CN103356813B - Indian stringbush root capsule - Google Patents
Indian stringbush root capsule Download PDFInfo
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- CN103356813B CN103356813B CN201210094476.7A CN201210094476A CN103356813B CN 103356813 B CN103356813 B CN 103356813B CN 201210094476 A CN201210094476 A CN 201210094476A CN 103356813 B CN103356813 B CN 103356813B
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Abstract
The invention belongs to the technical field of traditional Chinese medicines and particularly discloses an indian stringbush root capsule which is prepared from the effective part of an indian stringbush root. According to the invention, the curative effect of the indian stringbush root capsule is enhanced and the potential toxicity of the indian stringbush root capsule is reduced by improving the extraction process of the traditional medicinal material; for a long term, the indian stringbush root capsule is clinically applied to Chinese medicine in large quantity, but the deep mechanism research of the indian stringbush root capsule is not definitely researched and illuminated; the inventor determines to adopt the implementation mode disclosed by the invention by screening drugs which are obtained by carrying out different extraction and separation methods according to the formula in terms of the inhibition activities to multiple common viruses and germs. The invention aims to more effectively reach the purposes of safety, effectiveness and controllability by optimizing the extraction method of an indian stringbush root medicinal material, so as to provide a safer and more effective clinical capsule.
Description
[technical field]
The invention belongs to the technical field of Chinese medicine and preparation method thereof, be specifically related to a kind of preparation method extracting the Radix Wikstroemae capsule merging gained containing Radix Wikstroemae.
[background technology]
The name of Radix Wikstroemae begins to be loaded in " south of the Five Ridges gather medicinal herbs record ", its bitter in the mouth, pungent, cold in nature, poisonous, and function heat-clearing and toxic substances removing, dissipating blood stasis is relieved oedema or abdominal distension through diuresis or purgation, reducing swelling and alleviating pain.In Jiangxi, Guangdong, Guangxi, Zhejiang, Fujian, the among the people of the south of the lower reaches of the Yangtze River such as Hunan have good application foundation, is widely used in the diseases such as the bronchitis caused by pyretic toxicity, pneumonia, parotitis, tonsillitis, lymphadenitis, mastitis, furuncle carbuncle.
Radix Wikstroemae is conventional Chinese herbal medicine, formal name used at school wikstroemia indica [wikstroemiaindica (L.) C.A.May.], is thymelaeceae Flos Wikstroemiae Dolichanthae platymiscium, and nature and flavor bitter cold is micro-pungent, poisonous.Function heat-clearing and toxic substances removing, dissipating phlegm and resolving masses, stimulate the menstrual flow diuretic.Be distributed on the south China the Changjiang river and Southeast Asia one band, abounding with in the ground such as Zhejiang, Jiangxi, is half evergreen dwarf shrub, and the whole year can adopt, and general picking leaves in summer, autumn adopts root.Root system digs afterwash, dries for subsequent use, or strips root endothelium and dry for subsequent use, or when taking advantage of fresh, section is dried for subsequent use, or cooks section and dry for subsequent use.Radix Wikstroemae contains the compositions such as wikstroemin, Flos Wikstroemiae Dolichanthae element, hydroxyl Flos Wikstroemiae Dolichanthae element, daphnoretin, arctigenin-4'-gentiobioside, wickstromol, Luo Hong pinoresinol, (+)-Pinoresinol, cupreol, 7-ketone-cupreol, stigmastane-3,7-glycol, 5-bean steroid-3 β, 7a-glycol, polysaccharide, acidic resins, volatile oil, Saponin.
Studied by this project, improve the quality standard level of this medicine, will constant product quality be contributed to, the raising of clinical efficacy and safety.By changing dosage form, a kind of taking convenience, safe and effective Traditional Chinese Medicine Anti will be provided to infect new drug.
The preparation method of traditional Radix Wikstroemae capsule is: get Radix Wikstroemae and be about 440g, first time adds 8 times of water gagings, second time adds 6 times amount soak by water secondaries, each 5 hours, collecting decoction, filter, filtrate is concentrated into the extractum that relative density is 1.10 ~ 1.15 (60 DEG C), is spray dried to dry extract; Get dry extract 220g, add starch appropriate, mixing, granulate, less than 80 DEG C dry, encapsulated, makes 100 altogether, to obtain final product.
Disclose the relevant patent documentation of some Radix Wikstroemae at present: CN102311415A, CN102344454A, CN102000215A, CN1857522, CN1726979, CN1252285, CN1562233, CN101601666.
[summary of the invention]
The object of the present invention is to provide a kind of new taxi driver brother king's capsule.For a long time, Radix Wikstroemae capsule has the application of a large amount of tcm clinical practices, but its deep study mechanism does not have clear and definite research to illustrate; Inventor adopts different extracting and developing gained medicines to adopt the screening of the inhibit activities of multiple common virus and pathogenic bacteria to this formula, determines to adopt implementation of the present invention.
The object of the invention is to the optimization of the extracting method by Radix Wikstroemae medical material, can more effectively reach safe, effective and controlled object, safety and effective clinical capsule formulation are more provided.
Specifically disclose a kind of Radix Wikstroemae capsule, it is that the effective site of Radix Wikstroemae is made.The present invention, by the improvement to the extraction process of existing medical material, enhances the curative effect of Radix Wikstroemae capsule, reduces potential toxicity
Specifically, a kind of new Radix Wikstroemae capsule provided by the invention, adopts following methods preparation:
(1) Radix Wikstroemae 440g is through pulverizing to obtain medicinal material coarse powder, adds 50-80% alcohol reflux 2-7 time of 5 times amount, each 1-3 hour;
(2) ethanol is merged, reclaim the clear paste of ethanol to relative density 1.03-1.20, the macroporous resin (clear paste: macroporous resin=1: 1-5) that qinghuo reagent has been handled well, respectively with water, 30% ethanol, 50% ethanol, 95% ethanol each 4-10 times amount column volume eluting;
(3) merge water, 30% ethanol and 50% ethanolic moiety, reclaim ethanol, vacuum drying obtains dry extract, and get dry extract and add starch in right amount, mixing, granulate, less than 80 DEG C dry, encapsulated, makes 100 altogether, to obtain final product.
A kind of new Radix Wikstroemae capsule provided by the invention, can also adopt following methods to prepare:
(1) Radix Wikstroemae 440g is through pulverizing to obtain medicinal material coarse powder, adds 50-80% alcohol reflux 2-7 time of 5 times amount, each 1-3 hour;
(2) ethanol is merged, reclaim the clear paste of ethanol to relative density 1.03-1.20, the macroporous resin (clear paste: macroporous resin=1: 1-5) that qinghuo reagent has been handled well, respectively with water, 30% ethanol, 50% ethanol, 95% ethanol each 4-10 times amount column volume eluting;
(3) merge 30% ethanol and 50% ethanolic moiety, reclaim ethanol, vacuum drying obtains dry extract, and get dry extract and add starch in right amount, mixing, granulate, less than 80 DEG C dry, encapsulated, makes 100 altogether, to obtain final product.
A kind of new Radix Wikstroemae capsule provided by the invention, can also adopt following methods to prepare:
(1) Radix Wikstroemae 440g is through pulverizing to obtain medicinal material coarse powder, adds 50-80% alcohol reflux 2-7 time of 5 times amount, each 1-3 hour;
(2) ethanol is merged, reclaim the clear paste of ethanol to relative density 1.03-1.20, the macroporous resin (clear paste: macroporous resin=1: 1-5) that qinghuo reagent has been handled well, respectively with water, 30% ethanol and 95% ethanol each 4-10 times amount column volume eluting;
(3) merge water and 30% ethanolic moiety, reclaim ethanol, vacuum drying obtains dry extract, and get dry extract and add starch in right amount, mixing, granulate, less than 80 DEG C dry, encapsulated, makes 100 altogether, to obtain final product.
Above-mentioned Radix Wikstroemae capsule, the 50-80% alcohol reflux of described step (1) 5 times amount 2-4 time, each 1-3 hour.
Above-mentioned Radix Wikstroemae capsule, the 50-80% alcohol reflux of described step (1) 5 times amount 2 times, each 2 hours.
Above-mentioned Radix Wikstroemae capsule, the clear paste in described step (2): the ratio of macroporous resin=1: 1-3.
Above-mentioned Radix Wikstroemae capsule, the clear paste in described step (2): macroporous resin=1: the ratio of 3.
Above-mentioned Radix Wikstroemae capsule, in described step (2) with water, 30% ethanol, 50% ethanol, 70% and 95% ethanol each 4-6 times amount column volume eluting.
Above-mentioned Radix Wikstroemae capsule, it is characterized in that in described step (2) with water, 30% ethanol, 50% ethanol, each 5 times amount column volume eluting of 70% and 95% ethanol.
The application caught in medicine treated by above-mentioned Radix Wikstroemae capsule in preparation.
Above-mentioned macroporous resin is selected from the one in HP-10, HP-20, HP--30, HP-40, HP-50, ParapetP-S, ParapetQ, ParapetR, ParapetS, ParapetN, Chromosorb.
The object of the invention is to the optimization of the extracting method by Radix Wikstroemae medical material, can more effectively reach safe, effective and controlled object, more effective Clinical Dosage Form is provided.
[detailed description of the invention]
Embodiment 1
(1) Radix Wikstroemae 440g is through pulverizing to obtain medicinal material coarse powder, adds the alcohol reflux 3 times of 75% of 5 times amount, each 2 hours;
(2) ethanol is merged, reclaim the clear paste of ethanol to relative density 1.15-1.20, the macroporous resin (clear paste: macroporous resin HP-10=1: 5) that qinghuo reagent has been handled well, respectively with each 5 times amount column volume eluting of water, 30% ethanol, 50% ethanol and 95% ethanol;
(3) merge water, 30% ethanol and 50% ethanolic moiety, reclaim ethanol, vacuum drying obtains dry extract, gets dry extract and adds starch 30g, and mixing is granulated, and less than 80 DEG C dry, encapsulated, makes 100 altogether, to obtain final product.
Embodiment 2
(1) Radix Wikstroemae 440g is through pulverizing to obtain medicinal material coarse powder, adds the alcohol reflux 3 times of 50% of 5 times amount, each 1 hour;
(2) ethanol is merged, reclaim the clear paste of ethanol to relative density 1.15-1.20, the macroporous resin (clear paste: macroporous resin HP-10=1: 4) that qinghuo reagent has been handled well, respectively with each 5 times amount column volume eluting of water, 30% ethanol, 50% ethanol and 95% ethanol;
(3) merge water, 30% ethanol and 50% ethanolic moiety, reclaim ethanol, vacuum drying obtains dry extract, gets dry extract and adds starch 30g, and mixing is granulated, and less than 80 DEG C dry, encapsulated, makes 100 altogether, to obtain final product.
Embodiment 3
(1) Radix Wikstroemae 440g is through pulverizing to obtain medicinal material coarse powder, adds the alcohol reflux 3 times of 50% of 5 times amount, each 1 hour;
(2) ethanol is merged, reclaim the clear paste of ethanol to relative density 1.15-1.20, the macroporous resin (clear paste: macroporous resin HP-10=1: 6) that qinghuo reagent has been handled well, respectively with each 6 times amount column volume eluting of water, 30% ethanol, 50% ethanol and 95% ethanol;
(3) merge water, 30% ethanol and 50% ethanolic moiety, reclaim ethanol, vacuum drying obtains dry extract, gets dry extract and adds starch 30g, and mixing is granulated, and less than 80 DEG C dry, encapsulated, makes 100 altogether, to obtain final product.
Embodiment 4
(1) Radix Wikstroemae 440g is through pulverizing to obtain medicinal material coarse powder, adds the alcohol reflux 3 times of 80% of 5 times amount, each 1 hour;
(2) ethanol is merged, reclaim the clear paste of ethanol to relative density 1.03-1.10, the macroporous resin (clear paste: macroporous resin HP-10=1: 8) that qinghuo reagent has been handled well, respectively with each 10 times amount column volume eluting of water, 30% ethanol, 50% ethanol and 95% ethanol;
(3) merge water, 30% ethanol and 50% ethanolic moiety, reclaim ethanol, vacuum drying obtains dry extract, gets dry extract and adds starch 30g, and mixing is granulated, and less than 80 DEG C dry, encapsulated, makes 100 altogether, to obtain final product.
Embodiment 5
(1) Radix Wikstroemae 440g is through pulverizing to obtain medicinal material coarse powder, adds the alcohol reflux 2 times of 75% of 5 times amount, each 3 hours;
(2) ethanol is merged, reclaim the clear paste of ethanol to relative density 1.15-1.20, the macroporous resin (clear paste: macroporous resin HP-20=1: 5) that qinghuo reagent has been handled well, respectively with each 5 times amount column volume eluting of water, 30% ethanol, 50% ethanol and 95% ethanol;
(3) merge water, 30% ethanol and 50% ethanolic moiety, reclaim ethanol, vacuum drying obtains dry extract, gets dry extract and adds starch 30g, and mixing is granulated, and less than 80 DEG C dry, encapsulated, makes 100 altogether, to obtain final product.
Embodiment 6
(1) Radix Wikstroemae 440g is through pulverizing to obtain medicinal material coarse powder, adds the alcohol reflux 2 times of 50% of 5 times amount, each 2 hours;
(2) ethanol is merged, reclaim the clear paste of ethanol to relative density 1.15-1.20, the macroporous resin (clear paste: macroporous resin HP-20=1: 4) that qinghuo reagent has been handled well, respectively with each 6 times amount column volume eluting of water, 30% ethanol, 50% ethanol and 95% ethanol;
(3) merge water, 30% ethanol and 50% ethanolic moiety, reclaim ethanol, vacuum drying obtains dry extract, gets dry extract and adds starch 30g, and mixing is granulated, and less than 80 DEG C dry, encapsulated, makes 100 altogether, to obtain final product.
Embodiment 7
(1) Radix Wikstroemae 440g is through pulverizing to obtain medicinal material coarse powder, adds the alcohol reflux 2 times of 50% of 5 times amount, each 1 hour;
(2) ethanol is merged, reclaim the clear paste of ethanol to relative density 1.15-1.20, the macroporous resin (clear paste: macroporous resin HP-20=1: 6) that qinghuo reagent has been handled well, respectively with each 8 times amount column volume eluting of water, 30% ethanol, 50% ethanol and 95% ethanol;
(3) merge water, 30% ethanol and 50% ethanolic moiety, reclaim ethanol, vacuum drying obtains dry extract, gets dry extract and adds starch 30g, and mixing is granulated, and less than 80 DEG C dry, encapsulated, makes 100 altogether, to obtain final product.
Embodiment 8
(1) Radix Wikstroemae 440g is through pulverizing to obtain medicinal material coarse powder, adds the alcohol reflux 2 times of 80% of 5 times amount, each 3 hours;
(2) ethanol is merged, reclaim the clear paste of ethanol to relative density 1.10-1.15, the macroporous resin (clear paste: macroporous resin HP-20=1: 8) that qinghuo reagent has been handled well, respectively with each 10 times amount column volume eluting of water, 30% ethanol, 50% ethanol and 95% ethanol;
(3) merge water, 30% ethanol and 50% ethanolic moiety, reclaim ethanol, vacuum drying obtains dry extract, gets dry extract and adds starch 30g, and mixing is granulated, and less than 80 DEG C dry, encapsulated, makes 100 altogether, to obtain final product.
Embodiment 9
(1) Radix Wikstroemae 440g is through pulverizing to obtain medicinal material coarse powder, adds the alcohol reflux 3 times of 75% of 5 times amount, each 2 hours;
(2) ethanol is merged, reclaim the clear paste of ethanol to relative density 1.15-1.20, the macroporous resin (clear paste: macroporous resin HP-30=1: 5) that qinghuo reagent has been handled well, respectively with each 5 times amount column volume eluting of water, 30% ethanol and 95% ethanol;
(3) merge water and 30% ethanolic moiety, reclaim ethanol, vacuum drying obtains dry extract, gets dry extract and adds starch 30g, and mixing is granulated, and less than 80 DEG C dry, encapsulated, makes 100 altogether, to obtain final product.
Embodiment 10
(1) Radix Wikstroemae 440g is through pulverizing to obtain medicinal material coarse powder, adds the alcohol reflux 3 times of 50% of 5 times amount, each 1 hour;
(2) ethanol is merged, reclaim the clear paste of ethanol to relative density 1.15-1.20, the macroporous resin (clear paste: macroporous resin HP-30=1: 4) that qinghuo reagent has been handled well, respectively with each 5 times amount column volume eluting of water, 30% ethanol and 95% ethanol;
(3) merge water and 30% ethanolic moiety, reclaim ethanol, vacuum drying obtains dry extract, gets dry extract and adds starch 30g, and mixing is granulated, and less than 80 DEG C dry, encapsulated, makes 100 altogether, to obtain final product.
Embodiment 11
(1) Radix Wikstroemae 440g is through pulverizing to obtain medicinal material coarse powder, adds the alcohol reflux 3 times of 50% of 5 times amount, each 1 hour;
(2) ethanol is merged, reclaim the clear paste of ethanol to relative density 1.15-1.20, the macroporous resin (clear paste: macroporous resin HP-30=1: 6) that qinghuo reagent has been handled well, respectively with each 6 times amount column volume eluting of water, 30% ethanol and 95% ethanol;
(3) merge water and 30% ethanolic moiety, reclaim ethanol, vacuum drying obtains dry extract, gets dry extract and adds starch 30g, and mixing is granulated, and less than 80 DEG C dry, encapsulated, makes 100 altogether, to obtain final product.
Embodiment 12
(1) Radix Wikstroemae 440g is through pulverizing to obtain medicinal material coarse powder, adds the alcohol reflux 3 times of 80% of 5 times amount, each 1 hour;
(2) ethanol is merged, reclaim the clear paste of ethanol to relative density 1.03-1.10, the macroporous resin (clear paste: macroporous resin HP-30=1: 8) that qinghuo reagent has been handled well, respectively with each 10 times amount column volume eluting of water, 30% ethanol and 95% ethanol;
(3) merge water and 30% ethanolic moiety, reclaim ethanol, vacuum drying obtains dry extract, gets dry extract and adds starch 30g, and mixing is granulated, and less than 80 DEG C dry, encapsulated, makes 100 altogether, to obtain final product.
Embodiment 13
(1) Radix Wikstroemae 440g is through pulverizing to obtain medicinal material coarse powder, adds the alcohol reflux 2 times of 75% of 5 times amount, each 3 hours;
(2) ethanol is merged, reclaim the clear paste of ethanol to relative density 1.15-1.20, the macroporous resin (clear paste: macroporous resin HP-40=1: 5) that qinghuo reagent has been handled well, respectively with each 5 times amount column volume eluting of water, 30% ethanol and 95% ethanol;
(3) merge water and 30% ethanolic moiety, reclaim ethanol, vacuum drying obtains dry extract, gets dry extract and adds starch 30g, and mixing is granulated, and less than 80 DEG C dry, encapsulated, makes 100 altogether, to obtain final product.
Embodiment 14
(1) Radix Wikstroemae 440g is through pulverizing to obtain medicinal material coarse powder, adds the alcohol reflux 2 times of 50% of 5 times amount, each 2 hours;
(2) ethanol is merged, reclaim the clear paste of ethanol to relative density 1.15-1.20, the macroporous resin (clear paste: macroporous resin HP-50=1: 4) that qinghuo reagent has been handled well, respectively with each 6 times amount column volume eluting of water, 30% ethanol and 95% ethanol;
(3) merge water and 30% ethanolic moiety, reclaim ethanol, vacuum drying obtains dry extract, gets dry extract and adds starch 30g, and mixing is granulated, and less than 80 DEG C dry, encapsulated, makes 100 altogether, to obtain final product.
Embodiment 15
(1) Radix Wikstroemae 440g is through pulverizing to obtain medicinal material coarse powder, adds the alcohol reflux 2 times of 50% of 5 times amount, each 1 hour;
(2) ethanol is merged, reclaim the clear paste of ethanol to relative density 1.15-1.20, the macroporous resin (clear paste: macroporous resin ParapetP-S=1: 6) that qinghuo reagent has been handled well, respectively with each 8 times amount column volume eluting of water, 30% ethanol and 95% ethanol;
(3) merge water and 30% ethanolic moiety, reclaim ethanol, vacuum drying obtains dry extract, gets dry extract and adds starch 30g, and mixing is granulated, and less than 80 DEG C dry, encapsulated, makes 100 altogether, to obtain final product.
Embodiment 16
(1) Radix Wikstroemae 440g is through pulverizing to obtain medicinal material coarse powder, adds the alcohol reflux 2 times of 80% of 5 times amount, each 3 hours;
(2) ethanol is merged, reclaim the clear paste of ethanol to relative density 1.10-1.15, the macroporous resin (clear paste: macroporous resin ParapetQ=1: 8) that qinghuo reagent has been handled well, respectively with each 10 times amount column volume eluting of water, 30% ethanol and 95% ethanol;
(3) merge water and 30% ethanolic moiety, reclaim ethanol, vacuum drying obtains dry extract, gets dry extract and adds starch 30g, and mixing is granulated, and less than 80 DEG C dry, encapsulated, makes 100 altogether, to obtain final product.
Embodiment 17
(1) Radix Wikstroemae 440g is through pulverizing to obtain medicinal material coarse powder, adds the alcohol reflux 3 times of 75% of 5 times amount, each 2 hours;
(2) ethanol is merged, reclaim the clear paste of ethanol to relative density 1.15-1.20, the macroporous resin (clear paste: macroporous resin ParapetR=1: 5) that qinghuo reagent has been handled well, respectively with each 5 times amount column volume eluting of water, 30% ethanol, 50% ethanol and 95% ethanol;
(3) merge 30% ethanol and 50% ethanolic moiety, reclaim ethanol, vacuum drying obtains dry extract, gets dry extract and adds starch 30g, and mixing is granulated, and less than 80 DEG C dry, encapsulated, makes 100 altogether, to obtain final product.
Embodiment 18
(1) Radix Wikstroemae 440g is through pulverizing to obtain medicinal material coarse powder, adds the alcohol reflux 3 times of 50% of 5 times amount, each 1 hour;
(2) ethanol is merged, reclaim the clear paste of ethanol to relative density 1.15-1.20, the macroporous resin (clear paste: macroporous resin ParapetS=1: 4) that qinghuo reagent has been handled well, respectively with each 5 times amount column volume eluting of water, 30% ethanol, 50% ethanol and 95% ethanol;
(3) merge 30% ethanol and 50% ethanolic moiety, reclaim ethanol, vacuum drying obtains dry extract, gets dry extract and adds starch 30g, and mixing is granulated, and less than 80 DEG C dry, encapsulated, makes 100 altogether, to obtain final product.
Embodiment 19
(1) Radix Wikstroemae 440g is through pulverizing to obtain medicinal material coarse powder, adds the alcohol reflux 3 times of 50% of 5 times amount, each 1 hour;
(2) ethanol is merged, reclaim the clear paste of ethanol to relative density 1.15-1.20, the macroporous resin (clear paste: macroporous resin ParapetN=1: 6) that qinghuo reagent has been handled well, respectively with each 6 times amount column volume eluting of water, 30% ethanol, 50% ethanol and 95% ethanol;
(3) merge 30% ethanol and 50% ethanolic moiety, reclaim ethanol, vacuum drying obtains dry extract, gets dry extract and adds starch 30g, and mixing is granulated, and less than 80 DEG C dry, encapsulated, makes 100 altogether, to obtain final product.
Embodiment 20
(1) Radix Wikstroemae 440g is through pulverizing to obtain medicinal material coarse powder, adds the alcohol reflux 3 times of 80% of 5 times amount, each 1 hour;
(2) ethanol is merged, reclaim the clear paste of ethanol to relative density 1.03-1.10, the macroporous resin (clear paste: macroporous resin Chromosorb=1: 8) that qinghuo reagent has been handled well, respectively with each 10 times amount column volume eluting of water, 30% ethanol, 50% ethanol and 95% ethanol;
(3) merge 30% ethanol and 50% ethanolic moiety, reclaim ethanol, vacuum drying obtains dry extract, gets dry extract and adds starch 30g, and mixing is granulated, and less than 80 DEG C dry, encapsulated, makes 100 altogether, to obtain final product.
Embodiment 21
(1) Radix Wikstroemae 440g is through pulverizing to obtain medicinal material coarse powder, adds the alcohol reflux 2 times of 75% of 5 times amount, each 3 hours;
(2) ethanol is merged, reclaim the clear paste of ethanol to relative density 1.15-1.20, the macroporous resin (clear paste: macroporous resin HP-20=1: 5) that qinghuo reagent has been handled well, respectively with each 5 times amount column volume eluting of water, 30% ethanol, 50% ethanol and 95% ethanol;
(3) merge 30% ethanol and 50% ethanolic moiety, reclaim ethanol, vacuum drying obtains dry extract, gets dry extract and adds starch 30g, and mixing is granulated, and less than 80 DEG C dry, encapsulated, makes 100 altogether, to obtain final product.
Embodiment 22
(1) Radix Wikstroemae 440g is through pulverizing to obtain medicinal material coarse powder, adds the alcohol reflux 2 times of 50% of 5 times amount, each 2 hours;
(2) ethanol is merged, reclaim the clear paste of ethanol to relative density 1.15-1.20, the macroporous resin (clear paste: macroporous resin HP-20=1: 4) that qinghuo reagent has been handled well, respectively with each 6 times amount column volume eluting of water, 30% ethanol, 50% ethanol and 95% ethanol;
(3) merge 30% ethanol and 50% ethanolic moiety, reclaim ethanol, vacuum drying obtains dry extract, gets dry extract and adds starch 30g, and mixing is granulated, and less than 80 DEG C dry, encapsulated, makes 100 altogether, to obtain final product.
Embodiment 23
(1) Radix Wikstroemae 440g is through pulverizing to obtain medicinal material coarse powder, adds the alcohol reflux 2 times of 50% of 5 times amount, each 1 hour;
(2) ethanol is merged, reclaim the clear paste of ethanol to relative density 1.15-1.20, the macroporous resin (clear paste: macroporous resin HP-20=1: 6) that qinghuo reagent has been handled well, respectively with each 8 times amount column volume eluting of water, 30% ethanol, 50% ethanol and 95% ethanol;
(3) merge 30% ethanol and 50% ethanolic moiety, reclaim ethanol, vacuum drying obtains dry extract, gets dry extract and adds starch 30g, and mixing is granulated, and less than 80 DEG C dry, encapsulated, makes 100 altogether, to obtain final product.
Embodiment 24
(1) Radix Wikstroemae 440g is through pulverizing to obtain medicinal material coarse powder, adds the alcohol reflux 2 times of 80% of 5 times amount, each 3 hours;
(2) ethanol is merged, reclaim the clear paste of ethanol to relative density 1.10-1.15, the macroporous resin (clear paste: macroporous resin HP-20=1: 8) that qinghuo reagent has been handled well, respectively with each 10 times amount column volume eluting of water, 30% ethanol, 50% ethanol and 95% ethanol;
(3) merge 30% ethanol and 50% ethanolic moiety, reclaim ethanol, vacuum drying obtains dry extract, gets dry extract and adds starch 30g, and mixing is granulated, and less than 80 DEG C dry, encapsulated, makes 100 altogether, to obtain final product.
Reference examples 1
Get Radix Wikstroemae and be about 440g, first time adds 8 times of water gagings, and second time adds 6 times amount soak by water secondaries, each 5 hours, collecting decoction, and filter, filtrate is concentrated into the extractum that relative density is 1.10 ~ 1.15 (60 DEG C), is spray dried to dry extract; Get dry extract 22g, add starch appropriate, mixing, granulate, less than 80 DEG C dry, encapsulated, makes 100 altogether, to obtain final product.
Reference examples 2
The embodiment 1 of CN102000215A
Reference examples 3
The embodiment 1 of CN101601666
Experimental example 1-antiviral activity contrast experiment
1 materials and methods
1.1 material
Waters, US 2010 series of high efficiency liquid chromatograph (HPLC); Japan Shimadzu SHIMADZU1/10 ten thousand electronic balance; Denmark TL3072 superclean bench; Japan MODEL304 carbon dioxide incubator; Japan Olympas microscope; Syncytial virus (RSV), adenovirus type III (Ad
3), adenovirus type VII (Ad
7), change of coxsackie b virus 3 type (CB
3), change of coxsackie b virus 5 type (CB
5), influenza virus Type A3 (Fa
3), parainfluenza virus IV type (PF
3) virus.
1.2 method
1.2.1 diluent preparation
Solution (embodiment 1-2 and the lyophilization of reference examples 1 dry extract of Example 1-4 and reference examples 1-3 dry extract, embodiment 3-4 directly uses powder pin pressed powder, be made into 10% strength solution respectively) 150 μ l, respectively with cell maintenance medium from high to low 2 times of serial dilutions become 1/20,1/40,1/80,1/160,1/320,1/640,1/1280,1/2560,1/5120,1/10240 each concentration liquid, often organizing medicine is divided in 10 centrifuge tubes by variable concentrations, and the 11st arm is the blank only having maintenance medium and Hep-2 cell.Cultivate to auxiliary plate in the tissue culturing plate of Hep-2 cell successively, put into the medicine 100 μ l of each concentration from low to high, put into 50%CO
2incubator 37 DEG C is cultivated 1 ~ 5 day, with the drug level when cell of 50% being produced to toxicity for CC
50.
1.2.2 the toxicity test of virus
Virus liquid MEM cell maintenance medium is done 10 times of serial dilutions, measures RSV, Ad with above-mentioned same procedure
3, Ad
7, CB
3, CB
5the virulence of virus, thus cultured cell Hep-2 pathological changes reaches 50% calculating TCID
50; Fa is measured with hemagglutination test (HA test)
3, PF
3the virulence of virus, forms ring-type with chicken red blood cell at the bottom of V-arrangement micro titer plate well, and surrounding has viral suspension dilution factor during little grumeleuse to be the hemagglutinin of 1 unit.
1.2.3 anti-RSV, Ad
3, Ad
7, CB
3, CB
5viral experiment neutralization test:
Example 1-4 and reference examples 1 dry extract, be made into 10% strength solution respectively), according to often kind of medicine CC
50, downward doubling dilution, gets 6 variable concentrations, establishes virus control, cell controls, drug control simultaneously successively.Adopt the 100TCID of above-mentioned virus
50after diluting with medicine equivalent, inoculation has become 96 well culture plates of cell monolayer, puts incubator and cultivates 1 ~ 5 day, result of determination under mirror.
1.2.4 anti-Fa3, PF3 Viral experiment hemagglutination inhibition test:
Example 1-4 and reference examples 1 dry extract, according to often kind of medicine CC
50get the medicinal liquid of 92 times of serial dilutions respectively, respectively with the Fa3 of 4 units, PF3 mixed in equal amounts, vibration, after 37 DEG C of effect 1.5h, add at microtitration plate successively multiple proportions normal saline dilution, separately establish erythrocyte to contrast, virus control, respectively add 1% chicken erythrocyte suspension 0.5ml in all well, after 45min, record result (above test all does 2 times, and result is reference each other).
2 results
2.1 result of determination standards:
1. RSV, Ad
3, Ad
7, CB
3, CB
5virus, in neutralization test, with the most high dilution that the cultured cell of 50% can be protected not produce pathological changes, is the end point titres judging Antiviral Effect.
2. Fa
3, PF
3the hemagglutination inhibition test that virus adopts, can suppress 4 unit Fa3 completely, the most high dilution of the medicine of the red cell agglutination caused by PF3 is for judging end point titres.
The results are shown in subordinate list 1.
The most highly diluted concentration results of table 1 antiviral drugs
"-" refers to that the cultured cell that drug on viral causes adjusts unrestraint effect of dying.
2. conclusion
This experiment embodies the scope of the preventing respiratory viruses of embodiment 1-4.By this experiment, we confirm, embodiment 1-4 has obvious inhibitory action to the most common 7 kinds of viruses of respiratory tract.And reference examples 1 couple of RSV, Ad
3, CB
3and CB
5virus does not have inhibitory action, as a rule 2 couples of CB
5and Fa
3virus does not have inhibitory action, and they to other HIV suppression concentration also higher than embodiment 1-4.This shows, the granule of invention all has good In-vitro Inhibitory Effect for the modal 7 kinds of viruses of respiratory tract, and this antiviral activity further illustrating the Radix Wikstroemae capsule of invention has experiment and theoretical basis.
The antibacterial Activity Screening Test of experimental example 2-Radix Wikstroemae capsule
1. material
Standard bacteria: escherichia coli (ATCC25922), Pseudomonas aeruginosa (ATCC27853) (Nat'l Pharmaceutical & Biological Products Control Institute provides).Clinical isolation: escherichia coli (57, No. 95), Pseudomonas aeruginosa (57, No. 66), Candida albicans (44,92,66, No. 97) (be separated from hospital respiratory system patient sputum sample and obtain).
The antibiotic drug sensitive scraps of paper: Nat'l Pharmaceutical & Biological Products Control Institute provides.
Screening of medicaments: embodiment 11-14 dry extract and reference examples 1 and 3 dry extract.
2 methods and result
2.1 fastbacteria antibiotics susceptibility tests
Fastbacteria antibiotics susceptibility test carries out according to antibiotic drug sensitive conventionally test power method (paper disk method). the results detailed in Table 1
Table 12 kind of Clinical isolation is to the drug sensitive test result of medicine
The preparation of 2.2 medicinal liquids
Take screening of medicaments (embodiment 11-14 and reference examples 1 dry extract) each 1.0g with electronic analytical balance, being made into concentration with sterile distilled water (containing 0.1%DMSO hydrotropy) is that the solution of 400mg/ml makes primary dcreening operation.Get above-mentioned solution, adopt 2 times of dilution methods, namely get 10 sterile test tube, often prop up bacterium test tube and add 0.5ml distilled water, numbering, get 0.5ml original liquid and be placed in the 1st test tube, Homogeneous phase mixing, then draw 0.5ml and add the 2nd in vitro, push away successively and be diluted to the 9th pipe, discard 0.5m, the 10th pipe is managed in contrast, and the medicinal liquid of gained concentration can be used for measuring minimum inhibitory concentration (MIC).
The preparation of 2.3 bacterium liquid
By inoculation on plain agar flat board, be placed in 35e calorstat and cultivate h, be transferred in test tube, add physiological saline solution with inoculating loop by bacterial strain, degree of being made into is that the bacterium liquid of 1,500,000,000/ml is used as primary dcreening operation, then to be diluted to concentration be 10
6individual/bacterium liquid for measuring MIC
2.4 bacteriostatic test assay methods are agar diffusion method.
Primary dcreening operation: be evenly distributed on M-HShi agar culture medium with the standard bacteria liquid that concentration is 1.5 hundred million/ml by aseptic cotton carrier, then be the aseptic Circular glass pipe punching of 6mm with diameter, during the medicinal liquid containing each extract concentrations being 100mg/ml is added, till filling it up with, must not overflow.Again culture dish is placed in 35 DEG C of calorstats cultivate 24h (anti-candida albicans test sabouraud's agar, cultivates 48h at 28 DEG C, take out observe, with the diameter of kind of calliper inhibition zone.
The mensuration of MIC: the same primary dcreening operation of method, select the medicine to the antibacterial circle diameter >=10mm of standard bacteria, respectively the medicinal liquid of variable concentrations is added in hand-hole and carry out training of carrying disease germs, the minimum liquor strength of antibacterial circle diameter >=10mm is its MIC value, the MIC value of fastbacteria is measured in the same method, the results detailed in Table 2 with screening of medicaments.
Table 2 medicine antibacterial experiment screening result
The measurement unit of inhibition zone is the measurement unit of mm, MIC is mg/ml, and above experimental data retains 2 position effective digitals.
3. the antibacterial effect of conclusion: embodiment 1-4 is better than reference examples 1 dry extract, and the antimicrobial spectrum of embodiment 11-14 is wider than reference examples 1 dry extract, especially has stronger inhibitory action to fastbacteria.
The contrast of experimental example 3-Radix Wikstroemae capsule for treating upper respiratory tract infection
Radix Wikstroemae capsule (embodiment 20) completes observes case 50 example, and comparative example 1 completes observes case 48 example, now result is summarized as follows.
1 case selection
1.1 diagnostic criteria
1.1.1 Western medicine diagnose standard: with reference to " guideline of clinical investigations of new Chinese medicine treatment flu " standard formulation.According to medical history, popularity, the symptom of nasopharynx part and sign, can make clinical diagnosis in conjunction with surrounding hemogram and x-ray inspection, carries out virus serology inspection and can to assign a cause for an illness diagnosis.
Clinical manifestation: dry pharynx pharyngalgia, nasal obstruction sneeze, watery nasal discharge, cough, heating, headache, systemic pain, weak poor appetite etc.; Surrounding hemogram numeration of leukocyte is normal or on the low side; Immunofluorescence serum-virus is separated and checks the positive.
1.1.2 Clinical typing
1.1.2.1 common cold: be commonly called as " cold ", also known as acute rhinitis or common cold, with nasopharynx part mucositis symptom for main manifestations.Common causative rhinovirus, coronavirus, influenza and parainfluenza virus, also have respiratory syncytial virus, echovirus and Coxsackie virus etc.
1.1.2.2 viral pharyngitis and laryngitis: acute viral pharyngitis is caused by rhinovirus, adenovirus, influenza virus, parainfluenza virus and enterovirus, respiratory syncytial virus etc.Facing body characteristics is: pharyngeal itch and burning sensation, pharyngalgia not obvious.
1.1.2.3 herpangina: often caused by CA, more than summer attack, be more common in child, occasionally in adult.
1.1.2.4 pharyngoconjunctival fever: cause primarily of adenovirus, Coxsackie virus etc., often betides summer, and propagated by swimming, child is common.
1.1.2.5 bacillary pharyngitis and tonsillitis: how to be caused by antibacterials such as Hemolytic streptococcuss.
1.1.3 tcm diagnosis standard
(1) aversion to cold, heating, nasal obstruction watery nasal discharge, sneeze, cough, headache, the symptoms such as general malaise.
(2) light red tongue or limit point red, thin fur or Huang, floating pulse.
(3) adverse weather or daily life cause accidentally, sudden onset.
1.1.4 Syndrome Differentiation of Chinese Medicine disease
Wind heat disease: fever of the body is work comparatively, micro evil wind, antiperspirant is let out not smooth, distending pain in the head, cough, and expectorant is sticky or yellow, and pharynx is made an uproar, or pharyngitis burning pain, nasal obstruction, stream turbid nasal discharge, thirst with desire to drink, tongue tip side of red, thin white fur of tongue or Huang, floating and rapid pulse.
1.2 test case standards
1.2.1 include case standard in
In meeting, Western medicine diagnose standard and Chinese medical discrimination, body temperature is more than 38 DEG C, and the course of disease is person within 48 hours, can include test case in.
1.2.2 Excluded cases standard
(1) medicine person had been used
(2) age is at under-18s or over-65s, gestation and women breast-feeding their children, allergic constitution and those who are allergic to this drug.
(3) the serious primary disease person such as cardiovascular, cerebrovascular, liver, kidney, hemopoietic system is merged, psychotic.
(4) do not meet inclusive criteria, do not take medicine by regulation, or data does not entirely cause and cannot judge curative effect or safety person.
2. test method
By randomized, patient is divided into observation 50 example, matched group 48 example.
2.1 test medications
2.1.1 test medicine: embodiment 20
2.1.2 control drug: comparative example 1
2.1.3 dosage regimen:
Test group: oral, one time 3,3 times on the one.
Matched group: oral, one time 3,3 times on the one.
2.1.4 the course for the treatment of: 3 days
3. observation index
3.1 safety observations
3.1.1 general physical examination project: pretest inspection once.
3.1.2 blood, urine, feces conventional project: before and after treatment, each inspection once.
3,1,3 hearts, Liver and kidney function inspection: before and after treatment, each inspection once.
3.2 health giving quality observations
3.2.1 observation of symptoms: nasal obstruction watery nasal discharge, sneeze, cough, headache, fever with aversion to cold, general malaise etc.After treating front and treatment, every day respectively checks once, until recovery from illness.
3.2,2 temperature takings: every day 2-3 time.
3.2.3 picture of the tongue, pulse condition: after treating front and treatment, every day respectively checks once, until recovery from illness.
3.2.4 total white blood cells adds classification: respectively check once before treatment and after treatment.
4, clinical development standard
4.1 recoveries from illness: normally, the symptom of flu all disappears to treat temperature recovery within 3 days.
4.2 is effective: it is normal to treat within 3 days body temperature, most of transference cure of flu.
4.3 is effective: treat body temperature within 3 days and reduce than before, the cardinal symptom partial disappearance of flu
4,4 is invalid: treat body temperature within 3 days and do not fall or body temperature rising, the cardinal symptom of flu is improved.
5. statistical method
SAS software is adopted to carry out Data Analysis Services.Two Sets of Measurement Datas adopt mean ± standard deviation (x ± s) to carry out statistics and describe, and adopt paired t-test, treat difference before and after comparable group internal therapy, and before and after two groups of treatments, the change of group adopts variance analysis to compare.Two groups of enumeration datas adopt constituent ratio to carry out statistics and describe, and the change before and after two groups of treatments adopts x
2inspection compares.
6, analysis of comparable between two groups
Between 6.1 liang of groups, gender comparison refers to table 1
Table 1, test group and matched group gender comparison
| Group | Number of cases | Man | Female |
| Test group | 50 | 28 | 22 |
| Matched group | 48 | 25 | 23 |
x
2＝0.2264p＞0.05
Between 6.2 liang of groups, the age compares and refers to table 2
Table 2, test group compared with the matched group age
| Group | Number of cases | < 30 years old | 31-40 year | 41-50 year | 51-60 year |
| Test group | 50 | 8 | 16 | 12 | 14 |
| Matched group | 48 | 7 | 15 | 14 | 12 |
x
2＝3.511p＞0.05
Analyze: compare in Sex, Age between two groups by finding out in table 1, table 2, after statistical procedures without significant difference (p > 0.05), show that two groups have comparability.
7, result
7.1 test group and matched group symptom comparitive study, refer to table 3
Table 3, test group and matched group transference cure situation compare
| Group | Number of cases | All | Major part | Part | Without improving |
| Test group | 50 | 24 | 13 | 12 | 1 |
| Matched group | 48 | 15 | 8 | 20 | 5 |
x＝6.2193，p＜0.05
Before and after 7.2 test group and treatment of control group, the change of body temperature, refers to table 4
The comparison of body temperature before and after table 4 liang group treatment
| Group | Number of cases | Normally | Reduce | Do not fall |
| Test group | 50 | 39 | 9 | 2 |
| Matched group | 48 | 24 | 22 | 2 |
x
2＝0.8049，p＞0.05
Before and after 7.3 test group and treatment of control group, the contrast of tongue, pulse condition, refers to table 5
The change of tongue, pulse condition before and after table 5 liang group treatment
x
2＝0.0977，p＞0.05；x
2＝1.6056p＞0.05
8, result and discussion:
8.1 obviously improve symptom
Treatment before and after test group and matched group upper respiratory tract infection symptoms disappear, and there were significant differences (p < 0.05), and the former is better than the latter.
8.2 reduce body temperature
Two groups of treatments are compared, and after treatment, body temperature all has obvious reduction maybe can reach normally, and two groups are compared no difference of science of statistics (p > 0.05).
Compare before and after 8.3 liang of group treatments, tongue, pulse condition be not statistically significant (p > 0.05) all.
Compare total white blood cells before and after 8.4 test group treatments obviously to raise (p < 0.01), total lymphocyte count obviously declines (p < 0.05); Total white blood cells before treatment of control group and total lymphocyte count show remarkable rising (p < 0.01) respectively and decline (p < 0.05).
8.5 through safety observations, and this medicine is without any side effects to the heart, Liver and kidney function.
To sum up telling, inventor reaches a conclusion: the definite effect of the granule therapy upper respiratory tract infection of invention, is effective anti-infectives.
Experimental example 4-drug administration by injection position irritation test
1 given the test agent
Embodiment 1-24, reference examples 1.
2 laboratory animals
Totally 4 groups of rabbit, are respectively experimental group (embodiment 1-24), matched group (reference examples 1-3) and blank group (normal saline), often group 5.
3 medications
The route of administration of medicine is defined as auricular vein intravenous injection, every day 1 time, each 1 milliliter, two ears alternately, continuous 2 days, adopt identical injection maneuver every day, inject at one time.
4 results are observed
Whether redness was occurred to animal and injection site in 24 hours before administration and after rear single administration, carry out perusal.The animal stayed, according to the feature of tested material and irritative response situation, continues observation and within 14 days, checks, to understand the degree of reversibility of irritative response again.
5 evaluation of result
The zest of the injection of embodiment 1-24 is less than reference examples 2-3, and this is also one of advantage of invention.
Claims (8)
1. a Radix Wikstroemae capsule, is characterized in that adopting following methods preparation:
(1) Radix Wikstroemae 440g is through pulverizing to obtain medicinal material coarse powder, adds 50-80% alcohol reflux 2-7 time of 5 times amount, each 1-3 hour;
(2) ethanol is merged, reclaim the clear paste of ethanol to relative density 1.15-1.20, clear paste and macroporous resin weight ratio are 1:4-5, the macroporous resin that qinghuo reagent has been handled well, respectively with water, 30% ethanol, 50% ethanol, 95% ethanol each 4-10 times amount column volume eluting;
(3) merge water, 30% ethanol and 50% ethanolic moiety, reclaim ethanol, vacuum drying obtains dry extract, gets dry extract and adds starch in right amount, mixing, granulate, 80 DEG C of dryings, encapsulated, makes 100 altogether, to obtain final product.
2. a Radix Wikstroemae capsule, is characterized in that adopting following methods preparation:
(1) Radix Wikstroemae 440g is through pulverizing to obtain medicinal material coarse powder, adds 50-80% alcohol reflux 2-7 time of 5 times amount, each 1-3 hour;
(2) ethanol is merged, reclaim the clear paste of ethanol to relative density 1.15-1.20, clear paste and macroporous resin weight ratio are 1:4-5, the macroporous resin that qinghuo reagent has been handled well, respectively with water, 30% ethanol, 50% ethanol, 95% ethanol each 4-10 times amount column volume eluting;
(3) merge 30% ethanol and 50% ethanolic moiety, reclaim ethanol, vacuum drying obtains dry extract, and get dry extract and add starch in right amount, mixing, granulate, less than 80 DEG C dry, encapsulated, makes 100 altogether, to obtain final product.
3. a Radix Wikstroemae capsule, is characterized in that adopting following methods preparation:
(1) Radix Wikstroemae 440g is through pulverizing to obtain medicinal material coarse powder, adds 50-80% alcohol reflux 2-7 time of 5 times amount, each 1-3 hour;
(2) merge ethanol, reclaim the clear paste of ethanol to relative density 1.15-1.20, clear paste and macroporous resin weight ratio are 1:4-5, the macroporous resin that qinghuo reagent has been handled well, respectively with water, 30% ethanol and 95% ethanol each 4-10 times amount column volume eluting;
(3) merge water and 30% ethanolic moiety, reclaim ethanol, vacuum drying obtains dry extract, and get dry extract and add starch in right amount, mixing, granulate, less than 80 DEG C dry, encapsulated, makes 100 altogether, to obtain final product.
4., according to the arbitrary described Radix Wikstroemae capsule of claim 1-3, it is characterized in that 50-80% alcohol reflux 2-4 time of described step (1) 5 times amount, each 1-3 hour.
5. Radix Wikstroemae capsule according to claim 4, is characterized in that the 50-80% alcohol reflux 2 times of described step (1) 5 times amount, each 2 hours.
6. according to the arbitrary described Radix Wikstroemae capsule of claim 1-3, it is characterized in that in described step (2) with water, 30% ethanol, 50% ethanol, 95% ethanol each 4-6 times amount column volume eluting.
7. Radix Wikstroemae capsule according to claim 6, it is characterized in that in described step (2) with water, 30% ethanol, 50% ethanol, each 5 times amount column volume eluting of 95% ethanol.
8. the application caught in medicine treated by the Radix Wikstroemae capsule described in claim 1-7 any one in preparation.
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