CN103006722B - Xiaoaiping composition, dropping pill and preparation method thereof - Google Patents
Xiaoaiping composition, dropping pill and preparation method thereof Download PDFInfo
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- CN103006722B CN103006722B CN201310001833.5A CN201310001833A CN103006722B CN 103006722 B CN103006722 B CN 103006722B CN 201310001833 A CN201310001833 A CN 201310001833A CN 103006722 B CN103006722 B CN 103006722B
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Abstract
The invention provides a Xiaoaiping composition which has the advantages of convenience for administration, stable curative effect and high bioavailability and a dropping pill preparation of the Xiaoaiping composition. The Xiaoaiping composition is prepared from active components, matrixes and other adjuvants. The Xiaoaiping composition provided by the invention is obviously enhanced in drug effect and bioavailability because an extraction method and an added material are improved and can be effectively used for the clinical treatment of cancer.
Description
Technical field
The invention belongs to technical field of medicine, be specifically related to the one flat compositions of cancer that disappears, drop pill and preparation method thereof.
Background technology
Radix Fissistigmatis Glaucescentis, has another name called Tenacious Condorvine Stem, Caulis Marsdeniae Tenacissimae etc., is the rattan of Luo Moke plant Caulis Marsdeniae Tenacissimae.Record in Chinese Pharmacopoeia 1977 editions.Originate in the ground such as Yunnan, Guangdong, Guizhou, Guangxi, Sichuan.The cancer flat products that disappears of approved comprises syrup, tablet, injection etc., and the clinical malignant tumor such as esophageal carcinoma, gastric cancer, pulmonary carcinoma, hepatocarcinoma that are used for the treatment of, have obtained good curative effect.
Drop pill refers to and adopts dropping preparation method that solid or liquid medicine and substrate heat fused are prepared into after solid dispersion, splashes into and in the condensed fluid immiscible with substrate, shrinks the pill that condensation forms.Drop pill can be divided into quick-acting heavy duty detergents, slow control release type, enteric solubility, external type hard capsule, liposome and coated drop pill etc., being prepared into after drop pill can also tabletting, make suppository etc., have wide range of applications, can be for oral, external, topical and mucosal drug delivery, compared with traditional tablet, there is the advantages such as surface area is large, dissolution rate is fast, bioavailability is high, gastrointestinal irritation effect is little.
Xiaoaiping dripping pill is a kind of known product, and domestic numerous producers have applied for several patents for this reason.ZL 20,051,003,262 3.8 discloses a kind of Xiaoaiping preparation against cancers, comprises drop pill, dispersible tablet or soft capsule.Wherein drop pill is to use dried cream powder and the polyethylene glycol 6000 of the flat extract of cancer that disappears to prepare.ZL200510031640.X discloses a kind of flat soft capsule of the cancer that disappears or drop pill of Radix Fissistigmatis Glaucescentis, comprises with making thick paste after water extraction Radix Fissistigmatis Glaucescentis, makes drop pill or soft capsule after then adding PEG400, vegetable oil, aromatic hydrocarbon esters etc.ZL2005100008618.3 discloses a kind of Xiaoaiping dripping pill, comprises with making thick paste after water extraction Radix Fissistigmatis Glaucescentis, then adds Polyethylene Glycol etc. to be prepared into drop pill.ZL200810189036.3 discloses a kind of Xiaoaiping dripping pill, comprises Polyethylene Glycol or poloxamer that Radix Fissistigmatis Glaucescentis extract and molecular weight are greater than 1000.
But the inventor, in production practices, finds that existing these preparations exist active constituent content not high, the shortcoming that drop pill bioavailability is low, these drawbacks limit the effectiveness of medicine, be unfavorable for that patient uses.The inventor, through meticulous research, has prepared better drop pill, and its active constituent content and bioavailability are all significantly improved.
Summary of the invention
The object of the invention is for a kind of convenient drug administration, stable curative effect, Xiaoaiping dripping pill preparation that bioavailability is high are provided.
First aspect of the present invention, the one flat compositions of cancer that disappears is provided, it is dropping pill formulation, made by active component, substrate and other adjuvants, wherein active component accounts for the 1%-40% of gross weight, Basic compose accounts for the 60%-95% of gross weight, and wherein the weight ratio of active component and Basic compose is 1:1-1:10, more preferably 1:2-1:6; The amount of other adjuvants is 1%-5%, and other adjuvants comprise the first adjuvant and the second adjuvant.Its mesostroma is selected from one or more in cetomacrogol 1000, Macrogol 4000 and poloxamer; The first adjuvant is sodium laurylsulfate or polyvinylpyrrolidone; The second adjuvant is carboxymethyl starch sodium or cross-linking sodium carboxymethyl cellulose, and wherein the ratio between the first adjuvant and the second adjuvant is 10:1-1:10, more preferably 5:1-1:5, most preferably 1:1-1:5.
The extract that wherein active component is Radix Fissistigmatis Glaucescentis.We find, in existing Xiaoaiping dripping pill or soft capsule the extraction of Radix Fissistigmatis Glaucescentis adopt be all water extraction, comprise by Radix Fissistigmatis Glaucescentis soak after water decoct 3 times, after collecting decoction through processing obtain dry powder or thick paste, using this as active component.But through research, we find, the material composition complexity that this traditional method obtains, comprises impurity too much, and active constituent content is not high, has both affected the performance of drug effect, makes again needs of patients take larger dose, causes application inconvenience.
Through studying for a long period of time, we have found new extracting method, not only simple and easy to control, and after extracting, ingredient is purer, can reduce dosed administration, are very easy to patient and use.
Therefore, of the present invention aspect first, the extracting method of active ingredient in Xiaoaiping dripping pill is provided, comprise described medical material through supersound process, its concrete steps are, get Radix Fissistigmatis Glaucescentis medical material, pulverize, the water soaking 8-15 hour that adds 10-15 doubly to measure, then at 250W, supersound process 30-60 minute under 220-280 Hz, filter, filtrate is concentrated into thick paste, the water soaking 1-2 hour that residue adds 5-8 doubly to measure, at 250W, supersound process 30-60 minute under 220-280 Hz, filter, filtrate is concentrated into thick paste, the water soaking 0.5-1.5 hour that residue adds 5-8 doubly to measure, at 250W, supersound process 30-60 minute under 220-280Hz, filter, filtrate is concentrated into thick paste, merge three times thick paste liquid, .
Although described method is only to add supersound process process on existing method basis, however its for active component content improve highly significant (embodiment vide infra), therefore effect is beat all.And column chromatography providing in prior art etc. cumbersome approaches, greatly improve production cost, be difficult to use in large-scale commercial production, the improvement of active component content has been considered to lose more than gain from cost performance simultaneously, there is no significant economic benefit, greatly improved patient's use cost.And method of the present invention had both improved curative effect of medication, can ensure again economic benefit, be a kind of simple, convenient and practical good method.
In yet another aspect, the invention provides the method for the described drop pill of preparation, comprising: substrate is heated to molten condition; Active ingredient, the first adjuvant and the second adjuvant are joined in above-mentioned substrate, after stirring, join in pill dripping machine, dripping becomes ball, wipes the liquid coolant on drop pill surface, dry, makes Xiaoaiping dripping pill.
The inventor finds, the Xiaoaiping dripping pill of preparing in prior art, and its dissolution is poor, and bioavailability is not high.The inventor is intended to by adding auxiliary substance to overcome this defect.But we find, add separately the several material of a kind of material or combination in any can not obviously improve dissolution, in similar Dissolution Rate Testing as described in Example 5, compared with other drop pill of the improving of this dissolution (the 15th minute time substantially not yet 70% left and right) and prior art, particularly for the dissolution of first 15 minutes, almost inappreciable, without any practical significance.For this reason, we continue further investigation, through screening and combination many times, be surprised to find that, and be that the first adjuvant is sodium laurylsulfate or polyvinylpyrrolidone when selecting the combination of two groups of adjuvants; When the second adjuvant is carboxymethyl starch sodium or cross-linking sodium carboxymethyl cellulose, as described in Example 5, the dissolution of drop pill has had significant improvement; The indices such as drop pill molding meanwhile,, medicine stability also keep good.
Finally, disappear the flat compositions of cancer and dropping pill formulation thereof described in the invention provides in the application being used for the treatment of in esophageal carcinoma, gastric cancer, pulmonary carcinoma, colorectal cancer, cervical cancer, leukemia.
Dropping pill formulation of the present invention can obviously improve the flat bioavailability of the cancer that disappears, and the flat fine-grain that forms of the cancer that makes to disappear is dispersed in Basic compose, forms solid dispersion, improve the dissolution velocity of medicine, eliminate gathering and the agglomeration of medicine, in gastrointestinal tract, can disperse rapidly, be beneficial to absorption.Xiaoaiping dripping pill and ordinary preparation be as compared with tablet, have onset rapidly, the outstanding feature such as taking convenience; Compared with XIAOAIPING TANGJIANG, have advantages of easy to carry; Compared with the drop pill of prior art, also have that active constituent content is high, stripping advantage rapidly, for patient provides a kind of convenient drug administration, has been convenient to the preparation swallowed, bioavailability is high.Extraction process of active component of the present invention and method for preparing drop pills are simply controlled, and economy and facility is applicable to suitability for industrialized production.
detailed description of the invention:
embodiment 1: preparation
Extract: get Radix Fissistigmatis Glaucescentis medical material 1 kg, pulverize, add the water soaking 10 hours of 10 kilograms, then at 250W, supersound process 50 minutes under 220-280 Hz, filter, filtrate is concentrated into thick paste, and residue adds the water soaking 1.5 hours of 6 kg, at 250W, supersound process 40 minutes under 220-280 Hz, filters, and filtrate is concentrated into thick paste, residue adds the water soaking 1 hour of 5 kg, at 250W, supersound process 30 minutes under 220-280Hz, filters, filtrate is concentrated into thick paste, merge three times thick paste liquid,, be the flat extract of the cancer that disappears.
Composition:
Flat extract 30 g of the cancer that disappears
Cetomacrogol 1000 65g
Sodium laurylsulfate 2.5g
Carboxymethyl starch sodium 2.5 g
Be prepared into 1000 balls
Drop pill preparation: by respectively estimating one's own ability, cetomacrogol 1000 is heated to molten condition; The flat extract of the cancer that will disappear, sodium laurylsulfate and carboxymethyl starch sodium join in above-mentioned substrate, after stirring, join in pill dripping machine, and dripping becomes ball, wipes the liquid coolant on drop pill surface, dry, make Xiaoaiping dripping pill.
embodiment 2: preparation
Extract: get Radix Fissistigmatis Glaucescentis medical material 1 kg, pulverize, add the water soaking 12 hours of 15 kilograms, then at 250W, supersound process 60 minutes under 220-280 Hz, filter, filtrate is concentrated into thick paste, and residue adds the water soaking 2 hours of 8 kg, at 250W, supersound process 30 minutes under 220-280 Hz, filters, and filtrate is concentrated into thick paste, residue adds the water soaking 1 hour of 6 kg, at 250W, supersound process 30 minutes under 220-280Hz, filters, filtrate is concentrated into thick paste, merge three times thick paste liquid,, be the flat extract of the cancer that disappears.
Composition:
Flat extract 20 g of the cancer that disappears
Macrogol 4000 65 g
Sodium laurylsulfate 4.5 g
Cross-linking sodium carboxymethyl cellulose 10.5g
Be prepared into 1000 balls
Drop pill preparation: except composition difference, identical with embodiment 1.
embodiment 3: preparation
Extract: get Radix Fissistigmatis Glaucescentis medical material 1 kg, pulverize, add the water soaking 15 hours of 12 kilograms, then at 250W, supersound process 40 minutes under 220-280 Hz, filter, filtrate is concentrated into thick paste, and residue adds the water soaking 1.5 hours of 5 kg, at 250W, supersound process 30 minutes under 220-280 Hz, filters, and filtrate is concentrated into thick paste, residue adds the water soaking 1 hour of 6 kg, at 250W, supersound process 30 minutes under 220-280Hz, filters, filtrate is concentrated into thick paste, merge three times thick paste liquid,, be the flat extract of the cancer that disappears.
Composition:
Flat extract 20 g of the cancer that disappears
Poloxamer 60 g
Polyvinylpyrrolidone 6 g
Carboxymethyl starch sodium 14 g
Be prepared into 1000 balls
Drop pill preparation: except composition difference, identical with embodiment 1.
embodiment 4: preparation
Extract: get Radix Fissistigmatis Glaucescentis medical material 1 kg, pulverize, add the water soaking 15 hours of 10 kilograms, then at 250W, supersound process 40 minutes under 220-280 Hz, filter, filtrate is concentrated into thick paste, and residue adds the water soaking 2 hours of 6 kg, at 250W, supersound process 40 minutes under 220-280 Hz, filters, and filtrate is concentrated into thick paste, residue adds the water soaking 1 hour of 6 kg, at 250W, supersound process 30 minutes under 220-280Hz, filters, filtrate is concentrated into thick paste, merge three times thick paste liquid,, be the flat extract of the cancer that disappears.
Composition:
Flat extract 15 g of the cancer that disappears
Macrogol 4000 75 g
Polyvinylpyrrolidone 2 g
Cross-linking sodium carboxymethyl cellulose 8 g
Be prepared into 1000 balls
Drop pill preparation: except composition difference, identical with embodiment 1.
the comparison of embodiment 5 active component contents
Contain multiple anticancer component because the cancer that disappears is flat, the present embodiment, only taking the most representative chlorogenic acid content as example, illustrates the advantage of drop pill of the present invention.Extracting method (they are as same extracting method) taking extracting method of the present invention (embodiment 2) and above-mentioned prior art patent, as example, proves the advantage of extract of the present invention.Gained thick paste liquid is through concentrated, dry, obtain extract dried cream powder.Taking chlorogenic acid as measuring item, measure its content, relatively these two kinds of active substances that method is extracted.
Instrument: U.S. Waters600 high performance liquid chromatograph, be furnished with Waters600 pump; Waters2487 UV-detector; Millennium
32chromatographic work station, UV-2550 ultraviolet-uisible spectrophotometer.SB-3200DT ultrasonic cleaner, BT-25S type electricity balance; Chlorogenic acid reference substance (lot number 234457-201108, Nat'l Pharmaceutical & Biological Products Control Institute), acetonitrile is chromatographically pure, and water is double distilled water, and all the other reagent are analytical pure.
Detect the selection of wavelength: adopt UV-550 ultraviolet-visible spectrophotometer, chlorogenic acid reference substance solution is scanned in 200-400 nn wave-length coverage, result has absorption maximum at 327 nm wavelength places, therefore, selected 327 nm are for detecting wavelength.
Chromatographic condition and system suitability test: chromatographic column is Kro-masilODS (5 μ m, 46mm x250 mm); Mobile phase: second eyeball-0.4% phosphoric acid (10:90); Detect wavelength: 327nm; Flow velocity: 1 mL/min; Column temperature: room temperature.Under this chromatographic condition, sample Content of Chlorogenic Acid chromatographic peak and other chromatographic peak separating degree are good, and theoretical cam curve is to calculate and to be not less than 5000 by chlorogenic acid peak.
The preparation of need testing solution: get above-mentioned Radix Fissistigmatis Glaucescentis dried cream powder, cross 40 mesh sieves, precision takes 0.5 g and puts in conical flask, and precision adds the close plug of 50% methanol 20 mL, weighed weight, supersound extraction 30 min, let cool, and weighed weight is supplied the weight of less loss with methanol, shake up, filter, get subsequent filtrate, to obtain final product.
All prove that through precision test, replica test, stability test, recyclability test etc. this law performance is good.
Assay: described test sample and reference substance are made to test liquid according to above-mentioned preparation method, measure their medical material peak area according to described chromatographic condition, calculate, result following (for measuring respectively the meansigma methods of 3 times):
| Test sample | Chlorogenic acid content % |
| Extract of the present invention | 0.344 |
| The extract of prior art | 0.148 |
Can find out, only need through simple supersound process, in extract, the content of active ingredient chlorogenic acid is above with regard to significantly doubling, although supersound process is a kind of conventional extracting method, but received beyond thought effect, this is that pharmacy personnel is difficult to predict in advance.Described extracting method a kind of simple extracting method efficiently of can yet be regarded as.
embodiment 5 dissolution in vitro comparisons
Drop pill of the present invention can overcome the low deficiency of existing dosage form bioavailability, constant product quality, and stripping is fast, and bioavailability is high.The drop pill of getting respectively in this experiment above-mentioned prior art patent (is all active ingredient with the extract that the present invention extracts, be prepared as respectively the drop pill of 10 mg by formula (first dropping pill formulation example in embodiment) separately, be respectively reference examples 1, 2, 3 and 4) and 10 mg drop pill of the embodiment of the present invention 1, according to dissolution method (2005 editions two annex XC first methods of Chinese Pharmacopoeia), taking 900 ml water as solvent, rotating speed is 100 revs/min, by method operation described in it, get solution 10 ml at different time points respectively, filter, get filtrate according to spectrophotography (2005 editions two annex IVA of Chinese Pharmacopoeia), measure content taking chlorogenic acid wherein as measuring item, wavelength place at 327nm measures trap, separately get identical extract equivalent, be measured in the same method, calculate the stripping quantity of per unit, the dissolution % of numeral shown in table.
| ? | 5 min | 10 min | 15 min | 20 min | 30 min | ?45 min | 60 min |
| Embodiment 1 | 43.2 | 72.8 | 84.2 | 91.8 | 95.6 | 98.5 | 100.1 |
| Reference examples 1 | 32.5 | 54.2 | 68.5 | 89.5 | 95.0 | 97.9 | 99.9 |
| Reference examples 2 | 35.6 | 55.1 | 69.9 | 90.5 | 94.9 | 98.0 | 99.8 |
| Reference examples 3 | 38.5 | 65.6 | 73.5 | 93.2 | 94.8 | 98.5 | 100.2 |
| Reference examples 4 | 29.2 | 53.5 | 65.5 | 77.8 | 92.3 | 96.8 | 99.9 |
As can be seen from the above table, drop pill dissolution of the present invention is faster than the drop pill dissolution rate of prior art, and particularly the advantage in first 15 minutes is more obvious.
Measure in the same way the drop pill of embodiment 2-4, data are substantially similar to embodiment 1, are significantly better than reference examples 1-4.
Visible, drop pill dissolution rate of the present invention is good, has unique advantage aspect bioavailability.
With reference to embodiment, invention has been described above, should be appreciated that pharmaceutical field technical staff can be with reference to this paper content, and in the situation that not departing from content of the present invention, spirit and scope, the link such as appropriate change technological parameter realizes technology of the present invention.Special needs to be pointed out is that the replacement that these are similar and change apparent to those skilled in the artly does not depart from spirit of the present invention, scope and content.
Claims (3)
1. the flat compositions of the cancer that disappears, it is dropping pill formulation, made by active component, substrate and other adjuvants, wherein active component accounts for 1%～40% of gross weight, Basic compose accounts for 60%～95% of gross weight, the amount of other adjuvants is 1%-5%, and wherein the weight ratio of active component and Basic compose is 1:2-1:6, other adjuvants comprise the first adjuvant and the second adjuvant, wherein said substrate is selected from one or more in cetomacrogol 1000, Macrogol 4000 and poloxamer, wherein said the first adjuvant is sodium laurylsulfate or polyvinylpyrrolidone, described the second adjuvant is carboxymethyl starch sodium or cross-linking sodium carboxymethyl cellulose, and wherein the ratio between the first adjuvant and the second adjuvant is 5:1-1:5, wherein said active component is the extract of Radix Fissistigmatis Glaucescentis, the extracting method of wherein said active component, comprise described medical material through supersound process, its concrete steps are, get Radix Fissistigmatis Glaucescentis medical material, pulverize, the water soaking 8-15 hour that adds 10-15 doubly to measure, then at 250W, supersound process 30-60 minute under 220-280Hz, filter, filtrate is concentrated into thick paste, the water soaking 1-2 hour that residue adds 5-8 doubly to measure, at 250W, supersound process 30-60 minute under 220-280Hz, filter, filtrate is concentrated into thick paste, the water soaking 0.5-1.5 hour that residue adds 5-8 doubly to measure, at 250W, supersound process 30-60 minute under 220-280Hz, filter, filtrate is concentrated into thick paste, merge three times thick paste liquid, .
2. the compositions of claim 1, wherein the ratio between the first adjuvant and the second adjuvant is 1:1-1:5.
3. the method for the compositions described in preparation claim 1 or 2, comprising: substrate is heated to molten condition; Active ingredient, the first adjuvant and the second adjuvant are joined in above-mentioned substrate, after stirring, join in pill dripping machine, dripping becomes ball, wipes the liquid coolant on drop pill surface, dry, makes Xiaoaiping dripping pill.
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| CN100358499C (en) * | 2005-02-28 | 2008-01-02 | 北京正大绿洲医药科技有限公司 | Xiaoaiping dripping pill for treating various cancers and its preparing method |
| CN101032464A (en) * | 2007-04-01 | 2007-09-12 | 杨喜鸿 | Combination containing rimonabant and polyvinyl pyrrolidone, solid dispersion and the preparing and medicine application thereof |
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