CN113144093B - Traditional Chinese medicine composition for treating circadian rhythm disorder, application and pills thereof - Google Patents

Abstract

A Chinese medicinal composition for treating circadian rhythm disorder and its application and pill comprise periostracum Cicadae 20-40 parts; 10-20 parts of rhizoma polygonati; 10-30 parts of salvia miltiorrhiza; 10-20 parts of lily; 10-30 parts of spina date seeds; 40-80 parts of honey. The preparation method of the pill comprises the following steps: pulverizing the 5 medicinal materials except Mel into powder; boiling Mel; mixing the medicinal powder and Mel, making into dough, kneading into pill; after the surface becomes hard, the mixture is wrapped by wax paper, preservative film, plastic bag or wax shell and the like and stored in a cool and dry place to obtain the product. The invention obtains good clinical practice effect, relieves the pain and discomfort of patients and solves the problem that ideal treatment medicines and methods are lacked at present for circadian rhythm disorder. The cicada slough and the sealwort are matched with monarch drug, so that the innovation is strong, and the method is a brand-new application in the treatment of circadian rhythm disorder. The problem of western medicine side effect is big is overcome, and various medicinal materials that relate are derived extensively, convenient and practical, are convenient for prepare and store.

Description

Traditional Chinese medicine composition for treating circadian rhythm disorder, application and pills thereof

Technical Field

The invention relates to a traditional Chinese medicine oral preparation, in particular to a traditional Chinese medicine composition for treating circadian rhythm disorder, application and pills thereof.

Background

Many vital activities and physiological phenomena of the human body exhibit a certain periodic variation, and among them, the vital activities and physiological phenomena exhibiting a periodic rhythm of 24 hours are called circadian rhythms. The circadian rhythm is regulated by the endogenous biological clock of the hypothalamic suprachiasmatic nucleus (SCN).

The vital activities and physiological phenomena with circadian rhythms mainly include: sleep-wake, blood pressure fluctuations, body temperature fluctuations, eating behaviors, and the like. There is a close relationship between circadian rhythms and central nervous system related diseases. The phenomenon of destabilization of the circadian rhythm system is found in neurodegenerative diseases such as Alzheimer Disease (AD), Parkinson Disease (PD), and Huntington Disease (HD) (non-patent document 1, journal of neuroimmunology and neurology, 2020,27(6), 50-52).

The existing technical means for regulating circadian rhythm disorder mainly comprise: a circadian rhythm regulator which regulates the secretion of a circadian rhythm-associated hormone melatonin, such as whey as a main active ingredient (patent document 1WO 2005/094849); regulating the expression of a gene related to a biological clock, such as a circadian rhythm regulator containing an alkaloid as a main active ingredient (patent document 2JP laid-open No. 2011-. In addition, studies suggest that the traditional Chinese medicine has a certain effect in treatment of circadian rhythm disorders, for example, a traditional Chinese medicine preparation consisting of cortex moutan, cape jasmine, scutellaria baicalensis, radix bupleuri, radix curcumae, poria cocos, radix paeoniae alba, rhizoma atractylodis macrocephalae, fried spina date seed, platycladi seed, polygala tenuifolia, ligusticum wallichii, angelica sinensis, keel, oyster, cortex albiziae and rhizoma nardostachyos has a good effect in treatment of circadian rhythm disorder sleep disorder (non-patent document 2, shanxi traditional Chinese medicine, 2019,40(8), 1081-supplement 1084). The traditional Chinese medicine preparation which is mainly composed of cortex moutan, cape jasmine, scutellaria baicalensis, radix bupleuri, micaceous mica, radix curcumae, poria cocos, radix paeoniae alba, fingered citron, citrus reticulata, bighead atractylodes rhizome, fried spina date seed, pig gall eggplant, platycladi seed, pericarpium trichosanthis, polygala tenuifolia, ligusticum wallichii, angelica sinensis, dried earthworms, dragon bones, oysters, sandalwood mud, cortex albiziae, nardostachys chinensis and the like is mainly used for treating day and night rhythm disorder sleep with syndrome differentiation of liver-qi depression and liver-blood deficiency (patent document 3CN 110841037A).

In the prior art, the traditional Chinese medicine mainly focuses on regulating circadian rhythm disorder sleep disorder, but the circadian rhythm disorder is not equal to the sleep disorder, and also comprises a series of disorders of vital activities and physiological phenomena related to circadian rhythm, such as blood pressure variation and body temperature variation. The western medicines have certain adverse reactions, such as central nervous system symptoms of dizziness, headache, lethargy, anxiety, depression and the like caused by regulating melatonin secretion, and can increase the risk of stroke and cause gonadal dysplasia and the like.

Therefore, there is currently no ideal treatment for circadian rhythm disorders. The natural yin-yang waning and waxing form the natural circadian rhythm, and the corresponding yin-yang waning and waxing of the human body determine the circadian rhythm of the human body. Lingshu, evil and evil spirits cloud: "Jue Qi can go to five zang organs and six fu organs, so defensive Qi can defend the exterior and move to yang but not enter yin. Yang qi is dominant in yang and yang qi is dominant in yang qi and fails to enter yin. Huang Di Huang due to yin deficiency. So the circadian rhythm disorder is mainly caused by the excess and deficiency of yang and yin and the imbalance of yin and yang under the action of various factors, and the treatment should be mainly focused on regulating yin and yang and nourishing yin and suppressing yang.

Disclosure of Invention

Aiming at the traditional Chinese medicine pathogenesis of circadian rhythm disorder, the invention mainly adjusts various aspects related to human circadian rhythm from the angles of regulating yin and yang, nourishing yin and suppressing yang, including sleep-wake, blood pressure change, body temperature change, diet behavior and the like. Thereby providing a convenient and practical traditional Chinese medicine composition with definite curative effect for treating circadian rhythm disorder, application and pills thereof.

A traditional Chinese medicine composition for treating circadian rhythm disorder is characterized by comprising the following raw traditional Chinese medicines in parts by weight: 20-40 parts of cicada slough; 10-20 parts of rhizoma polygonati; 10-30 parts of salvia miltiorrhiza; 10-20 parts of lily; 10-30 parts of spina date seeds; 40-80 parts of honey.

The traditional Chinese medicine composition for treating circadian rhythm disorder can be prepared by adopting the following formula, and the weight parts of the raw materials are as follows: 30 parts of cicada slough; 15 parts of rhizoma polygonati; 20 parts of salvia miltiorrhiza; 15 parts of lily; 15 parts of spina date seeds; 60 parts of honey.

The application of the traditional Chinese medicine composition in preparing traditional Chinese medicine pills for treating circadian rhythm disorder.

A traditional Chinese medicine pill for treating circadian rhythm disorder is characterized in that the pill is prepared by the following steps:

1) weighing the above materials in proportion, mixing 5 materials except Mel, and pulverizing into powder;

2) boiling Mel with strong fire, and decocting with slow fire until Mel turns yellow and foams;

3) mixing the powder obtained in step 1) with honey, kneading into balls, and kneading into pills by rubbing with hands;

4) after the pill surface becomes hard, the pill is wrapped by wax paper, preservative film, plastic bag or wax shell, etc., and stored in a cool and dry place.

The six traditional Chinese medicines have the following functions:

monarch drug: periostracum Cicadae and rhizoma Polygonati

Cicadae slough is sweet and cold in nature and enters lung and liver meridians. The traditional functions are wind-heat dispelling, nebula removing, ventilation and spasmolysis. The main treatment is as follows: wind-heat type cold, hoarseness, measles without adequate eruption, rubella itching, infantile convulsion and epilepsy and the like are rarely used for insomnia clinically, and are not reported to be used for circadian rhythm disorder, but the cicada slough can enter liver channels, can discharge liver fire and calm liver yang, and the mechanism is considered to be just capable of treating pathological manifestations of yang excess and yin deficiency and yin-yang imbalance of patients with circadian rhythm disorder. Rhizoma polygonati is sweet in taste and neutral in nature, and has the functions of tonifying qi and yin, invigorating spleen, moistening lung and tonifying kidney, and the rhizoma polygonati enters spleen channels, lung channels and kidney channels. Is mainly used for tiredness, hypodynamia, dry mouth, poor appetite, cough, hemoptysis, soreness and weakness of waist and knees, internal heat, thirst quenching and the like. It has strong action of nourishing yin and tonifying kidney, and can contain the liver fire of inflammation, and when it is combined with cicada slough, it can nourish yin and suppress yang, so as to make yin calm down yang and make mind play the role of psyche. At present, no report of the combination of cicada slough and rhizoma polygonati for treating circadian rhythm disorder is found, but clinical practice of the applicant shows that the cicada slough and the rhizoma polygonati can be used for treating various abnormal manifestations of circadian rhythm disorder just aiming at the pathogenesis of traditional Chinese and western medicine causes of circadian rhythm disorder.

Ministerial drugs including Saviae Miltiorrhizae radix and Bulbus Lilii

Salvia miltiorrhiza, being bitter in taste and slightly cold, enters heart and liver channels, has the functions of activating blood circulation, removing blood stasis, clearing heart fire and relieving restlessness, and can help cicada slough to clear heart fire and liver fire, strengthen the effects of calming heart spirit and calming liver yang. Meanwhile, people with circadian rhythm disorder mostly have qi and blood dysfunction, so that qi stagnation and blood stasis occur, and the blood activating and stasis removing effects of the salvia miltiorrhiza just aim at the pathogenesis to correct the qi and blood dysfunction state of the body; lily: sweet in flavor, cold in nature, entering heart and lung meridians. The functions are as follows: nourish yin and moisten lung, clear heart and induce tranquilization. It can help rhizoma Polygonati nourish yin of heart and lung, thereby enhancing the effects of nourishing yin and nourishing heart.

Adjuvant drugs: wild jujube seed

Sweet and sour in flavor, neutral in nature, entering liver, gallbladder and heart meridians. The traditional Chinese medicine has the functions of nourishing heart, tonifying liver, calming heart and soothing nerves, and is a common medicine for treating vexation and insomnia. Astringe heart qi, nourish liver yin, pacify liver yang, and play an assistant role in monarch and ministerial drugs from multiple aspects.

A messenger drug: honey

Regulating and tonifying spleen and stomach, harmonizing the recipe and the drugs, and forming into pills.

The traditional Chinese medicine composition has the effects of nourishing yin, suppressing yang, nourishing liver, nourishing kidney, promoting blood circulation and calming heart, and can improve the sleep quality and the sleep regularity of patients and adjust the disordered blood pressure, blood sugar and diet of the patients according to various aspects of the circadian rhythm disorder traditional Chinese medicine mechanism. Has comprehensive treatment effect on the circadian rhythm disorder.

Advantages of the invention

The invention provides a traditional Chinese medicine composition capable of effectively treating circadian rhythm disorder and pills thereof, which have good clinical practice effect, relieve the pain and discomfort of patients and solve the problem that ideal treatment medicines and methods are lacked at present for circadian rhythm disorder.

Secondly, the cicada slough and the sealwort are matched with monarch drug, so that the innovation is strong, and the method is a brand-new use method in the treatment of circadian rhythm disorder, and the matching is not found in the field of traditional Chinese medicine. The matching is obtained by analyzing and summarizing the traditional Chinese and western pharmacology actions of the cicada slough and the sealwort by the inventor, and repeated clinical experiments prove that the traditional Chinese medicine can effectively relieve various symptoms of circadian rhythm disorder.

Thirdly, the prescription is reasonable, the most reasonable monarch, minister, assistant and guide medicine formulas are obtained through clinical repeated application and practice, various medicines are mutually cooperated, and the treatment effect is exerted to the maximum extent aiming at various aspects of the traditional Chinese medicine mechanism of circadian rhythm disorder.

The invention overcomes the problems that the side effect of the western medicine adopted at present is great, the action range of the traditional Chinese medicine decoction adopted at present is limited, and the decoction is inconvenient to take.

And fifthly, various medicinal materials related to the invention have wide sources, are convenient and practical, and are convenient to prepare and store.

Detailed Description

The invention is described in detail below with reference to specific examples and representative cases:

example 1

The example comprises the following raw material medicaments in part by weight: 30 parts of cicada slough; 15 parts of rhizoma polygonati; 20 parts of salvia miltiorrhiza; 15 parts of lily; 15 parts of spina date seeds; 60 parts of honey.

The preparation method comprises the following steps:

1) weighing 5 Chinese medicinal materials except Mel according to the above proportion, mixing well, and pulverizing into fine powder;

2) weighing the honey according to the proportion, boiling with strong fire, and then slowly boiling with slow fire until the honey turns yellow and foams;

3) mixing the fine powder obtained in the step 1) with honey, kneading into a ball shape, and kneading into pills by rubbing with hands;

4) after the pill surface becomes hard, the pill is wrapped by wax paper, preservative film, plastic bag or wax shell, etc. and stored in a cool and dry place.

Example 2

The example comprises the following raw material medicaments in part by weight: 20 parts of cicada slough; 10 parts of rhizoma polygonati; 25 parts of salvia miltiorrhiza; 15 parts of lily; 20 parts of spina date seeds; 60 parts of honey.

The preparation method of the example is the same as that of example 1

Example 3

The example comprises the following raw material medicaments in part by weight: 40 parts of cicada slough; 15 parts of rhizoma polygonati; 15 parts of salvia miltiorrhiza; 10 parts of lily; 10 parts of spina date seeds; 60 parts of honey.

The preparation method of the example is the same as that of example 1

Typical cases 1,

The female is 55 years old, engages in medical treatment, and has long-term emergency treatment and operation, difficulty in falling asleep in nearly half a year, dreaminess, irritability and irritability in the daytime, poor appetite, low fever in the afternoon, unstable blood pressure control,

firstly, the patient uses zolpidem tartrate tablets (thinking) 10mg 1/night for symptomatic hypnotic treatment, and orally takes oryzanol 10mg 3/day to improve vegetative nerve functional disturbance, but the adverse reaction is obvious, the daytime fatigue and dysphoria symptoms are aggravated, and the patient still does not eat food.

Then, the Chinese patent medicine 'sweet dream oral liquid' is changed to have poor effect, and patients have internal heat symptoms such as mouth and tongue sores and poor blood pressure control.

The main medicines of the decoction, named Zizyphi Spinosae semen decoction, include Zizyphi Spinosae semen, Anemarrhena rhizoma, Chuan Xiong, Poria and Licorice, have no obvious curative effect.

The patients' tongue pulse, dark red tongue with little coating and thready and wiry pulse, considered yin deficiency as the main syndrome: heart and kidney yin deficiency failing to nourish the heart, manifested as insomnia and poor spirit; yin failing to contain yang, hyperactivity of liver-yang causing difficulty in falling asleep, irritability and unstable blood pressure control; mu Yu Ke Tu, but does not see diet. The patient has a dark red tongue and a thready and wiry pulse, which indicates the presence of blood stasis and is considered to be induced by qi and blood disorder.

From the clinical observation, the above mechanism is a general mechanism of circadian rhythm disorder. Therefore, we consider to focus on nourishing yin and suppressing yang, and also to activate blood and resolve stasis.

At first, the combination of yang-subduing medicines such as uncaria and dragon bone and yin-nourishing medicines is used, and the curative effect is still poor. Later, by combining clinical experience and multiple experiments, the combination of the cicada slough and the sealwort is found to be possible to better achieve the treatment purpose.

At present, the application of the periostracum cicada to circadian rhythm disorder is not reported, but the periostracum cicada can enter liver channels, can release liver fire and calm liver yang, and can be used for properly treating pathological manifestations of yang excess and yin deficiency and yin-yang imbalance of patients with circadian rhythm disorder. Huang Jing has stronger action of nourishing yin and tonifying kidney, and can contain the liver fire of inflammation. The two herbs are combined to nourish yin and subdue yang, so as to make yin calm and yang secret. In combination with lily for nourishing yin and clearing heart, salvia miltiorrhiza for clearing heart and activating blood, spina date seed for nourishing heart and tonifying liver, calming heart and soothing nerves.

After taking 3 doses, the effect is obvious. After 7 doses, all symptoms are improved. Then, in order to facilitate the taking of patients, the cicada slough and the rhizoma polygonati are used as monarch drugs, the salvia miltiorrhiza and the lily are used as ministerial drugs, the spina date seeds and the honey are matched for blending, and the traditional Chinese medicine pill is prepared by applying the method, is taken for 7 days, so that the sleep of the patients is basically normal, the mood is stable, afternoon low fever disappears, the blood pressure is stable, the mental diet is clear, and no obvious adverse reaction is caused.

Typical cases 2,

Patients male, 32 years old, engaged in administrative management, often write materials all night, conscious and dreaminess in nearly 3 months, easy to wake up after sleeping, poor spirit in daytime, difficult to concentrate, no appetite during normal three meals, irritability, rise in blood pressure and large fluctuation range. Various treatment methods such as hypnosis, hypertension and the like are applied, the effect is poor, the diagnosis is seen in the department of China, the circadian rhythm disorder is diagnosed, and the traditional Chinese medicine distinguishes that the heart-kidney yin deficiency and the liver-yang are disturbed upwards. By applying the traditional Chinese medicine pill for 7 days, the symptoms are obviously improved, and no obvious adverse reaction is caused.

Typical cases 3,

A female patient is 34 years old, is engaged in nursing work, frequently stays on duty at night, repeatedly suffers from low fever after nearly half year of fatigue, is difficult to fall asleep at night, is tired and poor in appetite in the daytime, is poor in diet, is unformed in excrement, is irritable, is diagnosed as circadian rhythm disorder in our department, and is differentiated as heart-spleen deficiency and liver-yang hyperactivity in traditional Chinese medicine. By applying the traditional Chinese medicine pill for 10 days, the symptoms are obviously improved, and no obvious adverse reaction is caused.

Typical cases 4,

A male patient is 81 years old, the Alzheimer disease is 5 years old, the blood pressure and the blood sugar are increased in nearly 2 years, the oral blood pressure and blood sugar reducing medicine cannot be reduced to normal, the daily sleep is less than 5 hours, dysphoria, daytime sleepiness and fatigue, poor appetite, unstable blood pressure and blood sugar, the circadian rhythm disorder is diagnosed, and the traditional Chinese medicine syndrome differentiation is liver and kidney deficiency and yang deficiency. The Chinese medicinal pills have the advantages of obviously improved sleep at night, improved mental diet, stable blood pressure and blood sugar and no obvious adverse reaction after being applied for 21 days.

Clinical Observation of Small specimens

The curative effect of the invention on the circadian rhythm disorder is primarily and clinically observed, and is compared with spina date seed decoction, 80 patients with the circadian rhythm disorder are included, 48 patients (20 men and 28 women have sleep rhythm and sleep quality abnormality, 20 patients have unstable blood pressure, 35 patients have abnormal diet rhythm and anorexia) in the invention group, 32 patients (13 men and 19 women have abnormal sleep rhythm and sleep quality, 16 patients have unstable blood pressure, and 22 patients have abnormal diet rhythm and anorexia) in the spina date seed decoction group, the treatment course is 14 days, the result is statistically analyzed by SPSS22.0, two independent samples are selected for the method, and the results are as follows.

Influence of one or two groups of traditional Chinese medicines on sleep rhythm and quality of circadian rhythm disorder patient

The result shows that compared with the spina date seed decoction, the spina date seed decoction has more remarkable effect of improving the sleep rhythm and quality of the circadian rhythm disorder patient.

Influence of the two groups of Chinese medicines on blood pressure of patients with circadian rhythm disorder

The results show that compared with the spina date seed decoction, the spina date seed decoction can better maintain the normal fluctuation of the blood pressure of the patient with circadian rhythm disorder and stabilize the blood pressure of the patient.

Influence of the two groups of the traditional Chinese medicines on the dietary rhythm and quality of patients with circadian rhythm disorder

The results show that compared with the spina date seed decoction, the spina date seed decoction has more remarkable effect of improving the eating rhythm and quality of the circadian rhythm disorder patients.

No obvious adverse reaction is found in the two groups of patients.

The invention has the advantages of definite curative effect, no obvious adverse reaction and convenient application by combining the above cases and clinical observation, and a further random control test is in progress at present.

The invention solves the problem that the circadian rhythm disorder lacks ideal treatment medicines and methods at present, and overcomes the problems that western medicines such as melatonin and the like have large side effects, the action range of the traditional Chinese medicine decoction adopted at present is limited, and the decoction is inconvenient to take. The formula is reasonable, various medicines are mutually cooperated, and the treatment effect is exerted to the maximum extent aiming at various aspects of the traditional Chinese medicine mechanism of the circadian rhythm disorder. The innovation is strong, and the combination of the monarch drug cicada slough and the sealwort is a brand-new application in the treatment of the circadian rhythm disorder. The medicinal materials related by the invention have wide sources, are convenient and practical, and are convenient to prepare and store.

Claims (4)

1. A traditional Chinese medicine composition for treating circadian rhythm disorder is characterized by comprising the following raw traditional Chinese medicines in parts by weight: 20-40 parts of cicada slough; 10-20 parts of rhizoma polygonati; 10-30 parts of salvia miltiorrhiza; 10-20 parts of lily; 10-30 parts of spina date seeds; 40-80 parts of honey.

2. The Chinese medicinal composition for treating circadian rhythm disorder according to claim 1, wherein the weight parts of each raw material medicament are as follows: 30 parts of cicada slough; 15 parts of rhizoma polygonati; 20 parts of salvia miltiorrhiza; 15 parts of lily; 15 parts of spina date seeds; 60 parts of honey.

3. Use of the Chinese medicinal composition of claim 1 or 2 for the preparation of a Chinese medicinal pill for the treatment of circadian rhythm disorders.

4. A traditional Chinese medicine pill for treating circadian rhythm disorder is characterized in that the pill is prepared by the following steps:

1) weighing the raw materials according to the proportion of claim 1 or 2, mixing 5 raw materials except Mel, and pulverizing into powder;

2) boiling Mel with strong fire, and decocting with slow fire until Mel turns yellow and foams;

3) mixing the powder obtained in step 1) with honey, kneading into balls, and kneading into pills by rubbing with hands;

4) after the pill surface becomes hard, wrapping with wax paper, preservative film, plastic bag or wax shell, and storing in dry place.