 to 4 is used, and the doctor determines that the remaining life is less than or equal to 3
  • Treatment Generally 5-7 days is a course of treatment, you can continue the next course without stopping.
  • the efficacy evaluation is divided into: significant, effective, generally effective, slightly effective, and ineffective.
  • the remaining life is extended by more than 5 years, the food intake is 90% of normal people, physical recovery, no vomiting symptoms, weight recovery before the disease;
  • the remaining life is extended by more than 3 years, the food intake is 80% of normal people, the physical strength is basically restored, there is no vomiting, and the body weight recovers 90% before the disease;
  • the remaining life is extended by more than 1 year, the food intake is 60% of normal people, dizziness, fatigue, no vomiting, weight recovery 80% before the disease;
  • the effective treatment rate of the present invention is 100%.
  • Cancer patients taking the traditional Chinese medicine composition of the present invention 5-7 agents can generally produce an effect, the dosage of the medicament is small, the time is fast, the effect is obvious, and the symptoms of rapid weight loss, convulsions, and rapid deterioration of the disease in patients with advanced cancer are effectively treated. Cancer patients will gain more time in the future with disease and survival treatment. In general, a cancer patient can extend the life expectancy by 1-7 years after taking the traditional Chinese medicine composition of the present invention. Moreover, the present invention has obvious therapeutic effects on many cancers, especially lung cancer, liver cancer, prostate cancer, breast cancer, cervical cancer, stomach cancer, and colorectal cancer.

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Abstract

一种补元消磨中药颗粒剂，用于治疗癌症晚期迅速消瘦等症状，原料为：黄芪110-130g、人参20-40g、山茱萸50-70g、五灵脂20-40g、丁香5-15g、郁金5-15g，由下述方法制得：称取各原料，粉碎并混匀；加水浸没药材后加热煎煮，分离煎出液，滤过后，将水煎煮液蒸发，冷后加入乙醇，放置沉淀，取其上清液，沉淀物用乙醇洗净，洗液与滤液合并，减压回收乙醇，过滤，滤液低温蒸发至稠膏装，得浸膏；将浸膏与辅料混匀后，加润湿剂制成软材，用颗粒机制成颗粒剂型，密封包装。

Description

一种补元消磨的中药颗粒剂 技术领域
本发明涉及医药领域，特别涉及一种补元消磨的中药颗粒剂。
背景技术
肿瘤是机体在各种致瘤因素作用下，局部组织的细胞在基因水平上失去对其生长的正常调控导致异常增生与分化而形成的新生物。新生物一旦形成，不因病因消除而停止生长，他的生长不受正常机体生理调节，而是破坏正常组织与器官，这一点在恶性肿瘤尤其明显。与良性肿瘤相比，恶性肿瘤生长速度快，呈浸润性生长，易发生出血、坏死、溃疡等，并常有远处转移，造成人体消瘦、无力、贫血、食欲不振、发热以及严重的脏器功能受损等，最终造成患者死亡。一般人们所说的“癌症”习惯上泛指所有恶性肿瘤。
现有治疗癌症的方法主要为手术、放疗或化疗，然而，各种晚期癌症之所以出现迅速消瘦、少气无力、病情迅速恶化，多由手术、放疗、化疗后复发或病情进一步发展而导致人体元气大伤，肾、脾、肺气化失常引起。癌症之阴邪迅速扩张，病人多半在短时期内死亡。此时虚实错杂，以虚为主，奄奄一息，无实可攻。
发明内容
本发明所要解决的技术问题在于，提供一种补元消磨的中药颗粒剂，药物组成简单，药剂用量少，时间较快，效果明显，可以有效治疗晚期癌症病人的迅速消瘦、气息奄奄、病情迅速恶化等症状，为今后生存治疗争取更多时间。
为达到上述技术效果，本发明提供了一种补元消磨的中药颗粒剂，所述中药颗粒剂的配方为：
黄芪110-130g、人参20-40g、山茱萸50-70g、五灵脂20-40g、丁香5-15g、郁金5-15g；
所述中药颗粒剂由下述方法制得：按配方称取各原料，粉碎并混合均匀；加水浸没药材后加热煎煮，分离煎出液，滤过后，将水煎煮液蒸发，冷后加入1-2倍量乙醇，放 置沉淀，取其上清液，沉淀物再用乙醇洗净，洗液与滤液合并，减压回收乙醇后，过滤，滤液低温蒸发至稠膏状，得到浸膏；将浸膏与辅料混匀后，加润湿剂制成软材；将软材用颗粒机制成颗粒剂型，密封包装。
作为上述方案的改进，所述中药颗粒剂的配方为：
黄芪115-125g、人参25-35g、山茱萸55-65g、五灵脂25-35g、丁香8-12g、郁金8-12g。
作为上述方案的改进，所述中药颗粒剂的配方为：
黄芪120g、人参30g、山茱萸60g、五灵脂30g、丁香10g、郁金10g。
作为上述方案的改进，所述的水煎煮液蒸发至浓度比重为1：1.14。
作为上述方案的改进，所述辅料为淀粉、糊精和/或蔗糖。
作为上述方案的改进，所述低温蒸发的温度为60-70℃。
作为上述方案的改进，所述润湿剂为75-85％乙醇。
作为上述方案的改进，将软材用颗粒机制成颗粒剂型的步骤包括：
将软材用颗粒机制成湿粒，湿粒的含水量为7-10％；
将湿粒通过干燥机干燥成颗粒剂型，干燥机的烘干温度为70-80℃。
实施本发明具有如下有益效果：
本发明药物组成简单、成本低、可普遍应用，其通过大剂量的黄芪、人参和山茱萸，加上相畏药对(人参20-40g与五灵脂20-40g、丁香5-15g与郁金5-15g)，来治疗晚期癌症病人的迅速消瘦、气息奄奄、病情迅速恶化等症状。其中，黄芪用量110-130g，最善补肺，提升一身之阳气。人参用量20-40g，大补元气归脾经，保护胃气，为救治危急之要药。山茱萸用量50-70g，大补肾气，其酸敛之性，可防黄芪升提之过。五灵脂与人参，补虚化瘀止痛，消磨癌瘤而不伤正。丁香与郁金，温中降气开郁，最善治癌瘤引起的腹胀、消化不良。又与参芪相合，相反相成，防止参、芪大剂量应用补益太过。本发明一般5-7剂有效，为癌症患者今后带病生存治疗争取更多时间。一般来说，癌症患者服用本发明所述中药组合物后，平均寿命可以延长1-7年。
而且，本发明对众多癌症均有明显的治疗效果，尤其是肺癌、肝癌、前列腺癌、乳腺癌、宫颈癌、胃癌、大肠癌。
具体实施方式
为使本发明的目的、技术方案和优点更加清楚，下面将对本发明作进一步地详细描述。
本发明提供了一种补元消磨的中药颗粒剂，所述中药颗粒剂的配方为：
黄芪110-130g、人参20-40g、山茱萸50-70g、五灵脂20-40g、丁香5-15g、郁金5-15g。
所述中药颗粒剂由下述方法制得：按配方称取各原料，粉碎并混合均匀；加水浸没药材后加热煎煮，分离煎出液，滤过后，将水煎煮液蒸发，冷后加入1-2倍量乙醇，放置沉淀，取其上清液，沉淀物再用乙醇洗净，洗液与滤液合并，减压回收乙醇后，过滤，滤液低温蒸发至稠膏状，得到浸膏；将浸膏与辅料混匀后，加润湿剂制成软材；将软材用颗粒机制成颗粒剂型，密封包装。
所述中药颗粒剂的配方优选为：
黄芪115-125g、人参25-35g、山茱萸55-65g、五灵脂25-35g、丁香8-12g、郁金8-12g。
更佳的，所述中药颗粒剂的配方为：
黄芪120g、人参30g、山茱萸60g、五灵脂30g、丁香10g、郁金10g。
其中，黄芪，又名绵芪，其有增强机体免疫功能、保肝、利尿、抗衰老、抗应激、降压和较广泛的抗菌作用。但表实邪盛，气滞湿阻，食积停滞，痈疽初起或溃后热毒尚盛等实证，以及阴虚阳亢者，均须禁服。
人参，味甘微苦，温，主补五脏，安精神，定魂魄，止惊悸，除邪气，明目，开心益智。久服，轻身延年。
山茱萸，为收敛性强壮药，有补肝肾止汗的功效。
五灵脂，可用于瘀血内阻、血不归经之出血，如妇女崩漏经多，色紫多块，少腹刺痛。
丁香，可治疗胃病，腹痛、呕吐、神经痛、牙痛等疾病。
郁金，具有活血止痛，行气解郁，清心凉血，利胆退黄之效，用于胸胁刺痛，胸痹心痛，经闭痛经，乳房胀痛，热病神昏，癫痫发狂，血热吐衄，黄疸尿赤。
本发明通过大剂量的黄芪、人参和山茱萸，加上相畏药对(人参20-40g与五灵脂20-40g、丁香5-15g与郁金5-15g)，来治疗晚期癌症病人的迅速消瘦、气息奄奄、病情迅速恶化等症状。其中，黄芪用量110-130g，最善补肺，提升一身之阳气。人参用量 20-40g，大补元气归脾经，保护胃气，为救治危急之要药。山茱萸用量50-70g，大补肾气，其酸敛之性，可防黄芪升提之过。五灵脂与人参，补虚化瘀止痛，消磨癌瘤而不伤正。丁香与郁金，温中降气开郁，最善治癌瘤引起的腹胀、消化不良。又与参芪相合，相反相成，防止参、芪大剂量应用补益太过。本发明一般5-7剂有效，为病人今后带病生存治疗争取更多时间。
关于上述制备方法，所述水煎煮液蒸发至浓度比重为1：1.14，有利于保持药效，保证治疗效果。
所述辅料为淀粉、糊精和/或蔗糖，但不限于此。需要说明的是，所述辅料还可以参照现有技术选择，其实施范围并不局限于本发明所举实施例。
所述低温蒸发的温度为60-70℃，所述润湿剂为75-85％乙醇，有利于提高中药的利用率，保持药效，易于吸收。
其中，将软材用颗粒机制成颗粒剂型的步骤包括：
将软材用颗粒机制成湿粒，湿粒的含水量为7-10％；
将湿粒通过干燥机干燥成颗粒剂型，干燥机的烘干温度为70-80℃。
采用本发明的中药颗粒剂的制备方法，可以提高中药材的利用率，使产品剂量准确，便于吸收，起效快。
下面以具体实施例进一步产生本发明
实施例1
(一)配方：黄芪110g、人参20g、山茱萸50g、五灵脂20g、丁香5g、郁金5g。
(二)制备方法：
按配方称取各原料，粉碎并混合均匀；加水浸没药材，浸泡20-40min，加热煎煮10-30min，分离煎出液，滤过后，将水煎煮液蒸发，所述水煎煮液蒸发至浓度比重为1：1.14，冷后加入1倍量乙醇，放置沉淀，取其上清液，沉淀物再用50％-60％乙醇洗净，洗液与滤液合并，减压回收乙醇后，过滤，滤液低温蒸发至稠膏状，低温蒸发的温度为60℃，稠膏的比重一般热测(80-90℃)为1.30-1.40，得到浸膏；将浸膏与辅料混匀后，加润湿剂制成软材；将软材用颗粒机制成湿粒，湿粒的含水量为7％；将湿粒通过干燥机干燥成颗粒剂型，干燥机的烘干温度为70℃，密封包装。
实施例2
(一)配方：黄芪120g、人参30g、山茱萸60g、五灵脂30g、丁香10g、郁金10g。
(二)制备方法：
按配方称取各原料，粉碎并混合均匀；加水浸没药材，浸泡20-40min，加热煎煮10-30min，分离煎出液，滤过后，将水煎煮液蒸发，所述水煎煮液蒸发至浓度比重为1：1.14，冷后加入2倍量乙醇，放置沉淀，取其上清液，沉淀物再用50％-60％乙醇洗净，洗液与滤液合并，减压回收乙醇后，过滤，滤液低温蒸发至稠膏状，低温蒸发的温度为65℃，稠膏的比重一般热测(80-90℃)为1.30-1.40，得到浸膏；将浸膏与辅料混匀后，加润湿剂制成软材；将软材用颗粒机制成湿粒，湿粒的含水量为8％；将湿粒通过干燥机干燥成颗粒剂型，干燥机的烘干温度为72℃，密封包装。
实施例3
(一)配方：黄芪125g、人参25g、山茱萸60g、五灵脂25g、丁香10g、郁金10g。
(二)制备方法：
按配方称取各原料，粉碎并混合均匀；加水浸没药材，浸泡20-40min，加热煎煮10-30min，分离煎出液，滤过后，将水煎煮液蒸发，所述水煎煮液蒸发至浓度比重为1：1.14，冷后加入1倍量乙醇，放置沉淀，取其上清液，沉淀物再用50％-60％乙醇洗净，洗液与滤液合并，减压回收乙醇后，过滤，滤液低温蒸发至稠膏状，低温蒸发的温度为60℃，稠膏的比重一般热测(80-90℃)为1.30-1.40，得到浸膏；将浸膏与辅料混匀后，加润湿剂制成软材；将软材用颗粒机制成湿粒，湿粒的含水量为9％；将湿粒通过干燥机干燥成颗粒剂型，干燥机的烘干温度为75℃，密封包装。
实施例4
(一)配方：黄芪130g、人参40g、山茱萸70g、五灵脂40g、丁香15g、郁金15g。
(二)制备方法：
按配方称取各原料，粉碎并混合均匀；加水浸没药材，浸泡20-40min，加热煎煮10-30min，分离煎出液，滤过后，将水煎煮液蒸发，所述水煎煮液蒸发至浓度比重为1：1.14，冷后加入2倍量乙醇，放置沉淀，取其上清液，沉淀物再用50％-60％乙醇洗净，洗液与滤液合并，减压回收乙醇后，过滤，滤液低温蒸发至稠膏状，低温蒸发的温度为70℃，稠膏的比重一般热测(80-90℃)为1.30-1.40，得到浸膏；将浸膏与辅料混匀后，加润湿剂制成软材；将软材用颗粒机制成湿粒，湿粒的含水量为10％；将湿粒通过干燥机干燥成颗粒剂型，干燥机的烘干温度为80℃，密封包装。
采用本发明的中药组合物对病人进行治疗，具体如下：
一、基本信息：
本组50例恶性肿瘤患者来自广东省各地。其中32例来自佛山市，15例来自广州，其余来自其他市。全部病例均曾在三级以上医院就诊，并经CT、病理等检查确诊为恶性肿瘤。
(1)性别分布：男性27例，女性23例。
(2)经三级以上医院用西医方法诊断，其剩余寿命不超过3个月。
剩余寿命分布如下：
剩余寿命 一个星期 半个月 一个月 两个月 三个月
例数 7 4 11 10 18
(3)病种分布：
病种 肺癌 肝癌 前列腺癌 乳腺癌 宫颈癌 胃癌 大肠癌 其他
例数 11 13 4 8 4 3 4 3
二、用药方法：
所有病例应用实施例1-4任一项所述的中药组合物，在医生判定剩余寿命小于等于3
个月后服用，日1剂，水煎分两次温服。
疗程：一般5-7天为一疗程，可以不停顿继续下一个疗程。
三、结果和疗效分析：
疗效评定分为：显著有效、较为有效、一般有效、略微有效、无效。
显著有效：剩余寿命延长5年以上，食纳为正常人90％，体力恢复，无呕吐症状，体重恢复病前；
较为有效：剩余寿命延长3年以上，食纳为正常人80％，体力基本恢复，无呕吐症状，体重恢复病前90％；
一般有效：剩余寿命延长1年以上，食纳为正常人60％，头晕、乏力减轻，无呕吐症状，体重恢复病前80％；
略微有效：剩余寿命延长3个月以上，食纳稍增，头晕、乏力减轻，有轻度呕吐症状，体重稍有恢复；
无效：剩余寿命不延长，食纳变化不大，仍有头晕、乏力、呕吐症状，体重未有恢复。
上述50例患者的疗效如下表所示：
疗效 显著有效 较为有效 一般有效 略微有效 无效
例数 10 25 13 2 0
由上表可知，本发明的有效治疗率为100％
四、结果：
癌症患者服用本发明的中药组合物5-7剂一般就可以产生效果，药剂用量少，时间较快，效果明显，有效治疗晚期癌症病人的迅速消瘦、气息奄奄、病情迅速恶化等症状，为癌症患者今后带病生存治疗争取更多时间。一般来说，癌症患者服用本发明所述中药组合物后，平均寿命可以延长1-7年。而且，本发明对众多癌症均有明显的治疗效果，尤其是肺癌、肝癌、前列腺癌、乳腺癌、宫颈癌、胃癌、大肠癌。最后所应当说明的是，以上实施例仅用以说明本发明的技术方案而非对本发明保护范围的限制，尽管参照较佳实施例对本发明作了详细说明，本领域的普通技术人员应当理解，可以对本发明的技术方案进行修改或者等同替换，而不脱离本发明技术方案的实质和范围。

Claims (8)

  1. 一种补元消磨的中药颗粒剂，其特征在于，所述中药颗粒剂的配方为：
    黄芪110-130g、人参20-40g、山茱萸50-70g、五灵脂20-40g、丁香5-15g、郁金5-15g；
    所述中药颗粒剂由下述方法制得：按配方称取各原料，粉碎并混合均匀；加水浸没药材后加热煎煮，分离煎出液，滤过后，将水煎煮液蒸发，冷后加入1-2倍量乙醇，放置沉淀，取其上清液，沉淀物再用乙醇洗净，洗液与滤液合并，减压回收乙醇后，过滤，滤液低温蒸发至稠膏状，得到浸膏；将浸膏与辅料混匀后，加润湿剂制成软材；将软材用颗粒机制成颗粒剂型，密封包装。
  2. 如权利要求1所述的中药颗粒剂，其特征在于，所述中药颗粒剂的配方为：
    黄芪115-125g、人参25-35g、山茱萸55-65g、五灵脂25-35g、丁香8-12g、郁金8-12g。
  3. 如权利要求2所述的中药颗粒剂，其特征在于，所述中药颗粒剂的配方为：
    黄芪120g、人参30g、山茱萸60g、五灵脂30g、丁香10g、郁金10g。
  4. 如权利要求1所述的中药颗粒剂，其特征在于，所述的水煎煮液蒸发至浓度比重为1：1.14。
  5. 如权利要求1所述的中药颗粒剂，其特征在于，所述辅料为淀粉、糊精和/或蔗糖。
  6. 如权利要求1所述的中药颗粒剂，其特征在于，所述低温蒸发的温度为60-70℃。
  7. 如权利要求1所述的中药颗粒剂，其特征在于，所述润湿剂为75-85％乙醇。
  8. 如权利要求1所述的中药颗粒剂，其特征在于，将软材用颗粒机制成颗粒剂型的 步骤包括：
    将软材用颗粒机制成湿粒，湿粒的含水量为7-10％；
    将湿粒通过干燥机干燥成颗粒剂型，干燥机的烘干温度为70-80℃。
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