CN101049408B - Preparation of Chinese traditional medicine for treating diseases of department of gynecology and preparation method - Google Patents
Preparation of Chinese traditional medicine for treating diseases of department of gynecology and preparation method Download PDFInfo
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Abstract
A Chinese medicine in the form of tablet for treating gynopathy is prepared from 6 Chinese-medicinal materials including flavescent sophora root, motherwort, safflower, Chinese gentian, etc. Its preparing process is also disclosed.
Description
Technical field
The present invention relates to a kind of Chinese medicine preparation that is used for the treatment of gynecological and preparation method thereof, belong to technical field of Chinese medicine.
Technical background
Development along with social economy and culture, the raising of people's living standard, the enhancing of women's self health consciousness, add because the sickness rate of women's gynecological inflammation is very high, show that according to the Ministry of Public Health investigation statistics gynaecopathia sickness rate is up to 75%, and repeated infection easily, therefore the development of gynecological's drug market has prospect very much, and market presents prosperity scene.Relevant data shows that gynecological inflammation medication market scale was about 52.8 hundred million yuan in 2004; Higher sickness rate makes the market capacity of China's Amino-Cerv constantly to increase, and predicts that gynecological inflammation medication market scale in 2008 will be up to 77.55 hundred million yuan; Estimate that year increasing degree is about 10%.And in this tempting market, Chinese patent medicine is little with its side effect, is suitable for life-time service, adapt to gynaecopathia especially gynecological inflammation easily the characteristics of recurrence in occupation of certain market share.According to statistics, enter in the Amino-Cerv kind of version medical insurance catalogue in 2004, Chinese medicine quantity has substantially exceeded Western medicine quantity; And having data to claim, on the gynecological retail medication market, the Chinese patent medicine proportion is 62%, and chemical medicine only is 38%.This shows that Chinese medicine occupies certain advantage in Amino-Cerv market.
Health woman's curing capsule is to be used for the treatment of on the folk remedy basis of gynecological diseases collection, the compatriot of excavation Guizhou Province Miao ethnic group, the utilization modern technologies are furtherd investigate the national medicine product of making to it, the Seedling doctor is the important branch of the traditional Chinese medical science, in recent years, along with the fast development of China's traditional medicine, national medicine constantly causes the attention of hygiene departments at different levels.Health woman's curing capsule is one of prominent example that organically blends of Seedling medical knowledge opinion and theory of Chinese medical science.Health woman's curing capsule by Jia Ouwan youth's (Herba Polygoni cymosi), add Gong Shan (Radix Sophorae Flavescentis), the rank rifle (Caulis Spatholobi) of sighing, add chatter to really (Herba Leonuri), add visit in frame mountain (red Radix Gentianae), the bean loud, high-pitched sound (Cortex Phellodendri), thin zhang reach (Rhizoma Smilacis Glabrae), nest howl always (Radix Angelicae Sinensis) wait eight Miao ethnic group that distinguish the flavor of to commonly use medical herbs and form; Say by Seedling doctor: function cures mainly to covering triumphant, and cloth is sent out and said the port, loud, high-pitched sound several high generations; Loud, high-pitched sound is slipped and to be received the Lip river, and the nest nest covers the autumn, and the nest nest promptly.The traditional Chinese medical science is said that function cures mainly and is heat clearing and damp drying, blood circulation promoting and blood stasis dispelling, adjusting meridian and stopping leukorrhea.By the Guizhou Province People ' s Hospital department of obstetrics and gynecology 80 routine menoxenias, amenorrhea patients are carried out clinical observation result, the treatment group: alleviate 43 examples fully, obviously alleviate 34 examples, slight 2 examples, invalid 1 example, the complete remission rate 53.75% alleviated, total obvious effective rate 96.25%, total effective rate 98.75%; By the GuiYang medical college Affiliated hospital, GuiZhou Province department of obstetrics and gynecology to pelvic inflammatory disease 45 examples, cervicitis 35 examples, vaginitis 63 routine patients carry out clinical observation result and find, treatment group pelvic inflammatory disease effective percentage 93.3%, to cervicitis effective percentage 92.3%, vaginitis effective percentage 95.5%; And in clinical use, do not find untoward reaction.
Based on the good clinical basis of this medicine, vast market prospect, but because of former dosage form is a capsule, less stable, the comparison difficulty of swallowing, in order to enrich the dosage form kind, bring into play the good efficacy of this medicine better, the inventor further studies it, change it into tablet, not only kept the curative effect of former preparation preferably, and the more former dosage form of swallowing is more convenient, carries, store also more convenient, and stability improves a lot, simultaneously, we have set up more perfect quality standard, can effectively control the quality of this kind.By retrieval, said preparation still belongs to internal blank.
Summary of the invention
The object of the present invention is to provide a kind of Chinese medicine preparation that is used for gynecological and preparation method thereof, said preparation mainly is made up of medicines such as Herba Polygoni cymosi, Radix Sophorae Flavescentis, Caulis Spatholobi, Herba Leonuri, red Radix Gentianaes; Has heat clearing and damp drying, blood circulation promoting and blood stasis dispelling, the effect of adjusting meridian and stopping leukorrhea.Through clinical verification, this medication is imitated significantly, and is right because original capsule is swallowed comparatively difficult, be easy to the moisture absorption, less stable is subjected to certain limitation clinically, in order to enrich the dosage form kind, better bring into play the curative effect of this medicine, the applicant further studies it, has developed the tablet of this medicine, has not only kept the curative effect of former preparation preferably, and take, carry, preserve more convenient, stability also greatly improves.
Technical scheme of the present invention is as follows:
A kind of Chinese medicine preparation that is used for gynecological, it is mainly to be made up of active ingredient and/or adjuvant.Count by weight percentage, it is mainly to be made up of active ingredient 70-85% and adjuvant 15-30%.
Calculate by weight, described active ingredient is mainly made by following raw materials according: 4 parts of Herba Polygoni cymosis, 2 parts of Radix Sophorae Flavescentiss, 1 part of Cortex Phellodendri, 2 parts of Caulis Spatholobis, 2 parts of Herba Leonuris, 1.33 parts of red Radix Gentianaes, 1 part of Rhizoma Smilacis Glabrae, 1.2 parts of Radix Angelicae Sinensis.
Preferred dosage form is a tablet.
Described adjuvant includes but not limited to one or more in starch, dextrin, lactose, microcrystalline Cellulose, pregelatinized Starch, 30 POVIDONE K 30 BP/USP 30, magnesium stearate, Pulvis Talci, the micropowder silica gel.
Preferred adjuvant is 30 POVIDONE K 30 BP/USP 30, starch, magnesium stearate.
Tablet is preparation like this: Radix Angelicae Sinensis powder is broken into fine powder, and is standby; After seven flavors such as all the other Herba Polygoni cymosis are soaked 30 minutes, decoct secondary, each 2 hours, collecting decoction filters, and filtrate decompression is concentrated into the clear paste that relative density is 1.25～1.30 (40 ℃), add above-mentioned Radix Angelicae Sinensis fine powder, mixing, drying, pulverize, add adjuvant or do not add adjuvant, mixing, granulate, drying, tabletting, promptly.
Specifically, method for preparing tablet thereof is: Radix Angelicae Sinensis powder is broken into fine powder, and is standby; Seven flavors such as all the other Herba Polygoni cymosis add 6-10 times of water gagings and soak after 30 minutes, decoct secondary, each 2 hours, collecting decoction filters, and filtrate decompression is concentrated into the clear paste that relative density is 1.25～1.30 (40 ℃), add above-mentioned Radix Angelicae Sinensis fine powder, mixing, drying, pulverize, add right amount of auxiliary materials, mixing, granulate drying, tabletting, coating or coating not, promptly.
Preferred tablet method for making is: Radix Angelicae Sinensis powder is broken into fine powder, and is standby; Seven flavors such as all the other Herba Polygoni cymosis add 8 times of water gagings and soak after 30 minutes, decoct secondary, and each 2 hours, collecting decoction, filter, filtrate decompression is concentrated into the clear paste that relative density is 1.25～1.30 (40 ℃), adds above-mentioned Radix Angelicae Sinensis fine powder, mixing, dry below 80 ℃, pulverize, it is an amount of to add polyvidone 15g and starch, and mixing is granulated, drying adds magnesium stearate 2.5g, mixing, be pressed into 1000, the bag film-coat, promptly.
At prior art, former preparation determined curative effect is subjected to the welcome of doctor and patient deeply.But there is the comparatively difficulty of swallowing in original capsule; Drawbacks such as the easy moisture absorption, less stable, for this reason, the inventor carries out secondary development to it, developed and be developed to tablet, both kept former preparation determined curative effect, advantage easy to carry, because of it is a Film coated tablets, increased stability of drug again, and store, take etc. all convenient; The present invention has carried out a large amount of tests to its supplementary product kind and consumption, the adjuvant of screening and principal agent reasonable mixture ratio, and technology is rationally feasible through lab scale, pilot scale, and is stable and controllable for quality, and suitable the amplification produces, and meets the modern requirement of Chinese medicine preparation.
The inventor has carried out a series of experiments, and is rationally feasible, stable and controllable for quality with proof technology of the present invention, to guarantee the beneficial effect of medicine.
Experimental example 1: extraction process examination
1, amount of water examination
According to following prescription ratio, take by weighing following medical material respectively:
Herba Polygoni cymosi 300g Radix Sophorae Flavescentis 150g Cortex Phellodendri 75g Caulis Spatholobi 150g
Herba Leonuri 150g red Radix Gentianae 100g Rhizoma Smilacis Glabrae 75g
Above medical material is mixed into 1 part, and nominal is got 8 parts, adds 6,8,10 times of water gagings of water respectively, soaks after 30 minutes, decocts secondary, each 2 hours, collecting decoction filtered, and merging filtrate concentrates, drying under reduced pressure, 3 parts of dry extracts, be evaluation index with the amount of n-butyl alcohol extractum, the result is as follows.
The table amount of water is investigated the result data table
Sample number inventory (g) adds water multiple paste volume (g) n-butyl alcohol extractum total amount (g)
1 1000 6、6 107.8 9.59
2 1000 6、4 102.5 9.15
3 1000 8、8 116.4 10.22
4 1000 8、6 111.9 10.04
5 1000 8、4 105.2 9.89
6 1000 10、10 124.5 10.43
7 1000 10、8 118.3 10.26
8 1000 10、6 115.7 10.11
Above result shows, with n-butyl alcohol extractum total amount is index, add for the first time 6-10 times of water gagings, add for the second time 4-10 times of water gagings, substantially extracts active ingredients can be come out, 8 times of amount of water have no significant effect with 10 times of total amounts to the n-butyl alcohol extractum of amount of water, and are suitable substantially, so take all factors into consideration from practical factors such as energy consumptions, determine that amount of water is 8 times of amounts of medical material.
Experimental example 2 preparations shaping technical studies
1, the selection of filler
The adjuvant that tablet is commonly used has starch, dextrin, lactose etc., is filler with starch, dextrin, lactose respectively therefore, carries out pressure testing, according to trial test, adopts 85% alcohol granulation, and tabletting serves as to investigate index with compressibility and disintegration time, and the result is as follows.
Table filler kind screening 1
Prescription principal agent (%) starch (%) dextrin (%) lactose (%) compressibility disintegration time hygroscopicity
1 80 20---general, hardness differ from slightly 37 minutes+
2 80-20-general, part sliver 40 minutes+
3 80---20 is general, sliver there are slightly 35 minutes-
4 80 10 10-general, hardness differ from slightly 34 minutes+
5 80-10 10 is general, slightly sliver 36 minutes-
6 80 10-10 is general, slightly sliver 38 minutes-
Annotate: compressibility is investigated:
Good: a wet granulation granule yield is more than 70%, and tablet hardness is good;
Generally: a wet granulation granule yield 50-70%, tablet hardness is poor slightly;
Difference: a wet granulation granule yield is below 50%, loose particles, and tablet hardness is poor.
Average disintegration time: press official method, get 6 meansigma methodss.
Hygroscopicity is investigated: relative humidity is 92.5%, investigates 24h:
+++color is dark, the surface is withered;
++ color is dark, the surface is not withered;
+ color is dark a little, the surface is not withered;
-color outward appearance no change.
According to The above results as can be known, more than the compressibility of three kinds of adjuvants all not ideal, and disintegration time is longer.Because of the low price of starch, so take all factors into consideration, on the basis of prescription 1, increase and use 30 POVIDONE K 30 BP/USP 30, to increase the hardness of tablet, the result is as follows.
The screening 2 of table filler kind
Prescription principal agent (%) starch (%) 30 POVIDONE K 30 BP/USP 30 (%) compressibility disintegration time
7 80 13 7 is not so good, sticking 28 minutes
8 80 15 5 is good, moderate 29 minutes of hardness
9 80 17 3 is good, moderate 32 minutes of hardness
Test shows, select 30 POVIDONE K 30 BP/USP 30 and starch can well improve the indexs such as compressibility, disintegration time of sheet, simultaneously microcrystalline Cellulose, pregelatinized Starch, dextrin, lactose, starch, 30 POVIDONE K 30 BP/USP 30 have been carried out the use that cooperatively interacts, find singly with bigger improvement is all arranged, but be used to good with 30 POVIDONE K 30 BP/USP 30 and starch especially; And 30 POVIDONE K 30 BP/USP 30 reaches 3% of total recipe quantity, can significantly improve the compressibility of sheet, and disintegration time is moderate, and the pressure that makes tablet also can reach the requirement of coating.The amount of polyvidone then has the sticking phenomenon, so take all factors into consideration slightly 7%, definite prescription is: select starch and 30 POVIDONE K 30 BP/USP 30 to be filler, wherein 30 POVIDONE K 30 BP/USP 30 consumptions are 2-6%, preferred 3% of the prescription total amount, starch adds to full dose and gets final product then according to the amount of every batch of medicated powder.
2, lubricant determines
The requirement of particulate flowability during in order to ensure tabletting adds the proper lubrication agent.The general conventional lubricants of tablet is magnesium stearate, micropowder silica gel, Pulvis Talci, through trial test, finding that above-mentioned adjuvant uses separately or is used can both satisfy the preparation requirement, but especially with magnesium stearate for well, so undertaken preferably by the consumption of particulate flowability to magnesium stearate, the result is as follows.
The consumption preference data table of table lubricant
The consumption of sample number magnesium stearate (%) is angle of repose as a result
10 mobility of particles still can 39.3
2 0.3 mobility of particles general 34.2
3 0.5 mobility of particles better 30.3
4 1.0 flowabilities 29.5
According to above-mentioned result of the test, the magnesium stearate consumption can both satisfy the preparation requirement between 0-1.0%, takes all factors into consideration, and the consumption of preferred magnesium stearate is 0.5%.
Concrete embodiment
Embodiment 1:
Herba Polygoni cymosi 600g Radix Sophorae Flavescentis 300g Cortex Phellodendri 150g Caulis Spatholobi 300g
Herba Leonuri 300g red Radix Gentianae 200g Rhizoma Smilacis Glabrae 150g Radix Angelicae Sinensis 180g
More than eight the flavor, Radix Angelicae Sinensis powder is broken into fine powder, and is standby; Seven flavors such as all the other Herba Polygoni cymosis add 8 times of water gagings and soak after 30 minutes, decoct secondary, and each 2 hours, collecting decoction, filter, filtrate decompression is concentrated into the clear paste that relative density is 1.25～1.30 (40 ℃), adds above-mentioned Radix Angelicae Sinensis fine powder, mixing, dry below 80 ℃, pulverize, it is an amount of to add 30 POVIDONE K 30 BP/USP 3015g and starch, and mixing is granulated, drying adds magnesium stearate 2.5g, mixing, be pressed into 1000, the bag film-coat, promptly.
Embodiment 2:
Herba Polygoni cymosi 600g Radix Sophorae Flavescentis 300g Cortex Phellodendri 150g Caulis Spatholobi 300g
Herba Leonuri 300g red Radix Gentianae 200g Rhizoma Smilacis Glabrae 150g Radix Angelicae Sinensis 180g
More than eight the flavor, Radix Angelicae Sinensis powder is broken into fine powder, and is standby; Seven flavors such as all the other Herba Polygoni cymosis add 10 times of water gagings and soak after 30 minutes, decoct secondary, and each 2 hours, collecting decoction, filter, filtrate decompression is concentrated into the clear paste that relative density is 1.25～1.30 (40 ℃), adds above-mentioned Radix Angelicae Sinensis fine powder, mixing, 70 ℃ of dryings are ground into fine powder, heavily about 425g adds pregelatinized Starch 15g, microcrystalline Cellulose 15g dextrin 45g, mixing, granulate, drying adds micropowder silica gel 2.5g, mixing is pressed into 1000, promptly.
Embodiment 3:
Herba Polygoni cymosi 600g Radix Sophorae Flavescentis 300g Cortex Phellodendri 150g Caulis Spatholobi 300g
Herba Leonuri 300g red Radix Gentianae 200g Rhizoma Smilacis Glabrae 150g Radix Angelicae Sinensis 180g
More than eight the flavor, Radix Angelicae Sinensis powder is broken into fine powder, and is standby; Seven flavors such as all the other Herba Polygoni cymosis add 6 times of water gagings and soak after 30 minutes, decoct secondary, and each 2 hours, collecting decoction, filter, filtrate decompression is concentrated into the clear paste that relative density is 1.25～1.30 (40 ℃), adds above-mentioned Radix Angelicae Sinensis fine powder, mixing, dry below 80 ℃, be ground into fine powder, heavily about 350g, add 15g 30 POVIDONE K 30 BP/USP 30,50g lactose, 85g microcrystalline Cellulose, mixing is granulated, drying adds Pulvis Talci 2.5g, mixing, be pressed into 1000, coating, promptly.
Embodiment 4:
Herba Polygoni cymosi 600g Radix Sophorae Flavescentis 300g Cortex Phellodendri 150g Caulis Spatholobi 300g
Herba Leonuri 300g red Radix Gentianae 200g Rhizoma Smilacis Glabrae 150g Radix Angelicae Sinensis 180g
More than eight the flavor, Radix Angelicae Sinensis powder is broken into fine powder, and is standby; Seven flavors such as all the other Herba Polygoni cymosis add 10 times of water gagings and soak after 30 minutes, decoct secondary (adding 8 times of water gagings for the second time), and each 2 hours, collecting decoction, filter, filtrate decompression is concentrated into the clear paste that relative density is 1.25～1.30 (40 ℃), adds above-mentioned Radix Angelicae Sinensis fine powder, mixing, 65 ℃ of dryings are pulverized, it is an amount of to add lactose 30g, pregelatinized Starch 20g and dextrin, and mixing is granulated, drying adds magnesium stearate 2.5g, Pulvis Talci 1g, mixing, be pressed into 1000, the bag film-coat, promptly.
Embodiment 5:
Herba Polygoni cymosi 600g Radix Sophorae Flavescentis 300g Cortex Phellodendri 150g Caulis Spatholobi 300g
Herba Leonuri 300g red Radix Gentianae 200g Rhizoma Smilacis Glabrae 150g Radix Angelicae Sinensis 180g
More than eight the flavor, Radix Angelicae Sinensis powder is broken into fine powder, and is standby; Seven flavors such as all the other Herba Polygoni cymosis add 8 times of water gagings and soak after 30 minutes, decoct secondary (amount of water is 6 times of amounts for the second time), each 2 hours, collecting decoction filters, and filtrate decompression is concentrated into the clear paste that relative density is 1.25～1.30 (40 ℃), add above-mentioned Radix Angelicae Sinensis fine powder, mixing, 55 ℃ of dryings, pulverize, mixing is granulated drying, be pressed into 1000, promptly.
Art for coating can adopt method in the foregoing description, but is not limited to this method:
1. the preparation of film coating liquid:
Add 70% ethanol as solvent in liquid dispensing container, the liquid level of solvent and the diameter of container are roughly the same.Agitator is stretched into 2/3 place under the liquid level.Start agitator, mixing speed is stirred the liquid in the container fully, and liquid level just forms whirlpool and is advisable.3～4% the film coating powder that accounts for label weight constantly is sprinkling upon on the whirlpool liquid level with isostatic speed, and it is suitable that adding speed should be whipped into whirlpool rapidly with powder.Behind reinforced the finishing, mixing speed slowed down whirlpool is just disappeared, continue to stir and dissolved fully to coating materials in 45 minutes, filter, promptly.
2. operational approach: will suppress, satisfactory label puts in the film coating machine, be preheated to about 45 ℃, under the condition of constantly blowing 50 ℃ of left and right sides hot blasts, on the label that constantly rolls, spray into above-mentioned coating solution, be wrapped and surface color when even to tablet, stop hydrojet with spray gun, changing to blow a cold wind over after dry about 15 minutes is cooled to about 30 ℃ tablet, take the dish out of the pot, drying, promptly.
3. coating equipment and process control parameter:
Coating equipment: high speed coating pan
Fluid delivery apparatus: peristaltic pump (40mm silica gel tube)
Liquid discharging device using it: automatic spray gun (spray gun diameter 1.4mm, high flat shape spraying)
Claims (1)
1. a Chinese medicine preparation that is used for gynecological is characterized in that, described tablet is preparation like this:
Herba Polygoni cymosi 600g Radix Sophorae Flavescentis 300g Cortex Phellodendri 150g Caulis Spatholobi 300g
Herba Leonuri 300g red Radix Gentianae 200g Rhizoma Smilacis Glabrae 150g Radix Angelicae Sinensis 180g
Radix Angelicae Sinensis powder is broken into fine powder, and is standby; Herba Polygoni cymosi, Radix Sophorae Flavescentis, Cortex Phellodendri, Caulis Spatholobi, Herba Leonuri, red Radix Gentianae, Rhizoma Smilacis Glabrae seven flavors add 8 times of water gagings and soak after 30 minutes, decoct secondary, and each 2 hours, collecting decoction, filter, relative density was 1.25～1.30 clear paste when filtrate decompression was concentrated into 40 ℃, added above-mentioned Radix Angelicae Sinensis fine powder, mixing, dry below 80 ℃, pulverize, it is an amount of to add 30 POVIDONE K 30 BP/USP 30 15g and starch, and mixing is granulated, drying adds magnesium stearate 2.5g, mixing, be pressed into 1000, the bag film-coat, promptly.
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| CN103028065B (en) * | 2012-12-07 | 2014-06-18 | 贵州师范大学 | Preparation containing herba violae, rhizoma cyperi and herba leonuri and preparation method and detection method thereof |
| CN106153808B (en) * | 2015-03-30 | 2018-03-27 | 贵州百灵企业集团和仁堂药业有限公司 | A kind of detection method of Kangfuling capsule |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1698853A (en) * | 2005-06-06 | 2005-11-23 | 谢子龙 | Gynecological inflammation treatment tablet and its preparation process |
| CN1772234A (en) * | 2005-10-12 | 2006-05-17 | 贵州和仁堂药业有限公司 | Chinese medicine prepn for treating women's disease and its prepn |
| CN1883644A (en) * | 2005-06-21 | 2006-12-27 | 杨次龄 | Chinese medicinal tablet for treating gynecological disease and preparation process thereof |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1698853A (en) * | 2005-06-06 | 2005-11-23 | 谢子龙 | Gynecological inflammation treatment tablet and its preparation process |
| CN1883644A (en) * | 2005-06-21 | 2006-12-27 | 杨次龄 | Chinese medicinal tablet for treating gynecological disease and preparation process thereof |
| CN1772234A (en) * | 2005-10-12 | 2006-05-17 | 贵州和仁堂药业有限公司 | Chinese medicine prepn for treating women's disease and its prepn |
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Assignee: Beijing Baode Runsheng Pharmaceutical Medical Technology Development Co., Ltd. Assignor: Beijing Yinkeruisi Biological Products Research Institute Contract record no.: 2011110000024 Denomination of invention: Traditional Chinese medicine preparation for curing gynecologic and its preparation method Granted publication date: 20110209 License type: Exclusive License Open date: 20071010 Record date: 20110407 |
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Address after: 102200 Beijing Changping District science and Technology Park, 79 battalion road 79, cloud Valley 24, 5 floor, 508 rooms. Patentee after: Beijing Ying Kerui Biological Medicine Research Co Ltd Address before: 100088 Beijing city Xicheng District, New Street No. 2 Tiancheng Technology building block B room 3003 Patentee before: Beijing Yinkeruisi Biological Products Research Institute |
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