CN103432380B - The mucosa ulceration medicine of Chinese medicine preparation production method and production thereof and assay method - Google Patents
The mucosa ulceration medicine of Chinese medicine preparation production method and production thereof and assay method Download PDFInfo
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- CN103432380B CN103432380B CN201310399692.7A CN201310399692A CN103432380B CN 103432380 B CN103432380 B CN 103432380B CN 201310399692 A CN201310399692 A CN 201310399692A CN 103432380 B CN103432380 B CN 103432380B
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Abstract
The invention relates to a kind of production method of Chinese medicine preparation, raw material is mixed in proportion rear coarse crushing and becomes granule, soak, decoct with water three times, each 1 hour, filter, filtrate is concentrated, obtains extractum.The invention still further relates to the medicine of the treatment mucosa ulceration that a kind of said method is produced, its raw material comprises Fructus Phyllanthi, Radix Ophiopogonis, Radix Paeoniae Rubra, Radix Rehmanniae and Radix Glycyrrhizae, the invention provides the assay method of this Chinese medicine preparation, the mensuration of paeoniflorin content and the mensuration of Radix Ophiopogonis total saponins content, measure its content with liquid chromatography and ultraviolet visible spectrophotometry respectively.The receipts cream amount of production method provided by the invention, effective component extraction rate obviously increase, and improve raw material availability and product quality.
Description
Technical field
The present invention relates to pharmaceutical formulating art, particularly relate to mucosa ulceration medicine and the assay method of a kind of Chinese medicine preparation production method and production thereof.
Background technology
Mucosa ulceration is a kind of common disease, be wherein its Typical Representative with oral ulcer again, the medicament of its treatment has Chinese medicine preparation, also Western medicine preparation is had, Chinese patent application CN99126606.4 discloses a kind of Chinese patent medicine for the treatment of oral ulcer and behcets disease, its raw material of Chinese medicine used and weight proportion are: Radix Ginseng 12-18 parts, Squama Manis 3-7 parts, Rhizoma Dioscoreae 8-12 parts, the Radix Astragali 17-23 parts, Flos Lonicerae 17-23 parts, Herba Menthae 17-23 parts, Cordyceps 8-12 parts, Cortex Cinnamomi 17-23 parts, Stigma Croci 12-18 parts.Chinese patent application CN97118982.X discloses one " ointment for toothache and stomatocase ", formed by the drug regimen of following weight component: 8-12 parts, Cinnabaris, Borax 8-12 parts, Rhizoma Coptidis 15-20 parts, Radix Et Rhizoma Rhei 13-15 parts, Cortex Phellodendri 15-20 parts, 15-20 parts, Radix Glycyrrhizae, Borneolum Syntheticum 25-30 parts, 30-35 parts, Cera Flava, Oleum sesami 650-700 parts.These medicines have certain positive role to treatment oral ulcer.
Chinese patent application CN03154193.3 discloses a kind of Chinese medicine preparation for the treatment of mucosa ulceration, combine by different proportion primarily of Fructus Phyllanthi, Radix Ophiopogonis, Radix Paeoniae Rubra, Radix Rehmanniae and Radix Glycyrrhizae, existing by natural plants to be Traditional Chinese medicine extraction method that raw material is made be Fructus Phyllanthi, Radix Ophiopogonis, Radix Paeoniae Rubra, Radix Rehmanniae, Radix Glycyrrhizae are mixed by a certain percentage after, decoct with water twice, add water 12 times at every turn, each 2 hours, filter, filtrate is concentrated into about 1.15, and the oral formulations such as mixture, tablet, granule, capsule, soft capsule made by extractum.
But the production method of above-mentioned Chinese medicine preparation, the leaching rate of its effective ingredient is lower, and raw material availability is lower, thus causes the waste of resource.
Summary of the invention
The object of the present invention is to provide mucosa ulceration medicine and the assay method of a kind of Chinese medicine preparation production method and production thereof, to improve the extractum of effective ingredient, to improve the quality of product, thus overcome the deficiency that existing production method effective ingredient extractum is low, raw material availability is low.
For solving the problems of the technologies described above, the invention provides a kind of production method of Chinese medicine preparation, raw material being mixed in proportion rear coarse crushing and becoming granule, soaking, decocting with water three times, each 1 hour, filter, filtrate is concentrated, obtains extractum.
As a modification of the present invention, the present invention also realizes by following proposal:
A production method for Chinese medicine preparation, wherein, described material coarse cutting is to 2-3mm granule.
A production method for Chinese medicine preparation, wherein, after coarse crushing, the time of soaking is more than 12 hours.
A production method for Chinese medicine preparation, wherein, when decocting with water, each amount of water is 8 times of raw material.
The invention still further relates to a kind of mucosa ulceration medicine applied said method and produce, wherein, described proportioning raw materials be Fructus Phyllanthi 1 weight portion, Radix Ophiopogonis 5 weight portion, Radix Paeoniae Rubra 5 weight portion, Radix Rehmanniae 5 weight portion and Radix Glycyrrhizae 1 weight portion.
Apply the mucosa ulceration medicine that said method is produced, wherein, described proportioning raw materials be Fructus Phyllanthi 2 weight portion, Radix Ophiopogonis 6 weight portion, Radix Paeoniae Rubra 6 weight portion, Radix Rehmanniae 5 weight portion and Radix Glycyrrhizae 2 weight portion.
The present invention also provides a kind of assay method of above-mentioned treatment mucosa ulceration medicine, and it is characterized in that comprising paeoniflorin content measures and Radix Ophiopogonis total saponins assay, described paeoniflorin content assay method is as follows: preparation reference substance solution; Measure test sample concentrated solution 5ml, put in 100ml volumetric flask, add methanol dilution to scale, shake up, filter; Measure subsequent filtrate 10ml, evaporate to dryness, residue adds water after appropriate dissolving, through alumina column, washes with water, collects eluent 23ml, pours in 25ml volumetric flask, be diluted with water to scale, shake up, and filters; Get reference substance solution and need testing solution 10ul respectively, injection liquid chromatography, adopt with methanol-water-glacial acetic acid 25:75:0.2 for mobile phase, the high performance liquid chromatography that theoretical cam curve is not less than 1500 by peoniflorin calculating measures.
The assay method of Radix Ophiopogonis total saponins content is as follows: get ruscorectal reference substance appropriate, make reference substance solution; Take perchloric acid as solvent, measure wavelength 397nm place absorbance with ultraviolet-visible spectrophotometer, drawing standard curve; Measure concentrated solution 20ml, put in 100ml volumetric flask, add ethanol 70ml, shake up, cool after supersound process, add ethanol dilution to scale, shake up filtration; Measure subsequent filtrate 10ml, by solvent evaporate to dryness, the residue 15ml that adds water makes dissolving, is transferred in separatory funnel, extracts 5 times with saturated n-butyl alcohol jolting, merges n-butyl alcohol liquid, washs 2 times, discard ammoniacal liquor with ammonia solution; N-butyl alcohol liquid evaporate to dryness, residue adds methanol and makes 25ml solution, filters; Measure subsequent filtrate 2ml to put in tool plug test tube, in water-bath, volatilize solvent, add perchloric acid 10ml, shake up, put in hot water and be incubated, taking-up frozen water cools, and take coordinative solvent as blank solution, with ultraviolet-visible spectrophotometer, measures wavelength 397nm place absorbance
After adopting such design, the present invention at least has the following advantages:
1, peoniflorin and ophiopogonin pharmacological evaluation show, be significantly improved immunity of organisms effect, obvious healing effect is had to oral ulcer, for treating the effective ingredient of the Chinese medicine preparation of mucosa ulceration in the present invention, and the receipts cream amount of production method provided by the invention, peoniflorin extraction ratio and ophiopogonin extraction ratio obviously increase, improve raw material availability and product quality.
2, shorten extraction time, improve production efficiency.
3, the present invention's measuring method used accuracy is high, simple to operation.
Detailed description of the invention
Embodiment 1
Employing prior art is prepared, get Fructus Phyllanthi 100g, Radix Ophiopogonis 500g, Radix Paeoniae Rubra 500g, Radix Rehmanniae 500g, Radix Glycyrrhizae 100g decoct with water twice, adds water 12 times at every turn, each 2 hours, filter, filtrate was concentrated into 1.15, receiving cream amount is 1500g, measures peoniflorin and ophiopogonin content.
Embodiment 2
Employing the inventive method is prepared, get Fructus Phyllanthi 100g, Radix Ophiopogonis 500g, Radix Paeoniae Rubra 500g, Radix Rehmanniae 500g, Radix Glycyrrhizae 100g, raw material is mixed in proportion rear coarse crushing and becomes granule, soak, decoct with water three times, each 1 hour, filter out medicinal residues, filtrate is concentrated into relative density 1.15, obtains extractum, measure the content of peoniflorin and ophiopogonin.
Embodiment 3
Employing prior art is prepared, get Fructus Phyllanthi 200g, Radix Ophiopogonis 600g, Radix Paeoniae Rubra 600g, Radix Rehmanniae 500g, Radix Glycyrrhizae 200g decoct with water twice, adds water 12 times at every turn, each 2 hours, filter, filtrate was concentrated into 1.15, receiving cream amount is 1500g, measures peoniflorin and ophiopogonin content.
Embodiment 4
Employing the inventive method is prepared, get Fructus Phyllanthi 200g, Radix Ophiopogonis 600g, Radix Paeoniae Rubra 600g, Radix Rehmanniae 500g, Radix Glycyrrhizae 200g, raw material is mixed in proportion rear coarse crushing and becomes granule, soak, decoct with water three times, each 1 hour, filter out medicinal residues, filtrate is concentrated into relative density 1.15, obtains extractum, measure the content of peoniflorin and ophiopogonin.
Preferably, in embodiment 2 and embodiment 4, material coarse cutting is become 2-3mm granule, soak more than 12 hours, when decocting with water, institute's amount of water is preferably 8 times of raw material.
The invention still further relates to a kind of assay method for the treatment of the Chinese medicine preparation of mucosa ulceration, comprise paeoniflorin content and measure and Radix Ophiopogonis total saponins assay.
(1) assay method of paeoniflorin content is as follows:
The preparation of reference substance solution: get peoniflorin reference substance appropriate, precise, adds water and makes the solution of every 1ml containing 40 μ g, to obtain final product.
Prepared by need testing solution: accurately measure the concentrated solution 5ml obtained by the present invention, put in 100ml volumetric flask, add methanol dilution to scale, shake up, and leaves standstill, and filters; Precision measures subsequent filtrate 10ml, evaporate to dryness, and residue adds water after appropriate dissolving, be placed in alumina column (internal diameter 1.0 ~ 1.5cm, neutral alumina 5g, 100 ~ 200 orders, with water 40ml prewashing) on, wash with water, collect eluent 23ml, pour in 25ml volumetric flask, be diluted with water to scale, shake up, filter.
Algoscopy: get reference substance solution and need testing solution 10ul respectively, injection liquid chromatography, measures.Chromatograph selects methanol-water-glacial acetic acid (25:75:0.2) to be mobile phase, and theoretical cam curve calculates should be not less than 1500 by peoniflorin, and its filler is octadecylsilane chemically bonded silica, and determined wavelength is 230nm.
(2) assay method of Radix Ophiopogonis total saponins content is as follows:
The preparation of reference substance solution: get ruscorectal reference substance appropriate, accurately weighed, add methanol and make the solution of every 1ml containing 50 μ g.
The preparation of standard curve: measure reference substance solution 0.5ml, 1.0ml, 2.0ml, 3.0ml, 4.0ml, 5.0ml and 6.0ml respectively, is placed in tool plug test tube, in water-bath, volatilizes solvent; Add perchloric acid 10ml respectively, shake up, put in hot water and be incubated 15min, taking-up frozen water cools, and take coordinative solvent as blank solution, with ultraviolet-visible spectrophotometer, measures wavelength 397nm place absorbance; Take absorbance as vertical coordinate, concentration is abscissa, drawing standard curve.
Measure: measure concentrated solution 20ml, be placed in 100ml volumetric flask, add ethanol 70ml, shake up, supersound process 20 minutes, is cooled to room temperature, adds ethanol dilution to scale, shakes up, filter; Precision measures subsequent filtrate 10ml, and by solvent evaporate to dryness, the residue 15ml that adds water makes dissolving, be transferred in separatory funnel, extract 5 times with saturated n-butyl alcohol jolting, each 15ml, merge n-butyl alcohol liquid, wash 2 times with ammonia solution, each 15ml, discard ammoniacal liquor, by n-butyl alcohol liquid evaporate to dryness, residue adds methanol makes dissolving, be transferred in 25ml measuring bottle, and add methanol dilution to scale, shake up, filter.Measure subsequent filtrate 2ml and be placed in tool plug test tube, in water-bath, volatilize solvent, precision adds perchloric acid 10ml, shake up, put in hot water and be incubated 15min, taking-up frozen water cools, take coordinative solvent as blank solution, with ultraviolet-visible spectrophotometer, measure the absorbance at wavelength 397nm place.
Calculate: calculate suitable ruscorectal content by the absorbance and reference substance solution absorbance standard curve that contrast need testing solution, the Radix Ophiopogonis total saponins in Chinese medicine preparation of the present invention is in ruscorectal.
The effective ingredient detecting each product of embodiment 1-4 according to above-mentioned detection method is known, and the Chinese medicine preparation that production method provided by the present invention obtains is compared with traditional processing technology, and its effective ingredient improves greatly, shortens the production time, improves production efficiency.Compare the Chinese medicine preparation production method described in the present invention and prior art production method the data obtained below, experimental data is as follows:
Table 1
Table 2
Illustrate: peoniflorin extraction ratio=(in extractum weight * extractum paeoniflorin content)/(in medical material weight * medical material paeoniflorin content)
Ophiopogonin extraction ratio=(in extractum weight * extractum ophiopogonin content)/(in medical material weight * medical material ophiopogonin content)
The extractum that Chinese medicine preparation production method of the present invention obtains can be made into the oral formulations such as mixture, tablet, granule, capsule, soft capsule.It has wide range of applications, and can be used in various Chinese medicine extraction, other two kinds of Chinese medicine formulas as described in the background art, and the extraction especially for the effective ingredient of the treatment such as peoniflorin and Radix Ophiopogonis total saponins mucosa ulceration has significant advantage.
The above; it is only preferred embodiment of the present invention; not do any pro forma restriction to the present invention, those skilled in the art utilize the technology contents of above-mentioned announcement to make a little simple modification, equivalent variations or modification, all drop in protection scope of the present invention.
Claims (4)
1. a production method for Chinese medicine preparation, is characterized in that: Fructus Phyllanthi, Radix Ophiopogonis, Radix Paeoniae Rubra, Radix Rehmanniae and Radix Glycyrrhizae are mixed in proportion rear coarse crushing and become 2-3mm granule, soak more than 12 hours, decoct with water three times, each 1 hour, filter, filtrate is concentrated, obtains extractum.
2. Chinese medicine preparation production method according to claim 1, is characterized in that: when decocting with water, each amount of water be Fructus Phyllanthi, Radix Ophiopogonis, Radix Paeoniae Rubra, Radix Rehmanniae and Radix Glycyrrhizae 8 times.
3. application rights requires to it is characterized in that the mucosa ulceration medicine that method described in 1 or 2 is produced: the proportioning of described Fructus Phyllanthi, Radix Ophiopogonis, Radix Paeoniae Rubra, Radix Rehmanniae and Radix Glycyrrhizae be Fructus Phyllanthi 1 weight portion, Radix Ophiopogonis 5 weight portion, Radix Paeoniae Rubra 5 weight portion, Radix Rehmanniae 5 weight portion and Radix Glycyrrhizae 1 weight portion.
4. application rights requires to it is characterized in that the mucosa ulceration medicine that method described in 1 or 2 is produced: the proportioning of described Fructus Phyllanthi, Radix Ophiopogonis, Radix Paeoniae Rubra, Radix Rehmanniae and Radix Glycyrrhizae be Fructus Phyllanthi 2 weight portion, Radix Ophiopogonis 6 weight portion, Radix Paeoniae Rubra 6 weight portion, Radix Rehmanniae 5 weight portion and Radix Glycyrrhizae 2 weight portion.
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Effective date of registration: 20191224 Address after: 650503 1298 Bio Valley Street, majinpu, Kunming, Yunnan Patentee after: Yunnan Shengke Pharmaceutical Co., Ltd Address before: 650106 No. 45, medical Road, hi tech Development Zone, Yunnan, Kunming Patentee before: Dihon Pharmaceutical Group Co., Ltd. |
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