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CN101569642A - Medicament composition for accelerating sleeping as well as preparation method and application thereof - Google Patents

Medicament composition for accelerating sleeping as well as preparation method and application thereof Download PDF

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Publication number
CN101569642A
CN101569642A CNA2008101053871A CN200810105387A CN101569642A CN 101569642 A CN101569642 A CN 101569642A CN A2008101053871 A CNA2008101053871 A CN A2008101053871A CN 200810105387 A CN200810105387 A CN 200810105387A CN 101569642 A CN101569642 A CN 101569642A
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Prior art keywords
ganoderma
semen platycladi
radix notoginseng
preparation
pharmaceutical composition
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Inventor
王爱民
李伟
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Beijing Zhuoyue Tongchuang Pharmaceutical Research Institute
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Beijing Zhuoyue Tongchuang Pharmaceutical Research Institute
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Priority to CNA2008101053871A priority Critical patent/CN101569642A/en
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Abstract

The invention discloses a medicament composition for accelerating sleeping as well as a preparation method and an application thereof. The medicament composition is characterized by comprising shelled cedar seeds, glossy ganoderma and panax notoginseng, an extract obtained from the shelled cedar seeds, the glossy ganoderma and the panax notoginseng as well as pharmaceutic adjuvant are prepared into an oral preparation comprising tablets, capsules, granules and soft capsules. The pharmacological experiment proves that the medicament composition has good pharmacological action in curing insomnia, and the like.

Description

A kind of pharmaceutical composition of hypnotic and preparation thereof and application
Technical field
The invention belongs to technical field of traditional Chinese medicine pharmacy, be specifically related to a kind of contain Semen Platycladi, Ganoderma, notoginseng medicine composition and preparation thereof and application.
Background technology
Insomnia: be often referred to the patient to the length of one's sleep and or quality do not satisfy and influence a kind of subjective experience of social function on daytime.Classify by clinical manifestation: 1. sleep is slipped into the phase: time for falling asleep was above 30 minutes; 2. sleep is kept: the number of times of awakening night surpass 2 times or morning early awakening; 3. sleep quality: many nightmares; 4. be less than 6 hours total length of one's sleep; 5. residual effect in the daytime: feel dizzy inferior morning, lassitude, drowsiness, weak etc.Classify by the course of disease: one crosses property or acute insomnia, and the course of disease is less than 4 weeks; Short-term or subacute insomnia, the course of disease greater than 4 weeks less than 3~6 months; Long-term or chronic insomnia, the course of disease was greater than 6 months.Classify by the order of severity: slight.Accidental, little to the quality of life influence; Moderate takes place every night, moderate influence quality of life, accompanies certain symptom (irritability, anxiety, tired etc.); Severe takes place every night, has a strong impact on quality of life, and clinical symptoms is had outstanding performance.
Chang Yong sleeping pill divides 3 big classes, i.e. Benzodiazepines, barbiturates and other non-barbiturates clinically.Taking the patient of sleeping pill can not steering vehicle and operate machine, and to avoid accident.Unsuitable for children, elderly patients should use cautiously, the careful usefulness of the hepatic and renal function person of going down, women breast-feeding their children and contraindication in pregnancy.The dosage of above medicine and usage must be followed the doctor's advice.Sleep well is the outstanding feature of psychosomatic health.Insomnia is modal sleep disorder, is meant not having enough sleep that a variety of causes causes, difficulty falling asleep, early awakening, the normal spiritedness fatigue of patient, feel dizzy, have a headache that tinnitus, shortness of breath and palpitation, memory are not concentrated, degradation performance under the work efficiency.
Said medicine can have such or such defective, therefore, is badly in need of a kind of medicine of Cure for insomnia clinically.
Summary of the invention
For these reasons, the present invention is under Chinese medical theory instructs, in conjunction with the clinical practice experience, carry out prescription with Chinese medicine Semen Platycladi, Radix Notoginseng, Ganoderma, carry out the extraction separation purification and obtain extract, add pharmaceutic adjuvant and be prepared into the solid preparation preparation, The pharmacological results shows that the present invention respectively organizes preparation and has better pharmacological action.
The object of the invention is to provide a kind of pharmaceutical composition that contains Semen Platycladi, Ganoderma, Radix Notoginseng.
The present invention also aims to provide a kind of preparation of pharmaceutical compositions that contains Semen Platycladi, Ganoderma, Radix Notoginseng to become the preparation method of tablet, capsule, granule, soft capsule.
The present invention also aims to provide this pharmaceutical composition and preparation thereof hypnotic, improve immunocompetence, central nervous system disease aspect in application.
The present invention is achieved by the following scheme.
A kind of pharmaceutical composition of hypnotic, this pharmaceutical composition is made up of Semen Platycladi, Ganoderma, Radix Notoginseng
Wherein Semen Platycladi 2-3 weight portion, Ganoderma 1-2 weight portion, Radix Notoginseng 1-2 weight portion.
Semen Platycladi, Ganoderma, Radix Notoginseng obtain extract through the extraction purification and are mixed with into tablet, capsule, granule, soft capsule with pharmaceutic adjuvant, and the control total saponin content is not less than 5.0%.
Pharmaceutical composition of the present invention can be prepared according to existing document, also can be prepared according to following method.
One, process recipes
(1) the pretreatment of raw material Semen Platycladi rolls out, Ganoderma is cut into slices, Radix Notoginseng is pulverized;
(2) extraction process: above three flavors, Semen Platycladi coarse grain, Ganoderma decoction pieces are ground into behind the coarse powder and panax mixed, decoct with water 1-3 time, each 0.5-1 hour, add 8-12 times of water gaging, collecting decoction at every turn, the 100-300 mesh sieve filters, filtrate is condensed into the clear paste that relative density is 1.10-1.20 (80 ℃), adds ethanol after the cooling and is 50%-70%, standing over night to containing the alcohol amount.Getting the supernatant decompression recycling ethanol does not extremely have pure flavor, and is condensed into the thick paste that relative density is 1.30-1.35 (80 ℃), and vacuum drying is crossed 40 mesh sieves after pulverizing, and gets dry extract;
(3) formulation preparation: get above-mentioned dry extract, add acceptable pharmaceutic adjuvant on the pharmaceutics, be prepared into tablet with conventional pharmaceutical technology, granule, capsule, soft capsule.
Two, check and analysis
The check and analysis of total saponins
Experimental result: see Table 1:
Active constituent content relatively in table 1 preparation
Conclusion: show that by above check and analysis experiment technology of the present invention has practical significance.
Three, pharmacology embodiment
Embodiment 1
Influence to mouse sleep time
Laboratory animal: 40 of Kunming kind white mice, body weight 18-22g, male and female half and half.
Test medicine: pharmaceutical composition of the present invention (Beijing Pharmaceutical Technology Co., Ltd laboratory provides); SHUIBAO JIAONANG (Tai Ji group provides).
Experimental technique: get mice, random packet, 10 every group, once a day, successive administration 2d after the last administration, enters the time of sleep with the electroencephalongraph mice, and experimental result sees Table 2:
The different preparations of table 2 are to promoting the influence of mice sleep
Figure A20081010538700071
Annotate: compare with the normal saline group *P<0.05, *P<0.01; Compare #P<0.05 with positive controls
Embodiment 2
To qi-deficiency type rats'liver tumor inhibition effect
Laboratory animal: rat, 150g~180g, male and female are regardless of.
Experiment medicine: pharmaceutical composition of the present invention (Beijing Pharmaceutical Technology Co., Ltd laboratory provides); Astragalus polysaccharides oral liquid; Reason saline
Experimental technique: get rat and do inoculation in the liver of W256, inoculate after 7 days, press the dosage intraperitoneal injection of anesthesia of 35mg/kg with pentobarbital sodium, fixing, cutting open the belly exposes liver, and tumor surface maximum diameter (a) and path (b) are pressed (a*b on the measurement liver 2)/2=V (gross tumor volume).Separate stomach, arteria duodenalis, common hepatic artery and proper hepatic artery, the ligation stomach, the arteria duodenalis far-end, with silver brain clip blocking-up common hepatic artery, in sending into proper hepatic artery again at the gastroduodenal artery upper cut and after inserting external diameter 0.3mm conduit under the operating loupe, inject respectively by the experiment grouping then and be subjected to the reagent thing, dosage is 0.3g crude drug/kg, normal saline etc. hold inequality, and postoperative tube drawing ligation gastroduodenal artery is decontroled the common hepatic artery silver brain clip, sew up the incision again, place animal housing to wait to revive rat, continue breeding observing, performed the operation back 8 days, detect gross tumor volume by last method, the results are shown in Table 3:
Table 3 preparation qi-deficiency type of the present invention rats'liver tumor inhibition effect
Figure A20081010538700081
Compare with the normal saline group *P<0.05, *P<0.01
Using pharmaceutical composition of the present invention carries out pharmacological evaluation the present invention to central nervous system disorders such as anxiety neurosis, depressions and respectively organizes preparation and all have pharmacological action preferably.
Conclusion: show by above pharmacological evaluation, pharmaceutical composition of the present invention and respectively organize preparation to hypnotic, improve immunocompetence, the central nervous system disease aspect all has better pharmacological action, and relatively has better pharmacological action with veriety.
Four, preparation embodiment
Embodiment 1
Consisting of of crude drug of the present invention: Semen Platycladi 2kg, Ganoderma 1kg, Radix Notoginseng 1kg;
(1) pretreatment of raw material
Semen Platycladi rolls out, Ganoderma is cut into slices, Radix Notoginseng is pulverized;
(2) extraction process
More than three the flavor, Semen Platycladi coarse grain, Ganoderma decoction pieces are ground into behind the coarse powder and panax mixed, decoct with water 1 time, each 0.5 hour, add 8 times of water gagings, collecting decoction at every turn, 100 mesh sieves filter, filtrate is condensed into the clear paste that relative density is 1.10 (80 ℃), and adding ethanol after the cooling is 50% to containing the alcohol amount, standing over night.Getting the supernatant decompression recycling ethanol does not extremely have pure flavor, and is condensed into the thick paste that relative density is 1.30 (80 ℃), and vacuum drying is crossed 40 mesh sieves after pulverizing, and gets dry extract;
(3) formulation preparation
Get above-mentioned dry extract, add acceptable pharmaceutic adjuvant on the pharmaceutics, be prepared into 1000 in tablet, or 1000 bags of granules, or 1000 of capsules with conventional pharmaceutical technology, or 1000 of soft capsules.
Embodiment 2
Consisting of of crude drug of the present invention: Semen Platycladi 3kg, Ganoderma 2kg, Radix Notoginseng 2kg;
(1) pretreatment of raw material
Semen Platycladi rolls out, Ganoderma is cut into slices, Radix Notoginseng is pulverized;
(2) extraction process
More than three the flavor, Semen Platycladi coarse grain, Ganoderma decoction pieces are ground into behind the coarse powder and panax mixed, decoct with water 3 times, each 1 hour, add 12 times of water gagings, collecting decoction at every turn, 300 mesh sieves filter, filtrate is condensed into the clear paste that relative density is 1.20 (80 ℃), and adding ethanol after the cooling is 70% to containing the alcohol amount, standing over night.Getting the supernatant decompression recycling ethanol does not extremely have pure flavor, and is condensed into the thick paste that relative density is 1.35 (80 ℃), and vacuum drying is crossed 40 mesh sieves after pulverizing, and gets dry extract;
(3) formulation preparation
Get above-mentioned dry extract, add acceptable pharmaceutic adjuvant on the pharmaceutics, be prepared into 1000 in tablet, or 1000 bags of granules, or 1000 of capsules with conventional pharmaceutical technology, or 1000 of soft capsules.
Embodiment 3
Consisting of of crude drug of the present invention: Semen Platycladi 2.5kg, Ganoderma 1.25kg, Radix Notoginseng 1.25kg;
(1) pretreatment of raw material
Semen Platycladi rolls out, Ganoderma is cut into slices, Radix Notoginseng is pulverized;
(2) extraction process
More than three the flavor, Semen Platycladi coarse grain, Ganoderma decoction pieces are ground into behind the coarse powder and panax mixed, decoct with water 2 times, each 1 hour, add 10 times of water gagings, collecting decoction at every turn, 200 mesh sieves filter, filtrate is condensed into the clear paste that relative density is 1.15 (80 ℃), and adding ethanol after the cooling is 60% to containing the alcohol amount, standing over night.Getting the supernatant decompression recycling ethanol does not extremely have pure flavor, and is condensed into the thick paste that relative density is 1.32 (80 ℃), and vacuum drying is crossed 40 mesh sieves after pulverizing, and gets dry extract;
(3) formulation preparation
Get above-mentioned dry extract, add acceptable pharmaceutic adjuvant on the pharmaceutics, be prepared into 1000 in tablet, or 1000 bags of granules, or 1000 of capsules with conventional pharmaceutical technology, or 1000 of soft capsules.
Embodiment 4
Consisting of of crude drug of the present invention: Semen Platycladi 2.5kg, Ganoderma 1.25kg, Radix Notoginseng 1.25kg;
(1) pretreatment of raw material
Semen Platycladi rolls out, Ganoderma is cut into slices, Radix Notoginseng is pulverized;
(2) extraction process
More than three the flavor, Semen Platycladi coarse grain, Ganoderma decoction pieces are ground into behind the coarse powder and panax mixed, decoct with water 1 time, each 0.7 hour, add 9 times of water gagings, collecting decoction at every turn, 150 mesh sieves filter, filtrate is condensed into the clear paste that relative density is 1.12 (80 ℃), and adding ethanol after the cooling is 55% to containing the alcohol amount, standing over night.Getting the supernatant decompression recycling ethanol does not extremely have pure flavor, and is condensed into the thick paste that relative density is 1.31 (80 ℃), and vacuum drying is crossed 40 mesh sieves after pulverizing, and gets dry extract;
(3) formulation preparation
Get above-mentioned dry extract, add acceptable pharmaceutic adjuvant on the pharmaceutics, be prepared into 1000 in tablet, or 1000 bags of granules, or 1000 of capsules with conventional pharmaceutical technology, or 1000 of soft capsules.
Embodiment 5
Consisting of of crude drug of the present invention: Semen Platycladi 2.5kg, Ganoderma 1.25kg, Radix Notoginseng 1.25kg;
(1) pretreatment of raw material
Semen Platycladi rolls out, Ganoderma is cut into slices, Radix Notoginseng is pulverized;
(2) extraction process
More than three the flavor, Semen Platycladi coarse grain, Ganoderma decoction pieces are ground into behind the coarse powder and panax mixed, decoct with water 3 times, each 0.9 hour, add 11 times of water gagings, collecting decoction at every turn, 250 mesh sieves filter, filtrate is condensed into the clear paste that relative density is 1.18 (80 ℃), and adding ethanol after the cooling is 65% to containing the alcohol amount, standing over night.Getting the supernatant decompression recycling ethanol does not extremely have pure flavor, and is condensed into the thick paste that relative density is 1.34 (80 ℃), and vacuum drying is crossed 40 mesh sieves after pulverizing, and gets dry extract;
(3) formulation preparation
Get above-mentioned dry extract, add acceptable pharmaceutic adjuvant on the pharmaceutics, be prepared into 1000 in tablet, or 1000 bags of granules, or 1000 of capsules with conventional pharmaceutical technology, or 1000 of soft capsules.
Embodiment 6
Consisting of of crude drug of the present invention: the consisting of of crude drug of the present invention: Semen Platycladi 25kg, Ganoderma 12.5kg, Radix Notoginseng 12.5kg;
(1) pretreatment of raw material
Semen Platycladi rolls out, Ganoderma is cut into slices, Radix Notoginseng is pulverized;
(2) extraction process
More than three the flavor, Semen Platycladi coarse grain, Ganoderma decoction pieces are ground into behind the coarse powder and panax mixed, decoct with water 2 times, each 1 hour, add 10 times of water gagings, collecting decoction at every turn, 200 mesh sieves filter, filtrate is condensed into the clear paste that relative density is 1.15 (80 ℃), and adding ethanol after the cooling is 60% to containing the alcohol amount, standing over night.Getting the supernatant decompression recycling ethanol does not extremely have pure flavor, and is condensed into the thick paste that relative density is 1.32 (80 ℃), and vacuum drying is crossed 40 mesh sieves after pulverizing, and gets dry extract;
(3) formulation preparation
Get above-mentioned dry extract, add acceptable pharmaceutic adjuvant on the pharmaceutics, be prepared into 10000 in tablet, or 10000 bags of granules, or 10000 of capsules with conventional pharmaceutical technology, or 10000 of soft capsules.

Claims (5)

1, a kind of pharmaceutical composition of hypnotic is characterized in that this pharmaceutical composition is made up of Semen Platycladi, Ganoderma, Radix Notoginseng.
2, pharmaceutical composition according to claim 1, wherein Semen Platycladi 2-3 weight portion, Ganoderma 1-2 weight portion, Radix Notoginseng 1-2 weight portion.
3, pharmaceutical composition according to claim 1, it is characterized in that Semen Platycladi, Ganoderma, Radix Notoginseng obtain extract through the extraction purification and be mixed with into tablet, capsule, granule, soft capsule with pharmaceutic adjuvant, the control total saponin content is not less than 5.0%.
4, preparation of drug combination method according to claim 1, its feature may further comprise the steps:
(1) pretreatment of raw material:
Semen Platycladi rolls out, Ganoderma is cut into slices, Radix Notoginseng is pulverized;
(2) extraction process:
More than three the flavor, Semen Platycladi coarse grain, Ganoderma decoction pieces are ground into behind the coarse powder and panax mixed, decoct with water 1-3 time, each 0.5-1 hour, add 8-12 times of water gaging, collecting decoction at every turn, the 100-300 mesh sieve filters, filtrate is condensed into the clear paste that relative density is 1.10-1.20 (80 ℃), adds ethanol after the cooling and is 50%-70%, standing over night to containing the alcohol amount.Get the supernatant decompression recycling ethanol to there not being the alcohol flavor, and the thick paste that to be condensed into 80 ℃ of relative densities be 1.30-1.35, vacuum drying is pulverized the back and is crossed 40 mesh sieves, dry extract;
(3) formulation preparation
Get above-mentioned dry extract, add acceptable pharmaceutic adjuvant on the pharmaceutics, be prepared into tablet with conventional pharmaceutical technology, granule, capsule, soft capsule.
5, as claim 1,2,3 each described pharmaceutical compositions hypnotic, improve immunocompetence, central nervous system disease aspect in application.
CNA2008101053871A 2008-04-30 2008-04-30 Medicament composition for accelerating sleeping as well as preparation method and application thereof Pending CN101569642A (en)

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103493939A (en) * 2013-10-15 2014-01-08 北京绿源求证科技发展有限责任公司 Sleeping-aid food-made tea granules for sleep improvement
CN106728962A (en) * 2016-12-28 2017-05-31 重庆硒旺华宝生物科技有限公司 A kind of pharmaceutical composition of strengthen immunity and its application
CN107252086A (en) * 2017-05-04 2017-10-17 成都众宜创展商贸有限公司 One kind enhancing body immunity and antidepressant health food
CN107252110A (en) * 2017-05-04 2017-10-17 成都众宜创展商贸有限公司 It is a kind of to strengthen the preparation method of body immunity and antidepression health food
CN107412369A (en) * 2017-07-25 2017-12-01 云南彝药生物科技有限公司 A kind of sanchi flower sleeping Pharmaceutical composition
CN117323381A (en) * 2023-11-21 2024-01-02 济南三源药业有限公司 Preparation method of ganoderma lucidum powder composition for promoting female sleep

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103493939A (en) * 2013-10-15 2014-01-08 北京绿源求证科技发展有限责任公司 Sleeping-aid food-made tea granules for sleep improvement
CN106728962A (en) * 2016-12-28 2017-05-31 重庆硒旺华宝生物科技有限公司 A kind of pharmaceutical composition of strengthen immunity and its application
CN106728962B (en) * 2016-12-28 2021-01-05 重庆硒旺华宝生物科技有限公司 Pharmaceutical composition for enhancing immunity and application thereof
CN107252086A (en) * 2017-05-04 2017-10-17 成都众宜创展商贸有限公司 One kind enhancing body immunity and antidepressant health food
CN107252110A (en) * 2017-05-04 2017-10-17 成都众宜创展商贸有限公司 It is a kind of to strengthen the preparation method of body immunity and antidepression health food
CN107412369A (en) * 2017-07-25 2017-12-01 云南彝药生物科技有限公司 A kind of sanchi flower sleeping Pharmaceutical composition
CN117323381A (en) * 2023-11-21 2024-01-02 济南三源药业有限公司 Preparation method of ganoderma lucidum powder composition for promoting female sleep
CN117323381B (en) * 2023-11-21 2024-04-02 济南三源药业有限公司 Preparation method of ganoderma lucidum powder composition for promoting female sleep

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