CN104069171A - Antidepressant medicine composition as well as preparation method and application thereof - Google Patents
Antidepressant medicine composition as well as preparation method and application thereof Download PDFInfo
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Abstract
The invention provides an antidepressant medicine composition. The antidepressant medicine composition is a preparation prepared from the following raw medicinal materials in parts by weight: 10 to 20 parts of radix bupleuri, 10 to 20 parts of angelica sinensis and 3 to 5 parts of mint. The invention further provides a preparation method and an application of the antidepressant medicine composition. The medicine composition formed by compounding the radix bupleuri, the angelica sinensis and the mint is obtained via the dismantlement of an original Xiaoyao powder formula, wherein the antidepressant activity of the medicine composition is equivalent to that of the original Xiaoyao powder formula after the radix bupleuri, the angelica sinensis and the mint are matched in specific proportion, so that the adding amount of the medicinal materials is obviously reduced, i.e., the dose is reduced. Thus, the treatment expense of a patient is extremely saved. Therefore, the popularization and the application of the antidepressant medicine composition are facilitated.
Description
Technical field
The present invention relates to a kind of antidepressant pharmaceutical composition and its production and use.
Background technology
Depression (Depression) is a kind of common mental sickness, that main manifestations is in a bad mood is low, interest attenuating, retardation of thinking, shortage initiative, pessimism, anorexia, sleep are poor, worry that oneself has disease, and suicide [1] even may appear in severe patient.Depression rate is very high, has become one of important diseases causing serious burden to the mankind at present, on patient, family members impact and loss that even society causes, is that other diseases is incomparable.Along with social development, the increase of people's life, operating pressure, people's stress also increases day by day, causes the sickness rate of depression always in rising trend, and its hazardness more and more causes the great attention of medical and health circle.Therefore, how to improve the therapeutic effect of depression, become the hot issue that medical research personnel pay close attention in recent years.
At present, the medicine of Cure of depression is not satisfactory, mainly take chemicals as main.But these medicines all exist, and treatment spectrum is narrow, erious adverse reaction, toleration is poor and the defect such as expensive.In recent years domestic scholars finds that Chinese medicine (particularly compound recipe XIAOYAO POWDER) is improving depressive symptom, reduces relapse rate, reducing the unique effects in aspect such as Western medicine side effect.
The full side of XIAOYAO POWDER is comprised of Radix Bupleuri 9g, Radix Angelicae Sinensis 9g, Radix Paeoniae Alba 9g, Rhizoma Atractylodis Macrocephalae 9g, Rhizoma Zingiberis Recens 9g, Poria 9g, Radix Glycyrrhizae Preparata 4.5g, Herba Menthae 1.5g.Yet the party's flavour of a drug are many, dose is large, and patients with depression needs again Long-term taking medicine, and its medical expense is higher, for patient has brought financial burden.
Summary of the invention
The object of the present invention is to provide a kind of than XIAOYAO POWDER flavour of a drug used still less but the good pharmaceutical composition of antidepressant effect.Another object of the present invention is to provide preparation method and the purposes of this pharmaceutical composition.
The invention provides a kind of antidepressant pharmaceutical composition, it is the preparation that the crude drug that contains following weight proportion is prepared from: 10～20 parts of Radix Bupleuri, 10～20 parts of Radix Angelicae Sinensis, 3～5 parts of Herba Menthaes.
Wherein, it is the preparation that the crude drug by following weight proportion is prepared from: 10～20 parts of Radix Bupleuri, 10～20 parts of Radix Angelicae Sinensis, 3～5 parts of Herba Menthaes.
Further, it is the preparation that the crude drug by following weight proportion is prepared from:
14～15 parts of Radix Bupleuri, 14～15 parts of Radix Angelicae Sinensis, 2.4～5.3 parts of Herba Menthaes.
Further, it is the preparation that the crude drug by following weight proportion is prepared from:
14～15 parts of Radix Bupleuri, 14～15 parts of Radix Angelicae Sinensis, 4.0～4.5 parts of Herba Menthaes.
Preferably, the consumption of Radix Bupleuri, Radix Angelicae Sinensis is 14.4 ± 0.2 parts, for example 14.4 parts.
Preferably, Herba Menthae consumption is 4.05 ± 0.05 parts, for example 4.056 parts.
Theory of Chinese medical science thinks, people's feelings will activity (being the variation of emotion and emotion) is closely related with the function of liver.Under pathological state, abnormal emotion-thought causes stagnation of QI due to depression of the liver, and depression of liver-QI further increases the weight of the fluctuation of emotion, emotion, the final whole body mechanism of qi that affects moves not smooth, by dredging to send out, hold back strongly fragrant irritability, nourish blood in addition and help liver use with tonifying liver body, can reach harmonizing emotions, improve the effect on the whole body.We with Radix Bupleuri with dispersing liver-energy, Radix Angelicae Sinensis tonifying liver blood and help liver circulation of qi promoting, Herba Menthae is pungent loose and help Radix Bupleuri circulation of qi promoting, three medicines to share dispersing the stagnated live-QI to relieve the stagnation of QI, harmonizing the functional activities of vital QI.
Further, also contain the Radix Paeoniae Alba in described crude drug, each crude drug weight proportion is as follows: 18 parts of Radix Bupleuri, 18 parts of Radix Angelicae Sinensis, the Radix Paeoniae Alba 18 minutes, 3 parts of Herba Menthaes.
Wherein, it is the medicated powder by the crude drug of described proportioning, or the water of crude drug is or/and extractive with organic solvent is active component, adds that pharmaceutically conventional adjuvant or complementary composition are prepared to obtain preparation.
Water extract or be used as medicine with medicated powder, is all Chinese medicine tradition occupation modes, after water extraction, because the soluble end of water is wide, can medicine is more easily absorbed by the body most of effective ingredient stripping, and onset is faster, such as form of medication such as decoctions; With former powder, be used as medicine, the surface area of medicated powder is larger, also be conducive to effective ingredient absorption in vivo in medical material, but medical material un-extracted, effective ingredient still needs stripping in vivo to absorb again, and the relative water extract of its onset is slower, but has also weakened the toxicity that in medical material, harmful components cause human body simultaneously, be suitable for long-term taking, as former powder is prepared into the form of medication such as pill.At present in pharmacy procedure, ethanol extracts medicine as solvent, also be one of the most common extracting mode, ethanol is semi-polarity solvent, solubility property circle is between polarity and non-polar solven, can dissolve water miscible some composition, also can dissolve some compositions that non-polar solven dissolves, conventionally with ethanol extraction, replace decocting, thereby avoid the stripping of a large amount of invalid components, improve concentration and the extraction efficiency of effective ingredient, but the price of ethanol is expensive compared with water, in the large production of modern pharmaceutical industry, can consider each side factor and determine extraction process.
Pharmaceutically acceptable adjuvant of the present invention, refer to the material being included in dosage form except active component, include but are not limited to filler (diluent), lubricant (fluidizer or antitack agent), dispersant, wetting agent, binding agent, regulator, solubilizing agent, antioxidant, antibacterial, emulsifying agent, disintegrating agent etc.Binding agent comprises syrup, arabic gum, gelatin, sorbitol, tragacanth, cellulose and derivant thereof (as microcrystalline Cellulose, sodium carboxymethyl cellulose, ethyl cellulose or hydroxypropyl methylcellulose etc.), gelatine size, syrup, starch slurry or polyvinylpyrrolidone etc.; Filler comprises lactose, Icing Sugar, dextrin, starch and derivant thereof, cellulose and derivant thereof, inorganic calcium salt (as calcium sulfate, calcium phosphate, calcium hydrogen phosphate, precipitated calcium carbonate etc.), sorbitol or glycine etc.; Lubricant comprises micropowder silica gel, magnesium stearate, Pulvis Talci, aluminium hydroxide, boric acid, hydrogenated vegetable oil, Polyethylene Glycol etc.; Disintegrating agent comprises starch and derivant (as carboxymethyl starch sodium, Explotab, pregelatinized Starch, modified starch, hydroxypropyl starch, corn starch etc.), polyvinylpyrrolidone or microcrystalline Cellulose etc.; Wetting agent comprises sodium lauryl sulphate, water or alcohol etc.; Antioxidant packages is containing sodium sulfite, sodium sulfite, sodium pyrosulfite, dibutyl benzoic acid etc.; Antibacterial comprises 0.5% phenol, 0.3% cresol, 0.5% chlorobutanol etc.; Regulator comprises hydrochloric acid, citric acid, potassium hydroxide (sodium), sodium citrate and buffer agent (comprising phosphoric acid dioxy sodium and sodium hydrogen phosphate) etc.; Emulsifier package containing Tween-80, do not have that sour Pyrusussuriensis is smooth, pluronic gram F-68, lecithin, fabaceous lecithin etc.; Solubilizing agent comprises tween 80, bile, glycerol etc.
Described pharmaceutically acceptable complementary composition, it has certain physiologically active, but adding of this composition can not change above-mentioned health product or the pharmaceutical composition leading position in disease treatment process, and only effect is assisted in performance, these auxiliary effects are only the utilizations to this composition known activity, are the habitual auxiliary treatment modes of field of medicaments.
Wherein, described preparation is through gastrointestinal absorption preparation.For example, tablet, powder, pill, capsule, granule, medicated wine or oral liquid.
The present invention also provides the preparation method of aforementioned pharmaceutical compositions, and it comprises following operating procedure:
(1) weighting raw materials by weight ratio;
(2) get crude drug, decoct with water, merge decocting liquid, add that pharmaceutically conventional adjuvant or complementary composition are prepared into preparation.
The present invention also provides the purposes of aforementioned pharmaceutical compositions in the antidepressant medicine of preparation.
The present invention is to the Radix Bupleuri of the former side of the XIAOYAO POWDER side of tearing open gained, Radix Angelicae Sinensis, Herba Menthae compound medicament composition, by three after specific consumption compatibility, former side is suitable for its antidepressant activity and XIAOYAO POWDER, obviously reduced flavour of a drug use, reduced dose, for patient has greatly saved medical expense, be more conducive to popularization and the use of product.
The specific embodiment
The preparation of embodiment 1 pharmaceutical composition of the present invention
Prescription: Radix Bupleuri 14.4g, Radix Angelicae Sinensis 14.4g, Herba Menthae 4.05g
Preparation method: the medicine taking is added to 8 times of water gagings, soak 30min, heated and boiled, slow fire boiling 1h, filters while hot; Add again 6 times of water gagings, with method, decoct respectively 40min and 30min; Merge three times filtrate, concentrating under reduced pressure under 60 ℃ of conditions, adds appropriate amount of auxiliary materials to prepare granule.
The preparation of embodiment 2 pharmaceutical compositions of the present invention
Prescription: Radix Bupleuri 14.6g, Radix Angelicae Sinensis 14.2g, Herba Menthae 4.00g
Preparation method: the medicine taking is added to 10 times of water gagings, soak 40min, heated and boiled, slow fire boiling 2h, filters while hot; Add again 8 times of water gagings, with method, decoct respectively 30min and 20min; Merge three times filtrate, obtain decoction
The preparation of embodiment 3 pharmaceutical compositions of the present invention
Prescription: Radix Bupleuri 14.2g, Radix Angelicae Sinensis 14.6g, Herba Menthae 4.10g
Preparation method: the medicine by taking, be crushed to impalpable powder, mix, prepare powder.
The compound recipe screening of embodiment 4 pharmaceutical compositions of the present invention
XIAOYAO POWDER is the recipe of dispersing the stagnated live-QI to relieve the stagnation of QI, antidepressant effect.Radix Bupleuri dispersing the stagnated live-QI to relieve the stagnation of QI wherein, bar reaches irritability, and Chinese Angelica blood replonishing is invigorated blood circulation, Radix Paeoniae Alba nourishing blood to suppress the hyperactive liver, Herba Menthae is pungent, and loose to reach the strongly fragrant Radix Bupleuri that helps soothing the liver.This experiment is planned Radix Bupleuri, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Herba Menthae four Chinese medicine thing and is formed a compound recipe, take to hang tail, swimming to stimulate the model mice dead time be observation index, and the impact of the compound recipe that examination four Chinese medicine thing forms on depressive symptom.
1 four Chinese medicine material forms the screening of compound recipe
The full side's group of design XIAOYAO POWDER, group 1 ingredients is: Radix Bupleuri 9g, Radix Angelicae Sinensis 9g, Radix Paeoniae Alba 9g, Rhizoma Atractylodis Macrocephalae 9g, Rhizoma Zingiberis Recens 9g, Poria 9g, Radix Glycyrrhizae Preparata 4.5g, Herba Menthae 1.5g; Organizing 2 ingredients is: Radix Bupleuri 9g, Radix Angelicae Sinensis 9g, Radix Paeoniae Alba 9g, Herba Menthae 1.5g.Two groups of medicines all adopt decocting to extract, and decocting liquid is standby.Separately establish blank group, give the pure water of equal volume.Each organizes mice gastric infusion every day 1 time, continuously 7d.
Outstanding tail test (TST): before experiment, water 12h is can't help in fasting, after last administration 60min, mice tail end is fixed in outstanding tail instrument on vertical metal rod with adhesive tape, make it be the state of hanging by the feet, head can not contact bottom platform, adapt to 2min, observe and record respectively the time of the interior mice accumulative total maintenance activity of 4min subsequently and motionless state.
Forced swimming test (FST): each is organized mice 24h before experiment and carries out 15min swimming adaptive training.Before experiment, water 12h is can't help in fasting, after last administration 60min, with reference to test methods such as Elzbieta N, improved, after last administration 1h, mouse head is put into self-control swimming beaker (23～25 ℃ of water temperatures, depth of water 20cm) down, adapt to 2min, observe and record the interior mice accumulative total dead time of 4min (mice stops struggling in water, is floating state, only has tiny limb motion to keep balance) subsequently.
Autonomic activities test: after last administration, 1h puts into ZZ-6 mice autonomic activities analyzer by mice, adapts to 2min, observes and record parallel activity number of times and the number of times of standing of the interior mice of 4min subsequently.All the results are shown in Table 1
Table 1CDB compound recipe respectively forms the impact of medicine on mouse tail suspension, non-swimming time and autonomic activities
With model group comparison, * P<0.05
By above-mentioned test, find, the compound recipe being formed by Radix Bupleuri, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Herba Menthae four Chinese medicine thing, the full side of its antidepressant effect and XIAOYAO POWDER is suitable, but drug dose obviously reduces.
2. the screening of compound medicine optimal dose of the present invention
Design medicine consists of: Radix Bupleuri, Radix Angelicae Sinensis, the Radix Paeoniae Alba be consumption 0g, 5g, 10g, 15g, 20g, 25g, 30g respectively; Herba Menthae 0g, 1g, 2g, 3g, 4g, 5g, 6g, become 28 groups by the random proportioning of these medicines, 2～29 (in Table 2) of writing out a prescription, and dosage sees the following form shown in 3.It is standby that the method that each group adopts said medicine to extract is prepared into decocting liquid.Separately establish blank group, give the pure water of equal volume.Each organizes mice gastric infusion every day 1 time, continuously 7d.By " 1 " lower method, carry out TST, FST and autonomic activities test, the results are shown in Table 3.
Table 2 prescription 2～29 drug ratios
The impact of each compound medicine of table 3 on mouse tail suspension, non-swimming time and autonomic activities
Note, with model group comparison, * P<0.05; * P<0.01.
By writing out a prescription, 2～29 can determine that the Radix Paeoniae Alba is less on the impact of depression model mice, by prescription 2～29, can determine that the consumption of Radix Bupleuri, Radix Angelicae Sinensis take 10～20 parts as good, the consumption of Herba Menthae be take 3～5 parts as good.
3. the screening of the best proportioning of compound medicine dosage of the present invention
By above-mentioned experiment, can determine that the consumption of Radix Bupleuri, Radix Angelicae Sinensis take 10～20 parts as good, the consumption of Herba Menthae be take 3～6 parts as good.The optimal dose of contrived experiment screening of medicaments proportioning below.
The proportion compatibility of Radix Bupleuri, Radix Angelicae Sinensis is with reference to the former side of XIAOYAO POWDER, with the consumption compatibility of 3,4,5 portions of Herba Menthaes, observes its antidepressant effect respectively., Radix Bupleuri, Radix Angelicae Sinensis are got respectively 10g, 15g, 20g to drug ratio, and with 3g, 4g, 5g Herba Menthae random group with become 9 groups (seeing the following form 4), dosage sees the following form shown in 5.It is standby that the method that all adopts said medicine to extract is prepared into decocting liquid.Separately establish blank group, give the pure water of equal volume.Each organizes mice gastric infusion every day 1 time, continuously 7d.By the method under " 1 " item, carry out TST, FST and autonomic activities test.The results are shown in Table 5.
Table 4 group 1～group 9 drug ratios
The impact of each compound medicine of table 5 on mouse tail suspension, non-swimming time and autonomic activities
Note, with model group comparison, * P<0.05; * P<0.01.
By above-mentioned experiment, can determine the optimum dose proportion that Radix Bupleuri 15g, Radix Angelicae Sinensis 15g, Herba Menthae 4g are the party.
4. the confirmatory experiment of the best proportioning of pharmaceutical composition of the present invention
By above experiment, can tentatively determine that the best proportioning of pharmaceutical composition antidepressant effect of the present invention is Radix Bupleuri 15g, Radix Angelicae Sinensis 15g, Herba Menthae 4g, for further determining the antidepressant effect of this ratio, design verification experiment.This experiment adopts two dosage groups 1, group 2 (20 times, 30 times adults (60kg) dosage) of compound recipe optimal proportion, set up the full side's group of XIAOYAO POWDER, amitriptyline group simultaneously, to observe various dose to impact that stress the model mice dead time, evaluate the antidepressant effect of this ratio.All with before screening experiment is consistent for experimental technique, experiment condition, experiment place.
Table 4CDB compound recipe respectively forms the impact of medicine on mouse tail suspension, non-swimming time and autonomic activities
Note, with model group comparison, * P<0.05; * P<0.01.
Comprehensive above-mentioned each conclusion (of pressure testing) is known:
(1), to the Radix Bupleuri of the former side of the XIAOYAO POWDER side of tearing open gained, Radix Angelicae Sinensis, Herba Menthae compound medicament composition, after three's consumption is adjusted, former side is suitable for its antidepressant activity and XIAOYAO POWDER, has effectively reduced flavour of a drug use, has reduced dose.
(2) the present invention is by repeatedly screening, analyze and verify discovery, and the best proportioning of Radix Bupleuri, Radix Angelicae Sinensis, Herba Menthae compound medicament composition is Radix Bupleuri: 14.4 parts, and Radix Angelicae Sinensis 14.4,4.056 parts of Herba Menthaes.Large, produce in part process, owing to weighing accuracy not as good as experiment lab scale, therefore, for the ease of taking of crude drug, allow each flavour of a drug of compound recipe to have certain weighing error, be 14～15 parts of Radix Bupleuri, 14～15 parts of Radix Angelicae Sinensis, 4.0～4.5 parts of Herba Menthaes, if further dwindle range of error, its pharmaceutical composition amount ranges allows in following scope: 14.4 ± 0.2 parts of Radix Bupleuri, 14.4 ± 0.2 parts of Radix Angelicae Sinensis, 4.05 ± 0.05 parts of Herba Menthaes.
Claims (10)
1. an antidepressant pharmaceutical composition, is characterized in that: it is the preparation that the crude drug that contains following weight proportion is prepared from:
10～20 parts of Radix Bupleuri, 10～20 parts of Radix Angelicae Sinensis, 3～5 parts of Herba Menthaes.
2. pharmaceutical composition according to claim 1, is characterized in that: it is the preparation that the crude drug by following weight proportion is prepared from:
14～15 parts of Radix Bupleuri, 14～15 parts of Radix Angelicae Sinensis, 2.4～5.3 parts of Herba Menthaes.
3. pharmaceutical composition according to claim 2, is characterized in that: it is the preparation that the crude drug by following weight proportion is prepared from:
14～15 parts of Radix Bupleuri, 14～15 parts of Radix Angelicae Sinensis, 4.0～4.5 parts of Herba Menthaes.
4. pharmaceutical composition according to claim 3, is characterized in that: the consumption of Radix Bupleuri, Radix Angelicae Sinensis is 14.4 ± 0.2 parts, is preferably 14.4 parts.
5. pharmaceutical composition according to claim 3, is characterized in that: Herba Menthae consumption is 4.05 ± 0.05 parts, is preferably 4.056 parts.
6. pharmaceutical composition according to claim 1, is characterized in that: in described crude drug, also contain the Radix Paeoniae Alba, each crude drug weight proportion is as follows:
18 parts of Radix Bupleuri, 18 parts of Radix Angelicae Sinensis, the Radix Paeoniae Alba 18 minutes, 3 parts of Herba Menthaes.
7. according to the pharmaceutical composition described in claim 1～6 any one, it is characterized in that: it is the medicated powder by the crude drug of described proportioning, or the water of crude drug, or/and extractive with organic solvent is active component, adds that pharmaceutically conventional adjuvant or complementary composition are prepared to obtain preparation.
8. according to the pharmaceutical composition described in claim 1～7 any one, it is characterized in that: described preparation is through gastrointestinal absorption preparation.
9. the preparation method of pharmaceutical composition described in claim 1～8 any one, is characterized in that: it comprises following operating procedure:
(1) weighting raw materials by weight ratio;
(2) get crude drug, decoct with water, merge decocting liquid, add that pharmaceutically conventional adjuvant or complementary composition are prepared into preparation.
Described in claim 1～8 any one pharmaceutical composition in preparation the purposes in antidepressant medicine.
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| CN114191426A (en) * | 2021-11-12 | 2022-03-18 | 成都中医药大学 | Compound extract of radix bupleuri, angelica sinensis and mint as well as preparation method and application thereof |
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| CN108126062A (en) * | 2018-03-09 | 2018-06-08 | 杨添淞 | A kind of oral Chinese medicine composition for treating depression and its preparation and preparation method |
| CN108126062B (en) * | 2018-03-09 | 2021-04-23 | 杨添淞 | Oral traditional Chinese medicine composition for treating depression, preparation and preparation method thereof |
| CN114191426A (en) * | 2021-11-12 | 2022-03-18 | 成都中医药大学 | Compound extract of radix bupleuri, angelica sinensis and mint as well as preparation method and application thereof |
| CN114191426B (en) * | 2021-11-12 | 2023-11-10 | 成都中医药大学 | Bupleurum, angelica and mint compound extract and preparation method and application thereof |
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