CN111840295A - Insomnia treatment medicine, preparation method and application thereof in treating insomnia - Google Patents
Insomnia treatment medicine, preparation method and application thereof in treating insomnia Download PDFInfo
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- CN111840295A CN111840295A CN202010832262.XA CN202010832262A CN111840295A CN 111840295 A CN111840295 A CN 111840295A CN 202010832262 A CN202010832262 A CN 202010832262A CN 111840295 A CN111840295 A CN 111840295A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
- A61K31/51—Thiamines, e.g. vitamin B1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4415—Pyridoxine, i.e. Vitamin B6
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
- A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
- A61K31/7064—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
- A61K31/7076—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines containing purines, e.g. adenosine, adenylic acid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/20—Hypnotics; Sedatives
Abstract
The invention discloses a medicament for treating insomnia, a preparation method and application thereof in treating insomnia; the insomnia treatment medicine contains 11-2 parts of vitamin B and 1-3 parts of inosine by weight of effective component medicines in each dose, and the insomnia treatment medicine also contains 65-20 parts of vitamin B by weight of effective component medicines in each dose. Has the advantages that: the scheme is based on the principle of a sleep mechanism in the whole (24-hour) physiological mechanism of a normal human body, and the reason of insomnia is set to be related to the substance imbalance of the sleep neurophysiology, so that the sleep physiological substance is supplemented, and the whole sleep physiological mechanism is adjusted, so that the normal state is improved and recovered. The invention uses the mixture ratio of three non-prescription drugs to supplement and restore the balance of the human self-sleep mechanism, and several drugs are necessary for human body and can be repeatedly taken, so that the patient has no dependence and antagonism to the drugs. After the medicine is taken, the sleep quality of patients can be obviously improved, and the insomnia is not easy to relapse after the medicine is stopped.
Description
Technical Field
The invention relates to the technical field of human physiological regulation conditioning medicines, in particular to an insomnia treatment medicine and application thereof in treating insomnia.
Background
Insomnia is a common sleep disorder. Insomnia is mainly manifested by difficulty in falling asleep, difficulty in maintaining sleep (easy waking, early waking), etc., and affects normal work, learning and life in the daytime. Chronic insomnia can cause obesity, cardiovascular and cerebrovascular diseases and other somatic diseases for a long time; anxiety, depression, etc.
Epidemiological studies have shown that 45.4% of respondents in our country have experienced varying degrees of insomnia in the past month. Insomnia has become the second largest disease in neurology clinics, second only to headache. The population covered by insomnia is also getting bigger and bigger in terms of occupation and age.
At present, the drug treatment for insomnia is mainly benzodiazepine receptor agonist, melatonin (hormone secreted by human body, and high secretion concentration of normal people in dark night) receptor agonist, appetite receptor antagonist and antidepressant with hypnotic effect. The medicine can generate dependence or antagonism after long-term use, and insomnia is easy to relapse after the medicine is stopped. Namely, all the medicines can treat the symptoms and the root causes, and the problem of sleep loss can not be fundamentally solved.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and provides an insomnia treatment drug and application thereof in treating insomnia.
The technical scheme adopted by the invention for solving the problems in the prior art is as follows: the medicine for treating insomnia contains effective component medicine comprising vitamin B11-2 weight portions and inosine 1-3 weight portions.
The above technical solution is further described as follows:
preferably, each dose of the effective component medicine contains 11 parts of vitamin B and 1 part of inosine according to the weight ratio.
Preferably, each dose of the effective component medicine also comprises 65-20 parts of vitamin B according to the weight ratio.
Preferably, each dose of the effective component medicine contains 11 parts of vitamin B, 1 part of inosine and 65 parts of vitamin B according to the weight ratio.
Preferably, the active ingredient medicine is prepared into a medicament which is solid, semi-solid or liquid.
Preferably, when the prepared medicament is in a solid form, it is in the form of a capsule, tablet, granule, powder or pill.
Preferably, when the prepared medicament is a solid type, the medicament further comprises the following auxiliary materials: starch, corn dextrin, pregelatinized starch, sodium starch glycolate, sucrose, povidone, calcium hydrogen phosphate, and magnesium stearate.
The invention solves the other technical scheme adopted by the prior art and comprises the following steps: a preparation method of a medicine for treating insomnia comprises the following steps:
s1, preparing materials: preparing two groups of vitamin B11-2 parts, inosine 1-3 parts and vitamin B65-20 parts according to the weight ratio, and preparing two groups of auxiliary materials, wherein each group of auxiliary materials comprises 0.5-1 part of starch, 0.5-1 part of corn dextrin, 0.5-1 part of pregelatinized starch, 0.5-3 parts of carboxymethyl starch sodium, 0.5-3 parts of cane sugar, 2-9 parts of povidone, 4-15 parts of calcium hydrophosphate, 0.2-0.6 part of magnesium stearate and 1000ml of purified water;
s2, preparing a corn starch solution; respectively putting 0.5-1 part of starch, 0.5-1 part of corn dextrin and 0.5-1 part of pregelatinized starch in the two groups prepared in the step S1 by weight into two spare vessels, respectively adding a certain amount of purified water for stirring, controlling the pH values of the two groups of stirring solutions to be between 5 and 7.5 by using a pH regulator, then heating to 80 ℃, and preserving heat for 30 minutes to prepare two groups of corn starch solutions of 5 to 15% (W/V);
s3, preparing the amount of the sucrose solution; respectively boiling 50mL of two groups of purified water, respectively adding 0.5-3 parts of cane sugar, stirring, dissolving, continuously heating to 100 ℃, filtering by using refined cotton, cleaning a filter by using proper amount of hot distilled water, mixing a washing solution and the filtrate, cooling, adding proper amount of distilled water to ensure that the total amount of the two groups of solutions is 100mL, and uniformly stirring to obtain two groups of cane sugar solutions;
s4, preparing a corn-sucrose solution; mixing the two groups of corn starch solutions prepared in the step S2 and the two groups of sucrose solutions prepared in the step S3 respectively, fully stirring for 30 minutes, and cooling to normal temperature to obtain two groups of corn-sucrose solutions;
s5, preparing a powdery solid medicine;
respectively crushing and sieving 11 to 2 parts of vitamin B, 1 to 3 parts of inosine, 0.5 to 3 parts of sodium carboxymethyl starch, 2 to 9 parts of povidone and 4 to 15 parts of calcium hydrophosphate in parts by weight prepared in the step S1, and fully and uniformly mixing the crushed and sieved vitamin B1, inosine, sodium carboxymethyl starch, povidone and calcium hydrophosphate to form a powdery solid medicine A;
respectively crushing and sieving 11 parts to 2 parts of another group of vitamin B, 1 part to 3 parts of inosine, 65 parts to 20 parts of vitamin B, 0.5 part to 3 parts of sodium carboxymethyl starch, 2 parts to 9 parts of povidone and 4 parts to 15 parts of calcium hydrophosphate in parts by weight prepared in the step S1, and fully and uniformly mixing the crushed and sieved vitamin B1, inosine, sodium carboxymethyl starch, povidone and calcium hydrophosphate to form a powdery solid medicine B;
s6, preparing dry granular medicines; adding the powdery solid medicine A and the powdery solid medicine B prepared in the step S5 into the two groups of corn-sucrose solutions prepared in the step S4 respectively, uniformly stirring, drying and sieving to form two groups of dry granular medicines;
s7, preparing tablets; adding the two groups of dry granular medicines prepared in the step S6 into 0.2-0.6 part of the two groups of magnesium stearate prepared in the step S1 by weight part respectively, uniformly mixing, and then pressing respectively to form a tablet A and a tablet B correspondingly;
s8, packaging the finished product; and (4) checking whether the tablets A and B are qualified, and respectively packaging the qualified tablets A and B into finished products.
The invention solves the technical problem and adopts another technical scheme that: the application of the insomnia treatment medicine in treating insomnia is to use the insomnia treatment medicine containing 11 parts of vitamin B and 1 part of inosine in each dose by weight once in the morning and afternoon of a patient respectively, and use the insomnia treatment medicine containing 11 parts of vitamin B, 1 part of inosine and 65 parts of vitamin B in each dose by weight once before the patient falls asleep.
The invention has the beneficial effects that:
the invention is based on the clear human body sleep mechanism, and is formulated according to the process of the sleep mechanism in the normal human body physiological activity mechanism, specifically, the scheme is based on the principle of the sleep mechanism in the normal human body integral (24 hours) physiological mechanism, the reason of insomnia is set to be related to the material unbalance of sleep nerve physiology, so the sleep physiological material is supplemented, the whole sleep physiological mechanism is adjusted, so the human body is improved and recovered to the normal state, specifically, the invention supplements and recovers the balance of the human body self sleep mechanism by the blending of the mixture ratio of three non-prescription drugs, the used drug dosage unit is the mixture ratio of each original drug dosage unit on the pharmacopeia, several preparation drugs are all human body essential substances and can be repeatedly taken, patients have no dependence and antagonism on the drugs, after the insomnia treatment drug provided by the invention is taken, the sleep quality of patients can be obviously improved, the insomnia is not easy to relapse after the medicine is stopped, and a considerable part of patients can thoroughly eradicate the insomnia so as to achieve the purpose of treating both symptoms and root causes and fundamentally solve the problem of the insomnia, so the invention can be effectively popularized and widely popularized.
Detailed Description
The technical solutions of the present invention will be described in detail below with reference to specific embodiments in order to clearly and intuitively understand the inventive substance of the present invention.
Insomnia pathogenesis
1. The traditional Chinese medicine considers that the key of the pathogenesis of insomnia is that yang does not enter yin;
lingshu, evil and visitor: "what qi makes things in the way when guests of foreign pathogens do not lie in or lie out? … … Jue Qi can invade the zang-organs and six fu-organs, so defensive Qi can defend its own body, but it can not invade yin, while it can invade yang, so yang qi can invade yang qi, while yang qi can invade yang, so it cannot invade yin, so it is invisible for people. "
Blood syndrome treatise cloud: "liver stores soul, the heart swims to the eye in the middle of the treatment and returns to the liver in sleep", which is caused by emotional damage, overstrain, prolonged illness, asthenia, improper diet and extreme five emotions. Insomnia is closely related to heart, liver, spleen and kidney, and is nourished by heart because of blood source, which is transformed from food essence and tends to heart; when stored in the liver, the liver body is soft; if the spleen is occupied, the biochemical process is not stopped; regulating the degree of the blood, transforming into essence and being hidden in the kidney; kidney essence is not born by the heart, heart-qi is handed over to the kidney, yin essence is kept internally, defensive yang is kept externally, and yin and yang are coordinated, so that the mind is calmed. If thinking, fatigue, injury to various organs, consumption of essence and blood, heart-spleen deficiency, malnutrition of heart-mind, disharmony between heart and kidney disturbing the mind, or phlegm-heat disturbing the mind, or liver depression transforming into fire disturbing the heart-mind, the mind is kept out of the heart, yang does not enter yin, and insomnia occurs.
2. Insomnia is considered as an independent disease by western medicine;
physiological disorders of human body (various systems) or mental disorders (emotion and the like) can cause physiological changes of normal sleep, and insomnia is one of the manifestations. However, after insomnia occurs due to physiological or psychological disorder of the body, psychological or physiological disorder (i.e., psychological or physical disease) is caused accordingly.
Secondly, the invention provides one of the technical schemes for solving the problems in the prior art
The medicine for treating insomnia contains effective component medicine comprising vitamin B11-2 weight portions and inosine 1-3 weight portions.
Preferably, each dose of the effective component medicine contains 11 parts of vitamin B and 1 part of inosine according to the weight ratio.
Based on this, in the first embodiment, each dose of the insomnia treatment drug provided by the invention contains effective component drugs comprising 15.0mg of vitamin B and 5.0mg of inosine according to the weight ratio;
in addition, in the technical scheme, each dose of the effective component medicine also comprises 65-20 parts of vitamin B according to the weight ratio.
Preferably, each dose of the effective component medicine contains 11 parts of vitamin B, 1 part of inosine and 65 parts of vitamin B according to the weight ratio.
Based on this, in the second embodiment, each dose of the insomnia treatment drug provided by the present invention contains effective component drugs comprising, by weight, vitamin b15.0mg, inosine 5.0mg, and vitamin b 625.0 mg.
The effective component medicament is prepared into a medicament, and the prepared medicament is solid, semisolid or liquid.
Further, when the prepared medicament is a solid type, it is a capsule, tablet, granule, powder or pill.
Further, when the prepared medicament is a solid type, the medicament further comprises the following auxiliary materials: starch, corn dextrin, pregelatinized starch, sodium starch glycolate, sucrose, povidone, calcium hydrogen phosphate and magnesium stearate, so that the medicament prepared by the method can be a tablet for the convenience of patients.
Thirdly, the invention provides another technical scheme for solving the problems of the prior art
A preparation method of a medicine for treating insomnia comprises the following steps:
s1, preparing materials: preparing two groups of vitamin B11-2 parts, inosine 1-3 parts and vitamin B65-20 parts according to the weight ratio, and preparing two groups of auxiliary materials, wherein each group of auxiliary materials comprises 0.5-1 part of starch, 0.5-1 part of corn dextrin, 0.5-1 part of pregelatinized starch, 0.5-3 parts of carboxymethyl starch sodium, 0.5-3 parts of cane sugar, 2-9 parts of povidone, 4-15 parts of calcium hydrophosphate, 0.2-0.6 part of magnesium stearate and 1000ml of purified water;
s2, preparing a corn starch solution; respectively putting 0.5-1 part of starch, 0.5-1 part of corn dextrin and 0.5-1 part of pregelatinized starch in the two groups prepared in the step S1 by weight into two spare vessels, respectively adding a certain amount of purified water for stirring, controlling the pH values of the two groups of stirring solutions to be between 5 and 7.5 by using a pH regulator, then heating to 80 ℃, and preserving heat for 30 minutes to prepare two groups of corn starch solutions of 5 to 15% (W/V);
s3, preparing the amount of the sucrose solution; respectively boiling 50mL of two groups of purified water, respectively adding 0.5-3 parts of cane sugar, stirring, dissolving, continuously heating to 100 ℃, filtering by using refined cotton, cleaning a filter by using proper amount of hot distilled water, mixing a washing solution and the filtrate, cooling, adding proper amount of distilled water to ensure that the total amount of the two groups of solutions is 100mL, and uniformly stirring to obtain two groups of cane sugar solutions;
s4, preparing a corn-sucrose solution; mixing the two groups of corn starch solutions prepared in the step S2 and the two groups of sucrose solutions prepared in the step S3 respectively, fully stirring for 30 minutes, and cooling to normal temperature to obtain two groups of corn-sucrose solutions;
s5, preparing a powdery solid medicine;
respectively crushing and sieving 11 to 2 parts of vitamin B, 1 to 3 parts of inosine, 0.5 to 3 parts of sodium carboxymethyl starch, 2 to 9 parts of povidone and 4 to 15 parts of calcium hydrophosphate in parts by weight prepared in the step S1, and fully and uniformly mixing the crushed and sieved vitamin B1, inosine, sodium carboxymethyl starch, povidone and calcium hydrophosphate to form a powdery solid medicine A;
respectively crushing and sieving 11 parts to 2 parts of another group of vitamin B, 1 part to 3 parts of inosine, 65 parts to 20 parts of vitamin B, 0.5 part to 3 parts of sodium carboxymethyl starch, 2 parts to 9 parts of povidone and 4 parts to 15 parts of calcium hydrophosphate in parts by weight prepared in the step S1, and fully and uniformly mixing the crushed and sieved vitamin B1, inosine, sodium carboxymethyl starch, povidone and calcium hydrophosphate to form a powdery solid medicine B;
s6, preparing dry granular medicines; adding the powdery solid medicine A and the powdery solid medicine B prepared in the step S5 into the two groups of corn-sucrose solutions prepared in the step S4 respectively, uniformly stirring, drying and sieving to form two groups of dry granular medicines;
s7, preparing tablets; adding the two groups of dry granular medicines prepared in the step S6 into 0.2-0.6 part of the two groups of magnesium stearate prepared in the step S1 by weight part respectively, uniformly mixing, and then pressing respectively to form a tablet A and a tablet B correspondingly;
s8, packaging the finished product; and (4) checking whether the tablets A and B are qualified, and respectively packaging the qualified tablets A and B into finished products.
Preferably, in the method for preparing the medicament for treating insomnia, each tablet A is prepared to contain effective components of vitamin B15.0mg and inosine 5.0mg, and each tablet B is prepared to contain effective components of vitamin B15.0mg, inosine 5.0mg and vitamin B625.0 mg.
The tablet A and the tablet B are both used for one dose, the tablet A is used in the daytime, and the tablet B is used before sleeping at night.
Fourthly, the invention provides another technical scheme for solving the problems of the prior art
An insomnia therapeutic drug is applied to treating insomnia, one dose is used each time, so that a patient uses the effective component drugs contained in each dose to respectively contain vitamin B15.0mg and inosine 5.0mg in the first embodiment according to the weight ratio once in the morning and afternoon, and uses the effective component drugs contained in each dose to contain vitamin B15.0mg, inosine 5.0mg and vitamin B625.0 mg in the second embodiment according to the weight ratio once before the patient goes to sleep.
And when the patient takes the insomnia treatment medicine provided by the application, the medicine can be taken before and after meals, and preferably taken once after breakfast, after lunch and one hour before sleeping at night.
Fifth, analysis of the drug
From the above, it can be seen that the insomnia treatment drug provided by the present invention mainly comprises three effective component drugs, namely vitamin B1, inosine, and vitamin B6;
vitamin B1: belongs to water-soluble vitamin, and research shows that vitamin B1 is an important bioactive substance for maintaining normal functions of nerves, heart and digestive system.
Inosine: used as auxiliary enzyme medicine and participating in metabolism and energy metabolism of organism.
Vitamin B6: belongs to water-soluble vitamin, is a composition component of certain coenzymes in human bodies and participates in various metabolic reactions.
The invention is based on the clear human body sleep mechanism and is made according to the process of the sleep mechanism in the normal human body physiological activity mechanism, in particular, the scheme is based on the principle of the sleep mechanism in the normal human body integral (24 hours) physiological mechanism, and the reason of insomnia is set to be related to the material unbalance of the sleep nerve physiology, so the sleep physiological material is supplemented, and the whole sleep physiological mechanism is adjusted, so that the normal state is improved and recovered. Specifically, the balance of the self-sleeping mechanism of the human body is restored by blending the mixture ratio of three non-prescription medicines, the used medicine dosage unit is the mixture ratio of each original medicine dosage unit on pharmacopoeia, and the prepared medicines are all necessary substances for the human body and can be repeatedly taken, so that patients have no dependence and antagonism on the medicines.
After the insomnia treatment medicine provided by the invention is taken, the sleep quality of patients can be obviously improved, the insomnia is not easy to relapse after the medicine is stopped, and a considerable part of patients can thoroughly eradicate the insomnia so as to achieve the purpose of treating both symptoms and root causes and fundamentally solve the insomnia problem.
Therefore, the invention can be effectively popularized and widely popularized.
Sixth, clinical research experiment
1. Source of case
The study was conducted on 300 patients with insomnia who were outpatient in Shenzhen Hospital, Beijing university, during the period of 2006-2020 and 8 months. 300 patients were divided into 150 cases of the control group (benzodiazepine receptor agonist group) and 150 cases of the treatment group (invention group) according to reasonable age and gender and the average distribution; all cases are diagnosed as the patient according to the Western medicine diagnosis standard and the traditional Chinese medicine syndrome diagnosis standard; the age is 20-70 years, and the course of disease is 1 month-2 years; the pathogenesis is mainly as follows: difficulty in falling asleep, easy to wake up after sleep and dreaminess.
The patients in the above 2 groups were reasonably and evenly distributed according to age and gender, had no apparent difference, and were comparable.
2. Diagnostic criteria:
2.1 the diagnosis standard of the disease symptoms of traditional Chinese medicine refers to the diagnosis curative effect standard of the disease symptoms of traditional Chinese medicine:
telling about physiological sleep dysfunction; second, fatigue, weakness, fullness in head, dizziness and other symptoms in the daytime are caused by sleep disorder; and thirdly, only the person with reduced sleep quantity and no discomfort in the daytime (short sleep) is not regarded as insomnia.
2.2 the Western diagnostic standard meets the Chinese mental disorder classification and diagnostic standard (3 rd edition) (CCMD-3) diagnostic standard of insomnia (F51.0):
(1) the time of falling asleep: difficulty falling asleep (> 30 min); (2) sleep weight: dreaminess, easy waking up (> 2 times), early waking up, and difficult sleeping after waking up; (3) total sleep time: nightly and major organic disease and psychotic disorder patients. Sleeping for less than 5 hours; the patients with insomnia, major organic diseases and mental disorders caused by ethanol, coffee, tea or medicines are excluded.
3. Grouping and testing method
Control group: the patient was given benzodiazepine receptor agonist therapy at 2mg each time, orally 30 minutes before sleep every night, for 28 consecutive days. During the treatment period, the two groups stop taking other western medicines, hypnotic drugs, hormone medicines and health products.
Treatment groups: one dose is used each time, so that the patient uses the effective component medicines contained in each dose to respectively contain the vitamin B15.0mg and the inosine 5.0mg in the first embodiment according to the weight ratio once in the morning and afternoon, and the effective component medicines contained in each dose to respectively contain the vitamin B15.0mg, the inosine 5.0mg and the vitamin B625.0 mg in the second embodiment according to the weight ratio once before the patient goes to sleep. 14 days are 1 course, and the treatment effect is evaluated in each course.
4. Observation of therapeutic effects
The therapeutic effect judgment standard is evaluated according to the guiding principle of clinical research of new traditional Chinese medicines.
4.1 clinical cure: recovering sleep time, or sleeping for more than 6h at night, and keeping deep sleep and refreshing;
4.2 significant effect: the sleep is improved obviously, the sleep time is increased by more than 3h, and the sleep depth is increased;
4.3 effective: the symptoms are relieved, and the sleep is increased for less than 3 hours compared with the prior sleep;
4.4 invalid: and insomnia after treatment is not obviously improved or is not aggravated.
5. Therapeutic results
The treatment effect evaluation is carried out according to the treatment effect judgment standard, and the result is shown in the following table.
Description of the tables:
the control group has 150 cases, wherein 25 cases are cured, accounting for 16.7 percent; 29 cases of obvious effect account for 19.3 percent; 49 effective cases account for 32.7 percent; 47 cases of invalid, accounting for 31.3 percent, and the total effective rate is 68.7 percent;
the treatment group had 150 cases, wherein 87 cases were healed, accounting for 58%; 31 cases of obvious effect account for 20.7 percent; 30 cases effective, 20% ratio; 2 cases of invalidity, the proportion is 1.3 percent, and the total effective rate is 98.7 percent;
from the above table, it is evident that: compared with two groups, the difference is obvious, and the insomnia treatment effect of patients diagnosed and treated by the invention is better.
Seven, typical cases
Patient case 1: all XX, male, 25 years old, pilot, before and after 2008, insomnia one month due to irregular work and rest, is expressed as: the sleep is difficult to fall asleep at 1-2 am, the patient is often awakened after falling asleep, the sleep time per day is less than 4 hours, and medicines mainly for sedation and hypnosis cannot be taken (if the patient needs to stop flying) due to occupational reasons, and after the medicine is selected for treatment for half a month, the sleep is recovered to about 8 hours, and the medicine is stopped. No relapse occurs after 6 months of follow-up visit after drug withdrawal.
Patient case 2: LongX, female, age 44, doctor, in 2006, serious insomnia appeared due to work mobilization and work pressure, sleep could not be gone to sleep in 24 hours (compulsively, the patient must not stop moving), oral sedative-hypnotic drugs and traditional Chinese medicines had no obvious effect, and melancholia symptom (suicide tendency) appeared. After 6 months, the insomnia is relieved after one month of treatment by using the medicament, the sleep can be continued for 1 to 2 hours at night, the treatment by using the medicament is continued for 5 months, and the medicament is stopped after the night sleep is recovered to 6 to 8 hours of the original normal sleep, so that the insomnia does not relapse.
Patient case 3: korean XX, female, age 49, vocalist workers, and people in charge of a group of art halls in a certain city, from 2 months in 2012, long-term insomnia (difficult to fall asleep at 1-3 am, often early awakening, and sleep time less than 3 hours at night) is not effective after long-term use of sedative drugs, treatment is performed by the drug in 2 months in 2012, sleep is restored to 7-8 hours after one month, and the drug is stopped after one month. The melatonin is used for treating insomnia recurrence (the sleep time is less than 4 hours) in 5 months in 2019 for more than 8 months, the medicine is used again in 3 months in 2020, and the medicine is stopped after the sleep is normal (7-8 hours) after 2 months. Follow-up was to date without recurrence.
Patient case 4: the rest X, women, age 45, announcers and program presenters, from 2016 and 3 months, have no relapse due to insomnia (difficult to fall asleep in the morning, poor effect of taking sedative and hypnotic drugs all the time when the sleep time is less than 4 hours, and worry about addiction) for a long time under working pressure, and the insomnia is not relapsed after the sleep is recovered to 7-8 hours after 2 months of treatment by using the drug provided by the invention.
Patient case 5: li XX, male, 53 years old, company manager, in 2019, the psychosis hospital is treated with related medicines for 3 months due to insomnia and melancholia (the medicines are changed for 2-3 times due to poor effect during the treatment period, the dosage of the antidepressant medicines is increased increasingly, but symptoms of insomnia (difficult falling asleep and insufficient sleep for 3 hours) and melancholia are aggravated, brain and cervical vertebra nuclear magnetic resonance examination in 2015 proves that meninges demyelination and cervical spondylosis occur), the medicine is used for treating in 2019 and 7 months (the quantity of the antidepressant medicines and the like are gradually reduced and stopped), the sleep is improved after half a month of the medicine application, the melancholia symptoms are reduced, the sleep can be maintained for 8 hours after 4 months, and the medicine is stopped when the melancholia symptoms disappear. No recurrence occurred for 6 months of follow-up.
Patient case 6: according to the traditional Chinese medicine, old XX is old, women are 68 years old, farmers are in charge of long-term insomnia (difficult to fall asleep in the morning and later, frequent awakening at night and sleep time less than 4 hours), the treatment effect is not obvious by using various methods and medicines, the sleep is obviously improved (6 hours of sleep) after one month of 2016 year treatment by using the medicine disclosed by the invention, the medicine is stopped after one month of continuous use of the medicine disclosed by the invention, and no relapse occurs after 6 months of follow-up.
Patient case 7: ZhouXX, male, 50 years old, the head was covered by the constructional engineering team, the bedridden with cerebral infarction in 2018 and 7 months old had serious insomnia (the patient can not fall asleep basically after 1 am, sleep for about 3 hours at night), the medicine of the invention is used in 9 months, the sleep is improved after one week, the sleep time is 6 hours, the sleep time is 7 hours after half month, the medicine is used for one month, the medicine is stopped after 8 hours, and the patient does not relapse after 6 months of follow-up.
Patient case 8: the medicine is selected for treatment (all other medicines are stopped simultaneously), the patient can sleep for 6 hours at night after 3 days, the symptoms of headache and melancholia disappear, the patient sleeps for 8 hours at night after one week, and the medicine is stopped after 3 months. No recurrence occurred for 6 months of follow-up.
In summary, in combination with the treatment effect of the cases, it can be summarized that: the scheme is based on the principle of a sleep mechanism in the whole (24-hour) physiological mechanism of a normal human body, and the reason of insomnia is set to be related to the substance imbalance of the sleep neurophysiology, so that the sleep physiological substance is supplemented, and the whole sleep physiological mechanism is adjusted, so that the sleep is improved and recovered to a normal state. Specifically, the balance of the human self-sleep mechanism is restored by blending the mixture ratio of three non-prescription medicines, the used medicine dosage unit is the mixture ratio of each raw medicine dosage unit on the pharmacopeia, and the prepared medicines are all human necessary substances and can be repeatedly taken, so that patients have no drug dependence or antagonism.
After the insomnia treatment medicine provided by the invention is taken, the sleep quality of patients can be obviously improved, the insomnia is not easy to relapse after the medicine is stopped, and a considerable part of patients can thoroughly eradicate the insomnia so as to achieve the purpose of treating both symptoms and root causes and fundamentally solve the insomnia problem. Therefore, the invention can be effectively popularized and widely popularized.
The above description is only a preferred embodiment of the present invention, and not intended to limit the scope of the present invention, and all changes in equivalent structure and equivalent flow, which are made by using the contents of the specification of the present invention, or directly or indirectly applied to other related technical fields, are intended to be embraced therein.
Claims (9)
1. The medicine for treating insomnia is characterized in that each dose of effective component medicine contains 11-2 parts of vitamin B and 1-3 parts of inosine according to the weight ratio.
2. The insomnia remedy according to claim 1, wherein each dose contains vitamin B11 parts and inosine 1 part as active ingredient.
3. The insomnia treating medicine according to claim 1, wherein each dose of the effective ingredient medicine further comprises 65-20 parts by weight of vitamin B.
4. The insomnia remedy according to claim 3, wherein each dose contains the effective ingredient drugs comprising vitamin B11 parts, inosine 1 part and vitamin B65 parts by weight.
5. The insomnia treatment drug according to any one of claims 1 to 4, wherein the drug containing the active ingredient is used to prepare a drug in a solid form, a semi-solid form or a liquid form.
6. The agent for treating insomnia according to claim 5, wherein the agent is in the form of a solid, capsule, tablet, granule, powder or pill.
7. The insomnia treatment drug of claim 6, wherein when the prepared drug is in a solid form, it further comprises the following auxiliary materials: starch, corn dextrin, pregelatinized starch, sodium starch glycolate, sucrose, povidone, calcium hydrogen phosphate, and magnesium stearate.
8. A preparation method of a medicine for treating insomnia is characterized by comprising the following steps:
s1, preparing materials: preparing two groups of vitamin B11 parts to 2 parts, inosine 1 part to 3 parts and vitamin B65 parts to 20 parts according to the weight ratio of claim 3, and preparing two groups of auxiliary materials, wherein each group of auxiliary materials comprises 0.5 part to 1 part of starch, 0.5 part to 1 part of corn dextrin, 0.5 part to 1 part of pregelatinized starch, 0.5 part to 3 parts of carboxymethyl starch sodium, 0.5 part to 3 parts of cane sugar, 2 parts to 9 parts of povidone, 4 parts to 15 parts of calcium hydrophosphate, 0.2 part to 0.6 part of magnesium stearate and 1000ml of purified water;
s2, preparing a corn starch solution; respectively putting 0.5-1 part of starch, 0.5-1 part of corn dextrin and 0.5-1 part of pregelatinized starch in the two groups prepared in the step S1 by weight into two spare vessels, respectively adding a certain amount of purified water for stirring, controlling the pH values of the two groups of stirring solutions to be between 5 and 7.5 by using a pH regulator, then heating to 80 ℃, and preserving heat for 30 minutes to prepare two groups of corn starch solutions of 5-15% (W/V);
s3, preparing the amount of the sucrose solution; respectively boiling 50mL of two groups of purified water, respectively adding 0.5-3 parts of sucrose, stirring, dissolving, continuously heating to 100 ℃, filtering with refined cotton, cleaning a filter with proper amount of hot distilled water, mixing the washing solution and the filtrate, cooling, adding proper amount of distilled water to make the total amount of the two groups of solutions to be 100mL, and stirring to obtain two groups of sucrose solutions;
s4, preparing a corn-sucrose solution; mixing the two groups of corn starch solutions prepared in the step S2 and the two groups of sucrose solutions prepared in the step S3 respectively, fully stirring for 30 minutes, and cooling to normal temperature to obtain two groups of corn-sucrose solutions;
s5, preparing a powdery solid medicine;
respectively crushing and sieving 11 to 2 parts of vitamin B, 1 to 3 parts of inosine, 0.5 to 3 parts of sodium carboxymethyl starch, 2 to 9 parts of povidone and 4 to 15 parts of calcium hydrophosphate in parts by weight prepared in the step S1, and fully and uniformly mixing the crushed and sieved vitamin B1, inosine, sodium carboxymethyl starch, povidone and calcium hydrophosphate to form a powdery solid medicine A;
respectively crushing and sieving 11 parts to 2 parts of another group of vitamin B, 1 part to 3 parts of inosine, 65 parts to 20 parts of vitamin B, 0.5 part to 3 parts of sodium carboxymethyl starch, 2 parts to 9 parts of povidone and 4 parts to 15 parts of calcium hydrophosphate in parts by weight prepared in the step S1, and fully and uniformly mixing the crushed and sieved vitamin B1, inosine, sodium carboxymethyl starch, povidone and calcium hydrophosphate to form a powdery solid medicine B;
s6, preparing dry granular medicines; adding the powdery solid medicine A and the powdery solid medicine B prepared in the step S5 into the two groups of corn-sucrose solutions prepared in the step S4 respectively, uniformly stirring, drying and sieving to form two groups of dry granular medicines;
s7, preparing tablets; adding the two groups of dry granular medicines prepared in the step S6 into 0.2-0.6 part of the two groups of magnesium stearate prepared in the step S1 by weight part respectively, uniformly mixing, and then pressing respectively to form a tablet A and a tablet B correspondingly;
s8, packaging the finished product; and (4) checking whether the tablets A and B are qualified, and respectively packaging the qualified tablets A and B into finished products.
9. Use of an insomnia treatment drug for treating insomnia, wherein one dose at a time is administered to a patient once in the morning and afternoon and once before sleep as in claim 4, respectively.
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