CN117442666A - Traditional Chinese medicine navel patch for treating insomnia and preparation method and application thereof - Google Patents
Traditional Chinese medicine navel patch for treating insomnia and preparation method and application thereof Download PDFInfo
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Classifications
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Abstract
The invention relates to a traditional Chinese medicine navel patch for treating insomnia, which is prepared from the following raw materials in parts by weight: 50-90 parts of coptis chinensis, 10-50 parts of cinnamon, 160-200 parts of dried rehmannia root, 50-90 parts of radix bupleuri, 50-90 parts of rose, 300-420 parts of spina date seed and 100-140 parts of schisandra chinensis. Clinically, the Anning powder navel therapy can effectively improve insomnia, has obvious curative effect and good application prospect.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine navel patch for treating insomnia and a preparation method and application thereof.
Background
Insomnia (Insomnia) is a subjective experience that affects daytime social functions by failing to meet normal physiological needs in terms of sleep quality or quantity due to difficulty in falling asleep and/or maintaining sleep, and is the most common sleep disturbance disorder. Today, the acceleration of social rhythm and the aggravation of competition, insomnia is a very common phenomenon. The prevalence rate of insomnia is very high, the prevalence rate of each country in Europe and America is 20% -30%, and the prevalence rate of each country in China is 10% -20%. Insomnia can cause inattention, hypomnesis, impaired judgment and daily work, and severe cases with anxiety, compulsions and depression. In addition insomnia is an independent risk factor for coronary heart disease and symptomatic diabetes. Therefore, the treatment of insomnia is of great importance to the physical and mental health of people.
At present, various treatment modes for insomnia include non-medicaments and medicaments, wherein the non-medicament treatment comprises cognitive behavior therapy, exercise therapy and the like, while western medicaments for treating insomnia comprise a benzodiazepine receptor agonist, a melatonin receptor agonist, an orexin receptor antagonist, an antidepressant with hypnotic effect, an antipsychotic medicament and the like, but from the aspect of traditional Chinese medicine, insomnia is mainly caused by non-return of yang, and is caused by disturbance of heart spirit by heat phlegm, disturbance of heart spirit by liver fire, hyperactivity of fire due to yin deficiency, blood non-nourishing heart, sympathology and the like, and the effect of long-term stability is difficult to achieve by adopting medicament therapy and certain side effects exist. The decoction, acupuncture, massage and the like in the traditional Chinese medicine therapy have better treatment effects on treating insomnia, and the traditional Chinese medicine therapy has no side effect, and continuously highlights the importance in treating insomnia. The patent CN107773604A, publication date 2018.03.09, discloses a Chinese medicinal composition for treating insomnia, which comprises the following components in part by weight: 10-30 parts of magnetite, 10-30 parts of red sage root, 10-20 parts of polygala tenuifolia, 10-20 parts of tuber fleeceflower stem, 10-20 parts of cortex albiziae, 5-10 parts of cinnabar, 20-30 parts of evodia rutaecarpa, 20-30 parts of chrysanthemum, 10-20 parts of radix scutellariae and 30-50 parts of white vinegar. The traditional Chinese medicine composition for treating insomnia is prepared from pure Chinese herbal medicines, and the materials are convenient to obtain; the foot bath can make the effective components of the traditional Chinese medicine fully promote the blood circulation of the foot, drive the internal circulation of the whole body, tonify and tranquilize, and achieve the long-term treatment effect. Another patent CN109908219a, publication date 2019.06.21, discloses a traditional Chinese medicine composition for treating insomnia, which is prepared from the following raw materials in parts by weight: 10-20 parts of medicinal cyathula root and 10-20 parts of evodia fruit. The preparation method of the external ointment with the auxiliary material matrix comprises the following steps: A. drying radix Cyathulae and fructus evodiae at 50-80deg.C for 2-5 hr, naturally cooling, pulverizing, and processing into fine powder; B. taking vaseline and hot melt adhesive, heating and melting, and uniformly mixing to serve as a matrix for standby; C. adding radix Cyathulae and fructus evodiae fine powder into matrix, stirring, mixing, and filling the mixture into blank plaster. The traditional Chinese medicine composition disclosed by the invention can be used for treating insomnia in a targeted manner, and is remarkable in effect, safe and reliable.
With the current increase of life rhythm, the pressure of work and study is increased, and the population suffering from insomnia is increased, so that an effective prescription for treating insomnia still needs to be developed, and the traditional Chinese medicine navel patch for treating insomnia, and the preparation method and application thereof, disclosed by the invention, are not reported at present.
Disclosure of Invention
The invention aims at providing a traditional Chinese medicine composition for treating insomnia, and a preparation method and application thereof, aiming at the defects in the prior art.
On the one hand, the invention provides a traditional Chinese medicine composition for treating insomnia, which is prepared from the following raw materials in parts by weight: 50-90 parts of coptis chinensis, 10-50 parts of cinnamon, 160-200 parts of dried rehmannia root, 50-90 parts of radix bupleuri, 50-90 parts of rose, 300-420 parts of spina date seed and 100-140 parts of schisandra chinensis.
As a preferred example, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 60-80 parts of coptis chinensis, 20-40 parts of cinnamon, 170-190 parts of radix rehmanniae, 60-80 parts of radix bupleuri, 60-80 parts of rose, 330-390 parts of spina date seed and 110-130 parts of schisandra chinensis.
More preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 72 parts of coptis chinensis, 36 parts of cinnamon, 180 parts of radix rehmanniae, 72 parts of radix bupleuri, 72 parts of rose, 360 parts of spina date seed and 120 parts of shizandra berry.
More preferably, the Chinese medicinal composition is an external preparation.
More preferably, the external preparation is an navel patch.
More preferably, the method of using the navel patch comprises the steps of:
(1) Is used for half an hour before sleeping;
(2) The patient lies on the back on the bed, the naked clothes expose the umbilicus, and the clean wet cloth cleans the umbilicus and the surrounding skin;
(3) An ning powder patch is applied to the umbilical region, and the center of the patch is moderately pressed to fully fill the ointment in the umbilical region. The patch is automatically taken down after being maintained for 6-8 hours, and the umbilical part is cleaned by cleaning wet cloth or cotton swabs;
(4) Once a night, a course of treatment is 10 days.
In a second aspect, a method for preparing the navel patch is provided, comprising the following steps:
(1) Weighing the raw materials according to any one of claims 1-3, pulverizing into fine powder (sieving with 100 mesh sieve), mixing, sieving, packaging, sealing, and labeling 1 kg per bag;
(2) Mixing 1000 g Anning powder with 600-800ml glycerol, stirring, making into pill, filling into plastic foam patch, and packaging to obtain 10 bags.
In a third aspect, the application of any one of the above-mentioned Chinese medicinal compositions in preparing medicament for treating insomnia is provided.
As a preferred example, the insomnia is heart-kidney disharmony.
The compatibility of the invention is as follows:
the compatibility of coptis chinensis and cinnamon in Anning powder is derived from Jiaotai pills in Korean medical general, and is a monarch drug, and the compatibility of medicines is characterized in that the compatibility of the cinnamon with the Gao Huanglian Qing Rou and the cinnamon with the Da Xin Dawen is used for treating heart-kidney disharmony syndrome of heart fire excess and kidney water non-rising, plays a role in transportation of heart and kidney, and has the formula ideas of cold and heat with low fire and qi generation, lifting and lowering correspondingly and heart and kidney congruence. Huang Lian is bitter in flavor and cold in nature. Enters heart, spleen, stomach, liver, gall and large intestine channels, has the effects of clearing heat, drying dampness, purging fire and detoxifying, and can clear heart and reduce fire. Rou Gui is pungent and sweet in flavor and is hot in nature. Enters kidney, spleen, heart and liver meridians, and has the effects of tonifying fire, supporting yang, dispelling cold, relieving pain, warming and dredging meridians.
Ministerial drugs: dried rehmannia root, radix rehmanniae, sweet, bitter and cold in taste. It enters heart, liver and kidney meridians. Has effects of clearing heat, cooling blood, nourishing yin and promoting salivation. The auxiliary drugs are used for nourishing kidney water, nourishing yin and clearing heat.
Semen Ziziphi Spinosae, sweet in taste, sour and flat. It enters liver, gallbladder and heart meridians. Has effects in nourishing heart, tonifying liver, tranquilizing mind, arresting sweating, and promoting salivation.
Schisandra chinensis, fructus Schisandrae chinensis, sour, sweet and warm in taste. It enters lung, heart and heart-kidney meridians. Has effects of astringing, invigorating qi, promoting salivation, invigorating kidney, and calming heart.
Adjuvant drug: the insomnia often has symptoms of liver depression and discomfort, or restlessness, or low mood, or anxiety and difficulty in relieving, so bupleuri radix and flos Rosae Rugosae are added to sooth liver and regulate qi, and relieve mental stress.
Bupleurum root: pungent and bitter in flavor and slightly cold in nature. It enters liver, gallbladder and lung meridians. Relieving exterior and interior syndrome, soothing liver, relieving depression, raising yang, lifting and sinking, and reducing fever and checking malaria.
Rose: sweet, slightly bitter and warm. Enters the liver and spleen meridians. Has the effects of promoting qi circulation, resolving stagnation, invigorating qi and replenishing blood.
Detailed Description
The invention is further described below in conjunction with the detailed description. It is to be understood that these examples are illustrative of the present invention and are not intended to limit the scope of the present invention. Further, it is understood that various changes and modifications of the present invention may be made by those skilled in the art after reading the description of the present invention, and such equivalents are intended to fall within the scope of the claims appended hereto.
Example 1A Chinese medicinal composition for treating insomnia according to the present invention
72 parts of coptis chinensis, 36 parts of cinnamon, 180 parts of radix rehmanniae, 72 parts of radix bupleuri, 72 parts of rose, 360 parts of spina date seed and 120 parts of shizandra berry.
Example 2A Chinese medicinal composition for external application for treating insomnia of the present invention (II)
72 parts of coptis chinensis, 20 parts of cinnamon, 190 parts of radix rehmanniae, 50 parts of radix bupleuri, 90 parts of rose, 360 parts of spina date seed and 110 parts of shizandra berry.
Example 3A Chinese medicinal composition for treating insomnia (III) of the present invention
60 parts of coptis chinensis, 40 parts of cinnamon, 160 parts of dried rehmannia root, 90 parts of radix bupleuri, 72 parts of rose, 330 parts of spina date seed and 130 parts of shizandra berry.
Example 4 Chinese medicinal composition for treating Insomnia (IV) of the present invention
80 parts of coptis chinensis, 10 parts of cinnamon, 200 parts of radix rehmanniae, 72 parts of radix bupleuri, 60 parts of rose, 390 parts of spina date seed and 180 parts of shizandra berry.
EXAMPLE 5 the Chinese medicinal composition for treating insomnia (V)
50 parts of coptis chinensis, 50 parts of cinnamon, 180 parts of radix rehmanniae, 60 parts of radix bupleuri, 80 parts of rose, 300 parts of spina date seed and 140 parts of shizandra berry.
EXAMPLE 6 Chinese medicinal composition for treating insomnia (VI) of the invention
90 parts of coptis chinensis, 36 parts of cinnamon, 170 parts of dried rehmannia root, 80 parts of radix bupleuri, 50 parts of rose, 420 parts of spina date seed and 120 parts of shizandra berry.
EXAMPLE 7 the Chinese medicinal composition for treating insomnia (seven)
72 parts of coptis chinensis, 40 parts of cinnamon, 160 parts of dried rehmannia root, 90 parts of radix bupleuri, 72 parts of rose, 330 parts of spina date seed and 130 parts of shizandra berry.
EXAMPLE 8A Chinese medicinal composition for treating insomnia (eight)
60 parts of coptis chinensis, 10 parts of cinnamon, 200 parts of radix rehmanniae, 72 parts of radix bupleuri, 60 parts of rose, 390 parts of spina date seed and 180 parts of shizandra berry.
EXAMPLE 9 the Chinese medicinal composition for treating insomnia (nine)
80 parts of coptis chinensis, 50 parts of cinnamon, 180 parts of radix rehmanniae, 60 parts of radix bupleuri, 80 parts of rose, 300 parts of spina date seed and 140 parts of shizandra berry.
EXAMPLE 10A Chinese medicinal composition for treating insomnia (ten)
50 parts of coptis chinensis, 36 parts of cinnamon, 170 parts of dried rehmannia root, 80 parts of radix bupleuri, 50 parts of rose, 420 parts of spina date seed and 120 parts of shizandra berry.
EXAMPLE 11 Chinese medicinal composition for treating insomnia (eleven) of the present invention
90 parts of coptis chinensis, 20 parts of cinnamon, 190 parts of radix rehmanniae, 50 parts of radix bupleuri, 90 parts of rose, 360 parts of spina date seed and 110 parts of shizandra berry.
EXAMPLE 12 preparation of the Chinese navel Patch for treating insomnia of the present invention
Weighing the raw materials according to the weight ratio of any one of the traditional Chinese medicine compositions in the embodiments 1-11, grinding into fine powder (sieving with a 100-mesh sieve) in common, mixing uniformly, sieving, sub-packaging, mixing 1000 g of the powder in the embodiment 12 with 600-800ml of glycerin by hand, making into pill, filling into plastic foam patches, sub-packaging, and 10 patches into 1 bag.
Example 13 clinical trials (I)
1. Data and method
1.1 case Source
60 cases were selected from the yellow-pu-district Xiangshan medical hospital patients meeting inclusion criteria.
1.2 diagnostic criteria
1.2.1 Western diagnostic criteria
Referring to the Chinese medical society of mental science, classification of mental disorders and diagnostic criteria (CCMD-3)): diagnostic criteria: insomnia is a condition of unsatisfactory sleep quality, which is mainly caused by insomnia, and other symptoms are secondary to insomnia, including difficulty in falling asleep, deep sleep, easy wakefulness, dreaminess, early wakefulness, difficulty in falling asleep after wakefulness, discomfort after wakefulness, fatigue, or drowsiness in the daytime. Insomnia can cause anxiety, depression, or fear in the patient, and lead to a decrease in mental activity efficiency, hampering social function.
Symptom criteria:
(1) almost the only symptoms of insomnia include difficulty in falling asleep, not deep sleep, dreaminess, early sleep or difficulty in following sleep. Discomfort after waking, fatigue, or daytime sleepiness;
(2) has the advantages of insomnia and extremely paying attention to the insomnia result;
(3) dissatisfaction with the number and quality of sleep causes significant distress and impaired social function;
(4) at least 3 times per week and at least 1 month;
(5) and the secondary insomnia caused by somatic diseases and mental disorder symptoms is eliminated.
1.2.2 diagnostic criteria for TCM
Refer to the Chinese medical society and issue the traditional Chinese medical syndrome part of the diagnosis and treatment guide of common diseases in Chinese medicine (Chinese medical Press, 2008), which belongs to the syndrome of incoordination between the heart and kidney. Palpitation, insomnia, dreaminess, amnesia, soreness and weakness of waist and knees, feverish sensation in chest, palms and soles, hectic fever, night sweat, dizziness, tinnitus and the like.
1.2.3 inclusion criteria
(1) Meets the Western medicine and Chinese medicine diagnosis standards, and PSQI is more than or equal to 7 points;
(2) elderly people with age of more than or equal to 60 years or perimenopausal women, the syndrome of incoordination between the heart and kidney;
1.2.4 exclusion criteria
(1) Allergic constitution or allergic to the drug and alcohol;
(2) serious primary diseases such as cardiovascular and cerebrovascular diseases, liver, kidney and hematopoietic system are combined;
(3) mental patients;
(4) pregnant women and women in lactation period.
1.3 general data
60 patients were in the Huangpu district Xiangshan traditional Chinese medical hospital. The random number was divided into two groups of 30 cases. 18 men in the treatment group, 12 women, age 62-86 years, average (75.00+ -1.36) years, course 2-8 years, average course (4.80+ -0.30) years. The control group had 19 men, 11 women, ages 60-90 years, average (77.89 + -1.45) years, course of disease 3-8 years, average course of disease (5.37+ -0.29) years. The two groups of age, sex, disease course, PSQI integral and traditional Chinese medicine syndrome integral are all statistically processed without significant difference (P > 0.05) and have comparability.
2 study method
The control group was given 1mg oral, QN, of esmolen (produced by Shanghai friendship) orally. The therapeutic group was applied to the umbilical region half an hour before sleep with an Anning powder navel treatment patch (prepared according to the formulation of example 1 and the preparation method of example 12 described above) for 8 hours. The treatment course is 10 days.
3 observation index
3.1 evaluation of Main efficacy
Before and after treatment, the score of the Pittsburgh Sleep Quality Index (PSQI) was recorded, and the integral of the Chinese medicine symptoms before and after treatment was observed.
Score criteria are formulated for primary and secondary symptoms and clinical actual conditions in the evaluation of curative effect criteria by referring to the clinical research guidelines for treating insomnia with new traditional Chinese medicines. The major clinical symptoms were classified into 3 grades by the degree of severity, respectively 3, 6 and 9 scores, the asymptomatic person was classified into 0 score, the minor clinical symptoms were classified into 3 grades by the degree of severity, respectively 1, 2 and 3 scores, and the asymptomatic person was classified into 0 score.
3.2 clinical efficacy
3.2.1 disease criteria
Efficacy was assessed by calculating the score reduction rate according to nimodipine method using the pittsburgh sleep quality scale (PSQI): score reduction rate = (pre-treatment score-post-treatment score)/pre-treatment score x 100%. Clinical cure: the score is reduced by more than or equal to 75 percent, and the effect is obvious: the score is reduced by more than or equal to 50 percent, and the effect is achieved: score decrease of more than or equal to 30% is improved, and no effect is achieved: score reduction <30%.
3.2.2 criteria for judging the Condition of the syndrome
And evaluating the curative effect standard according to the clinical research guiding principle of treating insomnia by using new traditional Chinese medicines.
Clinical recovery: the sleeping time is recovered to be normal or the sleeping time at night is increased to be more than 6 hours, the sleeping is deep and the vigor is full after waking. The effect is shown: the sleep is obviously improved, the sleep time is increased by more than 3 hours, and the sleep depth is increased. The method is effective: symptoms are relieved, and sleep time is increased by less than 3 hours before sleep. Invalidation: the sleep is not obviously improved.
4 statistical method
The database was built using the SPSS15.0 statistical software package. Under the condition that the normal distribution and variance uniformity of the metering data are met, t test is adopted, and X is adopted as counting data 2 The clinical efficacy group-to-group comparison uses Wilcon rank sum test.
5 results
5.1PSQI integral comparison
Compared in the two groups before and after treatment, the PSQI integral of the patients has significant difference (p < 0.01). The PSQI integral comparison between the two groups after treatment showed no significant differences (p > 0.05), as shown in Table 1.
Table 1 two sets of PSQI total integral comparisons (x+ -s, split)
P compared to pre-treatment<0.01; comparison with control group after treatment ▲ P>0.05
5.2 integral comparison of the symptoms of Chinese traditional medicine
Compared in the two groups before and after treatment, the integral of the traditional Chinese medicine symptoms of the patients has significant difference (p < 0.01). The integral comparison of the Chinese medicine symptoms between the two groups after treatment shows that the two groups have significant differences (p < 0.05), as shown in table 2.
Table 2 integration and comparison (x+ -s, divided) of two groups of Chinese medicinal symptoms
P compared to pre-treatment<0.01; comparison with control group after treatment ▲ P<0.05
5.3 comparison of effective rates of sleep quality after two groups of treatments
The treatment group was 80.00%, the control group was 83.33%, and the two groups were compared in terms of effective rate, and the difference was not significant (P > 0.05), as shown in Table 3.
Table 3 comparison of sleep quality effectiveness after two groups of treatments
Comparison with control group after treatment ▲ P>0.05
5.4 comparison of the curative effects of the two groups of treated Chinese traditional medicine syndromes
The navel treatment group is 86.67%, the Shule diazepam group is 63.33%, and compared with the curative effect of the two groups of traditional Chinese medicine symptoms, the difference has significance (p < 0.05), and the table 4 shows.
Table 4 comparison of the curative effects of the two groups of treated Chinese medical syndromes
Comparison with control group after treatment ▲ P<0.05
5.5 adverse reactions
No adverse effect was seen in both treatment and control groups of patients.
5.6 conclusion
According to the clinical research results, 30 cases of Anning powder navel therapy for treating insomnia are shown, wherein 26 cases are effective and 4 cases are ineffective, and the total effective rate is 86.67%. The score comparison of the Pittsburgh Sleep Quality Index (PSQI) after 2 groups of treatment shows that the difference has no significance (P > 0.05), and the integral comparison of the traditional Chinese medicine symptoms after 2 groups of treatment shows that the difference has significance (P < 0.05). The effective rate of sleep quality after 2 groups of treatment is compared, the difference has no significance (P is more than 0.05), the curative effect of traditional Chinese medicine symptoms after 2 groups of treatment is compared, and the difference has significance (P is less than 0.05). No significant adverse effects were found during the course of treatment in both groups. The above results show that the homemade Anning powder has definite clinical curative effect on treating insomnia.
Example 14 clinical trials (II)
1. Data and method
1.1 case Source
30 patients with insomnia at the end of tumor were patients with a medical ward for three collaborative units (the beach community health service center, the Yuyuan community health service center, and the Jin Shanwei town community health service center). Treatment group men 16, women 14.
1.2 diagnostic criteria
1.2.1 Western diagnostic criteria
Referring to the Chinese medical society of mental science, classification of mental disorders and diagnostic criteria (CCMD-3)): diagnostic criteria: insomnia is a condition of unsatisfactory sleep quality, which is mainly caused by insomnia, and other symptoms are secondary to insomnia, including difficulty in falling asleep, deep sleep, easy wakefulness, dreaminess, early wakefulness, difficulty in falling asleep after wakefulness, discomfort after wakefulness, fatigue, or drowsiness in the daytime. Insomnia can cause anxiety, depression, or fear in the patient, and lead to a decrease in mental activity efficiency, hampering social function.
Standard of symptoms
(1) Almost the only symptoms of insomnia include difficulty in falling asleep, not deep sleep, dreaminess, early sleep or difficulty in following sleep. Discomfort after waking, fatigue or daytime sleepiness;
(2) has the advantages of insomnia and extremely paying attention to the insomnia result;
(3) dissatisfaction with the number and quality of sleep causes significant distress and impaired social function;
(4) at least 3 times per week and at least 1 month;
(5) and the secondary insomnia caused by somatic diseases and mental disorder symptoms is eliminated.
1.2.2 diagnostic criteria for TCM
Refer to the Chinese medical society and issue the traditional Chinese medical syndrome part of the diagnosis and treatment guide of common diseases in Chinese medicine (Chinese medical Press, 2008), which belongs to the syndrome of incoordination between the heart and kidney. Palpitation, insomnia, dreaminess, amnesia, soreness and weakness of waist and knees, feverish sensation in chest, palms and soles, hectic fever, night sweat, dizziness, tinnitus and the like.
1.2.3 inclusion criteria
(1) Meets the Western medicine and Chinese medicine diagnosis standards, and PSQI is more than or equal to 7 points;
(2) patients with terminal tumor.
1.2.4 exclusion criteria
(1) Allergic constitution or allergic to the drug and alcohol;
(2) serious primary diseases such as cardiovascular and cerebrovascular diseases, liver, kidney and hematopoietic system are combined;
(3) mental patients.
1.3 general data
30 patients were patients in an annihilation care unit of three collaborative units (beach community health service center, yuan community health service center, jin Shanwei town community health service center). Treatment group men 16, women 14.
2 study method
The umbilicus-treating plaster is applied to the umbilical region for half an hour before sleeping, and is maintained for 8 hours. The treatment course is 10 days.
3 observation index
Before and after treatment, the Pittsburgh Sleep Quality Index (PSQI) score and the Chinese medicine syndrome score before and after treatment are observed.
The Chinese medicine syndromes are integrated: score criteria are formulated by referring to primary and secondary symptoms and clinical actual conditions in efficacy standard assessment of clinical study guidelines for treating insomnia of Chinese medicine. The major clinical symptoms were classified into 3 grades by the degree of severity, respectively 3, 6 and 9 scores, the asymptomatic person was classified into 0 score, the minor clinical symptoms were classified into 3 grades by the degree of severity, respectively 1, 2 and 3 scores, and the asymptomatic person was classified into 0 score.
4 clinical efficacy
4.1 disease criterion
Efficacy was assessed by calculating the score reduction rate according to nimodipine method using the pittsburgh sleep quality scale (PSQI): score reduction rate = (pre-treatment score-post-treatment score)/pre-treatment score x 100%. Clinical cure: the score is reduced by more than or equal to 75 percent, and the effect is obvious: the score is reduced by more than or equal to 50 percent, and the effect is achieved: score decrease of more than or equal to 30% is improved, and no effect is achieved: score reduction <30%.
4.2 criteria for judging the condition of syndrome
And evaluating the curative effect standard according to the clinical research guiding principle of treating insomnia by using new traditional Chinese medicines.
Clinical recovery: the sleeping time is recovered to be normal or the sleeping time at night is increased to be more than 6 hours, the sleeping is deep and the vigor is full after waking. The effect is shown: the sleep is obviously improved, the sleep time is increased by more than 3 hours, and the sleep depth is increased. The method is effective: symptoms are relieved, and sleep time is increased by less than 3 hours before sleep. Invalidation: the sleep is not obviously improved.
5 statistical method
The database was built using the SPSS15.0 statistical software package. Under the condition that the normal distribution and variance uniformity of the metering data are met, t test is adopted, and X is adopted as counting data 2 The clinical efficacy group-to-group comparison uses Wilcon rank sum test.
6 results
6.1 comparison of PSQI integral before and after treatment
Statistical analysis results:
table 1PSQI integral comparison (x+ -s, min)
Table 2Tests ofNormality
6.2 integration of Chinese medicine symptoms
Statistical analysis results:
table 3Paired Samples Statistics
TABLE 4TestNomality
Table 5 Paired Samples Test
6.3 PSQI integration before and after treatment and Chinese medicine symptoms integration
The PSQI integral before and after treatment and the Chinese medicine symptom integral are shown in Table 6, wherein 8 people are effective, 16 people are effective, 6 people are ineffective, and the effective rate is 80%. The PSQI integral before and after treatment and the traditional Chinese medicine syndrome integral have obvious differences (P < 0.01), which shows that the Anning navel powder therapy of the invention has obvious improvement effect on patients with insomnia at the end stage of tumor.
TABLE 6 PSQI score and Chinese medical symptoms score before and after treatment
P compared to pre-treatment<0.01， ▲ P<0.01。
Example 15 clinical trial (III)
1. Data and method
1.1 case Source
120 patients were in the Huangpu district Xiangshan traditional Chinese medical hospital.
1.2 diagnostic criteria
1.2.1 Western diagnostic criteria
Reference is made to the Insomnia diagnosis basis of ICD-10 classification of mental and behavioral disorders (2010) published by the national medical administration of medicine:
(1) difficulty in falling asleep, shallow sleep, easy wake after sleep, uncomfortable feeling after waking, and fatigue;
(2) sleep disorders occur at least 3 times per week and last for more than one month;
(3) attention is paid to insomnia at night, and adverse effects of insomnia are excessively worried;
(4) dissatisfaction with sleep quality causes significant anxiety, depression, fear psychology and affects social function.
1.2.2 diagnostic criteria for TCM
Meets the diagnosis basis of insomnia in the Chinese medical industry standard of the people's republic of China, and belongs to the syndrome of disharmony between the heart and the kidney. Palpitation, insomnia, dreaminess, amnesia, soreness and weakness of waist and knees, feverish sensation in chest, palms and soles, hectic fever, night sweat, dizziness, tinnitus and the like.
1.2.3 inclusion criteria
(1) Meets the Western medicine and Chinese medicine diagnosis standards, and the ISI is more than or equal to 8 minutes;
(2) the age is between 18 years and 90 years;
(3) informed consent was obtained from the patient or principal.
1.2.4 exclusion criteria
(1) Allergic constitution or allergic to the drug;
(2) serious primary diseases such as cardiovascular and cerebrovascular diseases, liver, kidney and hematopoietic system are combined;
(3) mental patients;
(4) pregnant women and women in lactation period.
1.3 general data
120 patients were patients in the Huangpu district Xiangshan traditional Chinese medical hospital, and were randomly divided into two groups of 60 patients each. The two groups of age, sex, disease course and ISI integral are statistically processed, and have no significant difference (P > 0.05) and comparability.
2 methods of treatment
Both groups were given 10mg, QN of oral zolpidem tartrate. The therapeutic group is applied to umbilical region for half an hour before sleeping, and is maintained for 8 hours. One treatment course is 10 days, and two treatment courses are continuously treated for 20 days.
3 observation index
Before and after treatment, insomnia severity Index Scale (ISI) score.
4 clinical efficacy evaluation criteria
The evaluation standard of the insomnia diagnosis and treatment scheme in the Chinese medicine administration of China is referred to in the notification about the diagnosis and treatment scheme of 8 kinds of diseases of the psychiatric department of the Insomnolence. Efficacy was assessed by calculating the score reduction rate according to nimodipine method using the insomnia severity Index Scale (ISI): score reduction rate = (pre-treatment score-post-treatment score)/pre-treatment score x 100%. Clinical cure: the score is reduced by more than or equal to 75 percent, and the effect is obvious: the score is reduced by more than or equal to 50 percent, and the effect is achieved: score decrease of more than or equal to 30% is improved, and no effect is achieved: score reduction <30%.
4 statistical method
The database was built using the SPSS15.0 statistical software package. Under the condition that the normal distribution and variance uniformity of the metering data are met, t test is adopted, and X is adopted as counting data 2 The clinical efficacy group-to-group comparison uses Wilcon rank sum test.
5 results
5.1 ISI integral comparison
Compared in the two groups before and after treatment, the integral of ISI of patients has significant difference (p < 0.01). ISI integral comparison between the two groups after treatment showed significant differences (p < 0.01), see table 1.
Table 1 two sets of ISI integral comparisons (x+ -s, split)
P compared to pre-treatment<0.01; comparison with control group after treatment ▲ P<0.01
5.2 comparison of clinical efficacy after two groups of treatments
The treatment group was 80.00%, the control group was 83.33%, and the two groups were compared in terms of effective rate, and the difference was not significant (P > 0.05), as shown in Table 2.
Table 2 comparison of clinical efficacy after two groups of treatments
Comparison with control group after treatment ▲ P<0.01
5.3 adverse reactions
No adverse effect was seen in both treatment and control groups of patients.
Conclusion 6
The results of clinical researches show that the Anning powder for navel therapy treats 60 cases of insomnia, wherein 2 cases of clinical cure, 33 cases of obvious effect, 21 cases of effective and 4 cases of ineffective cases, and the total effective rate is 93.33%. The difference was significant (P < 0.01) compared to the insomnia severity Index Scale (ISI) scores after treatment in group 2. Compared with clinical efficacy after treatment of 2 groups, the difference has significance (P < 0.01). No significant adverse effects were found during the course of treatment in both groups. The above results show that the Anning powder navel therapy combined with western medicines has definite clinical curative effect and high safety in treating insomnia.
The foregoing is merely a preferred embodiment of the present invention, and it should be noted that modifications and additions may be made to those skilled in the art without departing from the method of the present invention, which modifications and additions are also to be considered as within the scope of the present invention.
Claims (9)
1. The traditional Chinese medicine composition for treating insomnia is characterized by being prepared from the following raw materials in parts by weight: 50-90 parts of coptis chinensis, 10-50 parts of cinnamon, 160-200 parts of dried rehmannia root, 50-90 parts of radix bupleuri, 50-90 parts of rose, 300-420 parts of spina date seed and 100-140 parts of schisandra chinensis.
2. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 60-80 parts of coptis chinensis, 20-40 parts of cinnamon, 170-190 parts of radix rehmanniae, 60-80 parts of radix bupleuri, 60-80 parts of rose, 330-390 parts of spina date seed and 110-130 parts of schisandra chinensis.
3. The traditional Chinese medicine composition according to claim 2, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 72 parts of coptis chinensis, 36 parts of cinnamon, 180 parts of radix rehmanniae, 72 parts of radix bupleuri, 72 parts of rose, 360 parts of spina date seed and 120 parts of shizandra berry.
4. The traditional Chinese medicine composition according to any one of claims 1 to 3, wherein the traditional Chinese medicine composition is an external preparation.
5. The traditional Chinese medicine composition according to claim 4, wherein the external preparation is navel patch.
6. The Chinese medicinal composition according to claim 5, wherein the method of using the navel patch comprises the following steps:
(1) Is used for half an hour before sleeping;
(2) The patient lies on the back on the bed, the naked clothes expose the umbilicus, and the clean wet cloth cleans the umbilicus and the surrounding skin;
(3) An ning powder patch is applied to the umbilical region, and the center of the patch is moderately pressed to fully fill the ointment in the umbilical region. The patch is automatically taken down after being maintained for 6-8 hours, and the umbilical part is cleaned by cleaning wet cloth or cotton swabs;
(4) Once a night, a course of treatment is 10 days.
7. The method for preparing the navel patch according to claim 5, comprising the following steps:
(1) Weighing the raw materials according to any one of claims 1-3, pulverizing into fine powder (sieving with 100 mesh sieve), mixing, sieving, packaging, sealing, and labeling 1 kg per bag;
(2) Mixing 1000 g Anning powder with 600-800ml glycerol, stirring, making into pill, filling into plastic foam patch, and packaging to obtain 10 bags.
8. Use of a Chinese medicinal composition according to any one of claims 1-6 in the manufacture of a medicament for the treatment of insomnia.
9. The use according to claim 8, wherein the insomnia is characterized by heart-kidney disharmony.
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