CN103585466B - Herba Herminii saponin's composite precursor liposome and preparation method - Google Patents
Herba Herminii saponin's composite precursor liposome and preparation method Download PDFInfo
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Abstract
The present invention is a kind of Herba Herminii saponin's composite precursor liposome and preparation method, is prepared from according to a certain method by Herba Herminii saponin, Pericarpium Pyri extract, phospholipid, cholesterol, surfactant and water-solubility carrier.Herba Herminii saponin's composite precursor liposome of the present invention, easily prepares, and except can accomplishing scale production, Herba Herminii saponin's composite precursor liposome is the solid granular material that liquid state or drying have good flow performance, easily stores before aquation.After above-mentioned substance adds medically acceptable adjuvant, make any oral or exterior-applied formulation in pharmaceutics, ensure product quality better.Compatibility science of the present invention, have obvious synergism between life fruit saponin and Pericarpium Pyri extract, preparation technology is reasonable, does not destroy the effective ingredient of raw material of Chinese medicine, has no side effect, without additive, have no drug resistance.
Description
Technical field
The present invention is a kind of Herba Herminii saponin's composite precursor liposome and preparation method, and it is at supplementing QI and nourishing YIN, and the effect in antitumor field, belongs to technical field of traditional Chinese medicine preparation.
Background technology
During the nearly last ten years, Herba Herminii saponin is mainly used in prevention or the treatment aspect such as cardiovascular and cerebrovascular vessel and prophylaxis of tumours, but its dosage form is mainly with general formulation or injection, the availability of general formulation to Herba Herminii saponin is lower, and injection production and use all more complicated, therefore prepare a kind of taking convenience, and can medicine biology degree to obtain dosage form very necessary.Oral lipid body is taken advantage of a situation generation, adopts liposome to form again drug effective region or monomer, due to adding of wherein phospholipid, can extend its release time in vivo, increase the bioavailability of medicine.Prepare oral lipid body, method be recycle after being first prepared into liposome liposome powder in addition adjuvant make various dosage form.
And Pericarpium Pyri extract has clearing away heart-fire and moistening the lung, pathogenic fire reducing promotes the production of body fluid, effect of life lengthening; In " book on Chinese herbal medicine is new again ": saying of " promoting the production of body fluid to quench thirst, relieving restlessness being dried for clearing heart fire, nourishing kidney tonifying YIN ".Task of the present invention utilizes Herba Herminii saponin and Pericarpium Pyri extract to have obvious synergism, prepare a kind of can have higher curative effect for the preparation of supplementing QI and nourishing YIN and anti-tumor drug.
Summary of the invention
The invention provides a kind of Herba Herminii saponin's composite precursor liposome, for supplementing QI and nourishing YIN and antineoplastic medical usage.
Present invention also offers the preparation method of Herba Herminii saponin's composite precursor liposome, be applicable to suitability for industrialized production.
The present invention open Herba Herminii saponin's composite precursor liposome, to is characterized in that by following raw materials by weight portion than making:
Herba Herminii saponin 1, Pericarpium Pyri extract 0.01 ~ 1, phosphatidase 0 .2 ~ 5, cholesterol 0 ~ 0.5, surfactant 0 ~ 0.5, water-solubility carrier 0.2 ~ 20.
The preparation method of described Pericarpium Pyri extract is as follows:
Get 1 part of dry Pericarpium Pyri and decoct with water extraction 3 times, the quantity of solvent at every turn added is 4 ~ 8 (mass/volume) times of total medical material amount, and extraction time is 1 hour; Merge extractive liquid, is concentrated into 10% ~ 20% of original volume, adds 95% ethanol by the volume ratio of supernatant/95% ethanol=1/ (1 ~ 3), and precipitation, get supernatant, after concentration and recovery ethanol, spraying dry obtains extract dry powder.
The preparation method of Herba Herminii saponin's composite precursor liposome of the present invention, comprises the following steps:
(1) described water-solubility carrier, phospholipid, surfactant, cholesterol, Pericarpium Pyri extract, Herba Herminii saponin are made solution, mixing, filter;
(2) dry, sieve, both obtained Herba Herminii saponin's composite precursor liposome.
The preparation method of Herba Herminii saponin's composite precursor liposome of the present invention, also realizes by following steps:
(1) described water-solubility carrier, Pericarpium Pyri extract and Herba Herminii saponin are made solution, mixing, is placed in flask, rotary evaporation, and flask immerses in 30 ~ 70 DEG C of water-baths;
(2) phospholipid, cholesterol, surfactant dissolves are in dehydrated alcohol, make solution; Add gradually in the powder bed of rotation, vacuum decompression is evaporated to solvent and is substantially evaporated completely;
(3) by powder for drying, sieve, obtain Herba Herminii saponin's composite precursor liposome.
Or
(1) get Herba Herminii saponin and Pericarpium Pyri extract to add water and be prepared into solution, phospholipid, surfactant, cholesterol are dissolved in dehydrated alcohol;
(2) ethanol solution is injected Herba Herminii saponin's aqueous solution, make liposome solutions;
(3) water-solubility carrier is added in liposome solutions, spraying dry or lyophilization, obtain Herba Herminii saponin's composite precursor liposome.
After Herba Herminii saponin's composite precursor liposome adds medically acceptable adjuvant, make any oral or exterior-applied formulation in pharmaceutics.
The application of Herba Herminii saponin's composite precursor liposome in supplementing QI and nourishing YIN and antitumor field.
1, oral formulations is prepared: pharmaceutical composition Herba Herminii saponin's pro-liposome powder being made the different dosage form being applicable to use clinically, suitably add the excipient such as diluent, adsorbent, dispersant, wetting agent, binding agent, disintegrating agent, lubricant, absorption enhancer, solubilizing agent, antioxidant, surfactant, correctives, coloring agent as required again, namely can be made into the dosage form such as tablet, capsule, powder, granule being suitable for oral administration.
2, external preparation is prepared: pharmaceutical composition Herba Herminii saponin's pro-liposome powder being made the different dosage form being applicable to use clinically, suitably add additives or the substrate such as solubilizing agent, absorption enhancer, antiseptic, antioxidant, propellant, cosolvent, wetting agent, emulsifying agent, stabilizing agent, correctives, surfactant as required again, namely can be made into the dosage form such as cataplasma, spray, aerosol, cream, ointment being suitable for topical administration.
Good effect of the present invention is: utilize Herba Herminii saponin and Pericarpium Pyri extract to have obvious synergism, compatibility science, and preparation technology is reasonable, does not destroy the effective ingredient of raw material of Chinese medicine, has no side effect, without additive, have no drug resistance.
Detailed description of the invention
Below in conjunction with embodiment, the present invention is further explained.Should be understood that, following examples only for explaining the present invention, instead of limit the scope of the invention.
embodiment 1
Herba Herminii saponin's composite precursor liposome that the present embodiment is Herba Herminii saponin, Pericarpium Pyri extract, phospholipid (Ovum Gallus domesticus Flavus lecithin), surfactant (NaTDC), cholesterol and water-solubility carrier (mannitol) are prepared into.
Get the dry Pericarpium Pyri of 200g and decoct with water extraction 3 times, the quantity of solvent at every turn added is 1000mL times, and extraction time is 1 hour; Merge extractive liquid, is concentrated into 100mL, adds 95% ethanol 200mL, and precipitation, get supernatant, after concentration and recovery ethanol, spraying dry obtains extract dry powder.
Get Herba Herminii saponin 1g, Pericarpium Pyri extract dry powder 0.5g, Ovum Gallus domesticus Flavus lecithin 5g, NaTDC 0.25g, cholesterol 0.1g, mannitol 20g be dissolved in 30% alcoholic solution, mixing, filter, dry, sieve, both Herba Herminii saponin's composite precursor liposome.
embodiment 2
Herba Herminii saponin's pro-liposome that the present embodiment is Herba Herminii saponin, phospholipid (soybean lecithin), Pericarpium Pyri extract, surfactant (Tween 80), cholesterol and water-solubility carrier (fructose) are prepared into.
Get the dry Pericarpium Pyri of 100g and decoct with water extraction 3 times, the quantity of solvent at every turn added is 500mL, and extraction time is 1 hour; Merge extractive liquid, is concentrated into the 50mL of original volume, adds 95% ethanol 100mL, and precipitation, get supernatant, after concentration and recovery ethanol, spraying dry obtains extract dry powder.
Fructose 10g, Pericarpium Pyri extract 1g and Herba Herminii saponin 2g are made solution, mixing, be placed in flask, rotary evaporation, flask immerses in 60 DEG C of water-baths; Soybean lecithin 5g, cholesterol 1g, Tween 80 0.2g are dissolved in 20mL dehydrated alcohol, make solution; Add in the powder bed of rotation gradually; Vacuum decompression is evaporated to solvent and is substantially evaporated completely; By powder for drying, sieve, obtain Herba Herminii saponin's composite precursor liposome.
embodiment 3
Herba Herminii saponin's pro-liposome that the present embodiment is Herba Herminii saponin, phospholipid (soybean lecithin), Pericarpium Pyri extract, surfactant (NaTDC), cholesterol and water-solubility carrier (Macrogol 2000) are prepared into.
Get the dry Pericarpium Pyri of 100g and decoct with water extraction 3 times, the quantity of solvent at every turn added is 400mL, and extraction time is 1 hour; Merge extractive liquid, is concentrated into the 80mL of original volume, adds 95% ethanol 200mL, and precipitation, get supernatant, after concentration and recovery ethanol, spraying dry obtains extract dry powder.
Get Herba Herminii saponin 1g and Pericarpium Pyri extract 1g to add water and be prepared into solution, soybean lecithin 2g, NaTDC 0.2g, cholesterol 0.2g are dissolved in dehydrated alcohol; Ethanol solution is injected Herba Herminii saponin's aqueous solution, make liposome solutions; Water-solubility carrier Macrogol 2000 15g is added in liposome solutions, spraying dry, obtain Herba Herminii saponin's composite precursor liposome.
embodiment 4
Herba Herminii saponin's composite precursor liposome that the present embodiment is Herba Herminii saponin, Pericarpium Pyri extract, phospholipid (soybean lecithin), surfactant (NaTDC), cholesterol and water-solubility carrier (lactose) are prepared into.
Get the dry Pericarpium Pyri of 200g and decoct with water extraction 3 times, the quantity of solvent at every turn added is 1000mL times, and extraction time is 1 hour; Merge extractive liquid, is concentrated into 150mL, adds 95% ethanol 200mL, and precipitation, get supernatant, after concentration and recovery ethanol, spraying dry obtains extract dry powder.
Get Herba Herminii saponin 1g, Pericarpium Pyri extract dry powder 0.5g, soybean lecithin 5g, NaTDC 0.25g, cholesterol 0.1g, lactose 20g be dissolved in 60% alcoholic solution, mixing, filter, dry, sieve, both Herba Herminii saponin's composite precursor liposome.
embodiment 5
Herba Herminii saponin's pro-liposome that the present embodiment is Herba Herminii saponin, phospholipid (Ovum Gallus domesticus Flavus lecithin), Pericarpium Pyri extract, surfactant (NaTDC), cholesterol and water-solubility carrier (mannitol) are prepared into.
Get the dry Pericarpium Pyri of 100g and decoct with water extraction 3 times, the quantity of solvent at every turn added is 500mL, and extraction time is 1 hour; Merge extractive liquid, is concentrated into the 100mL of original volume, adds 95% ethanol 300mL, and precipitation, get supernatant, after concentration and recovery ethanol, spraying dry obtains extract dry powder.
Mannitol 10g, Pericarpium Pyri extract 1g and Herba Herminii saponin 2g are made solution, mixing, be placed in flask, rotary evaporation, flask immerses in 50 DEG C of water-baths; Ovum Gallus domesticus Flavus lecithin 5g, cholesterol 1g, NaTDC 0.1g are dissolved in dehydrated alcohol, make solution; Add in the powder bed of rotation gradually; Vacuum decompression is evaporated to solvent and is substantially evaporated completely; By powder for drying, sieve, obtain Herba Herminii saponin's composite precursor liposome.
embodiment 6
Herba Herminii saponin's pro-liposome that the present embodiment is Herba Herminii saponin, phospholipid (soybean lecithin), Pericarpium Pyri extract, surfactant (NaTDC), cholesterol and water-solubility carrier (Macrogol 2000) are prepared into.
Get the dry Pericarpium Pyri of 100g and decoct with water extraction 3 times, the quantity of solvent at every turn added is 400mL, and extraction time is 1 hour; Merge extractive liquid, is concentrated into the 50mL of original volume, adds 95% ethanol 150mL, and precipitation, get supernatant, after concentration and recovery ethanol, spraying dry obtains extract dry powder.
Get Herba Herminii saponin 1g and Pericarpium Pyri extract 1g to add water and be prepared into solution, soybean lecithin 2g, NaTDC 0.1g, cholesterol 0.1g are dissolved in dehydrated alcohol; Ethanol solution is injected Herba Herminii saponin's aqueous solution, make liposome solutions; Water-solubility carrier Macrogol 2000 15g is added in liposome solutions, lyophilization, obtain Herba Herminii saponin's composite precursor liposome.
embodiment 7
Herba Herminii saponin's pro-liposome that the present embodiment is Herba Herminii saponin, phospholipid (soybean lecithin), Pericarpium Pyri extract, cholesterol and water-solubility carrier (mannitol) are prepared into.
Get the dry Pericarpium Pyri of 100g and decoct with water extraction 3 times, the quantity of solvent at every turn added is 400mL, and extraction time is 1 hour; Merge extractive liquid, is concentrated into the 50mL of original volume, adds 95% ethanol 150mL, and precipitation, get supernatant, after concentration and recovery ethanol, spraying dry obtains extract dry powder.
Get Herba Herminii saponin 1g and Pericarpium Pyri extract 1g to add water and be prepared into solution, soybean lecithin 2g, cholesterol 0.1g are dissolved in dehydrated alcohol; Ethanol solution is injected Herba Herminii saponin's aqueous solution, make liposome solutions; Water-solubility carrier mannitol 15g is added in liposome solutions, lyophilization, obtain Herba Herminii saponin's composite precursor liposome.
embodiment 8
Herba Herminii saponin's pro-liposome that the present embodiment is Herba Herminii saponin, phospholipid (Ovum Gallus domesticus Flavus lecithin), Pericarpium Pyri extract, surfactant (span) and water-solubility carrier (mannitol) are prepared into.
Get the dry Pericarpium Pyri of 100g and decoct with water extraction 3 times, the quantity of solvent at every turn added is 400mL, and extraction time is 1 hour; Merge extractive liquid, is concentrated into the 50mL of original volume, adds 95% ethanol 150mL, and precipitation, get supernatant, after concentration and recovery ethanol, spraying dry obtains extract dry powder.
Get Herba Herminii saponin 1g and Pericarpium Pyri extract 1g to add water and be prepared into solution, Ovum Gallus domesticus Flavus lecithin 2g, span 0.1g are dissolved in dehydrated alcohol; Ethanol solution is injected Herba Herminii saponin's aqueous solution, make liposome solutions; Water-solubility carrier mannitol 15g is added in liposome solutions, spraying dry, obtain Herba Herminii saponin's composite precursor liposome.
embodiment 9
The present embodiment is Herba Herminii saponin's composite precursor liposome tablet.
Herba Herminii saponin's pro-liposome powder (embodiment 1): 1kg, starch, cyclodextrin mixtures and hypromellose (2/2/1): 1kg;
Get Herba Herminii saponin's pro-liposome powder, the adjuvant of weight such as to add as excipient, mix homogeneously, obtains mixed-powder; Add 95% ethanol and obtain soft material, 16-20 mesh sieve is granulated, wet granular 70 ~ 80 DEG C of dryings 30 minutes, 16-20 mesh sieve granulate, tabletting and get final product.Sundry item should meet Pharmacopoeia of People's Republic of China 2010 editions tablet project relevant requirements.
following experiments indicates the beneficial effect of Herba Herminii saponin's pro-liposome of the present invention:
1 experiment material and method
1.1 experiment material
Laboratory animal, SD male rat body weight 300 ± 10g, purchased from Jilin University's medical board Experimental Animal Center, in room temperature 20 ± 1 DEG C, humidity 55 ± 10%, rate of ventilation 20 ± 2 times/time, raise 1 week under 12 hours light and shade cycling conditions, for experiment.Between preparation feeding period, feeding solid feed (purchased from Jilin University's medical board Experimental Animal Center), water freely absorbs.Pericarpium Pyri extract is prepared voluntarily by this laboratory, and Herba Herminii saponin's composite precursor liposome (as embodiment 1, embodiment 2, embodiment 3) is prepared voluntarily by this laboratory.
1.2 experimental technique
1.2.1 medication and sample collecting
Select qualified SD male rat, be divided into 6 groups at random; Gavage Herba Herminii saponin (A), Pericarpium Pyri extract (B), the Herba Herminii saponin of weight ratio 1:1 and Pericarpium Pyri extract mixtures (C) and 3 groups of Herba Herminii saponin's composite precursor liposomees (embodiment 1, embodiment 2, embodiment 3) respectively, dosage is 200mg/kg.After administration, 10min, 25min, 40min, 75min, 120min, 180min, 240min, 300min and 600min get blood through orbital venous plexus, put in the plastic centrifuge tube of oiling heparin, the centrifugal 10min of 10000rpm, separated plasma ,-20 DEG C of Refrigerator stores are until analyze.
1.2.2 the preparation of blood serum sample
Get serum 200 μ L, add methanol ImL, vortex oscillation 1min, 5000rmin
-1centrifugal l0min, Aspirate supernatant, 40 DEG C of water-bath N2 dry up, and residue adds 200 μ L methanol, and vortex 1min, ultrasonic 5min makes residue fully dissolve, and obtains need testing solution.
2 experimental results
The pharmacokinetic parameter comparative result of the Herba Herminii saponin of Herba Herminii saponin (A), Pericarpium Pyri extract (B), weight ratio 1:1 and Pericarpium Pyri extract mixtures (C) and 3 groups of Herba Herminii saponin's composite precursor liposomees (embodiment 1, embodiment 2, embodiment 3) is as shown in the table
Table 1 pharmacokinetic parameter compares (n=6)
AUC value is one of important parameter evaluating drug bioavailability, and this experimental studies results shows, under the drug-time curve of Herba Herminii saponin's group (A), area is 12183.29 ± 23ngminmL
-1; Under the drug-time curve of Pericarpium Pyri extract (B), area is 11159.35 ± 123ngminmL
-1; Under the Herba Herminii saponin of weight ratio 1:1 and Pericarpium Pyri extract mixtures (C) drug-time curve, area is 16028 ± 221ngminmL
-1; Under 3 groups of Herba Herminii saponin's composite precursor liposome (embodiment 1, embodiment 2, embodiment 3) drug-time curves Line Integral be not 19235 ± 233,17235 ± 183,22235 ± 296ngminmL
-1.
The Evaluation On The Bioavailability result of study of Herba Herminii saponin (A), Pericarpium Pyri extract (B), Herba Herminii saponin and Pericarpium Pyri extract mixtures (C) and 3 groups of Herba Herminii saponin's composite precursor liposomees (embodiment 1, embodiment 2, embodiment 3) shows, Herba Herminii saponin and Pericarpium Pyri extract have significant synergism; On this basis, after being prepared as pro-liposome, extend its body absorption time, the bioavailability that improve Herba Herminii saponin to a certain degree, comparatively remarkable to the improvement of drug bioavailability, reach preparation object.
Claims (4)
1. Herba Herminii saponin's composite precursor liposome, to is characterized in that by following raw materials by weight portion than making:
Herba Herminii saponin 1, Pericarpium Pyri extract 0.01 ~ 1, phosphatidase 0 .2 ~ 5, cholesterol 0 ~ 0.5,
Surfactant 0 ~ 0.5, water-solubility carrier 0.2 ~ 20.
2. the preparation method of Herba Herminii saponin's composite precursor liposome according to claim 1, the following steps comprised:
1) described water-solubility carrier, phospholipid, surfactant, cholesterol, Pericarpium Pyri extract, Herba Herminii saponin are made solution, mixing, filter;
2) dry, sieve, obtain Herba Herminii saponin's composite precursor liposome.
3. the preparation method of Herba Herminii saponin's composite precursor liposome according to claim 1, the sequential steps comprised is:
1) described water-solubility carrier, Pericarpium Pyri extract and Herba Herminii saponin are made solution, mixing, is placed in flask, rotary evaporation, and flask immerses in 30 ~ 70 DEG C of water-baths;
2) phospholipid, cholesterol, surfactant dissolves are in dehydrated alcohol, make solution; Add gradually in the powder bed of rotation, vacuum decompression is evaporated to solvent and is substantially evaporated completely;
3) by powder for drying, sieve, obtain Herba Herminii saponin's composite precursor liposome.
4. the preparation method of Herba Herminii saponin's composite precursor liposome according to claim 1, the following steps comprised:
(1) get Herba Herminii saponin and Pericarpium Pyri extract to add water and be prepared into solution, phospholipid, surfactant, cholesterol are dissolved in dehydrated alcohol;
(2) ethanol solution is injected Herba Herminii saponin's aqueous solution, make liposome solutions;
(3) water-solubility carrier is added in liposome solutions, spraying dry or lyophilization, obtain Herba Herminii saponin's composite precursor liposome.
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