CN116327870A - Composition for relieving insomnia symptom, application, medicine and preparation method - Google Patents

Composition for relieving insomnia symptom, application, medicine and preparation method Download PDF

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CN116327870A
CN116327870A CN202310565921.1A CN202310565921A CN116327870A CN 116327870 A CN116327870 A CN 116327870A CN 202310565921 A CN202310565921 A CN 202310565921A CN 116327870 A CN116327870 A CN 116327870A
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陈娇花
朱嫣闵
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Shanghai Seventh Peoples Hospital
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/899Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
    • A61K36/8998Hordeum (barley)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/20Hypnotics; Sedatives
    • AHUMAN NECESSITIES
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/53Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
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Abstract

The application relates to a composition for relieving insomnia symptoms, application, a medicament and a preparation method. The composition for relieving insomnia comprises the following components in parts by weight: a. 10 parts of wild jujube seed; b. 3 to 3.5 portions of medlar; c. malt 2.5-3 parts; d. 5 to 5.5 portions of tuckahoe; e. 3 to 3.5 parts of reed rhizome, and 2 to 2.5 parts of liquorice. The medicine provided by the application can be used for relieving insomnia symptoms of patients, and is particularly suitable for being used together with the existing medicine for treating insomnia symptoms, so that a better treatment effect is achieved.

Description

Composition for relieving insomnia symptom, application, medicine and preparation method
Technical Field
The application relates to a composition for relieving insomnia symptoms, application, a medicament and a preparation method.
Background
The existing mode for relieving insomnia symptoms is usually treated by adopting medicines except physical regulation, and the existing medicines for treating insomnia symptoms are usually western medicines diazepam, and the effects of the western medicines are different for different patients.
Disclosure of Invention
The composition, application, medicine and preparation method for relieving insomnia provided by the application can be used for relieving insomnia of patients, and are particularly suitable for being used together with the existing medicine for treating insomnia so as to achieve a better treatment effect.
The first scheme provided by the application is as follows: the composition for relieving insomnia comprises the following components in parts by weight:
a. 10 parts of wild jujube seed;
b. 3 to 3.5 portions of medlar;
c. malt 2.5-3 parts;
d. 5 to 5.5 portions of tuckahoe
e. 3-3.5 parts of reed rhizome; and
f. 2 to 2.5 portions of liquorice.
Optionally, the composition comprises the following components in parts by weight:
a. 10 parts of wild jujube seed;
b. 3 parts of medlar;
c. 3 parts of malt;
d. poria cocos 5 parts
e. 3 parts of reed rhizome; and
f. 2 parts of liquorice.
Optionally, fruit juice concentrate is also included.
Optionally, the fruit juice concentrate is any one of blueberry juice concentrate, cherry juice concentrate and rose juice concentrate.
The present application also provides a second solution, namely a medicament prepared from any of the aforementioned compositions.
Optionally, the medicine is colloid or jelly.
The application also provides a third scheme, namely the application of any one of the compositions in preparing medicaments for relieving insomnia symptoms.
The application also provides a fourth scheme, namely a preparation method of the medicine, which comprises the following steps: mixing the components according to any weight ratio, grinding into coarse particles, applying pressure of 0.9-1.1 mpa by a pressurizing machine, adding water 3-4 times of the total weight of the components, heating, pressurizing and boiling, evaporating to 1-1.5 times of the total weight of the components, and filtering to obtain the medicament for relieving insomnia.
The application also provides a fifth scheme, namely a preparation method of the medicine, which comprises the following steps: mixing the components according to the weight ratio, grinding the mixture to particles with the particle size of 0.45-1.2mm, adding water with the weight which is 4-5 times of the total weight of the components, soaking the mixture for 24-36 hours at the temperature of 3-8 ℃, carrying out 3000-5000 rotor pulping at the temperature of not higher than 30 ℃, and filtering to obtain the medicament for relieving the insomnia.
The application also provides a sixth scheme, namely a preparation method of the medicine, which comprises the following steps: mixing the components according to any weight proportion, adding water which is 8-10 times of the total weight of the components, soaking for 2.5-3 hours, decocting for 60-80 minutes, filtering, concentrating for 7-8 hours under the condition that the vacuum degree is 60-65 kPa and the concentration temperature is 50-55 ℃, and filtering to obtain the medicament for relieving the insomnia.
The composition, the medicine and the like for relieving insomnia have the following advantages:
the obtained medicine can be used for relieving insomnia symptoms of patients, and is especially suitable for being used together with the existing medicines for treating insomnia symptoms so as to achieve a better treatment effect.
Detailed Description
For the purposes of making the objects, technical solutions and advantages of the embodiments of the present application more clear, the technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the embodiments of the present application, and it is apparent that the described embodiments are some embodiments of the present application, but not all embodiments. The components of the embodiments of the present application, as generally described and illustrated herein, may be arranged and designed in a wide variety of different configurations.
The following is a detailed illustration of the present application scheme:
the composition, application, medicine and preparation method for relieving insomnia can be used for relieving insomnia of patients, and are particularly suitable for being used together with the existing medicine for treating insomnia, so that a better treatment effect is achieved.
The following is an example of a specific preparation method of the drug for relieving insomnia obtained by the application:
example 1
The preparation method comprises the steps of mixing 10 parts of wild jujube seed, 3 parts of medlar, 3 parts of malt, 5 parts of poria cocos, 3 parts of reed rhizome and 2 parts of liquorice in parts by weight, grinding into coarse particles, applying pressure of 0.9mpa by a pressurizing machine, adding water which is 3 times of the total weight of the components, heating, pressurizing and boiling, evaporating to 1-1.5 times of the total weight of the components, and filtering to obtain the medicament for relieving insomnia symptoms of the embodiment 1.
Example 2
The preparation method comprises the steps of mixing 10 parts of wild jujube seed, 3.5 parts of medlar, 2.5 parts of malt, 5.5 parts of poria cocos, 3.5 parts of reed rhizome and 2.5 parts of liquorice in parts by weight, grinding into coarse particles, applying pressure of 1.1mpa by a pressurizing machine, adding water which is 4 times of the total weight of the components, heating, pressurizing, boiling, evaporating to 1-1.5 times of the total weight of the components, and filtering to obtain the medicament for relieving insomnia symptom of the embodiment 2.
Example 3
Mixing 10 parts of wild jujube seed, 3 parts of medlar, 3 parts of malt, 5 parts of poria cocos, 3 parts of reed rhizome and 2 parts of liquorice in weight proportion, grinding to particles with the particle size of 0.45-1.2mm, adding water with the weight being 4 times of the total weight of the components, soaking for 24 hours at the temperature of 3 ℃, carrying out 3000-5000 rotor pulping at the temperature of not higher than 30 ℃, and filtering to obtain the drug for relieving insomnia symptoms of the embodiment 3.
Example 4
The preparation method comprises the steps of mixing 10 parts of wild jujube seeds, 3.5 parts of medlar, 2.5 parts of malt, 5.5 parts of poria cocos, 3.5 parts of reed rhizome and 2.5 parts of liquorice in a weight ratio, grinding the mixture to particles with the particle size of 0.45-1.2mm, adding water with the weight which is 5 times that of the total weight of the components, soaking the mixture for 36 hours at 8 ℃, carrying out 3000-5000 r-pulping at the temperature of not higher than 30 ℃, and filtering to obtain the medicament for relieving insomnia symptoms of the embodiment 4.
Example 5
Mixing the components according to the weight ratio of 10 parts of wild jujube seed, 3 parts of medlar, 3 parts of malt, 5 parts of poria cocos, 3 parts of reed rhizome and 2 parts of liquorice, adding water which is 8 times of the total weight of the components, soaking for 2.5 hours, decocting for 60 minutes, filtering, concentrating for 7 hours under the conditions that the vacuum degree is 60kPa and the concentration temperature is 50 ℃, and filtering to obtain the medicament for relieving insomnia symptom of the embodiment 5.
Example 6
The ingredients were mixed in a weight ratio of 10 parts of semen Ziziphi Spinosae, 3.5 parts of fructus Lycii, 2.5 parts of malt, 5.5 parts of Poria, 3.5 parts of rhizoma Phragmitis and 2.5 parts of Glycyrrhrizae radix, and water 10 times of the total weight of the ingredients was added, soaked for 3 hours, decocted for 80 minutes, filtered, concentrated for 8 hours under a vacuum of 75kPa and a concentration temperature of 60 ℃, and filtered to obtain the drug for relieving insomnia symptom of example 6.
The following is a specific application effect description of the drug for alleviating insomnia obtained in the present application, and the drugs of examples 1 to 6 are specifically used:
1.1 treatment of subjects
The seventh people hospital in Shanghai, in 2021, receives 62 cases of insomnia patients from 10 months to 9 months of 2022, receives 31 cases of insomnia patients from 1 month to 3 months of 2023, groups the 31 cases of the control group recruited in 2021 to 2022 by a random digital table method, respectively, receives 31 cases of the test group recruited in 2021 to 2022 by a combination of the conventional western medicine treatment and the western medicine treatment of the present application (six random subgroups in 31 cases, 5 cases in five groups respectively, 6 cases in one group respectively, the medicines of the foregoing examples 1 to 6 of the present application are adopted respectively), and receives 31 cases of the drink group recruited in 2023 by the individual administration of the present application (31 cases of the random six subgroups, 5 cases in five groups respectively, 6 cases in one group, the medicines of the foregoing examples 1 to 6 of the present application are adopted respectively).
1.2 inclusion and exclusion criteria for treatment subjects
The standard of inclusion is (1) in accordance with the internal heat syndrome of yin deficiency of insomnia in traditional Chinese medicine; (2) difficulty in falling asleep or sleeping at night, and easy to wake, and difficulty in falling asleep after waking; (3) the waking is too early, and the sleeping time is less than 5 hours; (4) insomnia symptoms last for more than half a year; (5) signing the informed consent.
Exclusion criteria (1) women in lactation and gestation; (2) other organic lesions that interfere with sleep; (3) insomnia caused by drug dependence and alcohol factors; (4) there are psychotic patients.
1.3 methods of treatment
(1) Conventional western medicine treatment (control group)
The patient is instructed to take diazepam orally before sleeping. The dosage is 1 time per night, 2.5mg each time, and the dosage is adjusted according to the specific sleep state of the patient.
(2) Western medicine is combined with the application for oral administration (test group)
The patient is instructed to take diazepam orally before sleeping. The dosage is 1 time per night, 2.5mg each time, and the dosage is adjusted according to the specific sleep state of the patient. Meanwhile, 2 packages of wild jujube seed and lily drink are taken every day, and warm taking is carried out before noon and sleeping. During the administration period, the bad living habit needs to be corrected, a proper amount of exercise is kept, diet collocation is focused, the administration is carried out for 1 course of treatment (after 1 month), and the effect is observed.
(3) The medicine is orally taken (beverage group)
The recruited patients were instructed to take 2 packs per day, at noon and before sleep. During the administration period, the bad living habit needs to be corrected, a proper amount of exercise is kept, diet collocation is focused, the administration is carried out for 1 course of treatment (after 1 month), and the effect is observed.
2. Drug efficacy observation index
2.1 basic data
Sex, age.
2.2 therapeutic efficacy index
The sleep quality improvement effect of the insomnia patients is evaluated and observed by means of the PSQI Pittsburgh scale. PSQI is composed of 19 self-evaluation items and is divided into 7 components, and the 'hypnotic' component is removed because diazepam is the study control drug. Each component is scored according to 4 grades of 0, 1, 2 and 3, the sum of the accumulated component scores is the total score of PSQI, the total score ranges from 0 to 18, and the lower the score is, the better the sleep quality is, and the worse the sleep quality is, otherwise the worse the sleep quality is.
2.3 Standard of efficacy
And judging according to the curative effect standard of insomnia in the clinical research guidelines of new Chinese medicine.
2.4 safety index
And observing liver and kidney indexes before and after taking the medicine of a patient, and monitoring the safety of the product.
2.5 statistical methods
SPSS 21.0 for data analysis, measurement data (x.+ -.s) and count data (%) were subjected to t-test and X, respectively 2 The difference is statistically significant when P <0.05 is detected.
3. Results
3.1 general data comparison
3.1.1 comparison of general data for control and test groups
Comparison of general data of two groups of patients
Figure BDA0004236680050000071
Dividing into two parts
Figure BDA0004236680050000072
Note that: age comparison was comparable to pre-treatment comparison of the same group with P >0.05, with no statistical significance.
3.1.2 comparison of general data for control and beverage groups
Comparison of general data of two groups of patients
Figure BDA0004236680050000073
Dividing into two parts
Figure BDA0004236680050000081
Note that: age comparison, P >0.05, no statistical significance, comparability.
3.2 post-treatment results
3.2.1 comparison of control and test groups before and after treatment
Comparison of PSQI before and after treatment for two groups of patients
Figure BDA0004236680050000082
Dividing into two parts
Figure BDA0004236680050000083
Note that: PSQI total compared to pre-treatment with group P <0.05; Δp <0.05 was statistically significant compared to control post-treatment.
3.2.2 comparison of beverage groups before and after administration
Beverage groupComparison of PSQI before and after administration
Figure BDA0004236680050000091
Dividing into two parts
Figure BDA0004236680050000092
Note that: PSQI total was statistically significant compared to P <0.05 before consumption of the same group.
3.3 clinical efficacy
Comparative treatment effect of two groups of patients (example,%)
Figure BDA0004236680050000093
Note that: p <0.05, has statistical significance.
Treatment effect of control and drink group patients was compared (example,%)
Figure BDA0004236680050000101
Note that: p is more than 0.05, the total effective rate of the control group is higher than that of the beverage group, and the two groups have no statistical significance. 3.4 comparison of test group with control group ALT and creatinine
ALT and creatinine comparison before and after treatment of two groups of patients
Figure BDA0004236680050000102
Dividing into two parts
Figure BDA0004236680050000103
Note that: ALT and creatinine were compared to prior to treatment in the same group, P >0.05; compared with the control group after treatment, delta P is more than 0.05, has no statistical significance and is comparable.
4. Conclusion(s)
The research results prove that the curative effect of the medicine and western medicines (experimental groups) combined for treating insomnia is better than the curative effect of the western medicines (control groups) used alone, the curative effect of the medicine (drink groups) used alone is slightly poorer than the curative effect of the western medicines (control groups) used alone, and the medicine has no liver and kidney damage and ensures the safety, so the medicine is worthy of clinical popularization.
The foregoing description is only of the preferred embodiments of the present application and is not intended to limit the same, but rather, various modifications and variations may be made by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principles of the present application should be included in the protection scope of the present application.

Claims (10)

1. The composition for relieving insomnia is characterized by comprising the following components in parts by weight:
a. 10 parts of wild jujube seed;
b. 3 to 3.5 portions of medlar;
c. malt 2.5-3 parts;
d. 5 to 5.5 portions of tuckahoe
e. 3-3.5 parts of reed rhizome; and
f. 2 to 2.5 portions of liquorice.
2. The composition of claim 1, comprising the following ingredients in parts by weight:
a. 10 parts of wild jujube seed;
b. 3 parts of medlar;
c. 3 parts of malt;
d. poria cocos 5 parts
e. 3 parts of reed rhizome; and
f. 2 parts of liquorice.
3. The composition of claim 1, further comprising a fruit juice concentrate.
4. The composition of claim 1, wherein the fruit juice concentrate is any one of a blueberry juice concentrate, a cherry juice concentrate, a rose juice concentrate.
5. A medicament prepared from the composition of claim 1.
6. The medicament of claim 4, wherein the medicament is colloidal or jelly-like.
7. The use of the composition of claim 1 for preparing a medicament for relieving insomnia symptoms.
8. The method for preparing the medicine according to claim 5, comprising the following steps: mixing the components according to the weight ratio of claim 1, grinding into coarse particles, applying pressure of 0.9-1.1 mpa by a pressurizing machine, adding water 3-4 times of the total weight of the components, heating, pressurizing, boiling, evaporating to 1-1.5 times of the total weight of the components, and filtering to obtain the medicament for relieving insomnia according to claim 5.
9. The method for preparing the medicine according to claim 5, comprising the following steps: mixing the components according to the weight ratio of the claim 1, grinding the mixture to particles with the particle size of 0.45-1.2mm, adding water with the weight which is 4-5 times of the total weight of the components, soaking the mixture for 24-36 hours at the temperature of 3-8 ℃, carrying out 3000-5000 rotor grinding at the temperature of not higher than 30 ℃, and filtering to obtain the medicament for relieving insomnia according to the claim 5.
10. The method for preparing the medicine according to claim 5, comprising the following steps: mixing the components according to the weight ratio of the claim 1, adding water which is 8-10 times of the total weight of the components, soaking for 2.5-3 h, decocting for 60-80 min, filtering, concentrating for 7-8 h under the condition that the vacuum degree is 60-65 kPa and the concentration temperature is 50-55 ℃, and filtering to obtain the medicament for relieving insomnia according to the claim 5.
CN202310565921.1A 2023-05-19 2023-05-19 Composition for relieving insomnia symptom, application, medicine and preparation method Pending CN116327870A (en)

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CN102764340A (en) * 2012-08-14 2012-11-07 中国热带农业科学院热带生物技术研究所 Traditional Chinese medicine composite capable of improving sleep and preparation method and application thereof
CN103392872A (en) * 2013-08-03 2013-11-20 北京绿源求证科技发展有限责任公司 Food-grade health tea soluble granules capable of improving sleep
CN113907349A (en) * 2021-10-18 2022-01-11 上海市第七人民医院(上海中医药大学附属第七人民医院) Food for nourishing heart, regulating liver, clearing heart and helping sleep and preparation method thereof

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101732627A (en) * 2009-12-30 2010-06-16 西安谦坤投资咨询有限公司 Chinese medicinal composition for treating insomnia and preparation method thereof
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