CN115120687B - Traditional Chinese medicine composition for treating children enuresis and preparation method thereof - Google Patents
Traditional Chinese medicine composition for treating children enuresis and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition for treating children enuresis and a preparation method thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10-20 parts of salted semen cuscutae, 4-8 parts of ootheca Mantidis, 5-10 parts of salted fructus psoraleae, 5-15 parts of salted fructus alpiniae oxyphyllae, 5-15 parts of Chinese yam, 5-10 parts of combined spicebush root, 5-10 parts of rhizoma acori graminei, 5-10 parts of polygala tenuifolia, 3-8 parts of ephedra, 5-15 parts of calcined dragon bone, 5-10 parts of gorgon fruit and 2-6 parts of lotus stamen. The traditional Chinese medicine composition has the effects of tonifying kidney, strengthening the body resistance, inducing resuscitation and astringing essence to stop enuresis, is used for treating children enuresis, especially children enuresis with kidney-qi insecurity, has definite curative effect, does not have adverse reaction, and has good clinical value and application prospect.
Description
Technical Field
The invention belongs to the technical field of medicines, and mainly relates to a traditional Chinese medicine composition for treating children enuresis and a preparation method thereof.
Background
Enuresis, commonly known as bed wetting, refers to a condition of sleep, urination and defecation in children over 3 years old and awareness in the rear. Light people are for night or 1 time every night, and heavy people are for one night. The incidence rate is 5.6-14.7%, children over 3 years old and under 10 years old are more common, and a few can be prolonged to teenage years old or adult. The disease is mostly related to the weakness of the body, disorder after illness, recessive spinal fissure, external genital organs diseases, bad habit, brain dysfunction caused by various factors and the like, but the exact reason is not clear. The incidence of the disease is higher than that of girls, and part of the disease has obvious family history. The patients have longer course or repeated attacks, and the severe cases can also suffer from enuresis in daytime. If the children are not healed after a long time, the children can feel sped, mental depression, physical and mental health is affected, and even mental retardation is caused.
Western medicine considers that infantile enuresis is mostly functional and is caused by dysfunction of cerebral cortex and subcortical central nervous system. In particular, the most mental factors, partly with family history. A small number of enuresis are caused by organic lesions. For treating infantile enuresis, western medicine mainly adopts oral medicine treatment, and mainly comprises: a central stimulant for the patients with deep sleep and uneasiness; antidepressants are used for people who are insensitive to bladder filling during sleep. However, the usual drugs have many side effects such as imipramine: the mild side effects of the medicine are anxiety, insomnia, dry mouth and nausea, and arrhythmia, hypotension and convulsion can be caused by excessive administration, so parents should monitor and guide the children to take the medicine, and the medicine is not suitable for children under 6 years of age. Propanephrine: detrusor muscle can be relaxed, reducing uninhibited contractions. The adverse effects were dry mouth, nausea. Oxybutynin (oxybutynin): side effects are dry mouth, flushing, fever, excessive visual blurring and illusion. At present, no specific therapy exists in Western medicine for treating the disease.
The traditional Chinese medicine considers that the main pathogenesis of children enuresis is kidney qi insecurity, spleen-lung qi deficiency and liver channel damp-heat. Kidney qi deficiency and deficiency of the lower energizer failing to warm and nourish the bladder, dysfunction of bladder qi, failure of storing and closing, failure to restrict urine, which is enuresis. Qi deficiency of the spleen and lung, failure of spleen to transport and transform, failure of lung deficiency to control the joint, failure of the triple energizer to control the water channel, failure of the triple energizer to control the bladder, failure of body fluids to store, and enuresis. The disorder of liver meridian damp-heat and obstruction of qi flow affects the normal circulation of the triple energizer channel, and damp-heat is forced to enter the urinary bladder to cause enuresis. Among them, kidney-qi deficiency is the most common clinically.
The traditional Chinese medicine has certain advantages in treating children enuresis, and common clinical treatment formulas comprise semen cuscutae powder, a condensed spring pill, a middle-jiao and Qi tonifying decoction, gentian liver-purging decoction and the like, and the Chinese patent medicines comprise a condensed spring pill (capsule), a five-seed Yanzong pill, a middle-jiao and Qi tonifying pill and gentian liver-purging pill. However, the decoction is inconvenient to use, the Chinese patent medicines have single action and are difficult to take care of complex syndrome types, and particularly all the traditional Chinese patent medicines for treating enuresis have no function of resolving phlegm, inducing resuscitation and inducing resuscitation. The inventors believe that the pathogenesis of phlegm and orifice obstruction is widely existing in various children's enuresis, and is caused by phlegm-dampness accumulation in the children and orifice obstruction, so that the children cannot wake up due to sleep, and sleep, urine and feces are left. The lack of such treatment method has certain influence on the curative effect of the traditional Chinese patent medicine.
Disclosure of Invention
Aiming at the problems, the invention aims at providing a traditional Chinese medicine composition for treating children enuresis, a preparation method of the traditional Chinese medicine composition and an application of the traditional Chinese medicine composition in preparing medicines for treating children enuresis with unstable kidney qi. The traditional Chinese medicine composition aims at kidney qi-insecure children enuresis, mainly aims at tonifying kidney and consolidating the constitution, has the effects of inducing resuscitation and refreshing mind, has the effects of astringing essence and relieving seminal emission, has the advantages of synchronous deficiency and excess, treats both principal and secondary aspects of disease, has accurate symptoms, is mutually synergistic, has good curative effects on children enuresis, sleepiness and insomnia, listlessness, pale complexion, cold limbs, soreness of waist and legs and the like, and has no side effect.
The technical scheme adopted by the invention for achieving the purpose is as follows:
a traditional Chinese medicine composition for treating children enuresis comprises the following raw materials in parts by weight: 10-20 parts of salted semen cuscutae, 4-8 parts of ootheca Mantidis, 5-10 parts of salted fructus psoraleae, 5-15 parts of salted fructus alpiniae oxyphyllae, 5-15 parts of Chinese yam, 5-10 parts of combined spicebush root, 5-10 parts of rhizoma acori graminei, 5-10 parts of polygala tenuifolia, 3-8 parts of ephedra, 5-15 parts of calcined dragon bone, 5-10 parts of gorgon fruit and 2-6 parts of lotus stamen.
As a further optimization of the traditional Chinese medicine composition for treating children enuresis, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 15 parts of salted semen cuscutae, 6 parts of ootheca Mantidis, 8 parts of salted fructus psoraleae, 10 parts of salted fructus alpiniae oxyphyllae, 10 parts of Chinese yam, 8 parts of combined spicebush root, 8 parts of grassleaf sweelflag rhizome, 8 parts of polygala tenuifolia, 5 parts of ephedra, 10 parts of calcined dragon bone, 8 parts of gorgon fruit and 4 parts of lotus stamen.
Further, the traditional Chinese medicine composition is an oral preparation. The oral preparation is granule, tablet, capsule, pill, powder or oral liquid. Preferably, the oral preparation is a granule.
The invention also provides a preparation method of the traditional Chinese medicine composition for treating children enuresis, which comprises the following steps: the preparation method comprises the steps of weighing the raw materials according to the formula proportion, adding water which is 6-10 times of the total weight of the raw materials, soaking for 30 minutes, decocting and extracting for 1-3 times, each time for 1-2 hours, mixing the decoctions, filtering, concentrating to thick paste with the relative density of 1.25-1.35 at 80 ℃, adding pharmaceutically acceptable auxiliary materials, and preparing the required preparation according to the conventional process.
The invention further provides application of the traditional Chinese medicine composition in preparation of medicines for treating children enuresis caused by kidney qi deficiency.
The beneficial effects are that: in the traditional Chinese medicine composition, semen cuscutae, pungent and sweet, and the traditional Chinese medicine composition is capable of calming, tonifying liver, kidney and spleen channels, tonifying liver and kidney, and controlling nocturnal emission and urination; ootheca Mantidis is sweet, salty, flat, and has the effects of tonifying liver and kidney, stopping nocturnal emission, reducing urination, tonifying kidney and supporting yang. The two are mutually combined to treat the main pathogenesis of children's enuresis, and are monarch drugs for tonifying the kidney, consolidating the constitution, and stopping nocturnal emission and reducing urination. Fructus psoraleae, kidney warming and yang supporting; fructus alpiniae oxyphyllae, kidney warming, essence securing and urination reducing; chinese yam, rhizoma dioscoreae, capable of tonifying spleen and lung, tonifying kidney and astringing essence; radix linderae, radix Linderae, has effects of warming kidney and dispelling cold. The four medicines are assistant medicines for warming kidney and supporting yang, and controlling nocturnal emission and reducing urination, and are ministerial medicines. Rhizoma Acori Graminei has effects of inducing resuscitation, eliminating phlegm, refreshing mind and improving intelligence; polygala tenuifolia, radix Polygalae, calm the mind and improve the intelligence, traffic the heart and kidney, and eliminate phlegm. The two medicines are combined together, and the combination works together to ensure that qi is self-smooth and is self-opening, qi and blood are not smooth and are not upward reversed, phlegm is dispersed and is not easy to be absorbed, and the mind is self-clearing. The ephedra has obvious excitation effect on central nerve, which is equivalent to central excitant, western medicine and old medicine. The three are matched, so that the effects of resolving phlegm, inducing resuscitation and refreshing mind can be exerted. The calcined dragon bone, the lotus stamen are matched, so that the effects of reinforcing the kidney and stopping remains can be enhanced, and the symptom and the symptoms can be treated. The six above drugs are used as adjuvant drugs for inducing resuscitation and refreshing mind, and strengthening kidney and stopping enuresis. In the recipe, three ingredients of semen cuscutae, fructus psoraleae and fructus alpiniae oxyphyllae are prepared by salt, and the salty taste enters the kidney and the main sedimentation can enhance the effect of treating the deficiency of the kidney. The traditional Chinese medicine composition aims at kidney qi-insecure children enuresis, mainly aims at tonifying kidney and consolidating the constitution, has the effects of inducing resuscitation and refreshing mind as assistance, has the effects of astringing essence and relieving seminal emission, has the advantages of synchronous deficiency and excess, treats both principal and secondary aspects of disease, has accurate symptoms, is mutually synergistic, has good curative effects on children enuresis, sleepiness and insomnia, listlessness, pale complexion, cold limbs, soreness of waist and legs and the like, and has no side effect.
In long-term clinical practice, the inventor summarizes the evidence and treatment rules of the disease, breaks through the original theory, screens out and combines the medicines with obvious effects on children enuresis, especially kidney-qi-unstable children enuresis in a large number of prescription medicines, finds out the optimal dosage through a large number of clinical verification, and forms a novel traditional Chinese medicine preparation through process optimization. The invention overcomes the defects of the prior art, has good clinical value and application prospect, and is also a supplement to the existing method for treating children enuresis, in particular to the traditional Chinese patent medicine preparation.
Detailed Description
A traditional Chinese medicine composition for treating children enuresis is prepared from the following raw materials in parts by weight: 10-20 parts of salted semen cuscutae, 4-8 parts of ootheca Mantidis, 5-10 parts of salted fructus psoraleae, 5-15 parts of salted fructus alpiniae oxyphyllae, 5-15 parts of Chinese yam, 5-10 parts of combined spicebush root, 5-10 parts of rhizoma acori graminei, 5-10 parts of polygala tenuifolia, 3-8 parts of ephedra, 5-15 parts of calcined dragon bone, 5-10 parts of gorgon fruit and 2-6 parts of lotus stamen.
The preparation method of the traditional Chinese medicine composition for treating children enuresis comprises the following steps: the preparation method comprises the steps of weighing the raw materials according to the formula proportion, adding water which is 6-10 times of the total weight of the raw materials, soaking for 30 minutes, decocting and extracting for 1-3 times, each time for 1-2 hours, mixing the decoctions, filtering, concentrating to thick paste with the relative density of 1.25-1.35 at 80 ℃, adding pharmaceutically acceptable auxiliary materials, and preparing the required preparation according to the conventional process.
The technical solutions in the embodiments of the present invention will be clearly and completely described below in connection with the embodiments of the present invention.
Example 1
A traditional Chinese medicine composition for treating children enuresis is prepared from the following raw materials in parts by weight: 10 parts of salted semen cuscutae, 4 parts of ootheca Mantidis, 5 parts of salted fructus psoraleae, 5 parts of salted fructus alpiniae oxyphyllae, 5 parts of Chinese yam, 5 parts of combined spicebush root, 5 parts of grassleaf sweelflag rhizome, 5 parts of polygala tenuifolia, 3 parts of ephedra herb, 5 parts of calcined dragon bone, 5 parts of gorgon fruit and 2 parts of lotus stamen.
The preparation method comprises the steps of respectively weighing the raw materials according to the formula proportion, adding water which is 6-10 times of the total weight of the raw materials, soaking for 30 minutes, decocting and extracting for 1 time, 1 hour each time, mixing the decoctions, filtering, concentrating to thick paste with the relative density of 1.25 at 80 ℃, adding pharmaceutically acceptable auxiliary materials, and preparing into common oral preparations such as granules, tablets, capsules, pills, powder or oral liquid according to the conventional process.
When the traditional Chinese medicine composition is used for treating children enuresis, the prepared granules are taken, each bag contains 10g of crude drug, 1 bag is taken once, and 2 times a day. The prepared tablet, capsule, pill, powder or oral liquid is taken, and the dosage of the tablet, capsule, pill, powder or oral liquid is 10g for each time, 2 times a day.
Example 2:
a traditional Chinese medicine composition for treating children enuresis is prepared from the following raw materials in parts by weight: 15 parts of salted semen cuscutae, 6 parts of ootheca Mantidis, 8 parts of salted fructus psoraleae, 10 parts of salted fructus alpiniae oxyphyllae, 10 parts of Chinese yam, 8 parts of combined spicebush root, 8 parts of grassleaf sweelflag rhizome, 8 parts of polygala tenuifolia, 5 parts of ephedra, 10 parts of calcined dragon bone, 8 parts of gorgon fruit and 4 parts of lotus stamen.
The preparation method comprises the steps of respectively weighing the raw materials according to the formula proportion, adding water which is 8 times of the total weight of the raw materials, soaking for 30 minutes, decocting and extracting for 2 times, each time for 1.5 hours, mixing the decoctions, filtering, concentrating to thick paste with the relative density of 1.30 at 80 ℃, adding pharmaceutically acceptable auxiliary materials, and preparing into common oral preparations such as granules, tablets, capsules, pills, powder or oral liquid according to the conventional process.
Example 3:
a traditional Chinese medicine composition for treating children enuresis is prepared from the following raw materials in parts by weight: 20 parts of salted semen cuscutae, 8 parts of ootheca Mantidis, 10 parts of salted fructus psoraleae, 15 parts of salted fructus alpiniae oxyphyllae, 15 parts of Chinese yam, 10 parts of combined spicebush root, 10 parts of grassleaf sweelflag rhizome, 10 parts of polygala tenuifolia, 8 parts of ephedra, 15 parts of calcined dragon bone, 10 parts of gorgon fruit and 6 parts of lotus stamen.
The preparation method comprises the steps of weighing the raw materials according to the formula proportion, adding water 10 times of the total weight of the raw materials, soaking for 30 minutes, decocting and extracting for 3 times, each time for 2 hours, mixing the decoctions, filtering, concentrating to obtain thick paste with the relative density of 1.35 at 80 ℃, adding pharmaceutically acceptable auxiliary materials, and preparing into common oral preparations such as granules, tablets, capsules, pills, powder or oral liquid according to the conventional process.
The beneficial effects of the traditional Chinese medicine composition of the invention are further illustrated by test examples below.
78 patients meeting the diagnosis standard of children enuresis (kidney qi deficiency) were selected for outpatient service. The study was performed using a random-grouping, positive control method.
1. General data
78 cases of children enuresis, 54 men and 24 women are taken in and observed; ages 5-10 years, average 7.2 years; the course of the disease is 1-5 years; with 5 cases of invisible spinal fractures. The treatment groups were randomly divided into 2 groups according to the order of treatment, 39 treatment groups, and 39 control groups. The two groups have no significance (P is more than 0.05) in terms of gender, age, illness state and the like, and have comparability.
2. Case selection criteria
Reference is made to the "diagnostic efficacy Standard of traditional Chinese medical Condition" (the national standard of the pharmaceutical industry of the people's republic of China).
(1) Diagnosis standard for children enuresis
(1) Deep sleep, uneasiness, bed wetting occurs every night or every few days, even a plurality of times during night.
(2) The onset age is above 5 years.
(3) There were no abnormal findings of routine urination and urine culture.
(4) When the X-ray film is taken, a part of children patients can find hidden spinal column cracks, and structural abnormality can be seen by X-ray radiography of urinary system.
(2) Traditional Chinese medicine diagnosis standard for waiting for symptoms
Deficiency of kidney-qi: enuresis in sleep, excessive urine volume, clear urine color, deep sleep, difficult awakening, pale complexion, listlessness, cold limbs. A pale tongue with white coating and a deep, slow and weak pulse.
(3) Inclusion criteria
(1) Meets the diagnosis standard of children enuresis and the diagnosis standard of traditional Chinese medicine symptoms of kidney qi deficiency.
(2) The age is between 5 and 10 years.
(3) The disease course lasts for more than 3 months.
(4) Sign "informed consent".
(4) Exclusion criteria
(1) Patients aged over 10 years (excluding 10 years).
(2) Patients with mental diseases complicated with serious diseases of heart, brain, liver, kidney and hematopoietic system.
(3) Urinary system infection.
(5) Reject and drop criteria
(1) After case enrollment, those who do not meet inclusion criteria or who meet exclusion criteria are found.
(2) Serious adverse events occur, and the clinical trial should be stopped according to the judgment of doctors.
(3) Incomplete data after case selection or patients not according to the prescription.
(4) Subject compliance was poor, affecting efficacy assessors.
3. Therapeutic method
Treatment group: the medicine of the invention, namely the granule (each bag contains 10g of crude drug) prepared in the example 2, is taken 1 bag at a time, 2 times a day and is taken with boiled water. Control group: the preparation is administered orally in the form of a capsule (national standard Z19991039, hunan Hansen pharmaceutical Co., ltd.) 3 granules a time and 3 times a day.
The treatment course is 1 day 10. After 3 treatment periods are over, follow-up is carried out for 2 weeks and efficacy assessment is carried out.
4. Observation index
The number of enuresis.
Therapeutic effect criterion
Reference is made to the "diagnostic efficacy Standard of traditional Chinese medical Condition" (the national standard of the pharmaceutical industry of the people's republic of China).
(1) And (3) curing: after treatment, the patient is not left with enuresis.
(2) Improvement: the times of enuresis are reduced, and the patient can wake up to urinate during sleeping.
(3) The method is characterized in that: the enuresis is unchanged.
6. Therapeutic results
No case is removed and no case is dropped, and clinical observation is completed. The treatment results are shown in Table 1.
TABLE 1 comparison of therapeutic effects of treatment and control groups
After 3 weeks of treatment, the two groups of treatment effects are compared, and the total effective rate is significantly different (P < 0.05), which indicates that the treatment effect of the medicine is superior to that of the control medicine.
In the aspect of improving the symptoms of traditional Chinese medicine, the medicine and the reference medicine of the invention can improve the symptoms of clear urine, a lot of urine, pale complexion, listlessness, cold limbs and the like, and the medicine of the invention has better improving effect on white and greasy tongue fur.
The treatment group and the control group have no adverse reaction, which indicates that the medicine of the invention is safe to use.
Typical cases
Wang Mou men, 9 years old, 10 months in 2020 were diagnosed for enuresis for more than one year. The symptoms are that the patient can feel enuresis 3 to 7 times per week, the patient can not wake up easily after urination or after waking up, the patient can feel clear and long with urine, the complexion is pale and white, the hands and feet are not warm, the tongue is pale and the tongue coating is white Bao Ni, and the pulse is deep and weak. The medicine of the present invention (the granule prepared in example 2) was administered 1 bag at a time (containing 10g of crude drug) 2 times a day, prescribed for continuous administration for 30 days. After the patients are fed back by families, the times of enuresis are obviously reduced after the patients take the medicine for one week, and the patients have no enuresis after taking the medicine for three weeks and have no relapse until now.
It should be noted that the above-mentioned embodiments are to be understood as illustrative, and not limiting, the scope of the invention, which is defined by the appended claims. It will be apparent to those skilled in the art that various modifications and adaptations can be made to the present invention without departing from its spirit or scope.
Claims (2)
1. The traditional Chinese medicine composition for treating children enuresis is characterized by being prepared from the following raw materials in parts by weight: 10-20 parts of salted semen cuscutae, 4-8 parts of ootheca Mantidis, 5-10 parts of salted fructus psoraleae, 5-15 parts of salted fructus alpiniae oxyphyllae, 5-15 parts of Chinese yam, 5-10 parts of combined spicebush root, 5-10 parts of rhizoma acori graminei, 5-10 parts of polygala tenuifolia, 3-8 parts of ephedra, 5-15 parts of calcined dragon bone, 5-10 parts of gorgon fruit and 2-6 parts of lotus stamen;
the traditional Chinese medicine composition is an oral preparation; the oral preparation is granule, tablet, capsule, pill, powder or oral liquid;
the traditional Chinese medicine composition is prepared by the following steps: the preparation method comprises the steps of respectively weighing the raw materials according to the formula proportion, adding water which is 6-10 times of the total weight of the raw materials, soaking for 30 minutes, then decocting and extracting for 1-3 times, each time for 1-2 hours, merging the decoctions, filtering, concentrating to thick paste with the relative density of 1.25-1.35 at 80 ℃, adding pharmaceutically acceptable auxiliary materials, and preparing the corresponding preparation according to the conventional process.
2. The traditional Chinese medicine composition according to claim 1, which is prepared from the following raw materials in parts by weight: 15 parts of salted semen cuscutae, 6 parts of ootheca Mantidis, 8 parts of salted fructus psoraleae, 10 parts of salted fructus alpiniae oxyphyllae, 10 parts of Chinese yam, 8 parts of combined spicebush root, 8 parts of grassleaf sweelflag rhizome, 8 parts of polygala tenuifolia, 5 parts of ephedra, 10 parts of calcined dragon bone, 8 parts of gorgon fruit and 4 parts of lotus stamen.
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| 魏佑莲等."中药配合行为疗法治疗小儿遗尿的临床研究".《中国民间疗法》.1995,(第4期),第39-40页. * |
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