CN105168456A - Anle tablet - Google Patents
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- CN105168456A CN105168456A CN201510586388.2A CN201510586388A CN105168456A CN 105168456 A CN105168456 A CN 105168456A CN 201510586388 A CN201510586388 A CN 201510586388A CN 105168456 A CN105168456 A CN 105168456A
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Abstract
The invention relates to an Anle tablet and a preparation method thereof. Concretely, the preparation method comprises the steps of (1) carrying out ultrasonic extraction on effective components of radix bupleuri, angelica sinensis and white atractylodes rhizome; (2) carrying out continuous ethanol reflux extraction aiming at continuous concentration change of effective components of ligusticum wallichii, liquorice, uncaria, caulis polygoni multiflori and decoction dregs; (3) processing Tuckahoe, and mixing the Tuckahoe with thick paste; and (4) preparing the tablet. By using the preparation method disclosed by the invention, the Anle tablet which is high in bioavailability, excellent in effect and reduced in one-time dosage is obtained, and the clinical effect of the Anle tablet is ensured.
Description
Technical field:
The present invention relates to a kind of ANLE PIAN, concrete, the present invention relates to a kind of ANLE PIAN and preparation method thereof.
Background technology:
ANLE PIAN is recorded in Ministry of Public Health standard, and its prescription is Radix Bupleuri 90g, Radix Angelicae Sinensis 135g, Rhizoma Chuanxiong 90g, Poria 180g, Ramulus Uncariae Cum Uncis 180g, Caulis Polygoni Multiflori 180g, and the Rhizoma Atractylodis Macrocephalae (stir-fry) 180g, Radix Glycyrrhizae 68g are that raw material is made, and energy dispersing the stagnated live-QI to relieve the stagnation of QI, arresting convulsion is calmed the nerves.For spirit depressing, have a sleepless night in terror, discomfort uncomfortable in chest, anorexia Mental fatigue, to neurosis, the climacteric syndrome agent nocturnal fretfulness in infants, the symptom such as to grind one's teeth in sleep are effective in cure.
To the extraction of effective ingredient in conventional preparation techniques, usually adopt the method for beating powder and soak by water, the coarse backwardness of technique, impurity is many, thus causes patient's consumption excessive, is inconvenient to shortcomings such as taking, has had a strong impact on its clinical practice.
A kind of preparation method of ANLE PIAN is described in patent CN102824438A and CN10361794A, its prescription is: Radix Bupleuri 90g, Radix Angelicae Sinensis 135g, Rhizoma Chuanxiong 90g, Poria 180g, Ramulus Uncariae Cum Uncis 180g, Caulis Polygoni Multiflori 180g, Rhizoma Atractylodis Macrocephalae (parched) 180g, Radix Glycyrrhizae 68g, and adopts supercritical and microwave extraction technology to extract wherein effective ingredient.
In patent CN1739648A, gained medicine solves in prior art, and ANLE PIAN is long for disintegration, effective slow shortcoming, has prepared one and has had antidepressant Chinese medicine preparation.
For the preparation of anti-depression Chinese medicament ANLE PIAN and other preparation, although have employed diverse ways in prior art to avoid its dose large, effective slow shortcoming, the content that improve effective ingredient in its extraction process in various degree, but it has little effect, therefore urgent need one can improve its active constituent content at present, reduces dose, the product that bioavailability is high.
Summary of the invention:
For overcoming the problem of prior art, special proposition the present invention.
An object of the present invention is to provide a kind of ANLE PIAN;
Two of object of the present invention is the preparation method providing a kind of ANLE PIAN.
In order to realize the present invention, its technical scheme is as follows:
Prescription of the present invention
Radix Bupleuri 90g, Radix Angelicae Sinensis 135g, Rhizoma Chuanxiong 90g, Poria 180g, Ramulus Uncariae Cum Uncis 180g, Caulis Polygoni Multiflori 180g, the Rhizoma Atractylodis Macrocephalae (stir-fry) 180g, Radix Glycyrrhizae 68g;
Adjuvant: magnesium stearate
Preparation technology of the present invention is as follows:
1) supersound extraction of Radix Bupleuri, Radix Angelicae Sinensis, Rhizoma Atractylodis Macrocephalae effective ingredient
20-70 mesh sieve pulverized by the Radix Bupleuri of recipe quantity, Radix Angelicae Sinensis and the Rhizoma Atractylodis Macrocephalae, to add after powder mixing in supersonic extractors and the ethanol adding 50-80% to not having medical material, dipping 12-48h; The ratio regulating material and solution in extractor is afterwards 1:10-1:20, and being heated to temperature in extractor to extractor is 35-45 DEG C, and ultrasonic power is set to 180-240W, starts to carry out supersound extraction 35-45min;
Repeat ultrasonic 3 times, filter, collect filtrate and be condensed into dry extract, medicinal residues reclaim for subsequent use.
2) Rhizoma Chuanxiong, Radix Glycyrrhizae, Ramulus Uncariae Cum Uncis fleece-flower root rattan effective ingredient, and after the Rhizoma Chuanxiong of recipe quantity, Radix Glycyrrhizae, Ramulus Uncariae Cum Uncis fleece-flower root rattan pulverized 50-150 mesh sieve by the continuous concentration change alcohol reflux of medicinal residues effective ingredient, at the uniform velocity add in extractor, and in extractor I, add the alcoholic solution that concentration is 95%.
Extractor top connects a water tank I, makes it to be communicated with extractor I, is provided with valve switch and flow meter I between water tank I and extractor I, and wherein flow meter I can control water in water tank I and flow into the speed of extractor I.Water in water tank I is heated, makes water temperature in water tank I consistent with temperature in extractor I.
When temperature stabilization in water tank I and extractor I is after 65-75 DEG C, open the valve switch of water tank I, by controlling the flow velocity of water in water tank I, the water in water tank I is made slowly to instill in extractor I, ensure that in extractor I, concentration of alcohol rate of change is 0.5-1.5%/min, continuing to stir also, control temperature is constant.After reaction 0.5-1.5h, when in extractor I, concentration of alcohol is 50%, stopping adds water, extractor I bottom valve switch I and switch II, medicinal liquid in extractor I can be derived and collect by its breaker in middle I, medicinal liquid in part extractor I can export in extractor II by switch II, and at switch II place, effusion meter is housed.Now open the switch II in extractor I, after releasing the extracting solution of 1/3, closing switch II, carry out second time concentration of alcohol change detection continuously, and the rate of change controlling now concentration of alcohol is 0.33-0.67%/min, when being 10% to concentration of alcohol after reaction 1-2h, in switch I, releasing medicinal liquid and cool recovery.
Extractor I bottom switch II can flow out for medicinal liquid, and is communicated with extractor II.A concentration of alcohol regulating box is provided with between the pipeline that extractor I and extractor II are communicated with, the ethanol of 95% can be added in regulating box, the medicinal liquid flowed out in extractor I mixes according to certain ratio with the ethanol in concentration adjustment case, and in regulating box, detect the concentration of ethanol.After concentration of alcohol reaches certain value, the medicinal liquid in regulating box flows in extractor II, carries out continuous concentration of alcohol change reflux, extract.
Now the concentration of alcohol in concentration adjustment case being adjusted to concentration of alcohol is 70%, and the medicinal liquid after concentration adjustment is imported extractor II.Wherein, add step (1) Chinese medicine slag in extractor II, at 65-75 DEG C, controlling concentration of alcohol rate of change is 0.5-1%/min, reaction 1-2h, and when being 10% to the concentration of alcohol in extractor II, derive the medicinal liquid in extractor II, cooling is reclaimed.
After extractor I merges with the medicinal liquid in II, concentrating under reduced pressure becomes thick paste.
3) process of preparing Chinese medicine of Poria and the mixing of thick paste
After simply being washed by the Poria raw material of recipe quantity, be cut into the lamellar of thickness equalization, and in the positive and negative uniform application step 2 repeatedly of Indian buead tablet) thick paste of gained, steaming and decocting 15-45min in steamer, controls steamer temperature and is no more than 70 DEG C;
After first time steaming and decocting terminates, again smear remaining thick paste, carry out steaming and decocting; So steaming and decocting is infiltrated in Indian buead tablet completely to thick paste for 3 times repeatedly, is dried by Poria and wears into fine powder, for subsequent use;
4) preparation of tablet
By step 1) and 3) dried cream powder of gained and fine powder add water soft material processed, wet granulation, cross after 14 mesh sieves with 60-80 DEG C at dry;
Tabletting after being mixed with magnesium stearate by dried granule, obtains plain sheet, film coating, obtains ANLE PIAN 500, every more than sheet 0.5g.
Preferably, preparation method of the present invention is as follows:
1) supersound extraction of Radix Bupleuri, Radix Angelicae Sinensis, Rhizoma Atractylodis Macrocephalae effective ingredient
50 mesh sieves pulverized by the Radix Bupleuri of recipe quantity, Radix Angelicae Sinensis and the Rhizoma Atractylodis Macrocephalae, to add after powder mixing in supersonic extractors and the ethanol adding 70% to not having medical material, dipping 24h; The ratio regulating material and solution in extractor is afterwards 1:12, and being heated to temperature in extractor to extractor is 40 DEG C, and ultrasonic power is set to 200W, starts to carry out supersound extraction 40min;
Repeat ultrasonic 3 times, filter, collect filtrate and be condensed into dry extract, medicinal residues reclaim for subsequent use.
2) Rhizoma Chuanxiong, Radix Glycyrrhizae, Ramulus Uncariae Cum Uncis fleece-flower root rattan effective ingredient, and after the Rhizoma Chuanxiong of recipe quantity, Radix Glycyrrhizae, Ramulus Uncariae Cum Uncis fleece-flower root rattan pulverized 100 mesh sieves by the continuous concentration change alcohol reflux of medicinal residues effective ingredient, at the uniform velocity add in extractor, and in extractor I, add the alcoholic solution that concentration is 95%.
Extractor top connects a water tank I, makes it to be communicated with extractor I, is provided with valve switch and flow meter I between water tank I and extractor I, and wherein flow meter I can control water in water tank I and flow into the speed of extractor I.Water in water tank I is heated, makes water temperature in water tank I consistent with temperature in extractor I.
When temperature stabilization in water tank I and extractor I is after 68 DEG C, open the valve switch of water tank I, by controlling the flow velocity of water in water tank I, the water in water tank I is made slowly to instill in extractor I, ensure that in extractor I, concentration of alcohol rate of change is 0.75%/min, continuing to stir also, control temperature is constant.After reaction 1h, when in extractor I, concentration of alcohol is 50%, stopping adds water, extractor I bottom valve switch I and switch II, medicinal liquid in extractor I can be derived and collect by its breaker in middle I, medicinal liquid in part extractor I can export in extractor II by switch II, and at switch II place, effusion meter is housed.Now open the switch II in extractor I, after releasing the extracting solution of 1/3, closing switch II, carry out second time concentration of alcohol change detection continuously, and the rate of change controlling now concentration of alcohol is 0.44%/min, when being 10% to concentration of alcohol after reaction 1.5h, in switch I, releasing medicinal liquid and cool recovery.
Extractor I bottom switch II can flow out for medicinal liquid, and is communicated with extractor II.A concentration of alcohol regulating box is provided with between the pipeline that extractor I and extractor II are communicated with, the ethanol of 95% can be added in regulating box, the medicinal liquid flowed out in extractor I mixes according to certain ratio with the ethanol in concentration adjustment case, and in regulating box, detect the concentration of ethanol.After concentration of alcohol reaches certain value, the medicinal liquid in regulating box flows in extractor II, carries out continuous concentration of alcohol change reflux, extract.
Now the concentration of alcohol in concentration adjustment case being adjusted to concentration of alcohol is 70%, and the medicinal liquid after concentration adjustment is imported extractor II.Wherein, add step (1) Chinese medicine slag in extractor II, at 68 DEG C, controlling concentration of alcohol rate of change is 0.67%/min, reaction 1.5h, and when being 10% to the concentration of alcohol in extractor II, derive the medicinal liquid in extractor II, cooling is reclaimed.
After extractor I merges with the medicinal liquid in II, concentrating under reduced pressure becomes thick paste.
3) process of preparing Chinese medicine of Poria and the mixing of thick paste
After simply being washed by the Poria raw material of recipe quantity, be cut into the lamellar of thickness equalization, and in the positive and negative uniform application step 2 repeatedly of Indian buead tablet) thick paste of gained, steaming and decocting 30min in steamer, controls steamer temperature and is no more than 70 DEG C;
After first time steaming and decocting terminates, again smear remaining thick paste, carry out steaming and decocting; So steaming and decocting is infiltrated in Indian buead tablet completely to thick paste for 3 times repeatedly, is dried by Poria and wears into fine powder, for subsequent use;
4) preparation of tablet
By step 1) and 3) dried cream powder of gained and fine powder add water soft material processed, wet granulation, cross after 14 mesh sieves with 60-80 DEG C at dry;
Tabletting after being mixed with magnesium stearate by dried granule, obtains plain sheet, film coating, obtains ANLE PIAN 500, every sheet 0.62g.Beneficial effect of the present invention:
1. Radix Bupleuri, Radix Angelicae Sinensis, Rhizoma Atractylodis Macrocephalae effective ingredient adopt supersound extraction, and its response time is short, effective, and the yield of volatile oil increases, and wherein active constituent content also corresponding raising.
2. Rhizoma Chuanxiong, Radix Glycyrrhizae, Ramulus Uncariae Cum Uncis fleece-flower root rattan effective ingredient, and medicinal residues effective ingredient adopts continuous concentration change alcohol reflux, can ensure that medical material extracts active ingredients is complete, and its extraction efficiency effectively improves.
3. by the process of preparing Chinese medicine of Poria, and mix with thick paste in concocting process, the content of pachyman in Poria can be improved simultaneously, and ensure and fully the mixing of other effective ingredient, save the time mixed.
4. through preparation method of the present invention, the ANLE PIAN that specification is larger can be manufactured, thus reduce the taking dose of patient in taking, be convenient to take, alleviate misery when taking, experiment simultaneously proves that the bioavailability of ANLE PIAN of the present invention is high, effect shows, and can be used in clinical.
5. although it is simple replacement to existing extracting method that some steps in preparation method of the present invention seem, or limit is changed to experiment condition, or the improvement utilizing known principle of the prior art to carry out production equipment, but Chinese medicine is because the factor such as the complexity of its composition and uncertainty, its whole preparation method should be regarded as an overall technical scheme, consider its technological means, technical purpose and technique effect, its one step contrary can not solve technical problem of the present invention, also its technique effect cannot be expected, thus should by not separated for its single preparation process.Therefore, consider the general idea of preparation method of the present invention, can determine that the bioavailability existed in the prior art that the present invention solves is low, the problems such as efficient energy-saving, and reach corresponding technique effect, there is substantial feature and significant progress.
accompanying drawing illustrates:
Fig. 1 is continuous concentration change alcohol reflux device flow chart.
detailed description of the invention:
Embodiment 1
Prescription: Radix Bupleuri 90g, Radix Angelicae Sinensis 135g, Rhizoma Chuanxiong 90g, Poria 180g, Ramulus Uncariae Cum Uncis 180g, Caulis Polygoni Multiflori 180g, the Rhizoma Atractylodis Macrocephalae (stir-fry) 180g, Radix Glycyrrhizae 68g;
Adjuvant: magnesium stearate 1.5g
Preparation method:
1) supersound extraction of Radix Bupleuri, Radix Angelicae Sinensis, Rhizoma Atractylodis Macrocephalae effective ingredient
50 mesh sieves pulverized by the Radix Bupleuri of recipe quantity, Radix Angelicae Sinensis and the Rhizoma Atractylodis Macrocephalae, to add after powder mixing in supersonic extractors and the ethanol adding 70% to not having medical material, dipping 24h; The ratio regulating material and solution in extractor is afterwards 1:12, and being heated to temperature in extractor to extractor is 40 DEG C, and ultrasonic power is set to 200W, starts to carry out supersound extraction 40min;
Repeat ultrasonic 3 times, filter, collect filtrate and be condensed into dry extract, medicinal residues reclaim for subsequent use.
2) Rhizoma Chuanxiong, Radix Glycyrrhizae, Ramulus Uncariae Cum Uncis fleece-flower root rattan effective ingredient, and the continuous concentration change alcohol reflux of medicinal residues effective ingredient
After the Rhizoma Chuanxiong of recipe quantity, Radix Glycyrrhizae, Ramulus Uncariae Cum Uncis fleece-flower root rattan were pulverized 100 mesh sieves, at the uniform velocity added in extractor, and in extractor I, added the alcoholic solution that concentration is 95%.
Extractor top connects a water tank I, makes it to be communicated with extractor I, is provided with valve switch and flow meter I between water tank I and extractor I, and wherein flow meter I can control water in water tank I and flow into the speed of extractor I.Water in water tank I is heated, makes water temperature in water tank I consistent with temperature in extractor I.
When temperature stabilization in water tank I and extractor I is after 68 DEG C, open the valve switch of water tank I, by controlling the flow velocity of water in water tank I, the water in water tank I is made slowly to instill in extractor I, ensure that in extractor I, concentration of alcohol rate of change is 0.75%/min, continuing to stir also, control temperature is constant.After reaction 1h, when in extractor I, concentration of alcohol is 50%, stopping adds water, extractor I bottom valve switch I and switch II, medicinal liquid in extractor I can be derived and collect by its breaker in middle I, medicinal liquid in part extractor I can export in extractor II by switch II, and at switch II place, effusion meter is housed.Now open the switch II in extractor I, after releasing the extracting solution of 1/3, closing switch II, carry out second time concentration of alcohol change detection continuously, and the rate of change controlling now concentration of alcohol is 0.44%/min, when being 10% to concentration of alcohol after reaction 1.5h, in switch I, releasing medicinal liquid and cool recovery.
Extractor I bottom switch II can flow out for medicinal liquid, and is communicated with extractor II.A concentration of alcohol regulating box is provided with between the pipeline that extractor I and extractor II are communicated with, the ethanol of 95% can be added in regulating box, the medicinal liquid flowed out in extractor I mixes according to certain ratio with the ethanol in concentration adjustment case, and in regulating box, detect the concentration of ethanol.After concentration of alcohol reaches certain value, the medicinal liquid in regulating box flows in extractor II, carries out continuous concentration of alcohol change reflux, extract.
Now the concentration of alcohol in concentration adjustment case being adjusted to concentration of alcohol is 70%, and the medicinal liquid after concentration adjustment is imported extractor II.Wherein, add step (1) Chinese medicine slag in extractor II, at 68 DEG C, controlling concentration of alcohol rate of change is 0.67%/min, reaction 1.5h, and when being 10% to the concentration of alcohol in extractor II, derive the medicinal liquid in extractor II, cooling is reclaimed.
After extractor I merges with the medicinal liquid in II, concentrating under reduced pressure becomes thick paste.
3) process of preparing Chinese medicine of Poria and the mixing of thick paste
After simply being washed by the Poria raw material of recipe quantity, be cut into the lamellar of thickness equalization, and in the positive and negative uniform application step 2 repeatedly of Indian buead tablet) thick paste of gained, steaming and decocting 30min in steamer, controls steamer temperature and is no more than 70 DEG C;
After first time steaming and decocting terminates, again smear remaining thick paste, carry out steaming and decocting; So steaming and decocting is infiltrated in Indian buead tablet completely to thick paste for 3 times repeatedly, is dried by Poria and wears into fine powder, for subsequent use;
4) preparation of tablet
By step 1) and 3) dried cream powder of gained and fine powder add water soft material processed, wet granulation, cross after 14 mesh sieves with 60-80 DEG C at dry;
Tabletting after being mixed with magnesium stearate by dried granule, obtains plain sheet, film coating, obtains ANLE PIAN 500, every sheet 0.62g.
Embodiment 2:
Prescription: Radix Bupleuri 90g, Radix Angelicae Sinensis 135g, Rhizoma Chuanxiong 90g, Poria 180g, Ramulus Uncariae Cum Uncis 180g, Caulis Polygoni Multiflori 180g, the Rhizoma Atractylodis Macrocephalae (stir-fry) 180g, Radix Glycyrrhizae 68g;
Adjuvant: magnesium stearate 1.5g
Preparation method:
1) supersound extraction of Radix Bupleuri, Radix Angelicae Sinensis, Rhizoma Atractylodis Macrocephalae effective ingredient
20 mesh sieves pulverized by the Radix Bupleuri of recipe quantity, Radix Angelicae Sinensis and the Rhizoma Atractylodis Macrocephalae, to add after powder mixing in supersonic extractors and the ethanol adding 50% to not having medical material, dipping 48h; The ratio regulating material and solution in extractor is afterwards 1:10, and being heated to temperature in extractor to extractor is 35 DEG C, and ultrasonic power is set to 180W, starts to carry out supersound extraction 35min;
Repeat ultrasonic 3 times, filter, collect filtrate and be condensed into dry extract, medicinal residues reclaim for subsequent use.
2) Rhizoma Chuanxiong, Radix Glycyrrhizae, Ramulus Uncariae Cum Uncis fleece-flower root rattan effective ingredient, and the continuous concentration change alcohol reflux of medicinal residues effective ingredient
After the Rhizoma Chuanxiong of recipe quantity, Radix Glycyrrhizae, Ramulus Uncariae Cum Uncis fleece-flower root rattan were pulverized 50 mesh sieves, at the uniform velocity added in extractor, and in extractor I, added the alcoholic solution that concentration is 95%.
Extractor top connects a water tank I, makes it to be communicated with extractor I, is provided with valve switch and flow meter I between water tank I and extractor I, and wherein flow meter I can control water in water tank I and flow into the speed of extractor I.Water in water tank I is heated, makes water temperature in water tank I consistent with temperature in extractor I.
When temperature stabilization in water tank I and extractor I is after 65 DEG C, open the valve switch of water tank I, by controlling the flow velocity of water in water tank I, the water in water tank I is made slowly to instill in extractor I, ensure that in extractor I, concentration of alcohol rate of change is 1.5%/min, continuing to stir also, control temperature is constant.After reaction 0.5h, when in extractor I, concentration of alcohol is 50%, stopping adds water, extractor I bottom valve switch I and switch II, medicinal liquid in extractor I can be derived and collect by its breaker in middle I, medicinal liquid in part extractor I can export in extractor II by switch II, and at switch II place, effusion meter is housed.Now open the switch II in extractor I, after releasing the extracting solution of 1/3, closing switch II, carry out second time concentration of alcohol change detection continuously, and the rate of change controlling now concentration of alcohol is 0.33%/min, when being 10% to concentration of alcohol after reaction 2h, in switch I, releasing medicinal liquid and cool recovery.
Extractor I bottom switch II can flow out for medicinal liquid, and is communicated with extractor II.A concentration of alcohol regulating box is provided with between the pipeline that extractor I and extractor II are communicated with, the ethanol of 95% can be added in regulating box, the medicinal liquid flowed out in extractor I mixes according to certain ratio with the ethanol in concentration adjustment case, and in regulating box, detect the concentration of ethanol.After concentration of alcohol reaches certain value, the medicinal liquid in regulating box flows in extractor II, carries out continuous concentration of alcohol change reflux, extract.
Now the concentration of alcohol in concentration adjustment case being adjusted to concentration of alcohol is 70%, and the medicinal liquid after concentration adjustment is imported extractor II.Wherein, add step (1) Chinese medicine slag in extractor II, at 65 DEG C, controlling concentration of alcohol rate of change is 0.5%/min, reaction 2h, and when being 10% to the concentration of alcohol in extractor II, derive the medicinal liquid in extractor II, cooling is reclaimed.
After extractor I merges with the medicinal liquid in II, concentrating under reduced pressure becomes thick paste.
3) process of preparing Chinese medicine of Poria and the mixing of thick paste
After simply being washed by the Poria raw material of recipe quantity, be cut into the lamellar of thickness equalization, and in the positive and negative uniform application step 2 repeatedly of Indian buead tablet) thick paste of gained, steaming and decocting 15min in steamer, controls steamer temperature and is no more than 70 DEG C;
After first time steaming and decocting terminates, again smear remaining thick paste, carry out steaming and decocting; So steaming and decocting is infiltrated in Indian buead tablet completely to thick paste for 3 times repeatedly, is dried by Poria and wears into fine powder, for subsequent use;
4) preparation of tablet
By step 1) and 3) dried cream powder of gained and fine powder add water soft material processed, wet granulation, cross after 14 mesh sieves with 60-80 DEG C at dry;
Tabletting after being mixed with magnesium stearate by dried granule, obtain plain sheet, film coating obtains ANLE PIAN 500, every sheet 0.55g.
Embodiment 3
Prescription: Radix Bupleuri 90g, Radix Angelicae Sinensis 135g, Rhizoma Chuanxiong 90g, Poria 180g, Ramulus Uncariae Cum Uncis 180g, Caulis Polygoni Multiflori 180g, the Rhizoma Atractylodis Macrocephalae (stir-fry) 180g, Radix Glycyrrhizae 68g;
Adjuvant: magnesium stearate 1.5g
Preparation method:
1) supersound extraction of Radix Bupleuri, Radix Angelicae Sinensis, Rhizoma Atractylodis Macrocephalae effective ingredient
70 mesh sieves pulverized by the Radix Bupleuri of recipe quantity, Radix Angelicae Sinensis and the Rhizoma Atractylodis Macrocephalae, to add after powder mixing in supersonic extractors and the ethanol adding 80% to not having medical material, dipping 12h; The ratio regulating material and solution in extractor is afterwards 1:20, and being heated to temperature in extractor to extractor is 45 DEG C, and ultrasonic power is set to 220W, starts to carry out supersound extraction 45min;
Repeat ultrasonic 3 times, filter, collect filtrate and be condensed into dry extract, medicinal residues reclaim for subsequent use.
2) Rhizoma Chuanxiong, Radix Glycyrrhizae, Ramulus Uncariae Cum Uncis fleece-flower root rattan effective ingredient, and the continuous concentration change alcohol reflux of medicinal residues effective ingredient
After the Rhizoma Chuanxiong of recipe quantity, Radix Glycyrrhizae, Ramulus Uncariae Cum Uncis fleece-flower root rattan were pulverized 150 mesh sieves, at the uniform velocity added in extractor, and in extractor I, added the alcoholic solution that concentration is 95%.
Extractor top connects a water tank I, makes it to be communicated with extractor I, is provided with valve switch and flow meter I between water tank I and extractor I, and wherein flow meter I can control water in water tank I and flow into the speed of extractor I.Water in water tank I is heated, makes water temperature in water tank I consistent with temperature in extractor I.
When temperature stabilization in water tank I and extractor I is after 75 DEG C, open the valve switch of water tank I, by controlling the flow velocity of water in water tank I, the water in water tank I is made slowly to instill in extractor I, ensure that in extractor I, concentration of alcohol rate of change is 0.5%/min, continuing to stir also, control temperature is constant.After reaction 1.5h, when in extractor I, concentration of alcohol is 50%, stopping adds water, extractor I bottom valve switch I and switch II, medicinal liquid in extractor I can be derived and collect by its breaker in middle I, medicinal liquid in part extractor I can export in extractor II by switch II, and at switch II place, effusion meter is housed.Now open the switch II in extractor I, after releasing the extracting solution of 1/3, closing switch II, carry out second time concentration of alcohol change detection continuously, and the rate of change controlling now concentration of alcohol is 0.67%/min, when being 10% to concentration of alcohol after reaction 1h, in switch I, releasing medicinal liquid and cool recovery.
Extractor I bottom switch II can flow out for medicinal liquid, and is communicated with extractor II.A concentration of alcohol regulating box is provided with between the pipeline that extractor I and extractor II are communicated with, the ethanol of 95% can be added in regulating box, the medicinal liquid flowed out in extractor I mixes according to certain ratio with the ethanol in concentration adjustment case, and in regulating box, detect the concentration of ethanol.After concentration of alcohol reaches certain value, the medicinal liquid in regulating box flows in extractor II, carries out continuous concentration of alcohol change reflux, extract.
Now the concentration of alcohol in concentration adjustment case being adjusted to concentration of alcohol is 70%, and the medicinal liquid after concentration adjustment is imported extractor II.Wherein, add step (1) Chinese medicine slag in extractor II, at 75 DEG C, controlling concentration of alcohol rate of change is 1%/min, reaction 1h, and when being 10% to the concentration of alcohol in extractor II, derive the medicinal liquid in extractor II, cooling is reclaimed.
After extractor I merges with the medicinal liquid in II, concentrating under reduced pressure becomes thick paste.
3) process of preparing Chinese medicine of Poria and the mixing of thick paste
After simply being washed by the Poria raw material of recipe quantity, be cut into the lamellar of thickness equalization, and in the positive and negative uniform application step 2 repeatedly of Indian buead tablet) thick paste of gained, steaming and decocting 45min in steamer, controls steamer temperature and is no more than 70 DEG C;
After first time steaming and decocting terminates, again smear remaining thick paste, carry out steaming and decocting; So steaming and decocting is infiltrated in Indian buead tablet completely to thick paste for 3 times repeatedly, is dried by Poria and wears into fine powder, for subsequent use;
4) preparation of tablet
By step 1) and 3) dried cream powder of gained and fine powder add water soft material processed, wet granulation, cross after 14 mesh sieves with 60-80 DEG C at dry;
Tabletting after being mixed with magnesium stearate by dried granule, obtains plain sheet, film coating.Obtain ANLE PIAN 500, every sheet 0.60g.
Embodiment 4
Prescription: Radix Bupleuri 90g, Radix Angelicae Sinensis 135g, Rhizoma Chuanxiong 90g, Poria 180g, Ramulus Uncariae Cum Uncis 180g, Caulis Polygoni Multiflori 180g, the Rhizoma Atractylodis Macrocephalae (stir-fry) 180g, Radix Glycyrrhizae 68g;
Adjuvant: magnesium stearate 1.5g, river wax 0.18g, gelatin 1.8g, sucrose 120g, Pulvis Talci 132g
Preparation method:
1) supersound extraction of Radix Bupleuri, Radix Angelicae Sinensis, Rhizoma Atractylodis Macrocephalae effective ingredient
40 mesh sieves pulverized by the Radix Bupleuri of recipe quantity, Radix Angelicae Sinensis and the Rhizoma Atractylodis Macrocephalae, to add after powder mixing in supersonic extractors and the ethanol adding 60% to not having medical material, dipping 36h; The ratio regulating material and solution in extractor is afterwards 1:15, and being heated to temperature in extractor to extractor is 38 DEG C, and ultrasonic power is set to 240W, starts to carry out supersound extraction 42min;
Repeat ultrasonic 3 times, filter, collect filtrate and be condensed into dry extract, medicinal residues reclaim for subsequent use.
2) Rhizoma Chuanxiong, Radix Glycyrrhizae, Ramulus Uncariae Cum Uncis fleece-flower root rattan effective ingredient, and the continuous concentration change alcohol reflux of medicinal residues effective ingredient
After the Rhizoma Chuanxiong of recipe quantity, Radix Glycyrrhizae, Ramulus Uncariae Cum Uncis fleece-flower root rattan were pulverized 150 mesh sieves, at the uniform velocity added in extractor, and in extractor I, added the alcoholic solution that concentration is 95%.
Extractor top connects a water tank I, makes it to be communicated with extractor I, is provided with valve switch and flow meter I between water tank I and extractor I, and wherein flow meter I can control water in water tank I and flow into the speed of extractor I.Water in water tank I is heated, makes water temperature in water tank I consistent with temperature in extractor I.
When temperature stabilization in water tank I and extractor I is after 72 DEG C, open the valve switch of water tank I, by controlling the flow velocity of water in water tank I, the water in water tank I is made slowly to instill in extractor I, ensure that in extractor I, concentration of alcohol rate of change is 0.75%/min, continuing to stir also, control temperature is constant.After reaction 1h, when in extractor I, concentration of alcohol is 50%, stopping adds water, extractor I bottom valve switch I and switch II, medicinal liquid in extractor I can be derived and collect by its breaker in middle I, medicinal liquid in part extractor I can export in extractor II by switch II, and at switch II place, effusion meter is housed.Now open the switch II in extractor I, after releasing the extracting solution of 1/3, closing switch II, carry out second time concentration of alcohol change detection continuously, and the rate of change controlling now concentration of alcohol is 0.51%/min, when being 10% to concentration of alcohol after reaction 1.8h, in switch I, releasing medicinal liquid and cool recovery.
Extractor I bottom switch II can flow out for medicinal liquid, and is communicated with extractor II.A concentration of alcohol regulating box is provided with between the pipeline that extractor I and extractor II are communicated with, the ethanol of 95% can be added in regulating box, the medicinal liquid flowed out in extractor I mixes according to certain ratio with the ethanol in concentration adjustment case, and in regulating box, detect the concentration of ethanol.After concentration of alcohol reaches certain value, the medicinal liquid in regulating box flows in extractor II, carries out continuous concentration of alcohol change reflux, extract.
Now the concentration of alcohol in concentration adjustment case being adjusted to concentration of alcohol is 70%, and the medicinal liquid after concentration adjustment is imported extractor II.Wherein, add step (1) Chinese medicine slag in extractor II, at 72 DEG C, controlling concentration of alcohol rate of change is 0.67%/min, reaction 1.5h, and when being 10% to the concentration of alcohol in extractor II, derive the medicinal liquid in extractor II, cooling is reclaimed.
After extractor I merges with the medicinal liquid in II, concentrating under reduced pressure becomes thick paste.
3) process of preparing Chinese medicine of Poria and the mixing of thick paste
After simply being washed by the Poria raw material of recipe quantity, be cut into the lamellar of thickness equalization, and in the positive and negative uniform application step 2 repeatedly of Indian buead tablet) thick paste of gained, steaming and decocting 38min in steamer, controls steamer temperature and is no more than 70 DEG C;
After first time steaming and decocting terminates, again smear remaining thick paste, carry out steaming and decocting; So steaming and decocting is infiltrated in Indian buead tablet completely to thick paste for 3 times repeatedly, is dried by Poria and wears into fine powder, for subsequent use;
4) preparation of tablet
By step 1) and 3) dried cream powder of gained and fine powder add water soft material processed, wet granulation, cross after 14 mesh sieves with 60-80 DEG C at dry;
Tabletting after being mixed with magnesium stearate by dried granule, obtains plain sheet, film coating.Obtain ANLE PIAN 500, every sheet 0.5g.
The extraction of comparative example 1 Radix Bupleuri effective ingredient
The dry coarse powder of Radix Bupleuri of recipe quantity, is placed in extractor and carries out, after flooding 6h, collect volatile oil at 40 DEG C;
By the alcohol reflux 1h that contain 95% of 5% ammonia of volatile oil by 8 times amount.Repeat extraction twice.
Comparative example 2: Radix Angelicae Sinensis extracts active ingredients
Drop in the volatile oil is drawn tank of SCF-CO 2 device after the Radix Angelicae Sinensis getting recipe quantity crosses 20-30 mesh sieve, the ethanol adding 20ml95% does entrainer.
To extraction kettle, separating still I, separating still II heats, when extraction temperature is shown as 40-45 DEG C, separating still I temperature is 35 DEG C, when separating still II temperature is 30 DEG C, opens CO2 gas cylinder, until extraction kettle pressure is 25-30MPa, separating still I pressure is 10MPa, when separating still II pressure is 8.0MPa, starts cycling extraction, the flow regulating CO2 is 6.5kg/h, constant temperature and pressure extracts, and after 180min, collects Radix Angelicae Sinensis volatile oil slightly oily.
Comparative example 3: Rhizoma Atractylodis Macrocephalae extracts active ingredients
Drop in the volatile oil is drawn tank of SCF-CO 2 device after 20-30 mesh sieve crossed by the Rhizoma Atractylodis Macrocephalae getting recipe quantity.
To extraction kettle, separating still I, separating still II heats, when extraction temperature is shown as 40 DEG C, separating still I temperature is 35 DEG C, when separating still II temperature is 30 DEG C, opens CO2 gas cylinder, until extraction kettle pressure is 30MPa, separating still I pressure is 10MPa, when separating still II pressure is 8.0MPa, starts cycling extraction, the flow regulating CO2 is 13.1kg/h, constant temperature and pressure extracts, and after 90min, collects Rhizoma Atractylodis Macrocephalae volatile oil slightly oily.
Comparative example 4: the extraction of Rhizoma Chuanxiong effective ingredient
Get Rhizoma Chuanxiong according to the percolation under fluid extract and extractum item with 70% ethanol for solvent stain is after 24 hours, carry out percolation, collect liquid of filtering, recovery ethanol alcohol, is condensed into the thick paste that relative density is 1.30 ~ 1.35 (20 DEG C).
Comparative example 5: the extraction of effective liquorice
Radix Glycyrrhizae decocts with water secondary, each 2 hours, filters. and merging filtrate also concentrates to obtain thick paste.
Comparative example 6; The extraction of Caulis Polygoni Multiflori effective ingredient
In the Caulis Polygoni Multiflori of recipe quantity, distilled water is added by solid-liquid ratio 1:10,50 DEG C of water-bath warm macerating 30min, the cellulase of 3% is added after cooling, be 5.0 at pH, hydrolysis temperature is enzymolysis 3h at 50 DEG C, and then under 90 DEG C of price modifications, constant temperature extracts 2h, filter, filtrate reduced in volume vacuum drying obtains Caulis Polygoni Multiflori extract.
The preparation of comparative example 7 ANLE PIAN
Prescription: Radix Bupleuri 90g, Radix Angelicae Sinensis 135g, Rhizoma Chuanxiong 90g, Poria 180g, Ramulus Uncariae Cum Uncis 180g, Caulis Polygoni Multiflori 180g, Rhizoma Atractylodis Macrocephalae (parched) 180g, Radix Glycyrrhizae 68g;
Preparation method:
Get Radix Angelicae Sinensis, Rhizoma Chuanxiong, join in CO2 supercritical extraction device, ethanol is as entrainer, the percent by volume that entrainer accounts for total extractant is 4-6%, extracting pressure 15-30MPa, temperature 30-50 DEG C, CO2 flow 1-3ml/g crude drug min, extraction time 150-180min, obtains supercritical extract, for subsequent use;
Get Radix Bupleuri, Poria, Ramulus Uncariae Cum Uncis, Caulis Polygoni Multiflori, Rhizoma Atractylodis Macrocephalae (parched), Radix Glycyrrhizae, pulverize, add 70% ethanol of 2L, drop in microwave extracting apparatus and carry out microwave extracting, extraction power 400-600W, extracts 2 times, each 4-8 minute, combining extraction liquid, concentrated, be added on D101 macroporous adsorptive resins, 50% ethanol elution, collect 5 times amount column volume eluents, decompression recycling ethanol, concentrated and dry, obtain microwave extraction thing, for subsequent use; By above-mentioned supercritical extract and the mixing of microwave extraction thing, add starch, 70% ethanol granule, dry, tabletting, makes 1000.
The preparation of comparative example 8 ANLE PIAN
Prescription: Radix Bupleuri 90g, Radix Angelicae Sinensis 135g, Rhizoma Chuanxiong 90g, Poria 180g, Ramulus Uncariae Cum Uncis 180g, Caulis Polygoni Multiflori 180g, Rhizoma Atractylodis Macrocephalae (parched) 180g, Radix Glycyrrhizae 68g;
Preparation method:
Get Radix Bupleuri 90g, Radix Angelicae Sinensis 135g, Rhizoma Chuanxiong 90g, Poria 180g, Ramulus Uncariae Cum Uncis 180g, Caulis Polygoni Multiflori 180g, Rhizoma Atractylodis Macrocephalae (parched) 180g, Radix Glycyrrhizae 68g, join in CO2 supercritical extraction device, ethanol is as entrainer, the percent by volume that entrainer accounts for total extractant is 4-6%, extracting pressure 15-30MPa, temperature 30-50 DEG C, CO2 flow 1-3ml/g crude drug min, extraction time 150-180min, obtains supercritical extract, adds starch, 70% ethanol granule, drying, tabletting, makes 500.
The preparation of comparative example 9 ANLE PIAN
Prescription: Radix Bupleuri 90g, Radix Angelicae Sinensis 135g, Rhizoma Chuanxiong 90g, Poria 180g, Ramulus Uncariae Cum Uncis 180g, Caulis Polygoni Multiflori 180g, the Rhizoma Atractylodis Macrocephalae (stir-fry) 180g, Radix Glycyrrhizae 68g;
Preparation method:
Above eight tastes, hook taking rattan, Radix Bupleuri half and half amount, be ground into fine powder, sieve; The Six-elements such as second half and all the other Poria decoct with water secondary, each 2 hours, collecting decoction, and filter, filtrate is concentrated into the clear paste that relative density is about 1.28, add the mixing of above-mentioned powder, make granule, dry, are pressed into 1000, sugar coating, obtain final product.
The supersound extraction research of experimental example 1, Radix Bupleuri, Radix Angelicae Sinensis, Rhizoma Atractylodis Macrocephalae effective ingredient
1.1 steps 1 of the present invention) research of experiment condition
Step 1 of the present invention) in the extracting method of Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae and Radix Bupleuri be supersound extraction, the method belongs to modern extraction process, compared with traditional extraction technique, has very superior performance, can improve the extraction ratio of effective ingredient in raw material.This study portion, for the extraction process of this step of the present invention, contrasts with prior art, measures the content with property composition in the yield of its volatile oil and each material.
Wherein in Radix Bupleuri, the mensuration of saikoside a content measures according to the assay method of saikoside a described in version " Chinese Pharmacopoeia " Chinese medicine in 2010 Radix Bupleuri part.
The assay of ferulic acid from Chinese angelica measures according to assay method described in version " Chinese Pharmacopoeia " Chinese medicine in 2010 Radix Angelicae Sinensis part.
In the Rhizoma Atractylodis Macrocephalae, the mensuration of pulchinenoside content measures described in version " Chinese Pharmacopoeia " Chinese medicine in 2010 Rhizoma Atractylodis Macrocephalae part.
The investigation of table 1 experiment condition of the present invention
Conclusion: step 1 of the present invention) extraction process taked effectively can improve the yield of volatile oil yield and effective ingredient, has good effect.
In addition, about the reason that its effective ingredient improves, although its reason cannot be known, infer may because wherein in each material effective ingredient can mutually promote in leaching process.
Experimental example 2: Rhizoma Chuanxiong, Radix Glycyrrhizae, Ramulus Uncariae Cum Uncis fleece-flower root rattan effective ingredient, and the continuous concentration change alcohol reflux research of medicinal residues effective ingredient
Chemical composition of Chinese materia medica is complicated, and heterogeneity polarity difference is large, the polyol that such as glucose, sucrose equimolecular are smaller, has strongly hydrophilic, very easily water-soluble.Protein and aminoacid are all soda acid amphoteric compounds, have polarity to a certain degree, so can be water-soluble, be insoluble to or be insoluble in organic solvent.The dissolubility of flavone compound has very big-difference because of structure and existence (glycosides or aglycon, monoglycosides, disaccharidase glycosides or three glucosides) difference.Glycoside is all strong than the hydrophilic of its aglycon, and be particularly often combined with most glycan molecule in the molecule of saponin due to them, hydroxy number is many, can show stronger hydrophilic, and sapogenin then belongs to the strong compound of lipotropy.Most free alkaloids is lipophilic compound, after acid is in conjunction with salify, can ionizing, and strengthen polarity, these alkaloids can be described as semi-polarity compound.So alkaloidal salt is soluble in water, insoluble or be insoluble in organic solvent; And most free alkaloid is insoluble or be insoluble in water, be soluble in lipophilic solvent.Oils and fats, volatile oil, fat-soluble pigment are all strong lipophilic compositions.Chinese medicine extraction often needs effective component extracting as much as possible, strengthens pharmaceutically active.Step of the present invention (2) adopts continuously the method that dynamically concentration of alcohol extracts to extract Chinese medicine, can extract the effective ingredient of opposed polarity more fully.
This research step is for step 2) extracting method of Raw, extraction conditions and extraction effect are studied, and random selecting Rhizoma Chuanxiong, Radix Glycyrrhizae fleece-flower root rattan are object of study, wherein principle active component is investigated.
Wherein, in Rhizoma Chuanxiong, Radix Glycyrrhizae fleece-flower root rattan, the assay method of effective ingredient all measures according to version " Chinese Pharmacopoeia " Chinese medicine in 2010 Rhizoma Chuanxiong, the described method of Radix Glycyrrhizae fleece-flower root rattan part.It is as shown in table 2 that it investigates result.
Table 2 extractor I method investigates result
Conclusion: table 2 can find out step 2 of the present invention) in extracting method compared with prior art, effectively can improve the yield of effective ingredient, there is good effect; And in table 3, investigated the effect that extractor II Chinese medicine slag extracts again further, the extracting method of unexpected discovery step of the present invention (2) not only further can improve extraction efficiency, and good effect is also served for the recycling of effective ingredient in medicinal residues, prove that the method is effective and feasible.
Experimental example 3: Processing Technology of Poria Cocos is studied
Step 3 of the present invention) in by Poria concoct after mix with thick paste.In the processing of medical material, the method that Chang Huiyong concocts is processed, and usual medical material, after concocting, can reduce the content of harmful substance, improves the ratio of effective ingredient.Therefore, step 3 of the present invention) method of also attempting to use for reference the process of preparing Chinese medicine conventional in Chinese medicine processes Poria and thick paste, to reaching useful effect.To this, the present invention to the effective ingredient after concocting in Poria and after concocting the mixture of Poria and thick paste analyze, its experimental procedure and result as follows.
The mensuration of 3.1 pachyman content
Phenol 100g is got in the preparation of 4% phenol solution, with aluminium flake 0.1g and sodium bicarbonate 0.05g, distill and collect 182 DEG C of fractions, taking 4g, be dissolved in water to graduation mark at 100ml volumetric flask, then put cold preservation in refrigerator (its fraction must be collected 182 DEG C time) for subsequent use.In still-process, also to control degree of condensation well, if the discharge in condensing tube is too fast, then can makes fraction crystallization wherein very soon and have influence on the normal collection of fraction.
Preparation standard curve
Precision takes the anhydrous grape saccharide 15mg putting dry more than 12h in phosphorus pentoxide vacuum drying apparatus, put in 25ml volumetric flask, be dissolved in water and be diluted to scale, shaking up (about 24 DEG C) under putting room temperature (concentration is 0.6mg/ml) for subsequent use.Precision measures reference substance solution 0.0,1.0,2.0,3.0,4.0,5.0ml, is placed in 100ml volumetric flask respectively, and adds water to scale, shake up.Precision measures above-mentioned each solution 2ml, puts in tool plug test tube, adds the phenol solution 1ml of 4% respectively, add rapidly concentrated sulphuric acid 7.0ml, shake up after mixing, and take out be incubated 30min in 45 DEG C of water-baths after, put in ice-water bath and take out after 5min.Then with the 1st part for blank group, measure its trap A with spectrophotography at the wavelength place of 490nm, with absorbance (A) for vertical coordinate, solution concentration C is abscissa.Statistics, carries out linear regression.Obtain regression equation: Y=0.0114+0.0183X, correlation coefficient r=0.9995, concentration of glucose is good linear relationship at 0.006 ~ 0.03mg/ml scope internal absorbance and concentration.
Phend-sulphuric acid surveys pachyman content
Each extracting method gained sample is made the solution of 1g/ml, precision measures 2ml, method under the preparation of sighting target directrix curve, with its absorbance of determined by ultraviolet spectrophotometry, from the regression equation of standard curve, calculate solution concentration to be measured, and calculate its polyoses content (with glucose gauge) further.Shown in its result table table 4.
Table 4 measurement result result
The investigation of Poria and thick paste after 3.2 processes of preparing Chinese medicine
Learnt from else's experience after concocting and be mixed with the Indian buead tablet of thick paste, observe outward appearance and the uniformity etc. of powder after beating powder of material after concocting, it the results are shown in Table 5.
The mixing situation of table 5 material
Conclusion: shown by the experiment of table 4 and 5, through the process of preparing Chinese medicine of step of the present invention (3), not only can improve the effective ingredient pachyman in Poria, and unexpected discovery the method can by thick paste and medical material Homogeneous phase mixing, this just makes the present invention in the preparation process of tablet, material be fully mixed into possibility, thus saving time, under saving the prerequisite of the energy, the content uniformity of medicine effective ingredient is improved, while raising drug effect, product of the present invention is realized further quality controllable, substantially increase its qualification rate.
Experimental example 4: zoopery
4.1 female Wistar rats, about body weight 260g, gets rear adaptability and feeds 3 days.
Oophorectomize: rat, with 30mg/kg.bw lumbar injection 1% sodium pentobarbital solution, carries out bilateral oophorectomy after anesthesia, the penicillin of postoperative muscle injection 20,000 units, for three days on end.Sham operated rats only excises about 0.5g fat after opening abdominal cavity, retain bilateral ovaries.
Animal divides into groups: female Wistar rats is divided into sham operated rats, model control group, positive controls and inventive samples group at random by body weight, often organizes 10 rats.Postoperative 3rd day starts to give tested material, and sham operated rats and model control group are with deionized water gavage, and positive controls per os gives the Alendronic Acid uranium of 1.0mg/kg.bw, and medicine group per os of the present invention gives respectively to organize rat oral gavage amount every day and is 10ml/kg.bw.The all single cage of experimental session every rat is raised, and feed self-control feedstuff, freely drink deionized water, experiment periods is three months.
4.2 index determinings:
(1) measured body weight and food utilization calculate: experimental session, routine observation rat general status, record rats eating amount, weigh weekly once, are calculated as follows:
Day body weight evolution/90, food utilization=90 day total food-intake × 100%
(2) femur weight in wet base, dry weight and length measurment: put to death rat after last gavage 24h, peels off rapidly right side femur, removes muscle and soft tissue, by ten thousand/electronic balance weighing femur weight in wet base, by its length of vernier caliper measurement.Femur is placed in 105 DEG C of baking 48h, claims femur dry weight, continue baking 2h, again weigh femur dry weight, twice difference is heavily less than 0.3mg, can think and reach constant weight.
(3) bone densitometry: remove after the femur of soft tissue is baked to constant weight, under identical conditions, utilize the SD-1000 type bone mineral measuring instrument through standard bone model calibration to measure bone mineral content (BMC) and the bone width (BW) of femur mid point and dry end respectively, be calculated as follows compact bone (BMD) often some replication twice of each measuring point.
Bone density (g/cm
2)=bone mineral content (g/cm)/bone width (cm)
(4) bone calcium measures: the femur of oven dry is put into micro-wave digestion pipe, adds 5ml nitric acid, clear up to clear solution in microwave oven; Sample solution after clearing up, after catching up with acid, quantitatively shifts with distilled water and is settled to and add 0.1g/l lanthanum chloride solution after 10.0ml suitably dilutes and substantially improve liquid, to be measured after distilled water standardize solution.GBW (E) 080118 calcium unit series Z5000 type atomic absorption spectrophotometer is measured this concentration in each standard pipe and sample cell at 422.7nm place, is calculated as follows calcium content of bone:
Calcium content of bone (mg/g)=(C-C
0) × v × B/M × 1000
In formula: C, Co-are respectively the calcium concentration (mg/L) in the sample and blank solution recorded;
V-sample constant volume (ml); B-extension rate; M-bone sample dry weight (g).
Data statistics: in experiment the data obtained SPSS statistical package, Independent samples t-test method carries out statistical analysis, p<0.05 is that difference has and shows property.
5.3 results:
(1) fine drug powder of the present invention is on the impact of rat body weight
Table 6 is on the impact of rat body weight
| Group | 0 month body weight (g) | Body weight in January (g) | Body weight in February (g) | Body weight in March (g) |
| Sham operated rats | 267±9.8 | 312.5±13.6 | 326.2±13.6 | 348.0±16 |
| Model control group | 267.8±10.1 | 356.9±15.7 | 371.2±15.7 | 387.1±12.8 |
| Embodiment 1 | 267.8±10.1 | 358.9±19.0 | 372.2±20.1 | 391.0±21.2 |
| Embodiment 2 | 267.8±10.1 | 360.0±18.3 | 372.4±22.8 | 389.1±24.1 |
| Embodiment 3 | 267.8±10.1 | 352.1±14.2 | 362.1±15.3 | 380.5±15.3 |
| Embodiment 4 | 267.8±10.1 | 354.2±13.5 | 370.9±14.3 | 388.7±15.8 |
| Comparative example 7 | 267.8±10.1 | 351.4±17.5 | 364.5±16.2 | 384.9±1638 |
| Comparative example 8 | 267.8±10.1 | 359.0±12.1 | 366.9±16.5 | 381.2±19.4 |
| Comparative example 9 | 267.8±10.1 | 349.1±11.0 | 368.1±17.4 | 380.6±13.7 |
| Positive controls | 266.5±10.1 | 351.5±14.5 | 364.6±14.6 | 3815±14.6 |
As shown in Table 6, medicine of the present invention body weight in each period compared with model comparison without significant difference.
(2) on the impact of rat body weight weightening finish, always intake and food utilization, in table 7.
Table 7 is on the impact of rat body weight weightening finish, always intake and food utilization
| Group | Number of elements (only) | Weightening finish (g) | Total intake (g) | Food utilization (%) |
| Sham operated rats | 10 | 80.6±11.6 | 1567.3±56.1 | 5.48±0.14 |
| Model control group | 10 | 120.3±9.3 | 1632.9±64.9 | 7.44±0.57 |
| Embodiment 1 | 10 | 125.3±15.8 | 1633.1±73.5 | 7.91±0.62 |
| Embodiment 2 | 10 | 122.3±11.6 | 1637.4±92.6 | 7.89±0.67 |
| Embodiment 3 | 10 | 124.5±12.7 | 1632.1±86.4 | 7.80±0.39 |
| Embodiment 4 | 10 | 121.8±13.4 | 1630.1±89.2 | 7.88±0.49 |
| Comparative example 7 | 10 | 116.7±15.4 | 1613.7±92.9 | 7.67±0.84 |
| Comparative example 8 | 10 | 117.5±14.2 | 1609.5±103.2 | 7.66±0.22 |
| Comparative example 9 | 10 | 119.3±13.1 | 1617.2±64.1 | 7.78±0.71 |
| Positive controls | 10 | 115.0±16.4 | 1620.4±57.2 | 7.01±0.74 |
As shown in Table 7, it is obvious that model group and sham operated rats compare weight gain, food use significantly improves (p<0.01), and all the other are respectively organized rat body weight weightening finish, total intake and food utilization and to compare with model group without significant difference (p>0.05).
(3) on the impact of rat body weight weightening finish, always intake and food utilization, the results are shown in Table 8.
Table 8 is on the impact of rat body weight weightening finish, always intake and food utilization
| Group | Number of elements (only) | Weight in wet base (g) | Dry weight (g) | Bone long (cm) |
| Sham operated rats | 10 | 0.74±0.04 | 0.566±0.004 | 3.48±0.04 |
| Model control group | 10 | 0.69±0.04 | 0.509±0.006 | 3.44±0.05 |
| Embodiment 1 | 10 | 0.77±0.04 | 0.586±0.001 | 3.91±0.06 |
| Embodiment 2 | 10 | 0.76±0.5 | 0.585±0.006 | 3.89±0.06 |
| Embodiment 3 | 10 | 0.75±0.05 | 0.587±0.006 | 3.80±0.03 |
| Embodiment 4 | 10 | 0.76±0.04 | 0.580±0.004 | 3.88±0.04 |
| Comparative example 7 | 10 | 0.74±0.05 | 0.574±0.003 | 3.67±0.08 |
| Comparative example 8 | 10 | 0.74±0.02 | 0.579±0.006 | 3.66±0.02 |
| Comparative example 9 | 10 | 0.74±0.01 | 0.581±0.008 | 3.78±0.07 |
| Positive controls | 10 | 0.75±0.03 | 0.581±0.010 | 3.81±0.07 |
From table 8, model group rats femur weight in wet base, dry weight significantly reduce with sham operated rats, and have significant difference (p<0.05); Positive controls compares with model group, and femur weight in wet base and dry weight have increase, and has significant difference (p<0.01); Medicine of the present invention compares with model group, and femur weight in wet base and dry weight have significant difference (p<0.05), individual dosage group rat femur length there was no significant difference (p>0.05).
(4) medicine of the present invention is on the impact of rat bone mineral content (BMC) and bone density (BMD).In table 9.
Table 9 is on the impact of rat bone mineral content (BMC) and bone density (BMD)
From table 9, rats in sham-operated group femur mid point and Distal femoral metaphysis bone density (BMD) bone mineral content (BMC) compare with model group significant difference (p<0.05), and positive controls and embodiment of the present invention group rat femur mid point and Distal femoral metaphysis bone density (BMD) bone mineral content (BMC) compare with model group significant difference (p<0.05).
(5) medicine of the present invention is on the impact of rat bone calcium content, in table 10
Table 10 is on the impact of rat bone calcium content
| Group | Number of elements (only) | Dosage (mg/kg.bw) | Calcium content of bone (mg/g) |
| Sham operated rats | 10 | 0 | 313.7±31.8 |
| Model control group | 10 | 0 | 278.7±17.1 |
| Embodiment 1 | 10 | 1260 | 305.5±11.5 |
| Embodiment 2 | 10 | 1258 | 302.2±31.7 |
| Embodiment 3 | 10 | 1254 | 311.6±17.8 |
| Embodiment 4 | 10 | 1247 | 307.5±16.7 |
| Comparative example 7 | 10 | 420 | 299.1±12.5 |
| Comparative example 8 | 10 | 210 | 300.2±25.7 |
| Comparative example 9 | 10 | 840 | 304.2±18.1 |
| Positive controls | 10 | 1 | 300.3±9.2 |
4.4 conclusion
(1) per os gives different drug test results and shows, medicine group rat femur weight in wet base of the present invention, dry weight, bone density (BMD), there were significant differences (p<0.05 or p<0.01) with model control group ratio for bone mineral content (BMC) and calcium content of bone, medicine group rat femur dry weight of the present invention, bone density (BMD), bone mineral content (BMC), calcium content of bone and model control group are than there were significant differences (p<0.05 or p<0.01), can judge that medicine of the present invention can increase rat bone density.
(2) on the impact of sexual function: medicine of the present invention makes anterior pituitary of rat, ovary, uterus weight; Make ovariectomized female rats hypophysis to injection luteinizing hormone releasing hormone (LRH) afterwards LH secretory reaction obviously increase, plasma LH levels significantly improves, and mice plasma testosterone concentration is obviously increased, testis and levator ani m. weightening finish, has obviously short sexual function effect.
(3) immunoregulation effect: medicine of the present invention makes sheep red blood cell (SRBC) (SRBC) immune serum hemolytic antibody level and spleen antibody tormation level improve, spleen antibody-producting cell (PFC) number increases, lymphocyte transformation can be promoted significantly, significantly strengthen macrophage phagocytic function, mouse peritoneal M φ phagocytic rate and phagocytic index are improved.Be significantly improved the cellular immune function of leukopenia patient, after treatment, lymphocyte stimulation indices increases, and immune complex titre has and reduces trend gradually.
(4) on the impact of cardiovascular system: medicine of the present invention obviously increases isolated guinea pig heart coronary flow, also protective effect is had to the Rabbit Myocardium ischemia injury that pituitrin brings out.
(5) anti-aging effects: fine drug powder of the present invention can resist the lymphproliferation response that D-gal Aging model mice spleen induced by ConA and significantly decline, and splenocyte lipid peroxide LPS induces
3h-TdR mixes B cell index obviously to be reduced, degradation effect under hepatocyte lipid peroxide (LPO) content rising regulating liver-QI total number born (SOD) vigor, and lipofuscin content in the heart, hepatic tissue is declined.
Claims (3)
1. an ANLE PIAN, its prescription comprises Radix Bupleuri 90g, Radix Angelicae Sinensis 135g, Rhizoma Chuanxiong 90g, Poria 180g, Ramulus Uncariae Cum Uncis 180g, Caulis Polygoni Multiflori 180g, Rhizoma Atractylodis Macrocephalae (parched) 180g, Radix Glycyrrhizae 68g; It is characterized in that: its preparation method is 1)) Radix Bupleuri, Radix Angelicae Sinensis, Rhizoma Atractylodis Macrocephalae effective ingredient supersound extraction, 2) Rhizoma Chuanxiong, Radix Glycyrrhizae, Ramulus Uncariae Cum Uncis fleece-flower root rattan effective ingredient, and the continuous concentration change alcohol reflux of medicinal residues effective ingredient, 3) process of preparing Chinese medicine of Poria and the mixing of thick paste, the 4) preparation of tablet.
2. ANLE PIAN according to claim 1, is characterized in that: its preparation method is
1) supersound extraction of Radix Bupleuri, Radix Angelicae Sinensis, Rhizoma Atractylodis Macrocephalae effective ingredient
20-70 mesh sieve pulverized by the Radix Bupleuri of recipe quantity, Radix Angelicae Sinensis and the Rhizoma Atractylodis Macrocephalae, to add after powder mixing in supersonic extractors and the ethanol adding 50-80% to not having medical material, dipping 12-48h; The ratio regulating material and solution in extractor is afterwards 1:10-1:20, and being heated to temperature in extractor to extractor is 35-45 DEG C, and ultrasonic power is set to 180-240W, starts to carry out supersound extraction 35-45min;
Repeat ultrasonic 3 times, filter, collect filtrate and be condensed into dry extract, medicinal residues reclaim for subsequent use;
2) Rhizoma Chuanxiong, Radix Glycyrrhizae, Ramulus Uncariae Cum Uncis fleece-flower root rattan effective ingredient, and the continuous concentration change alcohol reflux of medicinal residues effective ingredient
After the Rhizoma Chuanxiong of recipe quantity, Radix Glycyrrhizae, Ramulus Uncariae Cum Uncis fleece-flower root rattan were pulverized 50-150 mesh sieve, at the uniform velocity added in extractor, and in extractor I, added the alcoholic solution that concentration is 95%;
Extractor top connects a water tank I, makes it to be communicated with extractor I, is provided with valve switch and flow meter I between water tank I and extractor I, and wherein flow meter I can control water in water tank I and flow into the speed of extractor I; Water in water tank I is heated, makes water temperature in water tank I consistent with temperature in extractor I;
When temperature stabilization in water tank I and extractor I is after 65-75 DEG C, open the valve switch of water tank I, by controlling the flow velocity of water in water tank I, the water in water tank I is made slowly to instill in extractor I, ensure that in extractor I, concentration of alcohol rate of change is 0.5-1.5%/min, continuing to stir also, control temperature is constant, after reaction 0.5-1.5h, when in extractor I, concentration of alcohol is 50%, stopping adds water, extractor I bottom valve switch I and switch II, medicinal liquid in extractor I can be derived and collect by its breaker in middle I, medicinal liquid in part extractor I can export in extractor II by switch II, and at switch II place, effusion meter is housed, now open the switch II in extractor I, after releasing the extracting solution of 1/3, closing switch II, carry out second time concentration of alcohol change detection continuously, and the rate of change controlling now concentration of alcohol is 0.33-0.67%/min, when being 10% to concentration of alcohol after reaction 1-2h, in switch I, release medicinal liquid and cool recovery,
Extractor I bottom switch II can flow out for medicinal liquid, and is communicated with extractor II; A concentration of alcohol regulating box is provided with between the pipeline that extractor I and extractor II are communicated with, the ethanol of 95% can be added in regulating box, the medicinal liquid flowed out in extractor I mixes according to certain ratio with the ethanol in concentration adjustment case, and in regulating box, detect the concentration of ethanol; After concentration of alcohol reaches certain value, the medicinal liquid in regulating box flows in extractor II, carries out continuous concentration of alcohol change reflux, extract;
Now the concentration of alcohol in concentration adjustment case being adjusted to concentration of alcohol is 70%, and the medicinal liquid after concentration adjustment is imported extractor II,
Wherein, add step (1) Chinese medicine slag in extractor II, at 65-75 DEG C, controlling concentration of alcohol rate of change is 0.5-1%/min, reaction 1-2h, and when being 10% to the concentration of alcohol in extractor II, derive the medicinal liquid in extractor II, cooling is reclaimed;
After extractor I merges with the medicinal liquid in II, concentrating under reduced pressure becomes thick paste;
3) process of preparing Chinese medicine of Poria and the mixing of thick paste
After simply being washed by the Poria raw material of recipe quantity, be cut into the lamellar of thickness equalization, and in the positive and negative uniform application step 2 repeatedly of Indian buead tablet) thick paste of gained, steaming and decocting 15-45min in steamer, controls steamer temperature and is no more than 70 DEG C;
After first time steaming and decocting terminates, again smear remaining thick paste, carry out steaming and decocting; So steaming and decocting is infiltrated in Indian buead tablet completely to thick paste for 3 times repeatedly, is dried by Poria and wears into fine powder, for subsequent use;
4) preparation of tablet
By step 1) and 3) dried cream powder of gained and fine powder add water soft material processed, wet granulation, cross after 14 mesh sieves with 60-80 DEG C at dry;
Tabletting after being mixed with magnesium stearate by dried granule, obtains plain sheet, film coating; Obtain ANLE PIAN 500, every more than sheet 0.5g.
3. ANLE PIAN according to claim 2, is characterized in that: its preparation method is
1) supersound extraction of Radix Bupleuri, Radix Angelicae Sinensis, Rhizoma Atractylodis Macrocephalae effective ingredient
50 mesh sieves pulverized by the Radix Bupleuri of recipe quantity, Radix Angelicae Sinensis and the Rhizoma Atractylodis Macrocephalae, to add after powder mixing in supersonic extractors and the ethanol adding 70% to not having medical material, dipping 24h; The ratio regulating material and solution in extractor is afterwards 1:12, and being heated to temperature in extractor to extractor is 40 DEG C, and ultrasonic power is set to 200W, starts to carry out supersound extraction 40min;
Repeat ultrasonic 3 times, filter, collect filtrate and be condensed into dry extract, medicinal residues reclaim for subsequent use;
2) Rhizoma Chuanxiong, Radix Glycyrrhizae, Ramulus Uncariae Cum Uncis fleece-flower root rattan effective ingredient, and the continuous concentration change alcohol reflux of medicinal residues effective ingredient
After the Rhizoma Chuanxiong of recipe quantity, Radix Glycyrrhizae, Ramulus Uncariae Cum Uncis fleece-flower root rattan were pulverized 100 mesh sieves, at the uniform velocity added in extractor, and in extractor I, added the alcoholic solution that concentration is 95%;
Extractor top connects a water tank I, makes it to be communicated with extractor I, is provided with valve switch and flow meter I between water tank I and extractor I, and wherein flow meter I can control water in water tank I and flow into the speed of extractor I; Water in water tank I is heated, makes water temperature in water tank I consistent with temperature in extractor I;
When temperature stabilization in water tank I and extractor I is after 68 DEG C, open the valve switch of water tank I, by controlling the flow velocity of water in water tank I, the water in water tank I is made slowly to instill in extractor I, ensure that in extractor I, concentration of alcohol rate of change is 0.75%/min, continuing to stir also, control temperature is constant; After reaction 1h, when in extractor I, concentration of alcohol is 50%, stopping adds water, extractor I bottom valve switch I and switch II, medicinal liquid in extractor I can be derived and collect by its breaker in middle I, medicinal liquid in part extractor I can export in extractor II by switch II, and at switch II place, effusion meter is housed
Now open the switch II in extractor I, after releasing the extracting solution of 1/3, closing switch II, carry out second time concentration of alcohol change detection continuously, and the rate of change controlling now concentration of alcohol is 0.44%/min, when being 10% to concentration of alcohol after reaction 1.5h, in switch I, releasing medicinal liquid and cool recovery;
Extractor I bottom switch II can flow out for medicinal liquid, and is communicated with extractor II,
A concentration of alcohol regulating box is provided with between the pipeline that extractor I and extractor II are communicated with, the ethanol of 95% can be added in regulating box, the medicinal liquid flowed out in extractor I mixes according to certain ratio with the ethanol in concentration adjustment case, and in regulating box, detect the concentration of ethanol; After concentration of alcohol reaches certain value, the medicinal liquid in regulating box flows in extractor II, carries out continuous concentration of alcohol change reflux, extract;
Now the concentration of alcohol in concentration adjustment case being adjusted to concentration of alcohol is 70%, and the medicinal liquid after concentration adjustment is imported extractor II,
Wherein, add step (1) Chinese medicine slag in extractor II, at 68 DEG C, controlling concentration of alcohol rate of change is 0.67%/min, reaction 1.5h, and when being 10% to the concentration of alcohol in extractor II, derive the medicinal liquid in extractor II, cooling is reclaimed;
After extractor I merges with the medicinal liquid in II, concentrating under reduced pressure becomes thick paste;
3) process of preparing Chinese medicine of Poria and the mixing of thick paste
After simply being washed by the Poria raw material of recipe quantity, be cut into the lamellar of thickness equalization, and in the positive and negative uniform application step 2 repeatedly of Indian buead tablet) thick paste of gained, steaming and decocting 30min in steamer, controls steamer temperature and is no more than 70 DEG C;
After first time steaming and decocting terminates, again smear remaining thick paste, carry out steaming and decocting; So steaming and decocting is infiltrated in Indian buead tablet completely to thick paste for 3 times repeatedly, is dried by Poria and wears into fine powder, for subsequent use;
4) preparation of tablet
By step 1) and 3) dried cream powder of gained and fine powder, wet granulation, cross after 14 mesh sieves with 60-80 DEG C at dry;
Tabletting after being mixed with magnesium stearate by dried granule, obtains plain sheet, after film coating; Obtain ANLE PIAN 500, every sheet 0.62g.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510586388.2A CN105168456A (en) | 2015-09-16 | 2015-09-16 | Anle tablet |
| CN201910382530.XA CN110141612A (en) | 2015-09-16 | 2015-09-16 | A kind of ANLE PIAN |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510586388.2A CN105168456A (en) | 2015-09-16 | 2015-09-16 | Anle tablet |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201910382530.XA Division CN110141612A (en) | 2015-09-16 | 2015-09-16 | A kind of ANLE PIAN |
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| CN105168456A true CN105168456A (en) | 2015-12-23 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201910382530.XA Pending CN110141612A (en) | 2015-09-16 | 2015-09-16 | A kind of ANLE PIAN |
| CN201510586388.2A Pending CN105168456A (en) | 2015-09-16 | 2015-09-16 | Anle tablet |
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| CN201910382530.XA Pending CN110141612A (en) | 2015-09-16 | 2015-09-16 | A kind of ANLE PIAN |
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| CN103610794A (en) * | 2013-11-26 | 2014-03-05 | 常州科立信医疗器械有限公司 | Preparation method and application of nerve-calming tablets |
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- 2015-09-16 CN CN201910382530.XA patent/CN110141612A/en active Pending
- 2015-09-16 CN CN201510586388.2A patent/CN105168456A/en active Pending
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