CN108938988B - Baijiahei compound medicine for treating senile insomnia - Google Patents
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- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/72—Rhamnaceae (Buckthorn family), e.g. buckthorn, chewstick or umbrella-tree
- A61K36/725—Ziziphus, e.g. jujube
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/884—Alismataceae (Water-plantain family)
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/888—Araceae (Arum family), e.g. caladium, calla lily or skunk cabbage
- A61K36/8888—Pinellia
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
- A61K36/8967—Lilium, e.g. tiger lily or Easter lily
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/906—Zingiberaceae (Ginger family)
- A61K36/9062—Alpinia, e.g. red ginger or galangal
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Abstract
The invention discloses a melanization compound medicine for treating senile insomnia, which comprises a diurnal prescription and a nocturnal prescription, wherein the diurnal prescription comprises the following medicinal materials in parts by weight: 10 parts of cassia twig, 10 parts of kudzuvine root, 15 parts of polyporus umbellatus, 15 parts of oriental waterplantain rhizome, 10 parts of rhizoma pinellinae praeparata, 15 parts of salvia miltiorrhiza, 15 parts of codonopsis pilosula and 15 parts of fructus alpiniae oxyphyllae; the night prescription comprises the following medicinal materials in parts by weight: 30 parts of mother-of-pearl, 10 parts of magnetite, 20 parts of dragon bone, 15 parts of spina date seed, 15 parts of poria with hostwood, 15 parts of platycladi seed, 15 parts of radix curcumae and 20 parts of lily. The compound medicine has the physiological characteristics of 'qi and blood deficiency, muscle weakness, airway astringency, qi circulation of five internal organs, nutrient qi deficiency and defensive qi internal depression' of the old with latent prescription medicine to regulate nutrient and defensive qi, and simultaneously considers the insomnia of the old with more deficiency and excess mixed substances to treat the insomnia of the old with deficiency and excess, revivify the spirit in daytime, calm and tranquilize at night, so as to treat the insomnia of the old with the disorder of biological rhythm.
Description
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to a Baijiahei compound medicine for treating senile insomnia.
Background
The book Ling Shu & Ying health Association says: the aged who have qi and blood deficiency, dry muscles, unsmooth airways and qi of the five zang organs are mutually pulsating, so the aged have deficient ying-qi and deficient defensive qi, and have no essence in the daytime and no close one's eyes at night. The old people can not normally sleep due to aging, body weakness, viscera function decline day by day and internal consumption of nutrient and defense, so that nutrient and defense circulation is not coordinated, nutrient and defense qi can not flow along yin channels or viscera along with nutrient and defense qi at night, the nutrient and defense function is weakened, the nutrient and defense can not help five internal organs to contain and restrain spirit and qi, and the spirit and qi float, namely ' close one's eyes at night '; in the morning, defensive qi is in the nutrient-yin, the nutrient-yin deficiency, the defensive qi is in the inner place, and in the detention area, patients often suffer from mental lassitude, lethargy, slow reaction, hypomnesis, and the like, namely 'diurnal semen'. "not nocturnal but not close one's eyes" so it needs to raise the qi of clearing yang to help excitement; at night, subduing yang and soothing the nerves are needed to reduce excitability.
Disclosure of Invention
The invention provides a Baijiahei compound medicine for treating senile insomnia, aiming at the symptoms of ' untightness in daytime and night close one's eyes ' (namely sleepiness in daytime, dozing and no spirit and insomnia at night) of old people, which aims at the physiological characteristics of ' qi and blood deficiency, muscle weakness, airway astringency, qi circulation of five internal organs, nutrient and qi deficiency and defensive qi internal depression ' of old people, and is used as a latent medicine for harmonizing nutrient and defensive qi, and simultaneously considers the deficiency and excess inclusion of the senile insomnia, and treats deficiency and excess to treat the insomnia caused by the biological rhythm disorder of the old people.
In order to achieve the purpose, the invention adopts the following technical scheme:
the Baijiahei compound medicine for treating senile insomnia comprises a diurnal prescription and a nocturnal prescription, wherein the diurnal prescription comprises the following medicinal materials in parts by weight: 10 parts of cassia twig, 10 parts of kudzuvine root, 15 parts of polyporus umbellatus, 15 parts of oriental waterplantain rhizome, 10 parts of rhizoma pinellinae praeparata, 15 parts of salvia miltiorrhiza, 15 parts of codonopsis pilosula and 15 parts of fructus alpiniae oxyphyllae; the night prescription comprises the following medicinal materials in parts by weight: 30 parts of mother-of-pearl, 10 parts of magnetite, 20 parts of dragon bone, 15 parts of spina date seed, 15 parts of poria with hostwood, 15 parts of platycladi seed, 15 parts of radix curcumae and 20 parts of lily.
According to the diurnal prescription, based on the physiological characteristics of cassia twig and kudzuvine root for raising yang qi, the physiological characteristics of 'qi-blood deficiency, muscle dryness and unsmooth airway' of the old are established, codonopsis pilosula is used for tonifying qi and blood, polyporus umbellatus, rhizoma alismatis, rhizoma pinellinae praeparata and salvia miltiorrhiza are used for promoting diuresis and activating blood circulation airway, and the situation that the patient achieves 'diurnal essence' state is defended; the application of the grifola, the rhizoma alismatis, the rhizoma pinellinae praeparata, the salvia miltiorrhiza and the fructus alpiniae oxyphyllae simultaneously accords with the pathological characteristics of modern traditional Chinese medicine for researching the reason that the phlegm-blood stasis is combined into the senile insomnia, and is the most common reason for causing the senile sleep disorder. At night, mother-of-pearl, magnetite and keel are used for suppressing yang and guiding defense to enter nutrient, spina date seed, poria with hostwood, platycladi seed are used for nourishing heart blood, radix curcumae and lily are used for resolving stagnation and ventilating ducts, the physiological characteristics of ' heart governing mind and tranquility and sleep ' are established on the basis of guiding defense to enter nutrient, and tranquilizers are applied in large quantities to enable patients to enter a ' night close one's eyes ' state; the application of lily and curcuma aromatica combines the experience that emotions are often the inducing factors of insomnia so as to better treat senile insomnia. The physiological characteristics of the two-part standing-foot old, namely 'qi and blood deficiency, dry muscles, unsmooth air passages, qi circulation of five internal organs, deficiency of nutrient qi and internal qi depression of defensive qi' are overcome, the potential formula is used for regulating nutrient and defensive qi, and simultaneously, the deficiency and excess of the senile insomnia are mixed, and the deficiency and excess are supplemented to treat the insomnia caused by the biorhythm disorder of the elderly.
Detailed Description
In order to make the present invention more comprehensible, the technical solutions of the present invention are further described below with reference to specific embodiments, but the present invention is not limited thereto.
1 study case
And selecting an insomnia special outpatient service of a second people hospital in Fujian province from 2016 to 2017 for treatment in 12 months, and according with insomnia cases with complete data of the senile insomnia caused by ' insomnia with dim daytime and close one's eyes nighttime '.
2 diagnostic criteria
2.1 diagnostic criteria for insomnia in Western medicine
The diagnosis standard of insomnia refers to the diagnosis standard of non-organic sleep disorder, which is made in 2001 and is classified and diagnosed in 3 rd edition of Chinese mental disorder (CCMD-3): the insomnia is a state of unsatisfactory sleep quality mainly caused by insomnia, and other symptoms are secondary to insomnia and comprise difficulty in falling asleep, low sleep, easy waking, dreaminess, early waking, difficulty in sleeping again after waking, uncomfortable feeling after waking, fatigue or daytime sleepiness. Insomnia can cause anxiety, depression, or fear of the mind of the patient and lead to a decrease in the efficiency of mental activities and impairment of social functioning.
Age classification of the elderly: age 65 and older.
[ symptom Standard ]
(1) Insomnia is the main symptom, including difficulty in falling asleep, poor sleep, dreaminess, early awakening, difficulty in falling asleep again after awakening, uncomfortable feeling after awakening, fatigue, daytime sleepiness and the like;
(2) has the advantages of insomnia and extreme attention to insomnia results.
[ Severe criteria ] dissatisfaction with the quantity and quality of sleep causes significant distress or impaired social functioning.
The disease course criteria occurred at least 3 times per week for at least 1 month.
[ exclusion criteria ] Secondary insomnia caused by symptoms of physical diseases or mental disorders was excluded.
2.2 Chinese medicine diagnostic Standard
The insomnia diagnosis standard of the clinical trial guideline for treating insomnia by using new traditional Chinese medicines (according with the insomnia diagnosis standard of Western medicine) is met;
(1) the age is more than or equal to 65 years old;
(2) one or more of lassitude, sleepiness, amnesia, inattention, listlessness, and low mood during daytime;
(3) the accompanying person often has unconscious drowsy behaviors for the patient;
(4) judgment by the doctor: the medical history and symptoms of the patient accord with the traditional Chinese medicine diagnosis standard of insomnia, and the activity in daytime is normal (the patient can be judged to have the drowsiness behavior of unconsciousness or the increase of the bed-lying time).
The above (1) is the necessary standard, and the diagnosis can be carried out when one or more of (2), (3) and (4) are satisfied.
3 medicine and method of administration
Formula of day (half an hour after breakfast): 10g of cassia twig, 10g of kudzuvine root, 15g of polyporus umbellatus, 15g of oriental waterplantain rhizome, 10g of rhizoma pinellinae praeparata, 15g of salvia miltiorrhiza, 15g of codonopsis pilosula and 15g of fructus alpiniae oxyphyllae.
Night formula (taken half an hour after dinner): 30g of mother-of-pearl, 10g of magnetite, 20g of dragon bone, 15g of spina date seed, 15g of poria with hostwood, 15g of platycladi seed, 15g of radix curcumae and 20g of lily.
The above materials are decocted in water and taken on time. 7 days is a course of treatment.
4 inclusion criteria
(1) The age is more than or equal to 65 years, the insomnia diagnosis standard of ' light days, night close one's eyes ' is met, and the score of the Pittsburgh sleep quality index table is more than or equal to 7 points;
(2) the patients are treated by taking the day prescription and the night prescription only (4 courses of treatment, total 28 days) and the case data is complete;
(3) the western medicines, patent medicines and decoction for treating insomnia are not taken within one week before the treatment;
5 exclusion criteria
(1) The patients who use the sleep-affecting medicine within a week before the treatment;
(2) insomnia is caused by organic diseases or organic pathological changes which obstruct sleep, such as hyperthyroidism, heart failure, bronchial asthma acute attack, uremia stage, acute cerebrovascular disease and the like;
(3) mental disorders affecting sleep, such as anxiety, depression, with a score of more than 70 on the anxiety self-rating scale (SAS), depression self-rating scale (SDS);
(4) there is severe cognitive dysfunction.
6 rejection Standard
(1) The patients who take other drugs with the effect on sleep than the compound drugs during the treatment period; (2) those who have serious adverse events during treatment, such as allergies to the present compound or to the components contained therein.
7 criteria for evaluation of therapeutic Effect
Refer to ' clinical research guiding principle of treating insomnia with new Chinese medicine ' in 2002 ' and the evaluation of judgment standard of clinical curative effect of insomnia newly issued by WHO:
the total effectiveness is as follows: and (3) healing: the sleep time is recovered to be normal or the sleep time at night is increased to be more than 6h, the sleep is deep, the spirit is vigorous after waking up, and the sleep efficiency is more than 75%;
the effect is shown: the sleep is improved obviously, the sleep time is increased by more than 3h, the sleep depth is increased, and the sleep efficiency is more than 65%;
the method has the following advantages: the symptoms are relieved, the sleep time is increased by less than 3 hours compared with the prior art, and the sleep efficiency is more than 55 percent.
And (4) invalidation: after the treatment, the insomnia symptoms are not obviously improved or aggravated.
8 statistical results
159 complete cases are collected according to inclusion, exclusion and elimination criteria and divided into two groups according to the efficacy evaluation criteria, wherein 117 cases of the total effective group account for 73.58%, and 42 cases of the ineffective group account for 26.42%. Based on the curative effect groups, the statistical analysis is respectively carried out on the factors of the general data, the night sleep-related symptoms, the main symptoms and the secondary symptoms, and then the multi-factor logistic regression analysis is carried out on the single factor with statistical significance.
8.1 general data Single factor analysis
Age, PSQI score, course of disease, body mass index in general dataFirst as the measurement datatInspection orZNo statistical significance was observed in the tests and the resultsP> 0.05). See tables 1 and 2 for details.
TABLE 1 general informationtTest results
TABLE 2 general dataZTest results
The chi-square test is carried out on each single factor in general data, and the result prompts that: the contents of daily activities and the severity of insomnia have statistical significance: (P< 0.05). See table 3 for details.
TABLE 3 general data
Test results
8.2 Single factor analysis of symptoms associated with nocturnal sleep
The prescription checking is carried out on the symptoms related to the sleep at night, the symptoms belong to ordered continuous data and have three or more items, and the items are combined in sequence and then the prescription checking is carried out. And (4) prompting by a result: the time for falling asleep is limited to half an hour, namely whether the falling asleep is difficult or not has statistical significance (P is less than 0.05). See tables 4, 5, 6, 7 for details.
TABLE 4 time to sleep
Test results
TABLE 5 night wakening
Test results
TABLE 6 dream situation
Test results
TABLE 7 early wake-up conditions
Test results
8.3 Single factor analysis of chief complaints
The single-factor statistical analysis results of the main symptoms indicate that the sleepiness, the lassitude, the low mood and the mental fatigue have statistical significance (P< 0.05). See table 8 for details.
TABLE 8 Primary symptoms
Test results
8.4 minor symptom one-factor analysis
According to the statistical result of the frequency of the symptom scale of the traditional Chinese medicine, 18 times of symptoms (mental stress, vexation, irritability, palpitation, chest distress, timidity, easy fright and head fright) with highest frequency of occurrence are selected from the symptomsPerforming single-factor statistics on dizziness, headache, tinnitus, dry mouth, excessive anxiety, reduced interest, lusterless complexion, bitter taste, soreness and weakness of waist and knees, body pain, anorexia, frequent micturition at night and stool conditions (dryness, normality and rareness)), and displaying a statistical result: night pollakisuria is statistically significant (P< 0.05). See table 9 for details.
TABLE 9 minor symptoms
Test results
8.5 multifactor logistic regression analysis
The multi-factor binary logistic regression analysis of the curative effect difference of treating the insomnia of the old people with the pattern of ' white plus black therapy ' and ' no essence of the day ' and ' no close one's eyes at night ': the total valid set and the invalid set are set as dependent variables, wherein the invalid set is marked as 0, and the total valid set is marked as 1. The factors influencing the curative effect, which are obtained by single factor analysis, are as follows: daily activity content, insomnia severity, difficulty falling asleep, sleepiness and sleepiness, lassitude, feeble mood, mental fatigue and frequent nocturia are set as covariates and are digitally converted, wherein the daily activity content is as follows: normally recorded as 0, decrease recorded as 1; the severity of insomnia was recorded as 0, 1 and 2 from mild to severe, while the remaining symptoms were recorded as 0 and 1. The results suggest that the logistic regression model has statistical significance: (
=31.432，P= 0.000), the results of logistic regression analysis show that the content of daily activities, drowsiness, sleepiness, and nocturia are statistically significant (P< 0.05), see table 10 for details.
TABLE 10 Multi-factor logistic regression analysis results
9 conclusion
Through statistical analysis of the data of 159 cases of insomnia of the aged people of type "light-day nocturnal emission and night close one's eyes" treated by the' blackening method ", the following conclusions are obtained:
1. the 'white plus black' method can effectively improve the sleep of the old with 'insomnia caused by' light-day nocturnal emission and night close one's eyes'.
2. The 'white plus black' method is suitable for the old people: less daily activities, drowsiness, sleepiness, frequent nocturia.
The above description is only a preferred embodiment of the present invention, and all equivalent changes and modifications made in accordance with the claims of the present invention should be covered by the present invention.
Claims (1)
1. The Baijiahei compound medicine for treating senile insomnia comprises a diurnal prescription and a night prescription, and is characterized in that: the diurnal formula comprises the following medicinal materials in parts by weight: 10 parts of cassia twig, 10 parts of kudzuvine root, 15 parts of polyporus umbellatus, 15 parts of oriental waterplantain rhizome, 10 parts of rhizoma pinellinae praeparata, 15 parts of salvia miltiorrhiza, 15 parts of codonopsis pilosula and 15 parts of fructus alpiniae oxyphyllae;
the night prescription comprises the following medicinal materials in parts by weight: 30 parts of mother-of-pearl, 10 parts of magnetite, 20 parts of dragon bone, 15 parts of spina date seed, 15 parts of poria with hostwood, 15 parts of platycladi seed, 15 parts of radix curcumae and 20 parts of lily.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101130007A (en) * | 2007-09-14 | 2008-02-27 | 尹克华 | Traditional Chinese medicine for treating neurasthenia aypnia |
| CN107260940A (en) * | 2017-07-14 | 2017-10-20 | 王志军 | A kind of medicine and preparation method for treating insomnia |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101130007A (en) * | 2007-09-14 | 2008-02-27 | 尹克华 | Traditional Chinese medicine for treating neurasthenia aypnia |
| CN107260940A (en) * | 2017-07-14 | 2017-10-20 | 王志军 | A kind of medicine and preparation method for treating insomnia |
Non-Patent Citations (2)
| Title |
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| 五苓散加味辨治失眠症;曹觉予等;《现代中医药》;20100510;第30卷(第03期);第57页 * |
| 营卫运行失常与失眠病机探讨;谢斌等;《光明中医》;20170728;第32卷(第14期);第2007页左栏倒数第1段以及右栏第1段 * |
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Address after: 350003 No. 54, 282 Gulou District, Fujian, Fuzhou Patentee after: Fujian College of traditional Chinese Medicine Address before: 350003 No. 54, 282 Gulou District, Fujian, Fuzhou Patentee before: FUJIAN ACADEMY OF TRADITIONAL CHINESE MEDICINE (FUJIAN QINGCAOYAO DEVELOPMENT SERVICE CENTER) |