CN108524658B - Traditional Chinese medicine for treating restless legs syndrome and preparation method thereof - Google Patents
Traditional Chinese medicine for treating restless legs syndrome and preparation method thereof Download PDFInfo
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- CN108524658B CN108524658B CN201810802682.6A CN201810802682A CN108524658B CN 108524658 B CN108524658 B CN 108524658B CN 201810802682 A CN201810802682 A CN 201810802682A CN 108524658 B CN108524658 B CN 108524658B
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- Medicines Containing Plant Substances (AREA)
Abstract
The invention discloses a traditional Chinese medicine for treating restless legs syndrome and a preparation method thereof, wherein the traditional Chinese medicine is prepared from the following raw material medicines in parts by weight: 8-12 parts of radix rehmanniae, 4-8 parts of angelica, 40-60 parts of white peony root, 8-12 parts of ligusticum wallichii, 4-8 parts of ground beetle, 3-7 parts of scorpion, 25-35 parts of caulis spatholobi and 8-12 parts of liquorice; the Chinese angelica and the ligusticum wallichii are subjected to volatile oil extraction, inclusion by beta-cyclodextrin to obtain an inclusion compound, the white paeony root, the scorpion, the suberect spatholobus stem and the Chinese polyphaga are refluxed by using ethanol, the rehmannia root, the liquorice and the dregs of a decoction are decocted by water to prepare a preparation, the preparation has the effect of treating restless legs syndrome, particularly, no obvious toxic or side effect is found in research on yin deficiency and blood stasis type restless legs syndrome, the safety is high, and the preparation can be prepared into a pharmaceutical oral liquid and can be widely used.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine for treating restless legs syndrome and a preparation method and application thereof.
Background
Restless Leg Syndrome (RLS) is a common central sensorimotor disorder that mainly affects the legs. The patient has the discomforts that the shanks on both sides are difficult to be famous when sleeping or quietly at night, such as worm wriggling, stabbing, swelling, numbness and the like, and the desire to strongly move the legs, and the symptoms can be relieved by beating, moving the legs or walking down the bed. RLS syndrome is often accompanied by insomnia, sleep fragmentation, daytime sleepiness, and anxiety and depression symptoms, seriously affects life, and is easily misdiagnosed and mistreated. Investigations in several countries in the europe and the united states show that: the overall incidence of RLS syndrome is 5% -15%, with female and male incidence rates of about 2: 1; the incidence increases with age and the number of fertile children. Related reports in 2012 showed that RLS incidence in china was 7.2%. Risk factors for RLS syndrome include diabetes, renal failure, anemia, smoking, lack of exercise, and long-term use of diphenhydramine, tricyclic, phenothiazine type drugs, etc.
The exact cause of RLS is not fully understood from western medicine, and is presumably related to the accumulation of tissue metabolites due to local blood circulation disorders. The secondary angiopathy causes local metabolite accumulation, causes ischemia and anoxia, and leg movement improves blood circulation, so that the symptoms are relieved. Systemic diseases such as uremia, diabetes, cancer, rheumatoid arthritis, hypothyroidism and the like can be intrinsic and concurrent.
Clinically, RLS is divided into two major categories, primary and secondary. The primary cause of the disease is still unclear, and is mainly considered to be related to genetic factors, function impairment of dopaminergic neurons, iron deficiency in vivo, limb blood circulation disorder, endogenous opiate release and the like. The secondary RLS is mostly seen in Parkinson's disease, end-stage renal disease, particularly dialysis patients, peripheral neuropathy, anemia, pregnancy and the like, possibly related to the accumulation of metabolites of blood circulation disorder of patients, and possibly related to the imbalance of osteoblasts and osteoclastic dynamic balance in bone beds of the patients. In addition, liver disease, anemia, rheumatoid arthritis, late pregnancy can also cause the disease. Studies have shown that the primary RLS pathogenesis is associated with decreased iron stores, and that ferritin levels directly affect the severity of the disease, while fluctuations in serum iron may exacerbate the patient's nocturnal symptoms. In addition, iron deficiency in vivo affects heme synthesis, leading to hemoglobin reduction and iron deficiency anemia, which is one of the most common causes of secondary RLS.
From the perspective of traditional Chinese medicine, restless leg syndrome can be generalized to the categories of limb paralysis, restless leg syndrome, tibialic acid, myelinating acid, blood paralysis, leg contracture and the like in traditional Chinese medicine according to the records of symptoms related to ancient books. The pathological properties are mainly deficiency with marked excess, wherein the deficiency refers to yin deficiency and blood deficiency, and the marked excess refers to blood stasis. The disease is mainly responsible for the liver, and TCM believes that the daytime belongs to yang and the night belongs to yin; the liver governs tendons and stores blood, which is especially seen at night, and it is known that the disease is in yin and blood systems, while blood is in liver when lying at night, if liver blood or liver yin is insufficient, tendons are not nourished, and legs are restless; on the other hand, it is not cool and moist, failing to control yang, and yang hyperactivity causes muscle and tendon twitching and the hands and feet to stop.
Western medicine often adopts etiology treatment, RLS induction avoidance, healthy work and rest, behavior treatment such as warm foot washing before bedtime, moderate activity and symptomatic drug treatment (dopamine receptor agonist, anticonvulsant, sedative hypnotic, opioid, etc.). Dopaminergic drugs are used as first-line treatment drugs, have more side effects, and may have adverse reactions such as 'symptom worsening' and 'symptom rebound'. Although dopamine agonists have a very good therapeutic effect on RLS, unfortunately, the use of dopamine agonists for RLS results in a faster onset of drug tolerance. In addition, the anticonvulsant drug gabapentin is commonly used as a second line treatment for RLS. The opioid drugs oxycodone and dexpropoxyphenol can improve RLS symptoms and are mostly used as adjuvant therapy, but a large sample formal clinical research is lacked. Benzodiazepines are not effective in improving RLS symptoms, but may slightly improve sleep when the treatment is not effective after other therapeutic applications.
However, the traditional Chinese medicine field has few medicines for treating restless legs syndrome, the curative effect is not obvious enough, the effect is slow, and the traditional Chinese medicine can be used for treating pathogenesis and has definite curative effect.
Disclosure of Invention
The invention provides a traditional Chinese medicine for treating restless legs syndrome and a preparation method thereof, which have the advantages of obvious curative effect and small side effect and solve the problems of great side effect and the like of the existing western medicines.
The invention adopts the following technical scheme:
a traditional Chinese medicine for treating restless legs syndrome is prepared from the following raw material medicines in parts by weight: 8-12 parts of radix rehmanniae, 4-8 parts of angelica, 40-60 parts of white peony root, 8-12 parts of ligusticum wallichii, 4-8 parts of ground beetle, 3-7 parts of scorpion, 25-35 parts of caulis spatholobi and 8-12 parts of liquorice.
The traditional Chinese medicine for treating restless legs syndrome is prepared from the following raw material medicines in parts by weight: 10 parts of dried rehmannia root, 6 parts of angelica, 50 parts of white peony root, 10 parts of ligusticum wallichii, 6 parts of eupolyphaga sinensis, 5 parts of scorpion, 30 parts of suberect spatholobus stem and 10 parts of liquorice.
In the traditional Chinese medicine for treating restless legs syndrome, the white paeony root is fried white paeony root, and the liquorice is honey-fried liquorice.
The preparation method of the traditional Chinese medicine for treating restless legs syndrome comprises the following steps:
a. extracting volatile oil from rhizoma Ligustici Chuanxiong and radix Angelicae sinensis by steam distillation, clathrating the volatile oil with beta-cyclodextrin to obtain clathrate, and collecting distilled water solution;
b. extracting radix Paeoniae alba, Scorpio, caulis Spatholobi, and Eupolyphaga Seu Steleophaga with ethanol under reflux, filtering, recovering ethanol, and concentrating to obtain concentrated ethanol extract;
c. mixing the ligusticum wallichii and the angelica dregs after the volatile oil is extracted in the step a and the alcohol extraction dregs in the step b with the rehmannia root and the liquorice, adding the water solution obtained after the water vapor distillation in the step a, decocting the water solution in water, filtering, concentrating, cooling, adding ethanol for alcohol precipitation to obtain water extraction and alcohol precipitation concentrated solution, mixing the water extraction and alcohol precipitation concentrated solution with the alcohol extraction concentrated solution in the step b, concentrating and drying to prepare dry extract powder;
d. and (c) mixing the dry extract powder in the step (c) with the volatile oil inclusion compound in the step (a), performing wet granulation, drying, adding auxiliary materials, and preparing tablets, capsules or granules.
The preparation method of the traditional Chinese medicine composition for treating restless legs syndrome comprises the following steps of (a) extracting volatile oil by steam distillation, adding water with the weight being 10 times of the weight of medicinal materials during extraction, soaking for 1 hour, and performing steam distillation for 3 hours; adding 4-8 times of beta-cyclodextrin into the volatile oil, and preparing the beta-cyclodextrin volatile oil inclusion compound by a saturated aqueous solution method, wherein when the inclusion temperature is 30 ℃, the stirring speed is as follows: 120r/min, inclusion for 0.5 hour, and vacuum drying the inclusion compound at 40 ℃ for later use.
According to the preparation method of the traditional Chinese medicine composition for treating restless leg syndrome, in the step b, the amount of ethanol added in each time is 12 times of the total weight of decoction pieces, the ethanol concentration is 60%, reflux extraction is carried out for 2 times, each time lasts for 2 hours, the extracting solutions are combined and filtered, the ethanol is recovered from the filtrate under reduced pressure, and the filtrate is concentrated until no ethanol smell exists, so that the ethanol extraction concentrated solution is obtained.
The traditional Chinese medicine for treating restless legs syndrome is prepared by the preparation method of the traditional Chinese medicine composition for treating restless legs syndrome, the water adding amount in the step c is 20 times of the total weight of decoction pieces, the decoction is carried out for 0.5 hour and 3 times, the decoction pieces are mixed for 1 hour each time, the three times of water decoction are filtered, the filtrate is concentrated to the relative density of 1g/ml measured at 60 ℃, the filtrate is cooled, ethanol is added until the ethanol content reaches 50%, the mixture is stirred uniformly, placed for 48 hours and centrifuged, the precipitate is discarded, the ethanol is recovered, the ethanol is mixed with the ethanol extraction concentrated solution in the step b, and the concentrated solution is dried in vacuum at 70 ℃ to obtain dry extract powder.
The application of the traditional Chinese medicine for treating restless legs syndrome in preparing the medicine for treating restless legs syndrome is provided.
The traditional Chinese medicine for treating restless legs syndrome is applied to preparation of a medicine for treating restless legs syndrome, wherein the restless legs syndrome is yin deficiency and blood stasis type restless legs syndrome.
Compared with the prior art, the traditional Chinese medicine for treating restless legs syndrome and the preparation method thereof have the following technical effects:
1. clinical research results show that the traditional Chinese medicine preparation has the effects of nourishing yin and blood, softening liver and relieving urgency, calming endogenous wind and dredging collaterals.
2. The natural plants are adopted, no obvious toxic or side effect is found in the research, the safety is high, and the product can be prepared into tablets, capsules or granules in pharmacy.
3. The invention mainly treats the following diseases: restless leg syndrome, with the symptoms: spasm and spasm of legs and feet, convulsion of legs, soreness, swelling and pain of limbs and numbness, especially in the night, dry mouth and throat, dysphoria with feverish sensation in chest, palms and soles; the secondary symptoms are as follows: insomnia and dreaminess; scaly skin; soreness and weakness of waist and knees; tongue pulse: a tender red or dark red tongue with a thin, rapid or thready and unsmooth pulse. Therapeutic principle: nourish yin and blood, soften liver and relieve urgency, stop endogenous wind and dredge collaterals. Square solution: in the formula, the rehmannia root and the angelica are monarch drugs for nourishing yin and blood and tonifying yin and blood; the white peony root is used as a ministerial drug, is sour, bitter and slightly cold, and has the effects of benefiting yin, nourishing blood, nourishing liver and relieving urgency; the Chinese polyphaga, the scorpion, the szechuan lovage rhizome and the suberect spatholobus stem are adjuvant drugs, the Chinese polyphaga is salty in taste and cold in nature, enters liver channels, removes stasis and unblocks collaterals, the scorpion mainly enters the liver channels and moves along with the nature, not only calms down liver wind, but also searches for wind and unblocks collaterals, and has the effects of extinguishing wind and relieving convulsion and removing wind and relieving convulsion, the szechuan lovage rhizome enters blood to separately manage qi in blood, the suberect spatholobus stem is bitter and sweet in taste and warm in nature, also enters the liver channels, is red in color and enters the blood, moistens and disperses the body; the liquorice is used as a messenger drug for making the drugs sweet and warm, tonifying middle-jiao and relieving urgency, and is matched with paeony acid for sweetening yin, nourishing yin and blood, softening liver and relieving urgency, and can relieve the toxicity of insect drugs; the whole formula has the effects of nourishing yin without disturbing blood, enriching blood without stagnating blood, promoting blood circulation without breaking blood, and has the effects of nourishing yin and blood, softening liver and relieving spasm, calming endogenous wind and dredging collaterals.
Detailed Description
The present invention is further described with reference to the following examples, which are intended to be illustrative only and not to be limiting of the scope of the claims, and other alternatives which may occur to those skilled in the art are within the scope of the claims.
The traditional Chinese medicinal materials in the invention are all pharmacopoeia standards. The ethanol concentration described herein is a volume concentration.
Example 1: the preparation method comprises the following steps of taking 8 parts of radix rehmanniae, 8 parts of angelica, 40 parts of white peony root, 12 parts of ligusticum wallichii, 4 parts of eupolyphaga sinensis, 7 parts of scorpion, 25 parts of caulis spatholobi and 12 parts of liquorice, wherein the white peony root is fried white peony root, and the liquorice is honey-fried liquorice:
a. extracting volatile oil from rhizoma Ligustici Chuanxiong and radix Angelicae sinensis by steam distillation, adding water 10 times of the weight of the medicinal materials, soaking for 1 hr, and steam distilling for 3 hr; adding 4-8 times of beta-cyclodextrin into the volatile oil, and preparing the beta-cyclodextrin volatile oil inclusion compound by a saturated aqueous solution method, wherein when the inclusion temperature is 30 ℃, the stirring speed is as follows: 120r/min, clathrating for 0.5 h, vacuum drying at 40 deg.C for use, and collecting distilled water solution in another container;
b. extracting radix Paeoniae alba, Scorpio, caulis Spatholobi and Eupolyphaga Seu Steleophaga with ethanol under reflux, wherein the amount of ethanol added is 12 times of the total weight of decoction pieces each time, the ethanol concentration is 60%, reflux extracting for 2 times, each time for 2 hr, mixing extractive solutions, filtering, recovering ethanol from filtrate under reduced pressure, concentrating to no ethanol smell to obtain concentrated ethanol extract, filtering, recovering ethanol, and concentrating to obtain concentrated ethanol extract;
c. mixing the ligusticum wallichii and angelica dregs after the volatile oil is extracted in the step a and the alcohol extraction dregs in the step b with the rehmannia root and the liquorice, adding the water solution obtained after the water vapor distillation in the step a, adding water in an amount which is 20 times of the total weight of the decoction pieces, soaking for 0.5 hour, decocting for 3 times, mixing water decoction solutions for 1 hour each time, filtering, concentrating the filtrate to the relative density of 1g/ml when the filtrate is at 60 ℃, cooling, adding ethanol until the alcohol content reaches 50%, uniformly stirring, standing for 48 hours, centrifuging, removing precipitates, recovering the ethanol, mixing the ethanol with the alcohol extraction concentrated solution in the step b, concentrating, and performing vacuum drying at 70 ℃ to obtain dry extract powder;
d. and (c) mixing the dry extract powder in the step (c) with the volatile oil inclusion compound in the step (a), performing wet granulation, drying, adding auxiliary materials and preparing into tablets.
Example 2: taking 12 parts of radix rehmanniae, 4 parts of angelica, 60 parts of white paeony root, 8 parts of ligusticum wallichii, 8 parts of eupolyphaga sinensis, 3 parts of scorpion, 35 parts of caulis spatholobi and 8 parts of liquorice, wherein the white paeony root is fried white paeony root, and the liquorice is honey-fried liquorice, and the preparation method comprises the following steps:
a. extracting volatile oil from rhizoma Ligustici Chuanxiong and radix Angelicae sinensis by steam distillation, adding water 10 times of the weight of the medicinal materials, soaking for 1 hr, and steam distilling for 3 hr; adding 4-8 times of beta-cyclodextrin into the volatile oil, and preparing the beta-cyclodextrin volatile oil inclusion compound by a saturated aqueous solution method, wherein when the inclusion temperature is 30 ℃, the stirring speed is as follows: 120r/min, clathrating for 0.5 h, vacuum drying at 40 deg.C for use, and collecting distilled water solution in another container;
b. extracting radix Paeoniae alba, Scorpio, caulis Spatholobi and Eupolyphaga Seu Steleophaga with ethanol under reflux, wherein the amount of ethanol added is 12 times of the total weight of decoction pieces each time, the ethanol concentration is 60%, reflux extracting for 2 times, each time for 2 hr, mixing extractive solutions, filtering, recovering ethanol from filtrate under reduced pressure, concentrating to no ethanol smell to obtain concentrated ethanol extract, filtering, recovering ethanol, and concentrating to obtain concentrated ethanol extract;
c. mixing the ligusticum wallichii and angelica dregs after the volatile oil is extracted in the step a and the alcohol extraction dregs in the step b with the rehmannia root and the liquorice, adding the water solution obtained after the water vapor distillation in the step a, adding water in an amount which is 20 times of the total weight of the decoction pieces, soaking for 0.5 hour, decocting for 3 times, mixing water decoction solutions for 1 hour each time, filtering, concentrating the filtrate to the relative density of 1g/ml when the filtrate is at 60 ℃, cooling, adding ethanol until the alcohol content reaches 50%, uniformly stirring, standing for 48 hours, centrifuging, removing precipitates, recovering the ethanol, mixing the ethanol with the alcohol extraction concentrated solution in the step b, concentrating, and performing vacuum drying at 70 ℃ to obtain dry extract powder;
d. and (c) mixing the dry extract powder in the step (c) with the volatile oil inclusion compound in the step (a), performing wet granulation, drying, adding auxiliary materials and preparing into capsules.
Example 3: taking 10 parts of radix rehmanniae, 6 parts of angelica, 50 parts of white paeony root, 10 parts of ligusticum wallichii, 6 parts of eupolyphaga sinensis, 5 parts of scorpion, 30 parts of caulis spatholobi and 10 parts of liquorice, wherein the white paeony root is fried white paeony root, and the liquorice is honey-fried liquorice, and the preparation method comprises the following steps:
a. extracting volatile oil from rhizoma Ligustici Chuanxiong and radix Angelicae sinensis by steam distillation, adding water 10 times of the weight of the medicinal materials, soaking for 1 hr, and steam distilling for 3 hr; adding 4-8 times of beta-cyclodextrin into the volatile oil, and preparing the beta-cyclodextrin volatile oil inclusion compound by a saturated aqueous solution method, wherein when the inclusion temperature is 30 ℃, the stirring speed is as follows: 120r/min, clathrating for 0.5 h, vacuum drying at 40 deg.C for use, and collecting distilled water solution in another container;
b. extracting radix Paeoniae alba, Scorpio, caulis Spatholobi and Eupolyphaga Seu Steleophaga with ethanol under reflux, wherein the amount of ethanol added is 12 times of the total weight of decoction pieces each time, the ethanol concentration is 60%, reflux extracting for 2 times, each time for 2 hr, mixing extractive solutions, filtering, recovering ethanol from filtrate under reduced pressure, concentrating to no ethanol smell to obtain concentrated ethanol extract, filtering, recovering ethanol, and concentrating to obtain concentrated ethanol extract;
c. mixing the ligusticum wallichii and angelica dregs after the volatile oil is extracted in the step a and the alcohol extraction dregs in the step b with the rehmannia root and the liquorice, adding the water solution obtained after the water vapor distillation in the step a, adding water in an amount which is 20 times of the total weight of the decoction pieces, soaking for 0.5 hour, decocting for 3 times, mixing water decoction solutions for 1 hour each time, filtering, concentrating the filtrate to the relative density of 1g/ml when the filtrate is at 60 ℃, cooling, adding ethanol until the alcohol content reaches 50%, uniformly stirring, standing for 48 hours, centrifuging, removing precipitates, recovering the ethanol, mixing the ethanol with the alcohol extraction concentrated solution in the step b, concentrating, and performing vacuum drying at 70 ℃ to obtain dry extract powder;
d. and (c) mixing the dry extract powder in the step (c) with the volatile oil inclusion compound in the step (a), performing wet granulation, drying, adding auxiliary materials, and preparing into granules.
Example 4: clinical research experiment
1. Diagnostic criteria and case selection:
western diagnostic criteria: reference is made to the common recognition of the RLS diagnostic criteria set forth by the International Research Legs (IRLSSG) Study Group 2014
RLS diagnostic criteria (must have the following 5 items): firstly, the strong desire to move the two lower limbs is accompanied by the uncomfortable feeling of the two lower limbs or the moving desire caused by the uncomfortable feeling; (ii) a strong desire to move about, and any accompanying discomfort, arising at rest or inactivity (e.g. the patient is in a recumbent or sitting position), or aggravated at rest or inactivity; ③ the urge to move and the accompanying discomfort can be partially or completely relieved during the activity (such as walking or stretching the legs); (iv) the strong desire for activity and the accompanying discomfort aggravate in the evening or night, or only occur in the evening or night; the clinical manifestations cannot be explained by another disease or phenomenon, such as myalgia, venous stasis, edema of lower limbs, arthritis, spasm of lower limbs, malaise, habitual foot-beating.
The traditional Chinese medicine diagnosis standard is as follows: syndrome of yin deficiency and blood stasis (refer to the related content of "diabetic peripheral neuropathy diagnosis and treatment Standard preliminary draft of traditional Chinese medicine" 2010)
The main symptoms are: spasm and spasm of legs and feet, convulsion of legs, soreness, swelling and pain of limbs and numbness, especially in the night, dry mouth and throat, dysphoria with feverish sensation in chest, palms and soles;
the secondary symptoms are as follows: insomnia and dreaminess; scaly skin; soreness and weakness of waist and knees;
tongue pulse: a tender red or dark red tongue with a thin, rapid or thready and unsmooth pulse.
The 2 main symptoms and the 2 secondary symptoms can be confirmed by combining the tongue pulse.
Case selection: 30 RLS patients are selected for clinic visits of endocrinology department in the department of traditional Chinese medicine of Nanjing,
2. the treatment method comprises the following steps: the granules prepared in the above example 3 were taken to treat 30 patients with restless legs syndrome three times a day, one packet each time.
3. The curative effect standard is as follows:
traditional Chinese medicine syndrome integral curative effect determination standard
Refer to "clinical research guidelines for New traditional Chinese medicine" and "first draft of Chinese medical treatment and diagnosis Specification for diabetic peripheral neuropathy" in 2010
The clinical cure is that the sleep is stable at night, the lower limbs have no uncomfortable feeling, and the return visit after 3 months has no discomfort; the syndrome integral is more than or equal to 90 percent
Has obvious effect that after the medicine is taken, the subjective symptoms are relieved, and the lower limbs feel uncomfortable before falling asleep occasionally, but the sleep is not influenced; the syndrome integral is more than or equal to 70 percent
The sleep is basically stable at night, and people still feel uncomfortable on the lower limbs if the people are overstrain in the day; the syndrome integral is more than or equal to 30 percent
No effect, no improvement in symptoms after treatment; the syndrome integral is reduced by less than 30%.
Note: the calculation formula (nimodipine method) is: [ (pre-treatment integral-post-treatment integral) ÷ pre-treatment integral ] × 100%.
Questionnaire of RLS severity
Made according to the 2003 International RLS research group
IRLSSG Restless Legs Syndrome (RLS) severity self-rating scale
Name: sex: age: telephone:
please answer the following 10 questions based on your average recent 2 weeks:
(1) generally, how much do you get uncomfortable in the legs (or arms)?
A very severe (score 4), B severe (score 3), C moderate (score 2), D mild (score 1), E no discomfort (score 0)
(2) In general, how much do you want to get up because of leg discomfort?
A very severe (score 4), B severe (score 3), C moderate (score 2), D mild (score 1), E no discomfort (score 0)
(3) Generally, how much discomfort is relieved in your legs (or: buttocks) by activity?
A did not relieve (score 4) B slightly relieved (score 3) C moderate relieved (score 2) D completely or almost completely relieved (score 1) E no RLS symptoms, this problem did not apply to I (score 0)
(4) In general, how much is your sleep affected because of RLS symptoms?
A very severe (score 4), B severe (score 3), C moderate (score 2), D mild (score 1) E had no effect (score 0)
(5) How much do you get tired and sleepy because of the symptoms of RLS?
A very severe (score 4), B severe (score 3), C moderate (score 2), D mild (score 1), E completely absent (score 0)
(6) Generally, how severe do your RLS symptoms affect life?
A very severe (score 4), B severe (score 3), C moderate (score 2), D mild (score 1) E had no effect (score 0)
(7) How often you appear RLS symptoms?
A very frequent, 6-7 days/week (4 min) B frequent, 4-5 days/week (3 min) C moderate, 2-3 days/week (2 min) D occasional, < 1/week (1 min) E asymptomatic (0 min)
(8) How long is the mean duration of the day if RLS symptoms appear?
A very severe, >8 h/day (4 min) B severe, 3-8 h/day (3 min) C moderate, 1-3 h/day (2 min) D mild, <1 h/day (1 min) E asymptomatic (0 min)
(9) In general, how much do your RLS symptoms affect your ability to handle daily life transactions? The method comprises the following steps: family, school, social affairs, etc.
A very severe (score 4), B severe (score 3), C moderate (score 2), D mild (score 1) E had no effect (score 0)
(10) How severe do your RLS symptoms affect your mood? Mood as distress, depression, sadness, anxiety and irritation?
A very severe (score 4), B severe (score 3), C moderate (score 2), D mild (score 1) E had no effect (score 0)
The disease degree is divided into 5 grades, namely no symptom (accounting for 0), mild degree (accounting for 1-10), moderate degree (accounting for 11-20), severe degree (accounting for 21-30) and extremely severe degree (accounting for 31-40).
4. The statistical method comprises the following steps: using SPSS 22.0 statistical software to measure data
The counting data is expressed by composition ratio and rate, and the paired T test is adopted before and after treatment, wherein P is less than 0.05 as statistical significance, and P is less than 0.01 as significant difference.
5. The traditional Chinese medicine syndrome curative effect is as follows: 30 cases are treated by the prescription, and the total effective rate is 96 percent after 4 weeks of treatment. See table below.
Comparison of the therapeutic effects of the traditional Chinese medicine syndromes after treatment
6. Traditional Chinese medicine syndrome integral and RLS severity self-rating scale score comparison
By adopting the granule of the example 3 for treatment, the traditional Chinese medicine syndrome integral of the patient is obviously improved from 2 weeks of treatment compared with that before treatment, and the RLS of the patient is obviously improved after 4 weeks of treatment, and has significant difference (P is less than 0.01). The syndrome score and RLS score of the formula before, after 1 week, after 2 weeks and after 4 weeks are shown in the table below.
Chinese medicine syndrome score and RLS severity self-rating scale score after treatment (
n＝30)
Note: p <0.01 compared to pre-treatment
7. Comparison of integral of various symptoms in traditional Chinese medicine
After the treatment for 4 weeks by adopting the formula, compared with the treatment before, the symptoms of dysphoria with smothery sensation in chest, palms and soles of patients are improved to some extent except for soreness and weakness of waist and knees and scaly skin, the statistical difference is less than 0.05, and the integral of each symptom of the rest traditional Chinese medicines is obviously improved (P is less than 0.01). See table below.
The integral conditions of all the symptoms of the traditional Chinese medicine after treatment (
n＝30)
Note: p <0.05, P <0.01, compared to pre-treatment
8. And (4) conclusion: clinical observation shows that the method for nourishing yin and blood, softening liver and relieving urgency, calming wind and dredging collaterals is safe and effective for treating restless leg syndrome, has great effect on reducing traditional Chinese medicine symptom integral and RLS severity self-rating scale scores of patients and improves life quality of the patients.
Claims (8)
1. A traditional Chinese medicine for treating restless legs syndrome is characterized in that: the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 8-12 parts of radix rehmanniae, 4-8 parts of angelica, 40-60 parts of white peony root, 8-12 parts of ligusticum wallichii, 4-8 parts of ground beetle, 3-7 parts of scorpion, 25-35 parts of caulis spatholobi and 8-12 parts of liquorice;
the preparation method of the traditional Chinese medicine comprises the following steps:
a. extracting volatile oil from rhizoma Ligustici Chuanxiong and radix Angelicae sinensis by steam distillation, clathrating the volatile oil with beta-cyclodextrin to obtain clathrate, and collecting distilled water solution;
b. extracting radix Paeoniae alba, Scorpio, caulis Spatholobi, and Eupolyphaga Seu Steleophaga with ethanol under reflux, filtering, recovering ethanol, and concentrating to obtain concentrated ethanol extract;
c. mixing the ligusticum wallichii and the angelica dregs after the volatile oil is extracted in the step a and the alcohol extraction dregs in the step b with the rehmannia root and the liquorice, adding the water solution obtained after the water vapor distillation in the step a, decocting the water solution in water, filtering, concentrating, cooling, adding ethanol for alcohol precipitation to obtain water extraction and alcohol precipitation concentrated solution, mixing the water extraction and alcohol precipitation concentrated solution with the alcohol extraction concentrated solution in the step b, concentrating and drying to prepare dry extract powder;
d. mixing the dry extract powder in the step c with the volatile oil inclusion compound in the step a, performing wet granulation, drying, adding auxiliary materials, and preparing into tablets, capsules or granules;
the preparation method of the traditional Chinese medicine composition for treating restless legs syndrome comprises the following steps of (a) distilling with steam to extract volatile oil, adding water with the weight being 10 times of that of the medicinal materials during extraction, soaking for 1 hour, and distilling with steam for 3 hours; adding 4-8 times of beta-cyclodextrin into the volatile oil, and preparing the beta-cyclodextrin volatile oil inclusion compound by a saturated aqueous solution method, wherein when the inclusion temperature is 30 ℃, the stirring speed is as follows: 120r/min, inclusion for 0.5 hour, and vacuum drying the inclusion compound at 40 ℃ for later use.
2. The traditional Chinese medicine for treating restless legs syndrome according to claim 1, characterized in that: the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 10 parts of dried rehmannia root, 6 parts of angelica, 50 parts of white peony root, 10 parts of ligusticum wallichii, 6 parts of eupolyphaga sinensis, 5 parts of scorpion, 30 parts of suberect spatholobus stem and 10 parts of liquorice.
3. The traditional Chinese medicine for treating restless legs syndrome according to claim 1, characterized in that: the radix Paeoniae alba is parched radix Paeoniae alba, and Glycyrrhrizae radix is honey-processed Glycyrrhrizae radix.
4. The traditional Chinese medicine for treating restless legs syndrome according to claim 1, wherein the preparation method comprises the following steps:
a. extracting volatile oil from rhizoma Ligustici Chuanxiong and radix Angelicae sinensis by steam distillation, clathrating the volatile oil with beta-cyclodextrin to obtain clathrate, and collecting distilled water solution;
b. extracting radix Paeoniae alba, Scorpio, caulis Spatholobi, and Eupolyphaga Seu Steleophaga with ethanol under reflux, filtering, recovering ethanol, and concentrating to obtain concentrated ethanol extract;
c. mixing the ligusticum wallichii and the angelica dregs after the volatile oil is extracted in the step a and the alcohol extraction dregs in the step b with the rehmannia root and the liquorice, adding the water solution obtained after the water vapor distillation in the step a, decocting the water solution in water, filtering, concentrating, cooling, adding ethanol for alcohol precipitation to obtain water extraction and alcohol precipitation concentrated solution, mixing the water extraction and alcohol precipitation concentrated solution with the alcohol extraction concentrated solution in the step b, concentrating and drying to prepare dry extract powder;
d. mixing the dry extract powder in the step c with the volatile oil inclusion compound in the step a, performing wet granulation, drying, adding auxiliary materials, and preparing into tablets, capsules or granules;
the preparation method of the traditional Chinese medicine composition for treating restless legs syndrome comprises the following steps of (a) distilling with steam to extract volatile oil, adding water with the weight being 10 times of that of the medicinal materials during extraction, soaking for 1 hour, and distilling with steam for 3 hours; adding 4-8 times of beta-cyclodextrin into the volatile oil, and preparing the beta-cyclodextrin volatile oil inclusion compound by a saturated aqueous solution method, wherein when the inclusion temperature is 30 ℃, the stirring speed is as follows: 120r/min, inclusion for 0.5 hour, and vacuum drying the inclusion compound at 40 ℃ for later use.
5. The traditional Chinese medicine for treating restless legs syndrome according to claim 4, characterized in that: in the preparation method of the traditional Chinese medicine composition for treating restless legs syndrome, in the step b, the ethanol is added in an amount which is 12 times of the total weight of the decoction pieces each time, the ethanol concentration is 60%, reflux extraction is carried out for 2 times, each time lasts for 2 hours, the extracting solutions are combined, filtration is carried out, the ethanol is recovered from the filtrate under reduced pressure, and the filtrate is concentrated until no ethanol smell exists, so that the ethanol extract concentrated solution is obtained.
6. The traditional Chinese medicine for treating restless legs syndrome according to claim 4, characterized in that: the preparation method of the traditional Chinese medicine composition for treating restless legs syndrome comprises the steps of adding water in an amount which is 20 times of the total weight of decoction pieces in the step c, soaking for 0.5 hour, decocting for 3 times, decocting for 1 hour each time, combining the water decoction of the three times, filtering, concentrating the filtrate until the relative density measured at 60 ℃ is 1g/ml, cooling, adding ethanol until the alcohol content reaches 50%, stirring uniformly, standing for 48 hours, centrifuging, discarding the precipitate, recovering the ethanol, combining with the ethanol extraction concentrated solution in the step b, concentrating, and performing vacuum drying at 70 ℃ to obtain dry extract powder.
7. Use of the traditional Chinese medicine for treating restless legs syndrome according to claim 1 or 2 for the preparation of a medicament for treating restless legs syndrome.
8. The use of the traditional Chinese medicine for treating restless legs syndrome according to claim 7 in the preparation of a medicament for treating restless legs syndrome, characterized in that: the restless leg syndrome type is yin deficiency and blood stasis type restless leg syndrome.
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| Sleep Disorders, Restless Legs Syndrome, and Uremic Pruritus: Diagnosis and Treatment of Common Symptoms in Dialysis Patients;Jennifer S. Scherer;《American journal of kidney diseases》;20170131;第69卷(第1期);第117-128页 * |
| 桃红四物汤加味治疗糖尿病合并不安腿综合征经验;方长千等;《山东中医杂志》;20180430;第37卷(第4期);第1段和第325页 * |
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