CN102178714B - Preparation for improving oral adsorption of panax notoginsenosides and preparation method thereof - Google Patents
Preparation for improving oral adsorption of panax notoginsenosides and preparation method thereof Download PDFInfo
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- CN102178714B CN102178714B CN2011101044450A CN201110104445A CN102178714B CN 102178714 B CN102178714 B CN 102178714B CN 2011101044450 A CN2011101044450 A CN 2011101044450A CN 201110104445 A CN201110104445 A CN 201110104445A CN 102178714 B CN102178714 B CN 102178714B
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- radix notoginseng
- total arasaponins
- notoginseng total
- glycerol
- phospholipid
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Abstract
The invention relates to the field of medicinal preparations, in particular to a preparation for improving the oral adsorption of panax notoginsenosides, which is characterized in that a physical mixture of the panax notoginsenosides, glycerol and phospholipid is prepared by taking the glycerol as solvent and the phospholipid as an adsorption enhancer to establish a preparation method of the preparation for improving the oral adsorption of the panax notoginsenosides. The preparation can be prepared simply, and animal experimental results prove that the preparation has high bioavailability.
Description
Technical field
The present invention relates to field of pharmaceutical preparations; Be specifically related to a kind of preparation that improves the Radix Notoginseng total arasaponins oral absorption; With glycerol is solvent, and the physical mixture that phospholipid prepares Radix Notoginseng total arasaponins, glycerol, phospholipid for short absorbent improves the method for preparing of Radix Notoginseng total arasaponins oral absorption with foundation.
Background technology
Radix Notoginseng is the dry root and rhizome of araliaceae ginseng plant Radix Notoginseng (Panax notoginseng (Burk.F.H.Chen)), and Radix Notoginseng is arranged, Radix Notoginseng, Typhonium flagelliforme (Lodd.) Blume, the title of mountain lacquer.These article sweet and slightly bitter taste, warm in nature.Main product is in Yunnan, Sichuan, ground such as Guangxi.The hemostasis of the article of giving birth to ability dissipating blood stasis, reducing swelling and alleviating pain, ripe article can be enriched blood and invigorated blood circulation, and are one of China's tradition rare Chinese medicines, are regarded as the treasured in the medicine by ancient Chinese medicine doctor, so the saying of " Radix Stephaniae Sinicae (Radix Stephaniae Dielsianae) " is arranged.Modern pharmacology research proof Radix Notoginseng has analgesic activity to nervus centralis, and the protection ischemic brain injury improves myocardial ischemia, has immunomodulator, and antioxidation such as protects the liver at effect.
Radix Notoginseng contains Radix Notoginseng total arasaponins, dencichine, flavonoid, volatile oil, polysaccharide, multiple composition such as aminoacid.Content of the total saponins in radix notoginseng is about 12%～18%, dencichine 0.90%, flavonoid 0.38%, volatile oil 0.40%; Polysaccharide 0.28%, amino acids 7.73%. Radix Notoginseng total arasaponins is the material base of pseudo-ginseng blood-circulation-invigovating blood stasis dispelling, consistent its main active component [Yoshikawa, the M. of being considered to; Murakami, T., Ueno, T.; Et al. (1997a) .Chemical and Pharmaceutical Bulletin, 45,1056.]. ginsenoside Rg1 (protopanaxatriol; Ppt) be one of content is the highest in the Radix Notoginseng total arasaponins activated monomer, account for 30% of total saponins, can be used as the index components of PNS.
Main component ginsenoside's class of Radix Notoginseng total arasaponins has the polyhydroxy structure, belongs to hydrophilic compounds, so the Radix Notoginseng total arasaponins water solublity is very big.Because the Radix Notoginseng total arasaponins water solublity is strong and fat-soluble poor, and is low at gastrointestinal tract mucous permeability, adds the degraded of gastric juice sour environment to medicine, the enzymolysis and the liver first-pass effect of gastrointestinal tract and bacterial metabolism enzyme can't be realized the pharmacologically active of original shape medicine.It is a low key factor of its oral administration biaavailability that the fat-soluble difference of Radix Notoginseng total arasaponins causes its gastrointestinal tract film permeability low.
CN1951393A discloses a kind of Oily preparation of Radix Notoginseng total arasaponins, through Radix Notoginseng total arasaponins and phospholipids incorporate are formed complex, is dissolved in and forms Oily preparation in the oil phase to improve bioavailability of medicament.But Oily preparation is wrapped in Radix Notoginseng total arasaponins in a large amount of oil phases, is deleterious and eat too much oils to human body, elderly population especially occurred frequently to cardiovascular disease.
Glycerol promptly 1,2, the 3-glycerin is colourless, odorless, clear and bright syrupy liq.It is neutral that aqueous solution is, can mix with water, ethanol, methanol arbitrary proportion, and be one of common medicinal substrate, use early clinically.It is nonpoisonous and tasteless nuisanceless, eats human non-toxic, takes a large amount of glycerol before the motion, and blood glucose and insulin level almost do not have any variation during motion, explain that large dose oral administration glycerol can influence blood glucose and insulin level (" European applied physiology ") hardly.Be used as solvent, sweeting agent, antibiotic antiseptic, thickening agent in the oral solution; Be used as wetting agent and softener in the topical pharmaceutical formulations; Can also be as the medicine stabilizing agent.It is oral generally to have no adverse reaction.Acceptable daily intake is not done particular provisions.It is generally accepted it is safe.
Phospholipid is the protoplasm and the biomembranous important component of animal and plant cells, also is one type of common short absorbent.Phospholipid itself is nontoxic, and cardiovascular and cerebrovascular disease is had positive preventive effect, and is prone to degraded in vivo.As one of plasma membrane main component, phospholipid can improve medicine intestinal wall permeability, promotes its absorption and Transdermal absorption at small intestinal.Soybean phospholipid is present most widely used a kind of phospholipid, and wherein the content of lecithin is about 30%.
The drug oral administration is easy to accepted by the patient, if be prepared into side effects drug uses such as injection is prone to cause allergic reaction.But because the Radix Notoginseng total arasaponins hydrophilic is strong, membrane permeability is poor, is difficult for making its oral absorption amount few through cell membrane lipid barrier, and bioavailability is low.
Summary of the invention
The invention discloses a kind of oral formulations that improves the Radix Notoginseng total arasaponins oral absorption; The present invention is solvent with glycerol; Phospholipid is short absorbent, prepares the physical mixture of Radix Notoginseng total arasaponins, glycerol, phospholipid, has greatly strengthened the transmembrane transport of Radix Notoginseng total arasaponins; Reduce its degraded in gastrointestinal tract, thereby improved the oral absorption of Radix Notoginseng total arasaponins.
The oral formulations of Radix Notoginseng total arasaponins of the present invention contains Radix Notoginseng total arasaponins, phospholipid and glycerol or glycerine water solution.Be a kind of Radix Notoginseng total arasaponins phosphoglyceride solution.
Radix Notoginseng total arasaponins is in its contained Rg1 weight, and phospholipid is in its contained lecithin weight, the weight ratio of Rg1, lecithin, glycerol, water preferred 1: 0.25～1.5: 2.4～12: 0～9.6.The weight ratio of Rg1, lecithin, glycerol, water more preferably 1: 0.5～1.5: 7.2～12: 0～4.8.
Above-mentioned Radix Notoginseng total arasaponins phosphoglyceride solution can be processed various peroral dosage form preparations.Most preferably process and comprise enteric soft capsules, the liquid hard capsule of enteric-coated microcapsule or enteric is at interior enteric coated preparation.Only need Radix Notoginseng total arasaponins phosphoglyceride solution of the present invention be wrapped in the soft capsule rubber during preparation enteric soft capsules and get final product.If be prepared into solid preparation, promptly only need to add corresponding adjuvant mixing and get final product.
Radix Notoginseng total arasaponins phosphoglyceride solution is concrete among the present invention adopts following method to prepare:
Phospholipid is dissolved in the organic solvent, and the aqueous solution that adds glycerol or glycerol is even, and organic solvent is removed in decompression, adds Radix Notoginseng total arasaponins and mixes, and promptly gets.If be prepared into various preparations, then mixed solution to be processed and comprised enteric soft capsules, the liquid hard capsule of enteric-coated microcapsule or enteric promptly gets at interior enteric coated preparation.Said organic solvent is selected from dimethyl sulfoxide, chloroform, ethyl acetate, oxolane, normal hexane, cyclohexane extraction, C
1～C
6One or more mixture in the straight or branched low-grade alkane alcohol.The use amount of organic solvent is preferably the organic solvent that 1g phospholipid is not less than 3ml.The present invention preferably eliminates organic solvent with the method for reduction vaporization.Because the phospholipid hydrophobicity is strong, the shortage of microcosmic discrete form is very easily agglomerating, and glycerol is mobile poor, so phospholipid penetrance in glycerol is poor, is difficult to instantaneous being dissolved in the glycerol, and this has just fettered its application in reality.The present invention utilizes organic solvent dissolution phospholipid to molecular state, adds glycerol or glycerine water solution then, and mix homogeneously is removed organic solvent, obtains phosphoglyceride solution.
The formation of glycerol through suppressing medicine molecular ionization, micelle and intermolecular hydrogen bonding is with the dissolved state and the molecularity of the medicine that holds its shape among the present invention; The weak flowability of glycerol is protected medicine and does not receive the degraded of gastrointestinal tract environment liquid before being absorbed; The strong water retention of glycerol can be drawn the hydrone of non-stirring water layer on the mucous membrane of small intestine, enlarges the contact area of medicine and enterocyte film; Glycerol also can be via the aqueous pore transmembrane transport of epithelial cell membrane, and through the solvent draw, glycerol molecule can get into the aqueous pore, makes solvent environment basically identical in epithelial cell membrane and the enteric cavity, reduces the fat-soluble apparent expression of film; And phospholipid is as surfactant, can produce certain intermolecular association with each composition of Radix Notoginseng total arasaponins, strengthens the transmembrane transport of Radix Notoginseng total arasaponins, makes it be easy to penetrate intestinal mucosa, thereby improves bioavailability.The present invention also is suitable for improving the oral absorption of other similar hydrophilic medicaments.
Phospholipid of the present invention is selected from natural phospholipid or/and synthetic phospholipid, and wherein the preferred soybean phospholipid of natural phospholipid is or/and egg yolk lecithin; The preferred synthetic lecithin of synthetic phospholipid, dipalmitoyl phosphatidyl choline or DSPC.
The present invention improves its oral absorption through the membrane permeability of striding of preparation Radix Notoginseng total arasaponins phosphoglyceride solution enhancing Radix Notoginseng total arasaponins, and its absolute bioavailability improves 5～12 times than the Radix Notoginseng total arasaponins aqueous solution.Through the rat oral gavage medicine-feeding test, further specify the beneficial effect and the practicality of Radix Notoginseng total arasaponins phosphoglyceride solution of the present invention below.
The absorption test of Radix Notoginseng total arasaponins phosphoglyceride solution
Healthy male Sprague-Dawley (SD) rat freely drinks water, and behind the fasting 12h, adopts and irritates the direct gastric infusion of stomach pin, gets blood in a series of time point anesthesia posterior orbit venous plexuses.Adopt Radix Notoginseng total arasaponins aqueous solution gastric infusion group, Radix Notoginseng total arasaponins phosphoglyceride solution gastric infusion group of the present invention and Radix Notoginseng total arasaponins intravenous administration group; Every group 6 is the intravital blood drug level of rat after the administration of index high effective liquid chromatography for measuring with Rg1.
Radix Notoginseng total arasaponins aqueous solution administration group and Radix Notoginseng total arasaponins phosphoglyceride solution administration group are irritated stomach dosage and are 3200mg/kg; Radix Notoginseng total arasaponins aqueous solution intravenous injection dosage is that (calculating of absolute bioavailability is index with the content of Rg1 to 150mg/kg; Promptly be respectively 1024mg/kg and 50mg/kg); Measure the blood drug level of Rg1, the result sees Fig. 1. Rg1 tries to achieve AUC with trapezoidal method after irritating stomach
0-24hBe respectively 25.46 ± 7.81 (h μ g/ml) and 180.27 ± 29.16 (h μ g/ml), absolute bioavailability is respectively 0.42% and 2.99%, improves about 7 times, and visible Radix Notoginseng total arasaponins phosphoglyceride solution of the present invention can significantly improve the oral absorption of medicine.
Description of drawings
Fig. 1 is that Radix Notoginseng total arasaponins aqueous solution and Rg1 of the present invention and lecithin weight ratio are that 1: 0.9 and glycerol content are blood drug level-time graph of Rg1 after 100% the Radix Notoginseng total arasaponins phosphoglyceride solution rat oral gavage administration.
The specific embodiment
Embodiment 1
Take by weighing the 2g soybean phospholipid, wherein contain lecithin 0.6g, add ethyl acetate 5ml; After treating to dissolve fully, add glycerol 12g, mix homogeneously; Reduction vaporization is removed ethyl acetate; Add Radix Notoginseng total arasaponins 3.125g (content of Rg1 is 32.0%), mix homogeneously promptly gets Radix Notoginseng total arasaponins phosphoglyceride solution.
Embodiment 2
Take by weighing the 2g soybean phospholipid, wherein contain lecithin 0.6g, add ethanol 5ml; After treating to dissolve fully, adding glycerol weight ratio is 90% glycerine water solution 12g (wherein glycerol weight is 10.8g, and water is 1.2g); Mix homogeneously, reduction vaporization is removed ethanol, adds Radix Notoginseng total arasaponins 3.125g (content of Rg1 is 32.0%); Mix homogeneously promptly gets Radix Notoginseng total arasaponins phosphoglyceride solution.
Embodiment 3
Take by weighing the 1g egg yolk lecithin, wherein contain lecithin 0.7g, add chloroform 3ml, after treating to dissolve fully; Add glycerol 12g, mix homogeneously, reduction vaporization is removed chloroform; Add Radix Notoginseng total arasaponins 3.125g (content of Rg1 is 32.0%), mix homogeneously promptly gets Radix Notoginseng total arasaponins phosphoglyceride solution.
Embodiment 4
Take by weighing the 1g egg yolk lecithin, wherein contain lecithin 0.7g, add oxolane 3ml; After treating to dissolve fully, adding glycerol weight ratio is 80% glycerine water solution 12g (wherein glycerol weight is 9.6g, and water is 2.4g); Mix homogeneously, reduction vaporization is removed oxolane, adds Radix Notoginseng total arasaponins 3.125g; (content of Rg1 is 32.0%), mix homogeneously promptly gets Radix Notoginseng total arasaponins phosphoglyceride solution.
Embodiment 5
Take by weighing 1g dipalmitoyl phosphatidyl choline (DPPC), wherein contain lecithin 0.99g, add acetone 3ml; After treating to dissolve fully, add glycerol 12g, mix homogeneously; Reduction vaporization is removed acetone; Add Radix Notoginseng total arasaponins 3.125g (content of Rg1 is 32.0%), mix homogeneously promptly gets Radix Notoginseng total arasaponins phosphoglyceride solution.
Embodiment 6
Take by weighing 1g DSPC (DSPC), wherein contain lecithin 0.99g, add n-butyl alcohol 3ml; After treating to dissolve fully, adding glycerol weight ratio is 70% glycerine water solution 12g (wherein glycerol weight is 8.4g, and water is 3.6g); Mix homogeneously, reduction vaporization is removed n-butyl alcohol, adds Radix Notoginseng total arasaponins 3.125g (content of Rg1 is 32.0%); Mix homogeneously promptly gets Radix Notoginseng total arasaponins phosphoglyceride solution.
Embodiment 7
With the liquid hard capsule of Radix Notoginseng total arasaponins phosphoglyceride formulations prepared from solutions enteric
Get Radix Notoginseng total arasaponins phosphoglyceride solution an amount of (embodiment 1 method makes), directly fill is processed the liquid hard capsule of enteric in the liquid hard capsule of enteric.
Embodiment 8
With Radix Notoginseng total arasaponins phosphoglyceride formulations prepared from solutions enteric soft capsules
Get Radix Notoginseng total arasaponins phosphoglyceride solution an amount of (embodiment 1 method makes), process enteric soft capsules.
Embodiment 9
With Radix Notoginseng total arasaponins phosphoglyceride formulations prepared from solutions enteric-coated microcapsule
Get Radix Notoginseng total arasaponins phosphoglyceride solution an amount of (embodiment 1 method makes), process enteric-coated microcapsule.
Claims (5)
1. Radix Notoginseng total arasaponins oral formulations, it is characterized in that: formed by Radix Notoginseng total arasaponins, phospholipid and glycerol or glycerine water solution physical mixed, wherein Radix Notoginseng total arasaponins is in contained Rg1 weight; Phospholipid is in its contained lecithin weight, and the weight ratio of Rg1, lecithin, glycerol, water is 1: 0.25～1.5: 2.4～12: 0～9.6, is prepared by following method: phospholipid is dissolved in the organic solvent; The aqueous solution that adds glycerol or glycerol; Mix, organic solvent is removed in decompression, adds the Radix Notoginseng total arasaponins mix homogeneously; Promptly get mixed solution, wherein organic solvent is selected from dimethyl sulfoxide, chloroform, ethyl acetate, oxolane, normal hexane, cyclohexane extraction, C
1～C
6One or more mixture in the low-grade alkane alcohol.
2. the Radix Notoginseng total arasaponins oral formulations of claim 1, wherein the weight ratio of Rg1, lecithin, glycerol, water is 1: 0.5～1.5: 7.2～12: 0～4.8.
3. the Radix Notoginseng total arasaponins oral formulations of claim 1, wherein phospholipid is selected from soybean phospholipid, egg yolk lecithin, synthetic lecithin, dipalmitoyl phosphatidyl choline or DSPC.
4. the Radix Notoginseng total arasaponins oral formulations of claim 1 also comprises when wherein preparing the mixed solution that makes is wrapped in the soft capsule.
5. the Radix Notoginseng total arasaponins oral formulations of claim 1 comprises also when wherein preparing that the mixed solution that makes is added the enteric adjuvant makes enteric-coated microcapsule or enteric coated capsule.
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| CN110638781A (en) * | 2019-08-28 | 2020-01-03 | 浙江海洋大学 | Enteric capsule coating for improving anti-inflammatory effect of sulfasalazine |
| CN112915017B (en) * | 2021-02-22 | 2023-02-28 | 邵阳学院 | Preparation method of fluid medicament of lily total saponins and loading bottle thereof |
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