CN106581299B - Traditional Chinese medicine composition for improving kidney qi deficiency of middle-aged and old people and application thereof - Google Patents

Traditional Chinese medicine composition for improving kidney qi deficiency of middle-aged and old people and application thereof Download PDF

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CN106581299B
CN106581299B CN201710088526.3A CN201710088526A CN106581299B CN 106581299 B CN106581299 B CN 106581299B CN 201710088526 A CN201710088526 A CN 201710088526A CN 106581299 B CN106581299 B CN 106581299B
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史晓
沈雁
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Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of TCM
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Abstract

The invention relates to a traditional Chinese medicine composition for improving kidney qi deficiency of middle-aged and old people and application thereof. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 15-25 parts of codonopsis pilosula, 15-25 parts of radix astragali preparata, 12-18 parts of angelica, 15-25 parts of fructus psoraleae, 15-25 parts of pyrola, 10-20 parts of wolfberry fruit and 10-20 parts of red paeony root. Clinical tests show that the traditional Chinese medicine composition can obviously improve the symptoms and the life quality of middle-aged and elderly patients with kidney qi deficiency, so that the traditional Chinese medicine composition can be used for preparing medicines for treating the kidney qi deficiency and delaying senility, and has the advantages of few medicinal components, convenience in preparation and low cost.

Description

一种改善中老年肾气虚证的中药组合物及其应用A traditional Chinese medicine composition for improving kidney-qi deficiency syndrome in middle-aged and elderly people and its application

技术领域technical field

本发明涉及一种中药组合物,具体地说,涉及一种改善中老年肾气虚证的中药组合物及其应用。The present invention relates to a traditional Chinese medicine composition, in particular to a traditional Chinese medicinal composition for improving kidney-qi deficiency syndrome of middle-aged and elderly people and its application.

背景技术Background technique

目前随着社会的发展,我们正逐渐步入老龄化社会,如何延缓衰老进程、改善中老年人的生活质量正受到越来越多的关注。中医对人体衰老或早衰的认识源远流长,内容极其丰富,为大多数学者公认。而又有较好之实际效验者,当以肾虚致衰之说为最。肾藏精,为先天之本,生命之源,以肾为主宰而主持、维系人体的一切生理功能,使其统一平衡而又能自调自稳地正常活动,从而抵御疾病。肾气亏虚则五脏之气血津液生化乏源,各种衰老病症更日益显露出来。中医还认为,久病、慢性病没有不损及肾气的,所以又有“病久之疾、穷必及肾”之说。肾气受损则常见腰酸膝软,疲倦乏力等肾气虚证症状。At present, with the development of society, we are gradually entering an aging society. How to delay the aging process and improve the quality of life of middle-aged and elderly people is receiving more and more attention. The understanding of human aging or premature aging in traditional Chinese medicine has a long history and is extremely rich in content, which is recognized by most scholars. And those who have better actual effects should take the theory that kidney deficiency causes failure as the most important. The kidney stores the essence, which is the foundation of the innate and the source of life. The kidney is the master to preside over and maintain all the physiological functions of the human body, so that it can be unified and balanced, and can self-regulate and stabilize normal activities, thereby resisting diseases. Deficiency of kidney qi results in a lack of biochemical sources of qi, blood and body fluids in the five internal organs, and various aging diseases are increasingly exposed. Chinese medicine also believes that there is no chronic disease or chronic disease that does not damage the kidney qi, so there is a saying that "diseases that have been ill for a long time and poverty will affect the kidneys". If the kidney qi is damaged, symptoms of kidney qi deficiency such as soreness of the waist and weak knees, fatigue and fatigue are common.

目前中医治疗上有较多针对肾气虚证的中药组方。例如,中国专利文献CN200510075262.5,公开日2006.12.13,公开了一种治疗肾气虚证的药物组合物及其质量控制方法,该药物组合物由下述原料药制备而成:蛇床子20-40重量份、川芎20-40重量份、菟丝子50-80重量份、补骨脂20-40重量份、茯苓20-40重量份、红参15-25重量份、小茴香10-20重量份、五味子30-40重量份、金樱子60-120重量份、白术10-20重量份、当归40-60重量份、覆盆子25-40重量份、制何首乌60-90重量份、车前子10-20重量份、熟地黄60-120重量份、枸杞子50-80重量份、山药40-60重量份、淫羊藿60-120重量份、胡芦巴60-120重量份、黄芪40-60重量份、肉苁蓉40-60重量份、炙甘草10-20重量份,该药物组合物及其颗粒制剂具有调和阴阳,温阳补肾,安神固精,扶正固本的功能,临床用于阳萎,遗精,腰腿酸痛,精神不振,夜尿频多,畏寒怕冷,妇女月经过多,白带清稀诸症。又例如,申请人于中国期刊《辽宁中医杂志》2012年第39卷第7期刊出的论文“杞鹿健肾颗粒改善中老年肾气虚证临床观察”所公开的杞鹿健肾颗粒,方以参、芪、术益气健脾;归、芍补血濡养心肝;续断、补骨脂、鹿含草、枸杞子乙癸同补,健筋壮骨。此方为本专利申请人的院内自制制剂,始创于上世纪80年代,集多位名老中医智慧的结晶总结而成,在临床上取得了良好疗效。At present, there are many traditional Chinese medicine prescriptions for kidney-qi deficiency syndrome in traditional Chinese medicine treatment. For example, Chinese patent document CN200510075262.5, published on 2006.12.13, discloses a pharmaceutical composition for treating kidney-qi deficiency syndrome and a quality control method thereof. The pharmaceutical composition is prepared from the following raw materials: Cnidium 20- 40 parts by weight, 20-40 parts by weight of Chuanxiong, 50-80 parts by weight of Dodder, 20-40 parts by weight of Bakuchi, 20-40 parts by weight of Poria, 15-25 parts by weight of red ginseng, 10-20 parts by weight of cumin, 30-40 parts by weight of Schisandra, 60-120 parts by weight of Jinyingzi, 10-20 parts by weight of Atractylodes, 40-60 parts by weight of Angelica sinensis, 25-40 parts by weight of raspberries, 60-90 parts by weight of Polygonum multiflorum, 10 parts by weight of psyllium -20 parts by weight, 60-120 parts by weight of Rehmannia glutinosa, 50-80 parts by weight of Lycium barbarum, 40-60 parts by weight of Chinese yam, 60-120 parts by weight of Epimedium, 60-120 parts by weight of Fenugreek, 40-60 parts by weight of Astragalus Parts by weight, 40-60 parts by weight of Cistanche deserticola, 10-20 parts by weight of Zhigancao, the pharmaceutical composition and its granules have the functions of reconciling yin and yang, warming yang and tonifying the kidney, soothing the nerves and strengthening the essence, strengthening the body and strengthening the body, and are clinically used for impotence, Nocturnal emission, soreness in waist and legs, lack of energy, frequent urination at night, chills and chills, menorrhagia in women, and thin leucorrhea. For another example, the Qilu Jianshen Granule disclosed by the applicant in the paper "Qilu Jianshen Granule Improves the Clinical Observation of Kidney Qi Deficiency Syndrome in Middle-aged and Elderly" published in the Chinese journal "Liaoning Journal of Traditional Chinese Medicine" in 2012, Vol. 39, No. 7, is formulated with Ginseng, Qi, Zhu Yiqi and spleen; Gui, peony to nourish blood and nourish the heart and liver; Tsubaki, Psoralea, Lu Hancao, Lycium barbarum and Yigui tonic together, strengthen tendons and bones. This recipe is the patent applicant's homemade preparation in the hospital. It was founded in the 1980s. It is composed of the crystallization of the wisdom of many famous and old Chinese medicine practitioners, and has achieved good clinical effects.

然而,中医理论博大精深,中药方剂配伍方法众多,药材之间的配伍关系更是微妙,因此中医学者对于方剂都会有自己独到的体会,并加以改良。本申请发明人基于深厚的中医理论基础及自己对于方剂配伍的认识,在原有杞鹿健肾颗粒基础上做了进一步的改进,以期提高组方的治疗效果。However, the theory of traditional Chinese medicine is broad and profound, there are many ways of compatibility of traditional Chinese medicine prescriptions, and the compatibility relationship between medicinal materials is even more subtle. Therefore, Chinese medicine scholars will have their own unique experience of prescriptions and improve them. Based on the profound theoretical basis of traditional Chinese medicine and his own understanding of the compatibility of prescriptions, the inventor of the present application has made further improvements on the basis of the original Qilu Jianshen Granules, in order to improve the therapeutic effect of the prescription.

发明内容SUMMARY OF THE INVENTION

本发明的目的是针对现有技术中的不足,提供一种改善中老年肾气虚证的中药组合物。The purpose of the present invention is to aim at the deficiencies in the prior art, and to provide a traditional Chinese medicine composition for improving middle-aged and elderly people with kidney-qi deficiency syndrome.

本发明的再一的目的是,提供所述的中药组合物的用途。Another object of the present invention is to provide the use of the Chinese medicine composition.

本发明的另一的目的是,提供所述中药组合物颗粒剂的制备方法。Another object of the present invention is to provide a preparation method of the traditional Chinese medicine composition granules.

为实现上述第一个目的,本发明采取的技术方案是:For realizing above-mentioned first purpose, the technical scheme that the present invention takes is:

一种改善中老年肾气虚证的中药组合物,其由下述重量份的原料药制成:党参15-25份、炙黄芪15-25份、当归12-18份、补骨脂15-25份、鹿含草15-25份、枸杞子10-20份、赤芍10-20份。A traditional Chinese medicine composition for improving kidney-qi deficiency syndrome in middle-aged and elderly people, which is prepared from the following raw materials by weight: 15-25 parts of Codonopsis Radix, 15-25 parts of Zhi Huangqi, 12-18 parts of Angelica sinensis, 15-25 parts of Psoraleae 15-25 parts of deer containing grass, 10-20 parts of wolfberry fruit, 10-20 parts of red peony.

优选地,其由下述重量份的原料药制成:党参18-22份、炙黄芪18-22份、当归15-18份、补骨脂18-22份、鹿含草18-22份、枸杞子14-18份、赤芍14-18份。Preferably, it is made from the following raw materials by weight: 18-22 parts of Codonopsis Radix, 18-22 parts of Sunburn Astragalus, 15-18 parts of Angelica sinensis, 18-22 parts of Psoraleae, 18-22 parts of Deer Radix, 14-18 parts of wolfberry and 14-18 parts of red peony.

更优选地,其由下述重量份的原料药制成:党参20份、炙黄芪20份、当归16.67份、补骨脂20份、鹿含草20份、枸杞子15份、赤芍15份。More preferably, it is made of the following raw materials by weight: 20 parts of Codonopsis pilosula, 20 parts of Sunburn Astragalus, 16.67 parts of Angelica sinensis, 20 parts of psoralen, 20 parts of Deer Radix, 15 parts of wolfberry fruit, 15 parts of red peony root .

作为本发明的一种具体实施方式,所述的中药组合物的剂型是颗粒剂、胶囊剂、片剂或合剂。As a specific embodiment of the present invention, the dosage form of the traditional Chinese medicine composition is granule, capsule, tablet or mixture.

为实现上述第二个目的,本发明采取的技术方案是:For realizing the above-mentioned second purpose, the technical scheme that the present invention takes is:

如上任一所述的中药组合物在制备改善中老年肾气虚证的药物中的应用。Application of any one of the above-mentioned traditional Chinese medicine compositions in the preparation of medicines for improving kidney-qi deficiency syndrome in middle-aged and elderly people.

如上任一所述的中药组合物在制备抗衰老的药物中的应用。Application of any one of the above-mentioned traditional Chinese medicine compositions in the preparation of anti-aging medicines.

为实现上述第三个目的,本发明采取的技术方案是:For realizing the above-mentioned third purpose, the technical scheme that the present invention takes is:

如上任一所述的中药组合物的颗粒剂的制备方法,包括以下步骤:称取各原料药,分别加6-10倍量和2-6倍量的水煎煮二次,每次煮沸后于80-90℃保温10-30分钟,煎液滤过,合并滤液并浓缩至相对密度1.0以上,放置10小时以上,取上清液加入常规药用载体,混匀,干燥,粉碎成细粉,加乙醇适量制粒,干燥,即得。The preparation method of the granules of the traditional Chinese medicine composition as described in any one of the above, comprising the following steps: weighing each raw material, adding 6-10 times and 2-6 times of water respectively and decocting twice, after each boiling Incubate at 80-90°C for 10-30 minutes, filter the decoction, combine the filtrates and concentrate to a relative density of more than 1.0, leave it for more than 10 hours, take the supernatant and add it to a conventional pharmaceutical carrier, mix well, dry, and pulverize into fine powder , add an appropriate amount of ethanol to granulate, and dry to obtain the final product.

本文中,所述炙黄芪为黄芪的炮制加工品,制法:取黄芪片,照蜜炙法炒至不粘手;所述鹿含草又名鹿衔草、鹿蹄草,为鹿蹄草科植物鹿蹄草Pyrola calliantha H.Andres的干燥全草。In this article, the roasted Astragalus is the processed product of Astragalus, and the preparation method is as follows: take astragalus slices, stir-fry them according to the method of honey roasting until they are not sticky; Dried whole grass of Pyrola calliantha H.Andres.

本发明优点在于:The advantages of the present invention are:

1、本发明的中药组合物方选枸杞子、鹿含草为君,枸杞子味甘性平,归肝肾二经,功在偏补肾阴;鹿含草味微甘性温,归肝肾肺三经,功可补肾助阳、强壮筋骨;二者合为君药,补益肝肾、乙癸同补、滋阴温阳,共奏阴阳同补之效。另选补骨脂为臣,补骨脂辛苦性温,归脾肾二经,功可补肾助阳强腰,有助命门之火,更助鹿含草补阳之效。组方佐以党参、黄芪、当归,党参味甘性平,归脾肺二经,功可补中益气、和胃生津;黄芪味甘性微温,归脾肺二经,有补气升阳、益卫固表之效;当归味甘辛性温,归肝心脾经,有补血活血之功效;此三味药在佐助君臣药之余,亦能益气生津、养血活血,补而不滞,气血共调,使气血生化有源,瘀血不得存留。此外方中配有赤芍,其味苦、性微寒,归肝脾经,除取其活血散瘀之功效,另取其微寒之性,以制方中补阳药使其无暴亢之患。本方虽为健肾之名,实因肾为五脏阴阳之根本、补益之所重,而实为五脏气血阴阳同补之剂。临床实验表明本发明的中药组合物相比于原有杞鹿健肾方对于中老年肾气虚证患者的症状及生活质量的改善更加显著,配伍更为精当,在临床相关病症的治疗上具有巨大潜力。1, Chinese medicinal composition prescription of the present invention selects lycium barbarum, deer containing grass as the king, and wolfberry fruit is sweet and flat in nature, and returns to the two meridians of liver and kidney, and its function is to invigorate kidney yin; Gong can invigorate the kidneys, help the yang, strengthen the muscles and bones; the two are combined as a king drug, tonic for the liver and kidney, yi and gui tonic, nourishing the yin and warming the yang. Select Psoralea as the minister. Psoralea is hard-working and warm in nature. It belongs to the two meridians of the spleen and kidney. Its functions can invigorate the kidney, help the yang and strengthen the waist. The group formula is supplemented with Codonopsis, Astragalus, Angelica. Codonopsis is sweet and flat in nature, and belongs to the spleen and lung meridians. Its functions can invigorate the middle and invigorate the qi, and the stomach and produce body fluid. The effect of Wei Gubiao; Angelica is sweet and pungent in nature, warm in nature, returns to the liver, heart and spleen meridians, and has the effect of invigorating blood and activating blood; these three herbs, in addition to assisting the monarch and minister medicine, can also invigorate qi, generate body fluid, nourish blood and activate blood, tonic without stagnation, qi and blood Co-adjustment makes Qi and blood biochemically active, and blood stasis cannot remain. In addition, there is red peony root in the prescription, which is bitter in taste and slightly cold in nature. It belongs to the liver and spleen meridians. In addition to its effect of promoting blood circulation and dissipating blood stasis, it is also used for its slightly cold nature. trouble. Although the name of this prescription is for strengthening the kidney, it is actually a supplement for the five viscera, qi, blood, yin and yang because the kidney is the foundation of the five zang organs and the most important point of nourishment. Clinical experiments show that compared with the original Qilu Jianshen prescription, the traditional Chinese medicine composition of the present invention can improve the symptoms and quality of life of middle-aged and elderly patients with kidney-qi deficiency syndrome more significantly, and the compatibility is more precise, and it has great advantages in the treatment of clinically related diseases. potential.

2、本发明的中药组合物药味组成少,更便于制备,成本低。2. The traditional Chinese medicine composition of the present invention has less medicinal taste, is more convenient to prepare, and has low cost.

具体实施方式Detailed ways

下面对本发明提供的具体实施方式作详细说明。The specific embodiments provided by the present invention will be described in detail below.

实施例1本发明中药组合物合剂的制备(一)The preparation of embodiment 1 Chinese medicine composition mixture of the present invention (1)

党参15份、炙黄芪25份、当归12份、补骨脂25份、鹿含草15份、枸杞子20份、赤芍10份,常规方法煎煮。15 parts of Codonopsis Radix, 25 parts of Astragalus root, 12 parts of Angelica sinensis, 25 parts of Psoralea, 15 parts of Luhancao, 20 parts of Lycium barbarum, 10 parts of red peony, decocted by conventional method.

实施例2本发明中药组合物合剂的制备(二)The preparation of embodiment 2 Chinese medicine composition mixture of the present invention (two)

党参25份、炙黄芪15份、当归18份、补骨脂15份、鹿含草25份、枸杞子10份、赤芍20份,常规方法煎煮。25 parts of Codonopsis Radix, 15 parts of Sunburn Astragalus, 18 parts of Angelica sinensis, 15 parts of Psoralea, 25 parts of Luhancao, 10 parts of Lycium barbarum, 20 parts of red peony root, decocted by conventional method.

实施例3本发明中药组合物合剂的制备(三)The preparation of embodiment 3 Chinese medicine composition mixture of the present invention (three)

党参15份、炙黄芪15份、当归18份、补骨脂25份、鹿含草15份、枸杞子10份、赤芍20份,常规方法煎煮。15 parts of Codonopsis, 15 parts of Astragalus root, 18 parts of Angelica sinensis, 25 parts of Psoralea, 15 parts of Luhancao, 10 parts of Lycium barbarum, 20 parts of red peony, decocted by conventional method.

实施例4本发明中药组合物合剂的制备(四)The preparation of embodiment 4 Chinese medicine composition mixture of the present invention (four)

党参25份、炙黄芪25份、当归12份、补骨脂15份、鹿含草25份、枸杞子20份、赤芍10份,常规方法煎煮。25 parts of Codonopsis pilosula, 25 parts of roasted astragalus, 12 parts of Angelica sinensis, 15 parts of psoralen, 25 parts of Luhancao, 20 parts of wolfberry fruit, 10 parts of red peony root, decocted by conventional method.

实施例5本发明中药组合物合剂的制备(五)The preparation of embodiment 5 Chinese medicine composition mixture of the present invention (5)

党参15份、炙黄芪15份、当归12份、补骨脂15份、鹿含草25份、枸杞子20份、赤芍20份,常规方法煎煮。15 parts of Codonopsis Radix, 15 parts of Sunburn Astragalus, 12 parts of Angelica sinensis, 15 parts of Psoralea, 25 parts of Luhancao, 20 parts of Lycium barbarum, 20 parts of red peony root, decocted by conventional method.

实施例6本发明中药组合物合剂的制备(六)The preparation of embodiment 6 Chinese medicine composition mixture of the present invention (six)

党参25份、炙黄芪25份、当归18份、补骨脂15份、鹿含草15份、枸杞子10份、赤芍10份,常规方法煎煮。25 parts of Codonopsis, 25 parts of Astragalus root, 18 parts of Angelica sinensis, 15 parts of Psoralea, 15 parts of Luhancao, 10 parts of Lycium barbarum, 10 parts of red peony, and boiled by conventional method.

实施例7本发明中药组合物合剂的制备(七)The preparation of embodiment 7 traditional Chinese medicine composition mixture of the present invention (seven)

党参18份、炙黄芪22份、当归15份、补骨脂22份、鹿含草18份、枸杞子18份、赤芍14份,常规方法煎煮。18 parts of Codonopsis Radix, 22 parts of Sunburn Astragalus, 15 parts of Angelica sinensis, 22 parts of Psoralea, 18 parts of Luhancao, 18 parts of Lycium barbarum, 14 parts of Red Peony, decocted by conventional method.

实施例8本发明中药组合物合剂的制备(八)The preparation of embodiment 8 traditional Chinese medicine composition mixture of the present invention (eight)

党参22份、炙黄芪18份、当归18份、补骨脂18份、鹿含草22份、枸杞子14份、赤芍18份,常规方法煎煮。22 parts of Codonopsis, 18 parts of Astragalus root, 18 parts of Angelica sinensis, 18 parts of Psoralea, 22 parts of Luhancao, 14 parts of Lycium barbarum, 18 parts of red peony root, decocted by conventional method.

实施例9本发明中药组合物合剂的制备(九)The preparation of embodiment 9 Chinese medicine composition mixture of the present invention (nine)

党参18份、炙黄芪18份、当归18份、补骨脂22份、鹿含草18份、枸杞子14份、赤芍18份,常规方法煎煮。18 parts of Codonopsis Radix, 18 parts of Sunburn Astragalus, 18 parts of Angelica sinensis, 22 parts of psoralen, 18 parts of Luhancao, 14 parts of wolfberry fruit, 18 parts of red peony root, decocted by conventional method.

实施例10本发明中药组合物合剂的制备(十)Embodiment 10 Preparation of Chinese medicine composition mixture of the present invention (ten)

党参22份、炙黄芪22份、当归18份、补骨脂18份、鹿含草18份、枸杞子14份、赤芍18份,常规方法煎煮。22 parts of Codonopsis Radix, 22 parts of Sunburn Astragalus, 18 parts of Angelica sinensis, 18 parts of Psoralea, 18 parts of Luhancao, 14 parts of Lycium barbarum, 18 parts of red peony root, decocted by conventional method.

实施例11本发明中药组合物合剂的制备(十一)Embodiment 11 Preparation of Chinese medicine composition mixture of the present invention (Eleven)

党参20份、炙黄芪20份、当归16.67份、补骨脂20份、鹿含草20份、枸杞子15份、赤芍15份,常规方法煎煮。20 parts of Codonopsis, 20 parts of Astragalus root, 16.67 parts of Angelica sinensis, 20 parts of Psoralea, 20 parts of Luhancao, 15 parts of Lycium barbarum, 15 parts of Chishao, decocted by conventional method.

实施例12本发明中药组合物颗粒剂的制备Example 12 Preparation of Chinese medicine composition granules of the present invention

按照实施例1-11任一所述的重量份配比称取各原料药,分别加8倍量和4倍量的水煎煮二次,每次煮沸后于85℃保温20分钟,煎液滤过,合并滤液并浓缩至相对密度1.0以上,放置10小时以上,取上清液加入糊精和甜菊素适量,混匀,干燥,粉碎成细粉,加乙醇适量制粒,干燥,即得。Weigh each raw material according to the proportion by weight described in any one of Examples 1-11, add 8 times of water and 4 times of water and decocted for two times respectively, and keep the temperature at 85°C for 20 minutes after each boil. Filter, combine the filtrates and concentrate to a relative density of more than 1.0, leave it for more than 10 hours, take the supernatant, add an appropriate amount of dextrin and steviol, mix well, dry, pulverize into fine powder, add an appropriate amount of ethanol to granulate, and dry to obtain .

实施例13本发明中药组合物胶囊剂的制备Example 13 Preparation of Chinese medicine composition capsules of the present invention

按照实施例1-11任一所述的重量份配比称取各原料药,分别加8倍量和4倍量的水煎煮二次,每次煮沸后于85℃保温20分钟,煎液滤过,合并滤液并浓缩至相对密度1.0以上,放置10小时以上,取上清液加入糊精和甜菊素适量,混匀,干燥,粉碎成细粉,加乙醇适量制粒,干燥,粉碎,填充装胶囊。Weigh each raw material according to the proportion by weight described in any one of Examples 1-11, add 8 times of water and 4 times of water and decocted for two times respectively, and keep the temperature at 85°C for 20 minutes after each boil. Filter, combine the filtrates and concentrate to a relative density of more than 1.0, leave for more than 10 hours, take the supernatant, add an appropriate amount of dextrin and steviol, mix well, dry, pulverize into fine powder, add an appropriate amount of ethanol to granulate, dry, pulverize, Filled capsules.

实施例14本发明中药组合物片剂的制备Example 14 Preparation of Chinese medicine composition tablet of the present invention

按照实施例1-11任一所述的重量份配比称取各原料药,分别加8倍量和4倍量的水煎煮二次,每次煮沸后于85℃保温20分钟,煎液滤过,合并滤液并浓缩至相对密度1.0以上,放置10小时以上,取上清液加入糊精和甜菊素适量,混匀,干燥,粉碎成细粉,加乙醇适量制粒,干燥,粉碎,压制成片剂。Weigh each raw material according to the proportion by weight described in any one of Examples 1-11, add 8 times of water and 4 times of water and decocted for two times respectively, and keep the temperature at 85°C for 20 minutes after each boil. Filter, combine the filtrates and concentrate to a relative density of more than 1.0, leave for more than 10 hours, take the supernatant, add an appropriate amount of dextrin and steviol, mix well, dry, pulverize into fine powder, add an appropriate amount of ethanol to granulate, dry, pulverize, Compressed into tablets.

实施例15临床试验Example 15 Clinical trial

1资料与方法1 Materials and methods

1.1一般资料1.1 General information

收集2013年1月—2014年8月就诊于上海中医药大学附属岳阳中西医结合医院老年科门诊和住院病房患者160例,根据随机表法分为两组。治疗组80例,男57例,女23例;年龄46~88岁,平均(65.88±6.27)岁;体重平均(62.90±10.05)kg。对照组80例,男52例,女28例;年龄47~90岁,平均(64.08±8.73)岁;体重平均(61.41±7.99)kg。两组年龄、体重、性别等无显著差异(P>0.05),具有可比性。遵循自愿、知情同意原则。A total of 160 patients in the outpatient and inpatient wards of the geriatric department of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine from January 2013 to August 2014 were collected and divided into two groups according to the random table method. There were 80 patients in the treatment group, including 57 males and 23 females; the age ranged from 46 to 88 years, with an average age of (65.88±6.27) years; the average weight was (62.90±10.05) kg. The control group consisted of 80 patients, 52 males and 28 females; the age ranged from 47 to 90 years, with an average age of (64.08±8.73) years; the average weight was (61.41±7.99) kg. There was no significant difference in age, weight and gender between the two groups (P>0.05), and they were comparable. Follow the principle of voluntary and informed consent.

1.2病例选择1.2 Case selection

1.2.1纳入标准1.2.1 Inclusion criteria

参照1994年国家中医药管理局颁布的《中医病症诊断治疗标准》。(1)年龄>45岁;(2)符合肾气虚证诊断标准:具备肾气虚证的主症2项;或主症1项加次症2项。Refer to the "Traditional Chinese Medicine Disease Diagnosis and Treatment Standards" promulgated by the State Administration of Traditional Chinese Medicine in 1994. (1) Age > 45 years; (2) Meet the diagnostic criteria of kidney-qi deficiency syndrome: have 2 main symptoms of kidney-qi deficiency syndrome; or 1 main symptom plus 2 secondary symptoms.

中医证候诊断标准:主症:腰脊酸痛,疲倦乏力,或浮肿,纳少或脘胀;次症:大便溏,尿频或夜尿多,舌质淡红、有齿痕,苔薄白,脉细。Diagnostic criteria for TCM syndromes: Main symptoms: lumbar pain, fatigue, or edema, anorexia or abdominal distention; secondary symptoms: loose stools, frequent urination or nocturia, pale red tongue, tooth marks, thin white coating, Thin pulse.

1.2.2排除标准1.2.2 Exclusion criteria

(1)不符合纳入标准者;(2)不属于作用范围内病例;(3)有明显兼夹证或合并证者;(4)近1个月服用其他具有益气血、养肝肾、健筋壮骨、平和温补作用的药物;(5)患者3个月内参加了其他临床实验;(6)哺乳妊娠或正准备妊娠的妇女;(7)过敏体质及对多种药物过敏者;(8)怀疑或确有药物滥用史,或者根据研究者的判断,具有降低入组可能性或使入组复杂化的其他病变或情况,如工作环境经常变动等易造成失访的情况;(9)合并肝、肾、造血系统、内分泌系统等严重原发性疾病及精神病患者;(10)病情危重(如严重心功能不全、严重感染和肿瘤等),难以对药物的有效性和安全性做出确切评价者。(1) Those who do not meet the inclusion criteria; (2) Those who do not belong to the scope of action; (3) Those who have obvious concurrent or combined syndromes; Drugs that strengthen tendons and bones, calm and nourish; (5) The patient has participated in other clinical trials within 3 months; (6) Women who are breastfeeding pregnant or preparing to become pregnant; (7) Allergic constitutions and those allergic to multiple drugs (8) Suspect or have a history of drug abuse, or, according to the judgment of the investigator, have other diseases or conditions that reduce the possibility of enrollment or complicate enrollment, such as frequent changes in the working environment and other conditions that are likely to cause loss to follow-up; (9) Patients with serious primary diseases such as liver, kidney, hematopoietic system, endocrine system, and mental illness; (10) Critical illness (such as severe cardiac insufficiency, severe infection and tumor, etc.), it is difficult to determine the effectiveness and safety of drugs Sexuality makes an accurate assessment.

1.3治疗方法1.3 Treatment methods

治疗组给予本发明中药组合物颗粒剂,制备方法如下:称取党参200g、炙黄芪200g、当归166.7g、补骨脂200g、鹿含草200g、枸杞子150g、赤芍150g,分别加8倍量和4倍量的水煎煮二次,每次煮沸后于85℃保温20分钟,煎液滤过,合并滤液并浓缩至相对密度为1.5,放置12小时,取上清液加入糊精适量,甜菊素4.2g,混匀,干燥,粉碎成细粉,加乙醇适量制粒,干燥,制成1000g,每袋装12g。The treatment group was given the granules of the traditional Chinese medicine composition of the present invention, and the preparation method was as follows: Weigh 200 g of Codonopsis Radix, 200 g of Astragalus root, 166.7 g of Angelica sinensis, 200 g of psoralen, 200 g of Luhancao, 150 g of wolfberry fruit, and 150 g of red peony root, add 8 times The amount and 4 times the amount of water were decocted twice, after each boiling, the temperature was kept at 85 ° C for 20 minutes, the decoction was filtered, the filtrate was combined and concentrated to a relative density of 1.5, placed for 12 hours, and the supernatant was added. Add an appropriate amount of dextrin , Steviolin 4.2g, mix well, dry, pulverize into fine powder, add appropriate amount of ethanol to granulate, dry to make 1000g, 12g per bag.

对照组给予杞鹿健肾颗粒,制备方法如下:称取党参200g、炙黄芪200g、当归166.7g、续断200g、补骨脂200g、鹿含草200g、枸杞子150g、白术150g、白芍150g,分别加8倍量和4倍量的水煎煮二次,每次煮沸后于85℃保温20分钟,煎液滤过,合并滤液并浓缩至相对密度为1.5,放置12小时,取上清液加入糊精适量,甜菊素4.2g,混匀,干燥,粉碎成细粉,加乙醇适量制粒,干燥,制成1000g,每袋装12g。The control group was given Qilu Jianshen granules, and the preparation method was as follows: Weigh 200 g of Codonopsis Radix, 200 g of Astragalus root, 166.7 g of Angelica sinensis, 200 g of Danggui, 200 g of psoralen, 200 g of Luhancao, 150 g of Lycium barbarum, 150 g of Atractylodes Rhizoma, 150 g of Paeonia lactiflora , respectively add 8 times and 4 times the amount of water to decoct twice, after each boil, keep the temperature at 85 ° C for 20 minutes, filter the decoction, combine the filtrate and concentrate it to a relative density of 1.5, leave it for 12 hours, take the supernatant Add an appropriate amount of dextrin and 4.2g of steviol into the liquid, mix well, dry, pulverize into fine powder, add an appropriate amount of ethanol to granulate, and dry to make 1000g, 12g per bag.

以上药物均开水冲服,每次12g,每日2次。期间不能变更剂量。将合格入选后的首天作为研究用药的第1天。共治疗6周。The above medicines are taken with boiled water, 12g each time, 2 times a day. The dose cannot be changed during this period. The first day after qualifying enrollment was taken as the first day of study medication. A total of 6 weeks of treatment.

1.4观察项目1.4 Observation items

(1)安全性指标:心率、呼吸、血压等一般项目;血、尿、便常规检查;肝、肾功能;心电图。(2)疗效性评价:症状评分:主要症状包括腰脊酸痛、腰脊冷痛、疲倦乏力、浮肿、少气懒言、畏寒肢冷、头晕、耳鸣等。症状无或消失记0分;症状轻微或有时出现记1分;症状中等程度,时轻时重记2分;症状明显记3分。(1) Safety indicators: general items such as heart rate, respiration, blood pressure; routine examination of blood, urine and stool; liver and kidney function; electrocardiogram. (2) Efficacy evaluation: Symptom score: The main symptoms include lumbar pain, cold pain in the lumbar spine, fatigue, edema, lack of gas and lazy speech, chills, cold limbs, dizziness, tinnitus, etc. No or disappearance of symptoms was scored as 0; mild symptoms or occasional symptoms were scored as 1; moderate symptoms were scored as 2 scores when mild and severe; 3 scores were scored as obvious symptoms.

生活质量评分(参照《辽宁中医杂志》2012年第39卷第7期刊出的论文“杞鹿健肾颗粒改善中老年肾气虚证临床观察):主要有食欲、睡眠、一般活动、精神状态、情绪、与人交往、生活兴趣等。评分按照很好记0分,极差记10分,分别在0~10区间内选择。Quality of life score (refer to the paper "Qilu Jianshen Granule Improves Kidney-Qi Deficiency Syndrome in Middle-aged and Elderly" published in "Liaoning Journal of Traditional Chinese Medicine", Vol. 39, No. 7, 2012): mainly include appetite, sleep, general activity, mental state, mood , relationship with people, interest in life, etc. The score is scored as 0 points for very good, and 10 points for extremely poor, which are selected between 0 and 10 respectively.

评价标准:病例积分=各症状记分之和。临床痊愈:中医临床症状、体征消失或基本消失,证候积分减少≥95%。显效:中医临床症状、体征均有明显改善,证候积分减少≥70%。有效:中医临床症状、体征均有好转,证候积分减少≥30%。无效:中医临床症状、体征均无明显改善,甚或加重,证候积分减少<30%。Evaluation standard: case score=sum of each symptom score. Clinical recovery: TCM clinical symptoms and signs disappeared or basically disappeared, and the syndrome score decreased by ≥95%. Significantly effective: TCM clinical symptoms and signs were significantly improved, and the syndrome score was reduced by ≥70%. Effective: TCM clinical symptoms and signs have improved, and syndrome scores have been reduced by ≥30%. Invalid: TCM clinical symptoms and signs were not significantly improved, or even worsened, and the syndrome score was reduced by <30%.

注:计算公式(尼莫地平法)=(治疗前总积分-治疗后总积分)/治疗前总积分×100%。Note: Calculation formula (Nimodipine method)=(Total score before treatment-Total score after treatment)/Total score before treatment×100%.

1.5统计学处理1.5 Statistical processing

数据采用SPSS18.0软件进行分析,数据以

Figure BDA0001228125500000061
表示,计量资料用t检验及方差分析,计数资料用χ2检验作统计学处理。The data were analyzed using SPSS 18.0 software.
Figure BDA0001228125500000061
The measurement data were analyzed by t test and variance analysis, and the count data were analyzed by χ 2 test.

2结果与分析2 Results and Analysis

试验结束后共计脱落5例,脱落率为3.13%,其中治疗组脱落1例;对照组脱落4例。本试验最终纳入155例,治疗组79例,对照组76例。After the test, a total of 5 cases dropped out, with a drop-out rate of 3.13%, including 1 case in the treatment group and 4 cases in the control group. The trial finally included 155 cases, 79 cases in the treatment group and 76 cases in the control group.

2.1两组症状疗效比较2.1 Comparison of symptoms and curative effects between the two groups

治疗后两组患者的腰脊酸痛、腰脊冷痛、疲倦乏力、浮肿、少气懒言、畏寒肢冷、头晕、耳鸣等症状均有显著的改善,总有效率统计结果见表1。治疗组与对照组总有效率相比,差异具有统计学意义(P<0.01)。After treatment, the symptoms of lumbar spine pain, lumbar spine cold pain, fatigue, edema, lack of breath and lazy speech, chills, dizziness, tinnitus and other symptoms were significantly improved in the two groups of patients. The statistical results of the total effective rate are shown in Table 1. Compared with the control group, the total effective rate of the treatment group was significantly different (P<0.01).

表1两组症状疗效比较Table 1 Comparison of the symptoms and curative effects of the two groups

组别group 例数(例)Number of cases (cases) 临床痊愈(例)Clinical recovery (case) 显效(例)Effective (example) 有效(例)Valid (example) 无效(例)invalid (example) 总有效率total efficiency 治疗组therapy group 7979 1818 3333 22twenty two 66 92.41%**92.41%*** 对照组control group 7676 66 1717 3434 1919 75.00%75.00%

注:与对照组相比,**P<0.01。Note: Compared with the control group, **P<0.01.

2.2两组生活质量比较2.2 Comparison of quality of life between the two groups

治疗后两组患者的食欲、睡眠、一般活动、精神状态、情绪、与人交往和生活兴趣方面均有显著的改善,生活质量改善率统计结果见表2。治疗组与对照组生活质量改善率相比,在食欲、精神状态和情绪方面差异均具有统计学意义(P<0.01),在睡眠、一般活动和生活兴趣方面差异均具有统计学意义(P<0.05),在与人交往方面,差异无统计学意义(P>0.05),可能和与人交往情况除受到身体健康状况影响外,还受到个人性格、生活环境等诸多因素影响有关。After treatment, the appetite, sleep, general activities, mental state, mood, interpersonal communication and interest in life of the two groups of patients were significantly improved. The statistical results of the improvement rate of quality of life are shown in Table 2. Compared with the control group, the improvement rate of quality of life in the treatment group was statistically significant (P<0.01) in appetite, mental state and mood, and in sleep, general activities and interest in life (P<0.01). 0.05), there was no statistically significant difference in interacting with people (P>0.05), which may be related to the influence of personal personality, living environment and many other factors in the relationship with people in addition to physical health.

表2生活质量改善率比较

Figure BDA0001228125500000071
Table 2 Comparison of quality of life improvement rates
Figure BDA0001228125500000071

项目/组别Project/Group 治疗组therapy group 对照组control group 食欲appetite 0.84±0.330.84±0.33 0.55±0.20**0.55±0.20** 睡眠sleep 0.76±0.320.76±0.32 0.58±0.31*0.58±0.31* 一般活动general activities 0.72±0.400.72±0.40 0.57±0.29*0.57±0.29* 精神状态mental state 0.85±0.360.85±0.36 0.64±0.30**0.64±0.30** 情绪mood 0.77±0.420.77±0.42 0.52±0.27**0.52±0.27** 与人交往interact with people 0.69±0.390.69±0.39 0.59±0.340.59±0.34 生活兴趣life interest 0.71±0.280.71±0.28 0.56±0.24*0.56±0.24*

注:与对照组相比,*P<0.05,**P<0.01。Note: Compared with the control group, *P<0.05, **P<0.01.

以上所述仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员,在不脱离本发明方法的前提下,还可以做出若干改进和补充,这些改进和补充也应视为本发明的保护范围。The above are only the preferred embodiments of the present invention. It should be pointed out that for those skilled in the art, without departing from the method of the present invention, several improvements and supplements can be made, and these improvements and supplements should also be regarded as It is the protection scope of the present invention.

Claims (7)

1. A traditional Chinese medicine composition for improving kidney qi deficiency of middle-aged and elderly people is characterized by being prepared from the following raw material medicines in parts by weight: 15-25 parts of codonopsis pilosula, 15-25 parts of radix astragali preparata, 12-18 parts of angelica, 15-25 parts of fructus psoraleae, 15-25 parts of pyrola, 10-20 parts of wolfberry fruit and 10-20 parts of red paeony root; the preparation method of the traditional Chinese medicine composition comprises the following steps: weighing the raw materials, adding 6-10 times and 2-6 times of water respectively, decocting twice, keeping the temperature at 80-90 ℃ for 10-30 minutes after each boiling, filtering the decoction, combining the filtrates, concentrating to a relative density of more than 1.0, standing for more than 10 hours, taking the supernatant, adding a conventional medicinal carrier, mixing uniformly, drying, crushing into fine powder, adding a proper amount of ethanol, granulating, and drying to obtain the traditional Chinese medicine composition.
2. The traditional Chinese medicine composition according to claim 1, which is prepared from the following raw material medicines in parts by weight: 18-22 parts of codonopsis pilosula, 18-22 parts of radix astragali preparata, 15-18 parts of angelica, 18-22 parts of fructus psoraleae, 18-22 parts of pyrola, 14-18 parts of wolfberry fruit and 14-18 parts of red paeony root.
3. The traditional Chinese medicine composition according to claim 2, which is prepared from the following raw material medicines in parts by weight: 20 parts of codonopsis pilosula, 20 parts of radix astragali preparata, 16.67 parts of angelica, 20 parts of fructus psoraleae, 20 parts of herba pyrolae, 15 parts of wolfberry fruit and 15 parts of red paeony root.
4. The Chinese medicinal composition according to any one of claims 1 to 3, wherein the Chinese medicinal composition is in the form of granules, capsules or tablets.
5. The use of the Chinese medicinal composition of any one of claims 1-3 in the preparation of a medicament for improving kidney qi deficiency in the middle-aged and elderly.
6. Use of the Chinese medicinal composition of any one of claims 1-3 in the preparation of an anti-aging medicament.
7. A method for preparing granules of the Chinese medicinal composition according to any one of claims 1 to 3, which comprises the following steps: weighing the raw materials, adding 6-10 times and 2-6 times of water respectively, decocting twice, keeping the temperature at 80-90 ℃ for 10-30 minutes after each boiling, filtering the decoction, combining the filtrates, concentrating to a relative density of more than 1.0, standing for more than 10 hours, taking the supernatant, adding a conventional medicinal carrier, mixing uniformly, drying, crushing into fine powder, adding a proper amount of ethanol, granulating, and drying to obtain the traditional Chinese medicine composition.
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杞鹿健肾颗粒改善中老年肾气虚证临床观察;施丹等;《辽宁中医杂志》;20121231;第39卷(第7期);第1305-1306页,尤其是摘要和第1306页左栏最后1段 *

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