CN107737292B

CN107737292B - Traditional Chinese medicine preparation for treating senile nocturia and preparation method thereof

Info

Publication number: CN107737292B
Application number: CN201711136403.9A
Authority: CN
Inventors: 蒋林; 农毅清; 李芳婵; 周雅琪
Original assignee: Guangxi University of Chinese Medicine
Current assignee: Guangxi University of Chinese Medicine
Priority date: 2017-11-16
Filing date: 2017-11-16
Publication date: 2021-02-09
Anticipated expiration: 2037-11-16
Also published as: CN107737292A

Abstract

The invention relates to the field of traditional Chinese medicines, in particular to a traditional Chinese medicine preparation for treating senile nocturia and a preparation method thereof, wherein the traditional Chinese medicine preparation comprises the following raw materials in parts by weight: 15-30 parts of rhizoma polygonati; 10-25 parts of polygonatum; 12-26 parts of mulberry fruit; 10-25 parts of raspberry; 9-24 parts of fructus psoraleae; 4-18 parts of fructus alpiniae oxyphyllae; 3-17 parts of semen allii tuberosi; 1-14 parts of hawthorn; 1-15 parts of fructus cannabis. The traditional Chinese medicine preparation for treating nocturia of the old people is safe and effective, the whole formulas are mutually matched, the treatment process is simple, the cost is low, the effect is quick, the traditional Chinese medicine preparation has a remarkable treatment effect on nocturia patients, and the effective rate is high; the prepared traditional Chinese medicine preparation is safe and nontoxic, has no toxic or side effect on human bodies, and has no phenomenon of recurrence of nocturia after treatment and cure by adopting the traditional Chinese medicine preparation.

Description

Traditional Chinese medicine preparation for treating senile nocturia and preparation method thereof

Technical Field

The invention relates to the field of traditional Chinese medicines, and in particular relates to a traditional Chinese medicine preparation for treating senile nocturia and a traditional Chinese medicine preparation

A preparation method.

Background

Nocturia is a "nocturnal awakening and urination" condition, but clinically, it is generally called nocturia only when the nocturnal urine volume exceeds 1/3 times of the total daily urine volume or the number of nocturia times is not less than 2. The etiology frequently gets up and urinates at night for a long time, which interferes with normal sleep, causes mental fatigue, neurasthenia, cognitive function reduction, life quality and happiness of patients in the daytime, and even induces cardiovascular diseases or other organic lesions in some cases. The prevalence of nocturia increases with age, with annual growth rates of 7.3% and 3.5% for male and female. With the increasing population of the elderly in China, nocturia becomes a common disease in China.

Nocturia is a multifactorial disease, but the causes of nocturia in male and female patients are approximately the same, and common causes include behavioral, psychological and/or social factors; metabolic diseases such as polyuria or polyuria/polydipsia syndrome (diabetes, polydipsia syndrome, hypercalcemia, diabetes insipidus); nocturnal polyuria (hypoproteinemia, daytime fluid intake excess, congestive heart failure, kidney disease, neurological disorders); bladder storage or voiding problems (infection, bladder overactivity); sleep disorders (sleep disorders, sleep apnea, sedation overuse). Nocturia can be classified into 4 categories according to the cause and clinical manifestations: polyuria, nocturnal bladder volume decline, mixed type. Despite the complex etiology of nocturia, nocturnal polyuria is the most common cause of most elderly patients. Senile nocturia is a common but not well-understood disease, with the incidence increasing with age. It is reported in the United states that over 8O% of elderly people over age 8 have more than 1 night urination at over 8O, which severely interferes with sleep and affects quality of life and physical and mental health. Research shows that the degree of drowsiness in the daytime is more than 3 times that of normal women when more than 3 times of urination occurs at night. The insufficient sleep is easy to cause the body resistance to decline and various morbidity rates to improve. According to statistics, the disease duration of the patient who urinates more than 3 times per night is more than 75 days per year. Therefore, with the aging of the population in China, nocturia is an important problem which seriously interferes with the life quality of the old.

Nocturia is one of the common and most persistent Lower Urinary Tract Symptoms (LUTS), and seriously affects the quality of life of patients. As one of the most troublesome urinary symptoms, nocturia has been studied so far, but in actual treatment, the treatment effect of the drugs and treatment methods used for nocturia is not ideal.

Disclosure of Invention

The invention aims to provide a traditional Chinese medicine preparation for treating senile nocturia and a preparation method thereof, the traditional Chinese medicine preparation has good treatment effect on nocturia patients, has high effective rate and no toxic or side effect on human bodies, and no recurrence of the nocturia symptoms occurs after the traditional Chinese medicine preparation is used for curing.

In order to achieve the purpose, the invention adopts the following technical scheme:

a traditional Chinese medicine preparation for treating senile nocturia comprises the following raw materials in parts by weight: 15-30 parts of rhizoma polygonati; 10-25 parts of polygonatum; 12-26 parts of mulberry fruit; 10-25 parts of raspberry; 9-24 parts of fructus psoraleae; 4-18 parts of fructus alpiniae oxyphyllae; 3-17 parts of semen allii tuberosi; 1-14 parts of hawthorn; 1-15 parts of fructus cannabis; the Chinese medicinal preparation is oral liquid, powder, capsule, tablet, granule, tea bag, soft extract or other oral dosage forms.

The preparation method of the oral liquid of the traditional Chinese medicine preparation for treating senile nocturia comprises the following steps:

(1) weighing the medicines: weighing rhizoma polygonati, polygonatum, mulberry, raspberry, fructus psoraleae, fructus alpiniae oxyphyllae, semen allii tuberose, hawthorn and fructus cannabis in parts by weight for later use;

(2) water extraction: putting the traditional Chinese medicine into a traditional Chinese medicine extraction tank, adding 10-12 times of water by weight, heating and boiling for 1-1.5 hours, discharging liquid medicine, filtering, adding 5-8 times of water into dregs of a decoction, heating and boiling for 0.5-1 hour, discharging dregs of a decoction, filtering the liquid medicine, and combining the obtained two liquid medicines;

(3) mixing with appropriate amount of sucrose to obtain syrup, mixing with the above medicinal liquid, adding appropriate amount of antiseptic, standing, filtering, and packaging to obtain oral liquid.

The preparation method of the traditional Chinese medicine preparation for treating senile nocturia comprises the following steps: pulverizing rhizoma Polygonati, rhizoma Polygonati Odorati, Mori fructus, Rubi fructus, fructus Psoraleae, fructus Alpinae Oxyphyllae, semen Allii Tuberosi, fructus crataegi and fructus Cannabis to below lOO mesh, and vacuum packaging with plastic bag to obtain powder.

The preparation method of the traditional Chinese medicine preparation, capsule, tablet or granule for treating senile nocturia comprises the following steps: weighing dried rhizoma polygonati, radix polygonati officinalis, mulberry, raspberry, fructus psoraleae, fructus alpiniae oxyphyllae, semen allii tuberose, hawthorn and fructus cannabis in parts by weight, putting the traditional Chinese medicines into a traditional Chinese medicine extraction tank, adding 10-12 times of water by weight, heating and boiling for 1-1.5 hours, discharging liquid medicine, filtering, adding 5-8 times of water into medicine dregs, heating and boiling for 0.5-1 hour, discharging the medicine dregs, filtering the liquid medicine, and combining the obtained two liquid medicines; concentrating under reduced pressure at 60-70 deg.C to obtain fluid extract with relative density of 1.10-1.20 at 55 deg.C, adding 90% ethanol to make ethanol content 60%, standing at room temperature for 12 hr, filtering, recovering ethanol, concentrating to obtain soft extract with relative density of 1.30-1.35, adding pharmaceutically acceptable adjuvants, mixing, and making into capsule, tablet or granule by conventional method.

The traditional Chinese medicine preparation for treating senile nocturia is prepared by weighing dried rhizoma polygonati, radix polygonati officinalis, mulberry, raspberry, fructus psoraleae, fructus alpiniae oxyphyllae, semen allii tuberose, hawthorn and fructus cannabis according to parts by weight, crushing by using a crusher, sieving by using a 50-mesh sieve, filling into a breathable fiber bag, and preparing into a tea bag, wherein the weight of each bag is 3-5 g.

The preparation method of the traditional Chinese medicine preparation for treating senile nocturia comprises the following steps:

(1) weighing dried rhizoma polygonati, polygonatum odoratum and mulberry fruits according to parts by weight, putting the medicinal materials into a traditional Chinese medicine extraction tank, adding 6-14 times of water according to the weight, heating and boiling for 0.5-2 hours, discharging the liquid medicine, filtering, adding 5-12 times of water into dregs, heating and boiling for 0.5-1.5 hours, discharging dregs of a decoction, filtering the liquid medicine, combining the obtained two liquid medicines, and concentrating to obtain concentrated solution A;

(2) weighing raspberry, fructus psoraleae, fructus alpiniae oxyphyllae, semen allii tuberose, hawthorn and fructus cannabis in parts by weight, putting the medicinal materials into a traditional Chinese medicine extraction tank, adding 70% ethanol in an amount which is 6-14 times of the weight of the medicinal materials, heating and boiling for 1-2.5 hours, discharging liquid medicine, filtering, adding 70% ethanol in an amount which is 5-12 times of the weight of the medicinal residues, heating and boiling for 0.5-2 hours, filtering, combining the obtained two liquid medicines, concentrating and steaming the ethanol to obtain concentrated solution B;

(3) mixing the concentrated solution A and the concentrated solution B, concentrating at 60-100 ℃ under reduced pressure to obtain fluid extract with relative density of 1.20-1.30 at 55 ℃, adding refined sugar or refined honey, heating to relative density of 1.3-1.5, and collecting to obtain paste.

The pharmacological actions of the traditional Chinese medicine adopted by the invention are as follows:

rhizoma Polygonati is Polygonatum kingianum of LiliaceaePolygonatum kingianum Coll.et Hemsl.Rhizoma polygonatiPolygonatum sibiricum Red.Or Polygonatum cyrtonema HuaPolygonatum cyrtonema HuaDried rhizome of (4). Nature and taste: sweet and mild; meridian tropism: spleen, lung and kidney meridians. Has effects in nourishing yin and moistening lung; has the effects of invigorating spleen, replenishing qi, nourishing kidney and replenishing essence. The main treatment is as follows: cough due to yin deficiency, cough due to lung dryness, spleen deficiency, asthenia, anorexia, thirst, kidney deficiency, soreness of waist and knees, sexual impotence, nocturnal emission, tinnitus, dim eyesight, premature gray hair, asthenia, emaciation, and tinea. Rhizoma Polygonati has effects of lowering blood pressure, lowering blood sugar, reducing blood lipid, preventing atherosclerosis, delaying aging and resisting bacteria, and rhizoma Polygonati polysaccharide has immunity activating effect. Rhizoma Polygonati can be used for treating yin deficiency and lung dryness, dry cough with little phlegm, and yin deficiency of lung and kidneyChronic cough, etc.; can be used for treating weakness of spleen and stomach, invigorating spleen yin, and invigorating spleen qi, and can be used for treating dizziness due to kidney deficiency and essence deficiency, soreness of waist and knees, premature gray hair, and diabetes. Discussion of each family: 1. the original menstrual period was: huang Jing can tonify yin to strengthen spleen and replenish qi, harmonize five reservoirs, strengthen bone marrow and strengthen muscles. 2. The book materia Medica is just written: huang Jing is a greasy food, which is not hungry after long-term use, and is not suitable for spleen deficiency with dampness, and it is greasy and diaphragmatic. The medicine is sweet in taste like maltose, has smooth and moist properties, and is a genuine product for nourishing spleen yin.

Yuzhu, another name: rhizoma Polygonati Odorati, radix scrophulariae, herba Convolvuli Alsinoides, herba Violae Japonicae, radix Glycyrrhizae Praeparata, and herba Lophatheri; is a Liliaceae plant rhizoma Polygonati OdoratiPolygonatum odoratum（Mill.）DruceThe dried rhizome of (1) is sweet in nature and taste and slightly cold; meridian tropism: it enters lung and stomach meridians. The functional indications are as follows: nourish yin, moisten dryness, relieve restlessness and quench thirst. It is indicated for yin deficiency due to febrile disease, cough, polydipsia, consumptive disease, fever, food depletion, hunger and frequent micturition. Fragrant solomonseal rhizome is sweet and greasy in taste, soft and moist in quality, and is a good medicine for nourishing yin and promoting the production of body fluid; the vitamin A contained in the polygonatum odoratum improves the dry and cracked and rough skin conditions, enables the skin to be soft and smooth, and has the effects of beautifying and protecting the skin. Yuzhu contains steroid glycoside, and has effect on myocardium similar to that of herba Convallariae preparation. The polygonatum extract is injected into abdominal cavity to enhance phagocytosis of macrophage in abdominal cavity of burn mice, improve antibody level of serum hemolysin and improve proliferation reaction of spleen lymphocytes to ConA. Modern pharmacological studies prove that the polygonatum has a better cardiotonic effect, 20g of polygonatum is taken every day by being decocted in water, and the polygonatum has a certain curative effect on heart failure caused by rheumatic heart disease, coronary atherosclerotic heart disease and pulmonary heart disease. Discussion of each family: (I) Ben Jing: the main symptoms of sudden heat in wind, inability to shake and muscle drop are all disadvantages. Can be taken for a long time to remove the black and wild face, improve the color, moisten the face and lighten the body. ② Biyu (miscellaneous records): "predominate of stagnation of qi in the heart and abdomen, deficient heat, damp-toxicity, lumbago, cold in the stem, and eye pain, angular erosion, and lacrimal outflow".

Mulberry fruit, alternative name: mori fructus, and Mori fructus, which are clusters of Morus alba L of Moraceae; the latin plant animal mineral name is: morus alba l. Morus neutral taste: sweet in flavor and cold in nature. The functional indications are as follows: nourishing yin and blood, promoting fluid production, and moisturizing intestine; dizziness, soreness of waist, tinnitus, premature gray hair, insomnia, dreaminess, thirst due to body fluid consumption, diabetes, and constipation due to intestinal dryness. The mulberry has nutritive value, and has the effects of improving blood supply of skin (including scalp), nourishing skin, whitening skin, blackening hair, and delaying aging. The mulberry has the function of promoting immunity. Mulberry has the effects of increasing weight of spleen, enhancing hemolytic reaction, preventing arteriosclerosis and bone and joint sclerosis, and promoting metabolism. It can promote the growth of red blood cells, prevent leukopenia, and has adjuvant effect in treating diabetes, anemia, hypertension, hyperlipidemia, coronary heart disease, neurasthenia, etc. Mulberry has the functions of promoting the production of body fluid to quench thirst, promoting digestion, helping defecation and the like, and can promote gastric secretion, stimulate intestinal peristalsis and remove dryness-heat when being eaten in a proper amount. According to traditional Chinese medicine, the mulberry has sweet and cold nature and taste, and has the effects of tonifying liver and kidney, promoting fluid production, moistening intestines, blackening hair, improving eyesight and the like.

Rubi fructus is dried fruit of Rubus chingii Hu of Rubus of Rosaceae. Nature and taste: sweet, sour, warm; meridian tropism: it enters kidney and bladder meridians. The functional indications are as follows: to tonify kidney, secure essence and reduce urination. Can be used for treating enuresis due to kidney deficiency, frequent micturition, sexual impotence, premature ejaculation, spermatorrhea, and spermatorrhea. The raspberry fruit contains abundant nutrient elements such as vitamin A, vitamin C, calcium, potassium, magnesium and the like and a large amount of fiber. Per 100 g Rubi fructus, water content is 87%, protein content is 0.9 g, fiber content is 4.7 g, and heat of 209.3 kilojoules can be provided. The raspberry can effectively relieve cardiovascular diseases such as angina pectoris, and the discussion of each family is as follows: (ii) Bie Lu: "mainly tonify qi to lighten body and make hair not white". ② Rihuazi Ben Cao: "An five internal organs, benefit color, nourish essence and qi, grow hair and strengthen mind. Treating fever and convulsion due to apoplexy. ③ Kaibao Ben Cao (Kaibao materia Medica): tonify deficiency and make sure the skin, strengthen yin and build yang, nourish skin, harmonize viscera, warm middle energizer and benefit energy, treat strain and wind deficiency, tonify liver and improve eyesight. Fourthly, the materia Medica is derived: "benefit kidney and reduce stool". Fifth, materia Medica: it is used to treat fatigue, consumptive disease, aversion to cold due to deficiency of liver and kidney qi, cough due to deficiency of kidney qi, asthenia, pyrexia, diarrhea, reddish turbidity, arthroncus, blood syndrome and eye diseases.

Fructus Psoraleae is dried mature fruit of Psoralea corylifolia L. of Leguminosae, with pungent, bitter and warm taste; meridian tropism: it enters kidney and spleen meridians. The functional indications are as follows: warming kidney and tonifying yang, receiving qi, and stopping diarrhea; can be used for treating sexual impotence, spermatorrhea, frequent micturition, lumbago, gonalgia, asthma due to kidney deficiency, and diarrhea before dawn; it is used externally to treat vitiligo and alopecia areata. Discussion of each family: (xi) treatise on drug Property: mainly aims at the waist pain of men, cold knee and damp bladder, stubborn cold arthralgia, convenient stopping, and intercooling abdomen. ② Kaibao Ben Cao: ' Wulaoqishang damage, wind deficiency and cold, bone marrow damage, kidney cold, seminal emission and abortion of women's blood and qi '. (iii) compendium: treat kidney-qi deficiency, unblock the gate of life, warm the Dantian, astringe the spirit. Fourthly, Jade mountain ash Yao Jie (Yao's medical solution): the syndrome of warming water and soil, digesting food and drink, ascending spleen and stomach, astringing, diarrhea, spermatorrhea, leukorrhagia, drowning and slippery stools.

Fructus Alpinae Oxyphyllae is also called fructus Alpinae Oxyphyllae, fructus Alpinae Oxyphyllae 33404m, fructus Alpinae Oxyphyllae is fruit of Alpinia Oxyphyllae of Zingiberaceae, Latin is known as: fructus Alpinae Oxyphyllae. Nature and taste: pungent taste and warm nature; meridian tropism: spleen and kidney meridians.

The efficacy is as follows: warming spleen to arrest diarrhea and controlling salivation; warming kidney, reducing urination and stopping emission. The main treatment is as follows: deficiency-cold of the spleen and stomach; vomiting; diarrhea; intra-abdominal rearing; excessive saliva; enuresis due to kidney deficiency; the frequency of urination; spermatorrhea; white turbidity. Fructus Alpinae Oxyphyllae contains volatile oil, fructus Alpiniae Oxyphyllae ketone, vitamin B1, vitamin B2, vitamin C, vitamin E, various amino acids, fatty acids, etc. The fructus Alpinae Oxyphyllae decoction has effects of invigorating stomach, promoting diuresis, and reducing salivary secretion. The clinical application is as follows: 1. for diarrhea, enuresis and frequent urination due to cold syndrome of spleen and kidney deficiency, it is combined with other herbs of tonifying kidney and astringing, such as Tu Si Zi, sang Piao Xiao, Wu Yao and shan Yao, etc., and is added with Suo quan Wan. 2. For abdominal cold pain, vomiting, diarrhea, anorexia and increased saliva secretion caused by deficiency-cold of spleen and stomach, it is often added to Chenxia Yiqi Tang or Zhong Liang Tang. The discussion of each family is that "Ben Cao Jing Shu" (the book of Confucius diseases): ren Yi Zhi ren is also indicated for seminal emission, deficiency and dribbling urine due to astringing and controlling actions, which are also indicated for kidney qi insecurity. The kidney governs absorbing qi, while the deficiency can not receive . In addition, the five fluids are mainly the spleen, and the spleen and kidney are qi deficiency, so that the two zang organs are failing to function, the kidney cannot accept the spleen and the spleen cannot control the spleen, so that the adverse qi returns to original qi and the saliva and kidney descend.

Semen Allii Tuberosi, also called semen Allii Tuberosi, semen Allii Tuberosi is seed of Allium tuberosum of Liliaceae, and the latin plant animal mineral name is: exspreng, alliumtuberosum rottl. Pungent, sweet and warm in nature; meridian tropism including liver and kidney meridians; has the main functions of tonifying liver and kidney, strengthening yang and securing essence. It is indicated for impotence due to kidney deficiency, soreness and weakness of waist and knees, spermatorrhea, frequent micturition, turbid urine and clear and thin leucorrhea. Discussion of each family: 1. the Yunnan herbal medicine: tonify liver and kidney, warm waist and knee, improve yang channel, treat impotence. 2. Compendium (compendium): tonify liver and gate of life, treat frequent urination, enuresis, and white and lingering leucorrhea in women. 3. The book Ben Cao Hui Yan (treatise on materia Medica): dredge stranguria and promote diuresis. 4. The book materia Medica is as follows: women with cold-yin and pain in the lower abdomen. 5. Compendium (compendium): leek is the vegetable of liver, kidney is mainly closed and stored, and liver is mainly smoothing flow of qi; "Su Wen" (plain questions) recorded in the book of Su Wen, enuresis due to foot syncope yin disease, endless thought, too severe when entering a house, flaccidity of tendons, and whitish and obstinate sensation of the body, male descending with urine, female descending continuously; for seminal emission, leakage, frequent urination and leukorrhagia, it can enter jueyin to tonify liver and gate of life. Mingmen stores house essence, so they are both treated by clouds.

Fructus crataegi is dried mature fruit of Crataegus Pinnatifida Bge. Sour, sweet and slightly warm in nature and taste. Meridian tropism: it enters spleen, stomach and liver meridians. The functional indications are as follows: promote digestion, invigorate stomach, promote qi circulation and dissipate blood stasis. Can be used for treating meat food stagnation, gastric cavity distention, dysentery abdominal pain, blood stasis amenorrhea, puerperal blood stasis, heart and abdomen stabbing pain, and hernia pain; hyperlipidemia. The charred fructus crataegi has effects of resolving food stagnation. Can be used for treating food stagnation and diarrhea and dysentery. The hawthorn has the functions of reducing blood fat, blood pressure, strengthening heart, resisting arrhythmia and the like, is also a good medicine for strengthening spleen, stimulating appetite, promoting digestion, removing food stagnation, promoting blood circulation and reducing phlegm, and has good curative effects on symptoms such as chest, diaphragm, spleen fullness, hernia, blood stasis, amenorrhea and the like. The vitexin is a flavonoid compound in hawthorn, is a drug with strong anticancer effect, and the extract of the vitexin has certain effects on inhibiting the growth, proliferation and infiltration and metastasis of cancer cells in vivo. Discussion of each family: the method comprises the following steps: to resolve food stagnation, promote the circulation of qi, strengthen the stomach, widen the diaphragm and eliminate blood and lump in the abdomen. ② Yunnan Ben Cao: eliminating meat stagnation and descending qi; treat acid regurgitation and mass accumulation. (iii) compendium: 'digestion, elimination of meat accumulation, mass, phlegm retention, fullness and acid regurgitation, stagnation of blood and pain and distension'. Fourthly, renewal of materia medica: for dampness-heat due to spleen deficiency, promote digestion, remove food stagnation and induce diuresis.

Fructus Cannabis is dry mature seed of Cannabis sativa L, also called Cannabis sativa L, Cannabis sativa L. The nature, flavor and meridian tropism are sweet and mild; it enters spleen, stomach and large intestine meridians. The functional indications are as follows: moisten dryness, smooth intestines and relieve constipation, it is indicated for constipation due to blood deficiency and fluid deficiency with dryness of intestines. The efficacy of fructus cannabis: 1. moistening dryness and relaxing bowels: for senile patients with asthenia and constipation, it is often combined with intestine-moistening and bowel-relaxing herbs such as Dang Gui, Hei Ning and Cin; for excess heat in intestine, it is combined with Da Huang and Zhi Shi. 2. For diabetes, yin deficiency and intestinal dryness, it is combined with qi-tonifying and fluid-generating herbs to nourish yin and tonify deficiency to moisten dryness. 3. Fructus Cannabis has effects of repairing myocardium, repairing heart injury and promoting health. Discussion of each family: the theory of exogenous febrile disease: the book Ben Cao (materia Medica) says that moistening can remove withering. For dryness of the spleen and stomach, the sweet and moist herbs should be used. Ben Cao Jing Shu (the book of materia Medica Prime and Dredging): ma Zi is the most smooth and profitable. is indicated for puerperal diseases because sweet flavor can tonify middle energizer, sweet flavor can tonify qi, blood can tonify blood, blood vessel can dissipate blood stasis. When wind enters the wei-defensive system, the wei-defensive system will be healthy and deficient, and the blood and yin will also be healthy. The book of classic recorded that sweat comes out of the body of the patient with weak yin. Ma ren can tonify blood and nourish yin to harmonize and dispel wind pathogen to stop sweating. The water-draining urinate person can slide and flow downwards, and the water and the air are led out from the urinate.

The traditional Chinese medicine preparation for treating senile nocturia is prepared by processing rhizoma polygonati, radix polygonati officinalis, mulberry, raspberry, fructus psoraleae, fructus alpiniae oxyphyllae, semen allii tuberose, hawthorn and fructus cannabis according to a certain compatibility requirement by utilizing unique medicine properties of traditional Chinese medicines according to the traditional Chinese medicine theory. The traditional Chinese medicinal materials adopted by the invention can be matched with pharmaceutically acceptable carriers to prepare various oral preparations, such as pills, tablets, capsules, oral liquid, syrup, mixture and the like. The compatibility principle of the traditional Chinese medicines is as follows:

su Wen, Shang Gu Zhen Lun (ancient Tian Zhen Lun) Yun (Kidney Water … …) the yang qi of kidney helps the bladder to transform body fluid, which governs the opening and closing of bladder to restrain urine. Zhang Jingyue points out that the water spring is not enough and the bladder is not hidden, so qi is natural and qi is jellyfish, water can not store and qi can not consolidate. When kidney yang is deficient, the bladder is failing to circulate and open and close, and water is not solid, so there is much urine. The yang changes day to day and yin changes night to night, and after entering night, yin becomes more abundant and yang qi becomes more deficient, and kidney yang goes downward without warming qi, so kidney qi is not enough to restrict bladder and frequent urination at night. According to the principle of treating the disease by seeking the root and treating the abnormal diseases simultaneously in the traditional Chinese medicine, the inventor adopts a root-tonifying conditioning formula to mainly nourish yin and warm yang for the nocturia with deficiency of yin and yang and deficiency of spleen and kidney, so that the effects of seeking yang from yin and tonifying yin and yang are achieved, the kidney yang is nourished, the bladder is gasified, the water liquid is restrained, and the nocturia is reduced. In the formula, the sealwort, the polygonatum, the raspberry and the mulberry are sweet or sweet and sour in taste, mild in nature or slightly cold in nature, mainly nourish yin and nourish liver and kidney, and are mainly used for treating symptoms such as soreness and weakness of waist and knees, frequent micturition, enuresis, tinnitus, insomnia, early white beard and hair and the like caused by liver-kidney yin deficiency. The psoralea fruit, the sharpleaf galangal fruit and the tuber onion seed are pungent, warm, bitter or sweet, mainly warm yang, warm kidney and strengthen yang, secure qi and arrest seminal emission, stop enuresis and stop diarrhea, and treat impotence and spermatorrhea, enuresis and frequent micturition, cold pain in waist and knees, asthma due to kidney deficiency, morning diarrhea and other symptoms caused by spleen-kidney yang deficiency. Fructus Cannabis is sweet in flavor and neutral in nature. It enters spleen, stomach and large intestine meridians. Has effects in loosening bowel, relieving constipation, and nourishing. It has the action of moistening to correct the dryness of yang-warming herbs. The hawthorn is sour and warm in taste, qi and blood flow together, blood stasis is removed without damaging new blood, qi stagnation is removed without damaging healthy qi, and the hawthorn is mainly used for preventing large amount of yin nourishing and greasy. In the formula, the sealwort is monarch, the polygonatum, the raspberry and the mulberry fruit nourish yin, the psoralea, the fructus alpiniae oxyphyllae and the semen allii tuberosi warm yang, and are used as ministerial drugs, the fructus cannabis and the hawthorn are used for assisting the bias of yang warming and yin nourishing drugs, and are used as adjuvant drugs, and the drugs are used together to play the functions of nourishing liver and kidney, tonifying spleen and qi, warming kidney and supporting yang, and absorbing water and reducing urination, so that the effects of seeking yang from yin to middle and tonifying yin and yang are achieved, and the nocturia caused by deficiency of vital qi and deficiency of both yin and yang of the old.

The invention has the beneficial effects that:

1. the traditional Chinese medicine preparation for treating nocturia of the old people is safe and effective, the whole formulas are mutually matched, the treatment process is simple, the cost is low, the effect is quick, the traditional Chinese medicine preparation has a remarkable treatment effect on nocturia patients, and the effective rate is high. Clinical tests carried out by adopting the traditional Chinese medicine preparation disclosed by the invention prove that the frequency of nocturia of a patient treated by the Yigen conditioning formula is obviously reduced, and the difference is very significant (P is less than 0.01) when the frequency of nocturia is compared before and after treatment; the treatment results show that the total effective rate of the traditional Chinese medicine preparation for treating the nocturia of the old people is more than 93 percent, and the traditional Chinese medicine preparation has obvious effect and good curative effect.

2. The traditional Chinese medicine preparation for treating senile nocturia is scientific and reasonable in formula, simple in process, wide in source of adopted traditional Chinese medicinal materials, low in cost, safe and nontoxic, free of toxic and side effects on a human body, and free of recurrence of nocturia after treatment and cure by adopting the traditional Chinese medicine preparation.

Detailed Description

Example 1

A Chinese medicinal preparation for treating senile nocturia is prepared from oral liquid, and is prepared from:

(1) weighing the medicines: weighing 15 parts of rhizoma polygonati according to the parts by weight; 10 parts of polygonatum; mulberry fruit 12 parts; 10 parts of raspberry; 9 parts of fructus psoraleae; 4 parts of fructus alpiniae oxyphyllae; 3 parts of semen allii tuberosi; 1 part of hawthorn; 1 part of fructus cannabis; standby;

(3) mixing with appropriate amount of sucrose to obtain syrup, mixing with the above medicinal liquid, adding appropriate amount of antiseptic, standing, filtering, and packaging to obtain oral liquid. The obtained oral liquid is taken 2 times per day before meals in an amount of 150mL per fasting state, 1 hour before lunch and 1 hour before dinner.

Example 2

A Chinese medicinal preparation for treating senile nocturia, the preparation method of powder comprises the following steps: 22 parts of rhizoma polygonati according to parts by weight; 18 parts of polygonatum; 17 parts of mulberry fruit; 15 parts of raspberry; 16 parts of fructus psoraleae; 10 parts of fructus alpiniae oxyphyllae; 10 parts of semen allii tuberosi; 6 parts of hawthorn; 7 parts of fructus cannabis; pulverizing to below lOO mesh, and vacuum packaging with plastic bag to obtain powder. The obtained powder is taken with boiled water or rice water before meals, 3-5 g is taken each time, and the dose is taken twice a day.

Example 3

The preparation method of the traditional Chinese medicine preparation, capsule, tablet or granule for treating senile nocturia comprises the following steps: weighing 20 parts of dried rhizoma polygonati, 15 parts of polygonatum odoratum, 15 parts of mulberry, 15 parts of raspberry, 15 parts of fructus psoraleae, 9 parts of fructus alpiniae oxyphyllae, 9 parts of semen allii tuberose, 5 parts of hawthorn and 5 parts of fructus cannabis in parts by weight; putting the traditional Chinese medicine into a traditional Chinese medicine extraction tank, adding 10-12 times of water by weight, heating and boiling for 1-1.5 hours, discharging liquid medicine, filtering, adding 5-8 times of water into dregs of a decoction, heating and boiling for 0.5-1 hour, discharging dregs of a decoction, filtering the liquid medicine, and combining the obtained two liquid medicines; concentrating under reduced pressure at 60-70 deg.C to obtain fluid extract with relative density of 1.10-1.20 at 55 deg.C, adding 90% ethanol to make ethanol content 60%, standing at room temperature for 12 hr, filtering, recovering ethanol, concentrating to obtain soft extract with relative density of 1.30-1.35, adding pharmaceutically acceptable adjuvants, mixing, and making into capsule by conventional method.

Example 4

The preparation method of the traditional Chinese medicine preparation, tablet or granule for treating senile nocturia comprises the following steps: weighing 30 parts of dried rhizoma polygonati according to the weight parts; 25 parts of polygonatum; 26 parts of mulberry fruit; 25 parts of raspberry; 24 parts of fructus psoraleae; 18 parts of fructus alpiniae oxyphyllae; 17 parts of semen allii tuberosi; 14 parts of hawthorn; 15 parts of fructus cannabis; putting the traditional Chinese medicine into a traditional Chinese medicine extraction tank, adding 10-12 times of water by weight, heating and boiling for 1-1.5 hours, discharging liquid medicine, filtering, adding 5-8 times of water into dregs of a decoction, heating and boiling for 0.5-1 hour, discharging dregs of a decoction, filtering the liquid medicine, and combining the obtained two liquid medicines; concentrating under reduced pressure at 60-70 deg.C to obtain fluid extract with relative density of 1.10-1.20 at 55 deg.C, adding 90% ethanol to make ethanol content 60%, standing at room temperature for 12 hr, filtering, recovering ethanol, concentrating to obtain soft extract with relative density of 1.30-1.35, adding pharmaceutically acceptable adjuvants, mixing, and making into tablet or granule by conventional method.

Example 5

A traditional Chinese medicine preparation for treating nocturia of the elderly is prepared by weighing 25 parts of dried rhizoma polygonati in parts by weight; 20 parts of polygonatum; 21 parts of mulberry fruit; 20 parts of raspberry; 15 parts of fructus psoraleae; 13 parts of fructus alpiniae oxyphyllae; 13 parts of semen allii tuberosi; 8 parts of hawthorn; 8 parts of fructus cannabis; crushing by a crusher, sieving by a 50-mesh sieve, filling into a breathable fiber bag, and preparing into a tea bag, wherein the weight of each bag is 3-5 g.

Example 6

A traditional Chinese medicine preparation for treating senile nocturia is prepared by weighing 20 parts of dried rhizoma polygonati, 15 parts of polygonatum odoratum, 15 parts of mulberry, 15 parts of raspberry, 15 parts of fructus psoraleae, 9 parts of fructus alpiniae oxyphyllae, 9 parts of semen allii tuberosi, 5 parts of hawthorn and 5 parts of fructus cannabis in parts by weight for later use; adding the Chinese medicinal materials into a Chinese medicinal extraction tank, adding 10 times of water, heating and boiling for 1 hr, discharging medicinal liquid, filtering, adding 5 times of water, heating and boiling for 0.5 hr, discharging medicinal residue, filtering medicinal liquid, and mixing the two medicinal liquids; the decoction is obtained. The obtained decoction is taken 2 times a day 2 times with 150mL warm food in fasting state, 1 hr before lunch and 1 hr before dinner.

Example 7

The preparation method of the traditional Chinese medicine preparation for treating the nocturia of the old people comprises the following steps:

(1) weighing 20 parts of dried rhizoma polygonati, 15 parts of polygonatum odoratum and 15 parts of mulberry fruits according to parts by weight, putting the medicinal materials into a traditional Chinese medicine extraction tank, adding 6-14 times of water according to the weight, heating and boiling for 0.5-2 hours, discharging liquid medicine, filtering, adding 5-12 times of water to the dregs, heating and boiling for 0.5-1.5 hours, discharging dregs of a decoction, filtering the liquid medicine, combining the obtained two liquid medicines, and concentrating to obtain concentrated solution A;

(2) weighing 15 parts of raspberry, 15 parts of fructus psoraleae, 9 parts of fructus alpiniae oxyphyllae, 9 parts of semen allii tuberosi, 5 parts of hawthorn and 5 parts of fructus cannabis in parts by weight, putting the medicinal materials into a traditional Chinese medicine extraction tank, adding 6-14 times of 70% ethanol in parts by weight, heating and boiling for 1-2.5 hours, discharging liquid medicine, filtering, adding 5-12 times of 70% ethanol in the medicinal residues, heating and boiling for 0.5-2 hours, filtering, combining the obtained two liquid medicines, concentrating and steaming the ethanol to obtain concentrated solution B;

(3) mixing the concentrated solution A and the concentrated solution B, concentrating at 60-100 ℃ under reduced pressure to obtain fluid extract with relative density of 1.20-1.30 at 55 ℃, adding refined sugar or refined honey, heating to relative density of 1.3-1.5, and collecting to obtain paste. The obtained soft extract is taken 3 times per day 3 times with warm food in an empty stomach, and is taken 1 hr before lunch, Chinese meal and evening meal.

Experimental and clinical data:

first, animal experiment

1 materials and instruments

1.1 animal, SD rat, male and female, weight 160-.

1.2 drugs and reagents: adenine (Solarbio, lot No.: a 8330), shrinkage spring pill (lot No.: 100302), manufactured by hansen pharmaceutical limited, Hunan.

1.3 Instrument: EPOCH microplate reader (MeiBiote Co.), HH-8 digital display constant temperature water bath (Changzhou national Hua electric apparatus Co., Ltd.), and centrifuge Epoch type full wavelength microplate reader (DeBioTe Co.).

2. Experimental methods

2.1 grouping and dosing: 60 SD rats were randomly divided into 6 groups, blank group, model group, positive group, high, medium and low dose groups, and adenine was given at 250 mg/kg in addition to the blank group^-1Performing intragastric administration, duplicating kidney-yang deficiency polyuria animal model, molding for 2 weeks, then administering corresponding medicines, administering physiological saline to blank groups and model groups, administering contracted spring pills to positive groups at a concentration of 1.5g/kg, and administering high, medium and low dosage components respectively to the traditional Chinese medicine formula extract for treating senile nocturia of the invention (the extraction method of the extract comprises weighing 20 parts of rhizoma polygonati, 15 parts of rhizoma polygonati officinalis and 15 parts of mulberry fruit according to parts by weight, putting the medicinal materials into a traditional Chinese medicine extraction tank, adding 12 times of water, heating and decocting for 1.5 hours, decocting for 2 times, combining 2 times of medicinal liquid, concentrating, weighing 15 parts of raspberry, 15 parts of fructus psoraleae, 9 parts of fructus alpiniae oxyphyllae, 9 parts of semen allii, 5 parts of hawthorn and 5 parts of fructus cannabis according to parts by weight, putting the medicinal materials into the traditional Chinese medicine extraction tank, adding 12 times of 70% ethanol according to reflux and extracting for 2 hours, filtering, combining the obtained two times of medicinal liquid, concentrating and combining, concentrated to corresponding concentration) 17.0g/kg, 8.5g/kg, 1.7g/kg (calculated as crude drug); the weight was weighed every two days to adjust the dose, and the animal changes were observed and recorded.

2.2 Observation index

2.2.1 Observation: body weight was weighed weekly, and rat dorsum arcus, hair condition, mental state, and body weight change were carefully observed.

2.2.2 night urine volume and 24h urine volume: the urine volume in 12 h of the rat measured at 1 d before the administration is taken as the urine volume before the administration, and the urine volume in 12 h of the rat is measured after the last administration; the rats in each group are extruded to discharge urine in bladder after being taken with water (3 h) every other day, and are placed in a metabolism cage, the rats are not forbidden to take water, and the urine volume in 12 h is measured.

2.2.3 organ indices: the spleen, thymus and kidney were taken, and the wet weight was weighed to calculate the organ index. Organ index: organ index = organ mass/rat body mass × 100%.

2.2.4 plasma ALD, ADH content: after 6 weeks of experiment, blood is taken from abdominal aorta, standing at normal temperature for 30min, centrifuging at 5000r/min for 10min, and serum is taken. The contents of ADH and ALD in rat serum were determined strictly according to the ADH (antidiuretic hormone) and ALD (aldosterone) kit instructions.

3. Results

3.1 proportion of night urine volume to total urine volume

Compared with the blank group, the proportion of the urine volume at night in the model group is obviously increased before administration (P is less than 0.05); after administration, the specific gravity of each administration group was reduced, and the groups were significantly different from the model group.

3.2 organ indices

Compared with the blank group, the spleen index, the thymus index and the kidney index of each group of the model group are significantly different (P is less than 0.05). Compared with the model group, the spleen indexes of the positive group and the administration group are obviously different (P is less than 0.05); compared with the model group, the thymus indexes of the positive group, the high dose group and the medium dose group are all significantly different (P is less than 0.05); compared with the model group, the kidney indexes of the positive group, the high-dose group and the medium-dose group are all reduced, and the statistical significance is achieved (P is less than 0.05). The results of the protection effect of the extract of the traditional Chinese medicine formula for treating nocturia of the old on kidney-yang deficiency and diuresis of rats, namely kidney, spleen and thymus, are shown in table 2.

3.3 ADH and ALD in serum

Compared with a blank group, the content of ADH and ALD in the serum of the model group rats is reduced (P is less than 0.05); compared with a model group, the content of ADH in the blood serum of rats in each administration group is increased, and the content of ADH and ALD in the blood serum of rats in other groups except a low-dose group is obviously increased (P is less than 0.05), which shows that the traditional Chinese medicine formula extract for treating nocturia of the elderly has the effect of reducing urea of rats with kidney yang deficiency and diuresis. The results of measuring the content of ADH and ALD in the serum of each group of rats are shown in Table 3.

In conclusion, the traditional Chinese medicine formula extract for treating nocturia of the old people can increase the secretion of ADH and ALD in serum and reduce the generation of nocturnal urine.

Second, clinical data

1.1 general data clinical case analysis, patients are all adults over 60 years old who see frequent nocturia as the main symptom; the number of the patients is 45, 36 men and 9 women, the age is 60-88 years, the number of nocturia is 3-9, and the average number is 4.9; the non-interference sleep time is 55-155 minutes; the disease course is 1-10 years, and the average is 6.5 years; prostate hyperplasia was suggested in 10 of the male patients who underwent color ultrasound examination of the prostate.

1.2 the number of nocturia of adults over 60 years old is more than or equal to 2 when the standard is met; the syndrome differentiation of traditional Chinese medicine belongs to the syndrome of yin and yang deficiency and spleen and kidney deficiency (the standard of syndrome differentiation refers to the "standard of curative effect for diagnosis of traditional Chinese medicine disease").

1.3 excluding the syndrome of yin and yang deficiency and spleen and kidney deficiency in the standard Chinese medicine differentiation; the nocturia is treated by other medicines in about 1 month; treating sleep disorders with sedatives; acute urinary retention or indwelling urinary catheters; urinary system infection such as acute urethritis and cystitis; history of arrhythmia and heart failure.

2 method of treatment

All patients are treated by the traditional Chinese medicine preparation for treating senile nocturia, and the prescription is as follows: 20g of rhizoma polygonati, 15g of radix polygonati officinalis, 15g of mulberry fruit, 15g of raspberry, 15g of fructus psoraleae, 9g of fructus alpiniae oxyphyllae, 9g of semen allii tuberose, 5g of hawthorn and 5g of fructus cannabis; decocting in water for 2 times, and mixing decoctions for 2 times. The composition is taken 2 times a day 2 times in a warm state with an empty stomach 1 hr before lunch and 1 hr before dinner for 1 month. Follow-up observations were made on patients periodically weekly after treatment.

3 Observation index and statistical method

3.1 Observation indexes: observing the frequency of nocturia every night before and after treatment of the patient and the change of the undisturbed sleeping time.

3.2 assessment of efficacy

3.2.1 healing: the symptom disappears, the frequency of nocturia is less than 2, and the sleep time without interference is remarkably prolonged.

3.2.2 significant effect: the main symptoms are improved, the nocturia times are obviously reduced, and the non-interference sleep time is obviously prolonged.

3.2.3 invalid: the chief symptoms were unchanged.

3.3 statistical methods the data are expressed as means. + -. standard deviation, the comparison is done by t-test, the data are counted by χ²And (6) checking.

4 therapeutic results

4.1, 22 cases (48.89%) of curative effect, 20 cases (44.44%) of significant effect, 3 cases (6.67%) of ineffective effect and 93.33% of total effective rate.

4.2 comparison of nocturia before and after treatment and undisturbed sleep time Table 4 below

After the patient is treated by the traditional Chinese medicine preparation for treating senile nocturia, the number of nocturia is obviously reduced, and the difference is very significant (P is less than 0.01) compared with the number of nocturia before and after treatment. Meanwhile, the non-interference sleep time after treatment is correspondingly prolonged (P is less than 0.01). The prescription has quick response time, the nocturia times of all patients are obviously reduced after treatment for the 1 st week, only 8 patients with 1 nocturia are treated continuously, the nocturia times are further reduced, 2 patients without nocturia symptoms completely are treated for the 2 nd week, only 9 patients with 1 nocturia are treated, and analysis shows that the nocturia times of the 11 patients before treatment are 3-4 times, and the patients with the lower nocturia times belong to the patients with the lower nocturia times. After the treatment of week 4, there were 10 patients with no nocturia symptoms at all, and 12 patients with nocturia only 1 time. The number of nocturia of the female patients with nocturia of less than or equal to 4 under the age of 70 is 9, the effect after treatment is obvious, the number of nocturia is reduced to 1 and 3 in 1 week, and the number of nocturia is reduced to 1 and 4 in 2 weeks. After the treatment course is finished, 1 month of telephone follow-up visit is carried out to find that no 1 case of nocturia recurs.

Example 8

Wangzhi, female, 70 years old, and the diagnosis time is 2016, 4 and 18 days; the frequent nocturia for more than 10 years is treated in outpatient clinics of a plurality of hospitals, and the nocturia frequency is about 5 times every night; the traditional Chinese medicine preparation for treating the nocturia of the old is taken 1 day; after 5 days, the frequency of nocturia is reduced from 5 times per day to 2 times per day, and is reduced to 1 time within 2 weeks, the medicine is stopped after continuous treatment is continued for 4 weeks, and the disease does not relapse after the follow-up for half a year.

Claims

1. The traditional Chinese medicine preparation for treating senile nocturia is characterized by being prepared from the following traditional Chinese medicine raw materials in parts by weight: 15-30 parts of rhizoma polygonati; 10-25 parts of polygonatum; 12-26 parts of mulberry fruit; 10-25 parts of raspberry; 9-24 parts of fructus psoraleae; 4-18 parts of fructus alpiniae oxyphyllae; 3-17 parts of semen allii tuberosi; 1-14 parts of hawthorn and 1-15 parts of fructus cannabis; the Chinese medicinal preparation is oral liquid, powder, capsule, tablet, granule, tea bag or soft extract.

2. The traditional Chinese medicine preparation for treating nocturia of the elderly according to claim 1, which is characterized in that: the preparation method of the oral liquid comprises the following steps:

3. The traditional Chinese medicine preparation for treating senile nocturia according to claim 1, which is characterized in that the preparation method of the powder comprises the following steps: pulverizing rhizoma Polygonati, rhizoma Polygonati Odorati, Mori fructus, Rubi fructus, fructus Psoraleae, fructus Alpinae Oxyphyllae, semen Allii Tuberosi, fructus crataegi and fructus Cannabis to below l00 mesh, and vacuum packaging with plastic bag to obtain powder.

4. The traditional Chinese medicine preparation for treating senile nocturia according to claim 1, which is characterized in that the preparation method of capsules, tablets or granules comprises the following steps: weighing dried rhizoma polygonati, radix polygonati officinalis, mulberry, raspberry, fructus psoraleae, fructus alpiniae oxyphyllae, semen allii tuberose, hawthorn and fructus cannabis in parts by weight, putting the traditional Chinese medicines into a traditional Chinese medicine extraction tank, adding 10-12 times of water by weight, heating and boiling for 1-1.5 hours, discharging liquid medicine, filtering, adding 5-8 times of water into medicine dregs, heating and boiling for 0.5-1 hour, discharging the medicine dregs, filtering the liquid medicine, and combining the obtained two liquid medicines; concentrating under reduced pressure at 60-70 deg.C to obtain fluid extract with relative density of 1.10-1.20 at 55 deg.C, adding 90% ethanol to make ethanol content 60%, standing at room temperature for 12 hr, filtering, recovering ethanol, concentrating to obtain soft extract with relative density of 1.30-1.35, adding pharmaceutically acceptable adjuvants, mixing, and making into capsule, tablet or granule by conventional method.

5. The traditional Chinese medicine preparation for treating senile nocturia according to claim 1, which is characterized in that dried rhizoma polygonati, radix polygonati officinalis, mulberry, raspberry, fructus psoraleae, fructus alpiniae oxyphyllae, semen allii tuberosi, hawthorn and fructus cannabis are weighed according to parts by weight, crushed by a crusher, sieved by a 50-mesh sieve, and filled into a breathable fiber bag, wherein each bag is 3-5 g in weight to prepare a tea bag.

6. The traditional Chinese medicine preparation for treating senile nocturia according to claim 1, which is prepared by the following steps:

(1) weighing dried rhizoma polygonati, polygonatum odoratum and mulberry fruits according to parts by weight, putting the medicinal materials into a traditional Chinese medicine extraction tank, adding 6-14 times of water according to the weight, heating and boiling for 0.5-2 hours, discharging liquid medicine, filtering, adding 5-12 times of water into dregs, heating and boiling for 0.5-1.5 hours, discharging dregs of a decoction, filtering the liquid medicine, combining the obtained two liquid medicines, and concentrating to obtain concentrated solution A;