CN104491174A - Yishenling granule and preparation method thereof - Google Patents

Yishenling granule and preparation method thereof Download PDF

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Publication number
CN104491174A
CN104491174A CN201410702396.4A CN201410702396A CN104491174A CN 104491174 A CN104491174 A CN 104491174A CN 201410702396 A CN201410702396 A CN 201410702396A CN 104491174 A CN104491174 A CN 104491174A
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fructus
yishenling
granules
powder
extracting solution
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不公告发明人
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Heilongjiang Jiangheng Pharmaceutical Co Ltd
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Heilongjiang Jiangheng Pharmaceutical Co Ltd
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • AHUMAN NECESSITIES
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    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
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    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/487Psoralea
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    • A61K36/60Moraceae (Mulberry family), e.g. breadfruit or fig
    • A61K36/605Morus (mulberry)
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    • A61K36/62Nymphaeaceae (Water-lily family)
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/63Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
    • A61K36/638Ligustrum, e.g. Chinese privet
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K36/71Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
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    • A61K36/18Magnoliophyta (angiosperms)
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    • A61K36/73Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
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    • A61K36/81Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
    • A61K36/815Lycium (desert-thorn)
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    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
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    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying

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Abstract

The invention discloses a yishenling granule and a preparation method thereof. The yishenling granule is characterized by being prepared through the following steps: taking 280g of inula flower, 38g of resin of sweetgum, 80 of siegesbeckia herb, 200g of Chinese wolfberry, 300g of glossy privet fruit, 20g of processed aconite root, 300g of gorgon fruit, 100g of plantain seed, 200g of malaytea scurfpea fruit, 200g of raspberry, 50g of the fruit of Chinese magnoliavine, and 200g of mulberry, grinding the raw materials into coarse powder, putting the coarse powder into a cyclic ultrasonic extractor, adding water, germanium powder and tween 60, performing ultrasonic extraction and jet spray-drying to obtain nano extract powder, and then adding lactose and dextrin to obtain the yishenling granules. The yishenling granules are used for treating impotence, premature ejaculation, spermatorrhea or asthenozoospermia caused by kidney qi deficiency and yang-qi deficiency; the curative effect of the yishenling granules is remarkably superior to that of the yishenling granules in the market; a good effect is achieved.

Description

A kind of Yishenling Granules and preparation method thereof
Technical field
The present invention relates to the field of Chinese medicines, be specifically related to a kind of Yishenling Granules and preparation method thereof.
Background technology
Yishenling Granules is used for kidney qi virtual loss, sexual impotence caused by YANG QI deficiency, premature ejaculation, seminal emission or azoospermia.Commercially available Yishenling Granules is due to prescription and technological reason, and curative effect is not satisfactory, and preparation adopts traditional handicraft preparation, there is the shortcoming that curative effect is low.
Summary of the invention
The present invention, for overcoming above-mentioned deficiency, provides Yishenling Granules that a kind of curative effect is high and preparation method thereof.
Invention embodiment is as follows:
Get Flos Inulae 280g, Resina Liquidambaris 38g , Herba Siegesbeckiae 80g, Fructus Lycii 200g, Fructus Ligustri Lucidi 300g, Radix Aconiti Lateralis Preparata 20g, Semen Euryales 300g, Semen Plantaginis 100g, Fructus Psoraleae 200g, Fructus Rubi 200g, Fructus Schisandrae Chinensis 50g, Fructus Mori 200g, be ground into 40 order coarse powder, put in circulating ultrasonic extractor, add 19680g water, 6 ~ 8g germanium powder, 6 ~ 10g polysorbate60, selects supersonic frequency 50 ~ 60KHz, pressure 0.3 ~ 0.5 Mpa extracts 30 minutes, uses 80 mesh screen, obtains extracting solution; Getting extracting solution puts in jet spray dryer, and control inlet temperature 40 ~ 50 DEG C, pressure 0.02 ~ 0.04 Mpa, 400 ~ 600 meters per second of flow velocity, obtains nanometer extract powder; Get extract powder and add lactose 400g, dextrin 100g, use water wet granulation, 60 DEG C of dryings, granulate, adds Talcum 25g, mixing, obtained Yishenling Granules.
The raw material standards that above-mentioned embodiment is mentioned is as follows:
Flos Inulae: China's coastal port one ministerial standard.This product is the dry capitulum of feverfew Flos Inulae Inula japonica Thunb. or Eurasian trip Flos Inulae Inula britannica L..Summer, season in autumn two, the flowers are in blossom gathers when putting, and removing impurity, dries in the shade or dry.
Resina Liquidambaris: China's coastal port one ministerial standard.This product is the dry resin of Hamamelidaceae Plants Chinese sweet gum Liquidambar formosanaHance.7, isolate trunk between August, resin is flowed out and gathers the April .10 month to next year, dry in the shade.
Herba Siegesbeckiae: China's coastal port one ministerial standard.This product You Ming pig label, fire are signed, pig cream grass, rheumatism are careless.For feverfew
The aerial parts of pig label Siegsbeckia orientalisL., Xian Geng pig label Siegesbeckia pubescens Makino or Mao Geng pig label Siegesbeckia glabrescens Makio.Whole nation most area is all produced.Before summer, Qiu Erji are bloomed or the florescence all can gather, extract aerial parts, removing impurity, dry.
Fructus Lycii: China's coastal port one ministerial standard.This product is the dry mature fruit of plant of Solanaceae lycium barbarum Lycium barbarum L..Summer, autumn two gather when season, fruit took on a red color, hot-air seasoning, removing carpopodium, or dry in the air to rhicnosis, dry, removing carpopodium.
Fructus Ligustri Lucidi: China's coastal port one ministerial standard.This product is the dry mature fruit of Oleaceae plants Fructus Ligustri Lucidi Ligustrum lucidum Ait..Gather during fruit maturation in winter, removing branch and leaf, after slightly steaming or putting in boiling water and slightly scald, dry; Or convection drying.
Radix Aconiti Lateralis Preparata: China's coastal port one ministerial standard.This product is the processed goods of the daughter root of ranunculaceae plant Aconitum carmichjaelii Debx. Aconitum carmichaeli Debx..Late June excavated to early August, and removing parent root, fibrous root and silt, practise and claim " mud invests ", be processed into following kinds.(1) select large, a uniform mud Radix Aconiti Lateralis Preparata, clean, immerse in the aqueous solution of edible gallbladder bar and spend the night, again with Sal, continue to soak, every day takes out solarization and dries in the air, and extend solarization gradually and dry in the air the time, until investing till surface occurs that mass crystallization salt grain (salt efflorescence), body constitution are hardening, practising and claiming " Radix Aconiti Lateralis Preparata ".(2) get mud Radix Aconiti Lateralis Preparata, clean respectively by size, immerse a few days in the aqueous solution of edible gallbladder bar, boil to the saturating heart together with immersion, pull out, water floats, the sheet of rip cutting Cheng Houyue 0.5cm, float with water logging again, make Radix Aconiti Lateralis Preparata dye Umber by toner, take out, steam to after there is pasta, gloss, be dried to half-dried, then dry or continue to dry. practise and claim " Radix Aconiti Lateralis Preparata ".(3) select mud Radix Aconiti Lateralis Preparata of uniform size, clean, immerse a few days in the aqueous solution of edible gallbladder bar, boil to the saturating heart together with immersion, pull out, peel off crust. the sheet of rip cutting Cheng Houyue 0.3cm, with water logging drift, takes out, steams thoroughly, dry. practise and claim " Radix Aconiti Lateralis Preparata ".
Semen Euryales: China's coastal port one ministerial standard.This product is the dry mature kernal of nymphaeaceae plant Gorgon euryale Euryale ferox Salisb..Time of the year when autumn changes into winter gathers mature fruit, and removing peel, takes out seed, cleans, then removes duricrust (episperm), dry.
Semen Plantaginis: China's coastal port one ministerial standard.This product is the dry mature seed of Plantaginaceae plant Herba Plantaginis Plantago asiatica L. or Plantago depressa Willd Plantago depressa Willd..To gather when summer, autumn two season seed maturity fruit ear, dry, rub seed, removing impurity.
Fructus Psoraleae: China's coastal port one ministerial standard.This product is the dry mature fruit of legumes psoraleae Psoralea corylifolia L..To gather during fruit maturation in autumn infructescence, dry, rub fruit, removing impurity.
Fructus Rubi: China's coastal port one ministerial standard.This product is the dry fruit of rosaceous plant rubus chingii Hu Rubus chingii Hu.Gather when early summer fruit is greenish-yellow by green change, except destemming, leaf, put in boiling water and slightly scald or slightly steam, take out, dry.
Fructus Schisandrae Chinensis: China's coastal port one ministerial standard.This product is magnoliaceae schisandra Schisandra chfnensis(Turcz.) dry mature fruit of Baill., practise and claim " Radix Schisandrae Bicoloris ".Pluck during fruit maturation in autumn, dry or dry after steaming, removing carpopodium and impurity.
Fructus Mori: China's coastal port one ministerial standard.This product is the dry fruit ear of moraceae plants Mulberry Morus alba L..Gather when the 4-6 month, fruit reddened, dry, or dry after slightly steaming.
Germanium powder: germanium dioxide: No. CAS: 1310-53-8: industry standard: lark prestige Science and Technology Ltd.;
Polysorbate60: Chinese Pharmacopoeia version two ministerial standard in 2010;
Lactose: Chinese Pharmacopoeia version two ministerial standard in 2010;
Dextrin: Chinese Pharmacopoeia version two ministerial standard in 2010;
Pulvis Talci: Chinese Pharmacopoeia version one ministerial standard in 2010;
Raw material used by above Yishenling Granules all can be bought from pharmaceuticals and obtain, and is not limited to typical production producer, all can be used to implement the present invention program as long as meet quality standard.
The key equipment that foregoing invention embodiment is mentioned is as follows:
Circulating ultrasonic machine: supersonic frequency 20 ~ 100KHz,
(typical production producer: Beijing Hongxianglong Biotechnology Development Co., Ltd)
Jet spray dryer: inlet temperature scope 30 ~ 70 DEG C, 300 ~ 900 meters per second of effluxvelocity scope;
(typical production producer: Nai Nuo bio tech ltd, Beijing)
Raw material used by above Yishenling Granules all can be bought from pharmaceuticals and obtain, and all can be used to implement the present invention program as long as meet national standard.
In foregoing invention scheme, term used is pharmacy proprietary term, as " decompression " etc. all defers to Chinese Pharmacopoeia regulation and pharmaceutical practice of being correlated with.
Unit g in the present invention also can be other weight portion, does not affect the enforcement of the present invention program.
Equipment Market described in the present invention program all has sale, is not limited to typical production producer, as long as technical specification can reach requirement, all can be used to realize the present invention.
Detailed description of the invention
Specific embodiments of the invention 1
Get Flos Inulae 280g, Resina Liquidambaris 38g , Herba Siegesbeckiae 80g, Fructus Lycii 200g, Fructus Ligustri Lucidi 300g, Radix Aconiti Lateralis Preparata 20g, Semen Euryales 300g, Semen Plantaginis 100g, Fructus Psoraleae 200g, Fructus Rubi 200g, Fructus Schisandrae Chinensis 50g, Fructus Mori 200g, be ground into 40 order coarse powder, put in circulating ultrasonic extractor, add 6980g water, 6g germanium powder, 6g polysorbate60, selects supersonic frequency 50KHz, pressure 0.3Mpa extracts 30 minutes, uses 80 mesh screen, obtains extracting solution; Getting extracting solution puts in jet spray dryer, and control inlet temperature 40 DEG C, pressure 0.02Mpa, 400 meters per second of flow velocity, obtains nanometer extract powder; Get extract powder and add lactose 400g, dextrin 100g, use water wet granulation, 60 DEG C of dryings, granulate, adds Pulvis Talci 25g, mixing, obtained Yishenling Granules.
Specific embodiments of the invention 2
Get Flos Inulae 280g, Resina Liquidambaris 38g , Herba Siegesbeckiae 80g, Fructus Lycii 200g, Fructus Ligustri Lucidi 300g, Radix Aconiti Lateralis Preparata 20g, Semen Euryales 300g, Semen Plantaginis 100g, Fructus Psoraleae 200g, Fructus Rubi 200g, Fructus Schisandrae Chinensis 50g, Fructus Mori 200g, be ground into 40 order coarse powder, put in circulating ultrasonic extractor, add 6980g water, 8g germanium powder, 10g polysorbate60, selects supersonic frequency 60KHz, pressure 0.5 Mpa extracts 30 minutes, uses 80 mesh screen, obtains extracting solution; Getting extracting solution puts in jet spray dryer, and control inlet temperature 50 DEG C, pressure 0.04 Mpa, 600 meters per second of flow velocity, obtains nanometer extract powder; Get extract powder and add lactose 400g, dextrin 100g, use water wet granulation, 60 DEG C of dryings, granulate, adds Pulvis Talci 25g, mixing, obtained Yishenling Granules.
Specific embodiments of the invention 3
Get Flos Inulae 280g, Resina Liquidambaris 38g , Herba Siegesbeckiae 80g, Fructus Lycii 200g, Fructus Ligustri Lucidi 300g, Radix Aconiti Lateralis Preparata 20g, Semen Euryales 300g, Semen Plantaginis 100g, Fructus Psoraleae 200g, Fructus Rubi 200g, Fructus Schisandrae Chinensis 50g, Fructus Mori 200g, be ground into 40 order coarse powder, put in circulating ultrasonic extractor, add 6980g water, 7g germanium powder, 8g polysorbate60, selects supersonic frequency 55KHz, pressure 0.4Mpa extracts 30 minutes, uses 80 mesh screen, obtains extracting solution; Getting extracting solution puts in jet spray dryer, and control inlet temperature 45 DEG C, pressure 0.03Mpa, 500 meters per second of flow velocity, obtains nanometer extract powder; Get extract powder and add lactose 400g, dextrin 100g, use water wet granulation, 60 DEG C of dryings, granulate, adds Pulvis Talci 25g, mixing, obtained Yishenling Granules.
Above embodiment illustrates, adopts the extreme condition of embodiment of the present invention and optimal conditions all can make Yishenling Granules.Actual effect of the present invention is investigated below with the Yishenling Granules that embodiment 3 is obtained:
(1) embodiment 3 Yishenling Granules and commercially available Yishenling Granules treat sexual impotence caused by kidney qi virtual loss, YANG QI deficiency, premature ejaculation, seminal emission or azoospermia Disease Clinical observation of curative effect
1 case scenario
Statistics outpatient service and inpatient, observes kidney qi virtual loss, sexual impotence caused by YANG QI deficiency, premature ejaculation, seminal emission or azoospermia case 106 example, 48 years old mean age altogether.Patient is divided into two groups, test group takes embodiment 3 Yishenling Granules, and matched group takes traditional Yishenling Granules.
2 efficacy assessment standards
According to new Chinese medicine guideline of clinical investigations tcm syndrome curative effect determinate standard:
Cure: tcm clinical practice symptom, sign disappear or substantially disappear, syndrome integral reduces >=95%.
Effective: tcm clinical practice symptom, sign are obviously improved, syndrome integral reduces >=70%.
Effective: tcm clinical practice symptom, sign all take a favorable turn, syndrome integral reduces >=30%.
Invalid: tcm clinical practice symptom, sign are all not improved or increase the weight of, syndrome integral reduces < 30%.
Computing formula: [before (before treatment the rear integration of integration-treatment) ÷ treatment integration] × 100%.
3 clinical observation result
Table 1 embodiment 3 Yishenling Granules and the contrast of commercially available Yishenling Granules clinical efficacy
Above-mentioned clinical observation on the therapeutic effect result shows, Yishenling Granules prepared by the present invention treat the sexual impotence caused by kidney qi virtual loss, YANG QI deficiency, premature ejaculation, seminal emission or azoospermia time, evident in efficacy higher than commercially available Yishenling Granules, p < 0.05.

Claims (3)

1. a treatment kidney qi virtual loss, sexual impotence caused by YANG QI deficiency, premature ejaculation, the Chinese medicine of seminal emission or azoospermia, it is characterized in that getting Flos Inulae 280g, Resina Liquidambaris 38g, Herba Siegesbeckiae 80g, Fructus Lycii 200g, Fructus Ligustri Lucidi 300g, Radix Aconiti Lateralis Preparata 20g, Semen Euryales 300g, Semen Plantaginis 100g, Fructus Psoraleae 200g, Fructus Rubi 200g, Fructus Schisandrae Chinensis 50g, Fructus Mori 200g, be ground into 40 order coarse powder, put in circulating ultrasonic extractor, add 19680g water, 6 ~ 8g germanium powder, 6 ~ 10g polysorbate60, select supersonic frequency 50 ~ 60KHz, pressure 0.3 ~ 0.5 Mpa extracts 30 minutes, use 80 mesh screen, obtain extracting solution, getting extracting solution puts in jet spray dryer, and control inlet temperature 40 ~ 50 DEG C, pressure 0.02 ~ 0.04 Mpa, 400 ~ 600 meters per second of flow velocity, obtains nanometer extract powder, get extract powder and add lactose 400g, dextrin 100g, use water wet granulation, 60 DEG C of dryings, granulate, adds Talcum 25g, mixing, obtained Yishenling Granules.
2. the preparation method of Chinese medicine according to claim 1, is characterized in that getting Flos Inulae 280g, Resina Liquidambaris 38g Herba Siegesbeckiae 80g, Fructus Lycii 200g, Fructus Ligustri Lucidi 300g, Radix Aconiti Lateralis Preparata 20g, Semen Euryales 300g, Semen Plantaginis 100g, Fructus Psoraleae 200g, Fructus Rubi 200g, Fructus Schisandrae Chinensis 50g, Fructus Mori 200g, be ground into 40 order coarse powder, put in circulating ultrasonic extractor, add 19680g water, 6 ~ 8g germanium powder, 6 ~ 10g polysorbate60, select supersonic frequency 50 ~ 60KHz, pressure 0.3 ~ 0.5 Mpa extracts 30 minutes, uses 80 mesh screen, obtains extracting solution; Getting extracting solution puts in jet spray dryer, and control inlet temperature 40 ~ 50 DEG C, pressure 0.02 ~ 0.04 Mpa, 400 ~ 600 meters per second of flow velocity, obtains nanometer extract powder; Get extract powder and add lactose 400g, dextrin 100g, use water wet granulation, 60 DEG C of dryings, granulate, adds Talcum 25g, mixing, obtained Yishenling Granules.
3. the preparation method of Chinese medicine according to claim 1, is characterized in that getting Flos Inulae 280g, Resina Liquidambaris 38g , Herba Siegesbeckiae 80g, Fructus Lycii 200g, Fructus Ligustri Lucidi 300g, Radix Aconiti Lateralis Preparata 20g, Semen Euryales 300g, Semen Plantaginis 100g, Fructus Psoraleae 200g, Fructus Rubi 200g, Fructus Schisandrae Chinensis 50g, Fructus Mori 200g, is ground into 40 order coarse powder, puts in circulating ultrasonic extractor, add 6980g water, 7g germanium powder, 8g polysorbate60, selects supersonic frequency 55KHz, pressure 0.4Mpa extracts 30 minutes, uses 80 mesh screen, obtains extracting solution; Getting extracting solution puts in jet spray dryer, and control inlet temperature 45 DEG C, pressure 0.03Mpa, 500 meters per second of flow velocity, obtains nanometer extract powder; Get extract powder and add lactose 400g, dextrin 100g, use water wet granulation, 60 DEG C of dryings, granulate, adds Pulvis Talci 25g, mixing, obtained Yishenling Granules.
CN201410702396.4A 2014-11-29 2014-11-29 Yishenling granule and preparation method thereof Withdrawn CN104491174A (en)

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