CN1931250A - Fule micro pill and its prepn process - Google Patents
Fule micro pill and its prepn process Download PDFInfo
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- CN1931250A CN1931250A CN 200610113219 CN200610113219A CN1931250A CN 1931250 A CN1931250 A CN 1931250A CN 200610113219 CN200610113219 CN 200610113219 CN 200610113219 A CN200610113219 A CN 200610113219A CN 1931250 A CN1931250 A CN 1931250A
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Abstract
The Fule micro pill in the size below 2.5 mm is prepared with the extractum powder the same as for Fule granule, and through mixing with medicinal supplementary material and adhesive and other steps. The said medicinal supplementary material is one or several selected from starch, cane sugar, microcrystalline cellulose, dextrin, etc. The preparation process of the Fule micro pill may be a centrifugal lamination process, a water floating process, a stirring and pelletizing process, a ball rounding process in a sugar coating pot, or an extruding rounding process. The Fule micro pill has the bad taste of the medicine material masked for easy taking.
Description
Technical field
The present invention relates to Chinese medicine medicament pellet and preparation method thereof, particularly be used for the treatment of Chinese medicine medicament pellet of gynaecological inflammation disease and preparation method thereof.
Background technology
The happy ball of woman is to be formed by Caulis Lonicerae, Caulis Sargentodoxae, Radix Glycyrrhizae, Folium Isatidis, Herba Taraxaci, Cortex Moutan, Radix Paeoniae Rubra, Fructus Toosendan, Rhizoma Corydalis (system), Radix Et Rhizoma Rhei (system) ten flavor purification of tcm.Have clearing away heat and cooling blood, the effect of reducing swelling and alleviating pain is mainly treated the leukorrhagia that pelvic inflammatory disease, adnexitis, endometritis etc. cause, gynaecopathias such as stomachache.
Its flower of Caulis Lonicerae also claims to be Caprifoliaceae perennial evergreen voluble shrub by Flos Lonicerae in the side; Its stem, medicine name Caulis Lonicerae.Cold in nature, sweet in the mouth.Function heat-clearing and toxic substances removing, hold concurrently energy collateral dredging, sharp joint.Caulis Lonicerae all has stronger antibacterial action to dysentery bacterium, golden Portugal bacterium, first, laky blood streptococcus, escherichia coli, pseudomonas aeruginosa, dermatophytes, and the resisiting influenza virus effect is arranged.Caulis Sargentodoxae is a Lardizabalaceae defoliation liana, with rattan be used as medicine, property is flat, bitter in the mouth, function heat-clearing and toxic substances removing, promoting blood circulation to restore menstrual flow.Cure mainly diseases such as acute appendicitis, amenorrhea stomachache, arthralgia, various common bacterias are all had inhibitory action.Disease such as gynecology pelvic inflammatory disease, endometritis mostly is childbirth, post-abortion greatly and because of not noting menstrual period such as health etc., takes place that bacterial infection causes, common pathogenic bacterium have streptococcus, staphylococcus and escherichia coli etc.And Caulis Lonicerae and Caulis Sargentodoxae just in time can suppress these antibacterials.In addition, Folium Isatidis and Herba Taraxaci, Cortex Moutan, Radix Paeoniae Rubra have clearing away heat and cooling blood, the merit of the eliminating carbuncle of invigorating blood circulation.The Rhizoma Corydalis promoting blood circulation and stopping pain; Fructus Toosendan can be regulated the flow of vital energy and be alleviated pain; Radix Glycyrrhizae then is that QI invigorating is reseeded.The medicine of below respectively distinguishing the flavor of interacts and matches rationally, makes this medicine become rare good medicine aspect the treatment woman common disease.
The conventional formulation of the happy ball of Chinese medicine woman has decoction and electuary, and the two all needs to take with liquid form, and the compliance that causes the patient to use is very poor, and clinical practice also is restricted.Therefore, it is good that the patient wishes to obtain mouthfeel, easily swallows, oral formulations easy to use.
Summary of the invention
In order to satisfy clinical demand, overcome the happy pill of existing woman and take inconvenient defective, the invention provides that a kind of oral artifact availability is better, stability of drug products is high, mouthfeel good, easy to use, the fule micro pill preparation under promptly can obeying with low amounts of water.Simultaneously, the present invention also discloses the preparation method of this fule micro pill.
Fule micro pill provided by the invention is to prepare about the prescription of FULE CHONGJI regulation by Drug Standard of Ministry of Public Health of the Peoples Republic of China WS3-B-1541-93.In this standard, also stipulated the method for making of " FULE CHONGJI ".
This fule micro pill provided by the invention, ball footpath be less than 2.5mm, is that the extract extract powder by FULE CHONGJI standard prescription medical material mixes with pharmaceutic adjuvant; Add adhesive, make micropill.
Used pharmaceutic adjuvant is selected from any one or a few in starch, sucrose, microcrystalline Cellulose, the dextrin etc.
According to former FULE CHONGJI standard prescription, usage and consumption, through the The effects paste-forming rate, determining to be every bag by the fule micro pill unit dose package, to contain extract powder be 4.4g.
Prove that through experimentation every bag contains extract powder 4.4g, add the pellet preparations that appropriate amount of auxiliary materials can be made into the above loading amount of 5g.Every inspection meets requirement under an appendix I of the 2005 editions Pharmacopoeias of the People's Republic of China rules of preparations IA pill item.
The preparation method of this fule micro pill of the present invention comprise the preparation method of the happy ball standard prescription of woman medicinal substances extract extract powder, and extract powder is made the preparation method of micropill.
The preparation of the happy ball standard prescription of woman medicinal substances extract extract powder is carried out about the method for FULE CHONGJI regulation according to Drug Standard of Ministry of Public Health of the Peoples Republic of China WS3-B-1541-93.
The preparation method of fule micro pill, can adopt following method to carry out respectively:
1, centrifugal lamination method:
Definite through testing, adopt centrifugal lamination legal system to be equipped with micropill, in every bag, the 4.4g extract powder adds the 0.6g proper auxiliary materials promptly can prepare micropill.Therefore, when adopting centrifugal lamination legal system to be equipped with micropill, the minimum addition of adjuvant is 0.6g, and promptly every bag of minimum fill of pill is 5g.
It is as follows to adopt centrifugal lamination legal system to be equipped with the concrete technology of micropill:
Get the recipe quantity extract powder, add microcrystalline Cellulose and the sucrose mixed accessories is an amount of; The weight ratio of microcrystalline Cellulose and sucrose is 3: 2 in this mixture; Extract powder and auxiliary materials and mixing; Getting an amount of mixed powder, is adhesive with water, and 20 mesh sieves are granulated, drying, and sieve is got 30-40 order granule as the ball core, and is standby after clout drying, the pulverizing.Getting 30-40 order granule and put in right amount on the rotation disc, start rotation disc, is that adhesive sprays into the ball wicking surface again with water, is sprinkled into mixed powder, continues this long ball process to ball and directly meets the requirements, and takes out drying, and sieve is got 10-30 order part promptly.
Centrifugal lamination legal system is equipped with micropill, efficient height, process stabilizing, and controllability is strong, can prepare the micropill that meets the pharmacopeia regulation.
2, general method for making
Definite through testing, adopt general method for making to prepare micropill, in every bag, the 4.4g extract powder adds the 5.6g proper auxiliary materials promptly can prepare micropill.Therefore, adopt general method for making to prepare micropill, the minimum addition of adjuvant is 5.6g.
Adopt the concrete technology of general method for making as follows:
Get the recipe quantity extract powder, add microcrystalline Cellulose and the starch mixed accessories is an amount of; The weight ratio of microcrystalline Cellulose and starch is 3: 2 in this mixture; Extract powder and auxiliary materials and mixing; Getting an amount of mixed powder, is adhesive with water, plays female and general routinely method for making operation, continues this operation, and sieve is got 10-30 order part, drying, promptly.
3, coating pan spheronization
Definite through testing, adopt the coating pan spheronization to prepare micropill, in every bag, the 4.4g extract powder adds the 5.6g proper auxiliary materials promptly can prepare micropill.Therefore, adopt the coating pan spheronization to prepare micropill, the minimum addition of adjuvant is 5.6g.
Adopt the concrete technology of coating pan spheronization as follows:
Get the recipe quantity extract powder, add microcrystalline Cellulose and the starch mixed accessories is an amount of; The weight ratio of microcrystalline Cellulose and starch is 3: 2 in this mixture; Extract powder and auxiliary materials and mixing; Getting an amount of mixed powder, is adhesive with water, plays female and general routinely method for making operation, continues this operation, and sieve is got 10-30 order part, drying, promptly.
4, stirring-granulating method
Definite through testing, adopt the stirring-granulating legal system to be equipped with micropill, in every bag, the 4.4g extract powder adds the 3.6g proper auxiliary materials promptly can prepare micropill.Therefore, adopt the stirring-granulating legal system to be equipped with micropill, the minimum addition of adjuvant is 3.6g.
It is as follows to adopt the stirring-granulating legal system to be equipped with the concrete technology of micropill:
Get the recipe quantity extract powder, it is an amount of to add microcrystalline Cellulose, starch, dextrin mixed accessories; The weight ratio of microcrystalline Cellulose and starch, dextrin is 3: 2: 1 in this mixture; Extract powder and auxiliary materials and mixing; Getting an amount of mixed powder and put in the stirring granulating machine, is adhesive with the suitable quantity of water, starts stirring arm, and rotating speed is that per minute 800 changes; Rotated 5 minutes; Reducing revolution to rotating speed then is that per minute 100 changes; Alternately add binding agent and mixed powder, continue this operating process and only add to whole mixed powders, drying, sieve is got 10-30 order part, promptly.
5, extrude spheronization
Definite through testing, employing is extruded spheronization and is prepared micropill, and in every bag, the 4.4g extract powder adds the 5.6g proper auxiliary materials promptly can prepare micropill.Therefore, employing is extruded spheronization and is prepared micropill, and the minimum addition of adjuvant is 5.6g.
Spheronization is extruded in employing, and to prepare the concrete technology of micropill as follows:
Get the recipe quantity extract powder, add microcrystalline Cellulose, the starch mixed accessories is an amount of; The weight ratio of microcrystalline Cellulose and starch is 3: 2 in this mixture; Extract powder and auxiliary materials and mixing; Is 100: 17 ratio mixing with mixed powder and water according to weight ratio, and in the input banded extruder, the aperture is 1mm, extrudes the bar shaped cylinder and puts into high speed centrifuge, opens centrifuge, and rotating speed is that per minute 1000 changes, and rotates 5～10 minutes; Take out, drying, sieve is got 10-30 order part, promptly.
The micropill of above-mentioned several method preparation all meets requirement under an appendix I of the 2005 editions Pharmacopoeias of the People's Republic of China rules of preparations IA pill item.
Fule micro pill provided by the invention, by the preparation of FULE CHONGJI prescription, its advantage is: prepared micropill has been covered the disagreeable taste that original Chinese crude drug had to a great extent, the patient need not get and will drink very big one glass of " black coffee " formula medicine soup, for it is the bag piller of swallowing, can send down with low amounts of water, very convenient.
The invention will be further described for following embodiment, but and do not limit the present invention in any way.All any this areas of doing according to the disclosure of invention be equal to replacement, all belong within protection scope of the present invention.
The specific embodiment
Embodiment 1,
Fule micro pill, ball footpath be less than 2.5mm, mixed with pharmaceutic adjuvant by the extract extract powder of FULE CHONGJI standard prescription medical material; Adding adhesive makes.
The FULE CHONGJI standard prescription is Drug Standard of Ministry of Public Health of the Peoples Republic of China WS
3-B-1541-93 is about the prescription of FULE CHONGJI regulation, and the consumption proportion of each medical material is:
The consumption of Caulis Lonicerae is 6.76 weight portions, the consumption of Caulis Sargentodoxae is 6.76 weight portions, the consumption of Radix Glycyrrhizae is 0.67 weight portion, the consumption of Folium Isatidis is 2.03 weight portions, and the consumption of Herba Taraxaci is 2.03 weight portions, and the consumption of Cortex Moutan is 2.03 weight portions, the consumption of Radix Paeoniae Rubra is 2.03 weight portions, the consumption of Fructus Toosendan is 2.03 weight portions, and the consumption of Rhizoma Corydalis (system) is 2.03 weight portions, and the consumption of Radix Et Rhizoma Rhei (system) is 1.35 weight portions;
Press WS
3The method of-B-1541-93 standard code makes the extract extract powder of above-mentioned medical material;
Used pharmaceutic adjuvant is selected from any one or a few in starch, sucrose, microcrystalline Cellulose, the dextrin etc.
Embodiment 2,
As the fule micro pill of embodiment 1, but pharmaceutic adjuvant is a microcrystalline Cellulose; Perhaps by microcrystalline Cellulose be selected from sucrose, starch, the dextrin any one or a few and formed.The percentage by weight of each component is in the pharmaceutic adjuvant:
Microcrystalline Cellulose 10%～100%, sucrose, starch, dextrin are respectively 0～90%.
Embodiment 3,
As the preparation method of the fule micro pill of embodiment 1 or 2, the extract extract powder of FULE CHONGJI standard prescription medical material is mixed with pharmaceutic adjuvant; Add adhesive, any one method of select centrifugal lamination method, general method for making, stirring-granulating method, coating pan spheronization for use, extruding in the spheronization is made micropill.
Embodiment 4,
As the preparation method of embodiment 3, but adopt centrifugal lamination method: every 4.4g extract powder adds the 0.6g adjuvant; Adjuvant is microcrystalline Cellulose and sucrose mixture; The weight ratio of microcrystalline Cellulose and sucrose is 3: 2 in this mixture; Extract powder and auxiliary materials and mixing; Getting an amount of mixed powder, is adhesive with water, and 20 mesh sieves are granulated, drying; Sieve is got 30-40 order granule as the ball core, and is standby after clout drying, the pulverizing.Getting 30-40 order granule and put in right amount on the rotation disc, start rotation disc, is that adhesive sprays into the ball wicking surface again with water, is sprinkled into mixed powder, continues this long ball process to ball and directly meets the requirements, and takes out drying, and sieve is got 10-30 order part promptly.
Embodiment 5,
As the preparation method of embodiment 3, but adopt general method for making: every 4.4g extract powder adds the 5.6g adjuvant; Adjuvant is microcrystalline Cellulose and starch mixture; The weight ratio of microcrystalline Cellulose and starch is 3: 2 in this mixture; Extract powder and auxiliary materials and mixing; Getting an amount of mixed powder, is adhesive with water, plays female and general routinely method for making operation, continues this operation, and sieve is got 10-30 order part, drying, promptly.
Embodiment 6,
As the preparation method of embodiment 3, but adopt the coating pan spheronization.Every 4.4g extract powder adds the 5.6g adjuvant; Adjuvant is microcrystalline Cellulose and starch mixture; The weight ratio of microcrystalline Cellulose and starch is 3: 2 in this mixture; Extract powder and auxiliary materials and mixing; Getting an amount of mixed powder, is adhesive with water, plays female and general routinely method for making operation, continues this operation, and sieve is got 10-30 order part, drying, promptly.
Embodiment 7,
As the preparation method of embodiment 3, but adopt the stirring-granulating method.Every 4.4g extract powder adds the 3.6g adjuvant; Adjuvant is microcrystalline Cellulose, starch, dextrin mixture; The weight ratio of microcrystalline Cellulose and starch, dextrin is 3: 2: 1 in this mixture; Extract powder and auxiliary materials and mixing; Getting an amount of mixed powder and put in the stirring granulating machine, is adhesive with the suitable quantity of water, starts stirring arm, and rotating speed is that per minute 800 changes; Rotated 5 minutes; Reducing rotating speed to rotating speed then is that per minute 100 changes; Alternately add binding agent and mixed powder, continue this operating process to whole mixed powders and only add; Drying, sieve is got 10-30 order part, promptly.
Embodiment 8,
As the preparation method of embodiment 3, extrude spheronization but adopt.Every 4.4g extract powder adds the 5.6g adjuvant; Adjuvant is microcrystalline Cellulose and starch mixture, and the weight ratio of microcrystalline Cellulose and starch is 3: 2 in this mixture; Extract powder and auxiliary materials and mixing; Is 100: 17 ratio mixing with mixed powder and water according to weight ratio, and in the input banded extruder, the aperture is 1mm, extrudes the bar shaped cylinder and puts into high speed centrifuge, opens centrifuge, and rotating speed is that per minute 1000 changes, and rotates 5～10 minutes; Take out, drying, sieve is got 10-30 order part, promptly.
Embodiment 9,
As the fule micro pill of embodiment 1,2, the fule micro pill unit dose package is every bag, and to contain extract powder be 4.4g.
Claims (9)
1, fule micro pill is characterized in that micropill ball footpath less than 2.5mm, is mixed with pharmaceutic adjuvant by the extract extract powder of FULE CHONGJI standard prescription medical material; Adding adhesive makes;
The FULE CHONGJI standard prescription is Drug Standard of Ministry of Public Health of the Peoples Republic of China WS
3-B-1541-93 is about the prescription of FULE CHONGJI regulation, and the consumption proportion of each medical material is:
The consumption of Caulis Lonicerae is 6.76 weight portions, the consumption of Caulis Sargentodoxae is 6.76 weight portions, the consumption of Radix Glycyrrhizae is 0.67 weight portion, the consumption of Folium Isatidis is 2.03 weight portions, and the consumption of Herba Taraxaci is 2.03 weight portions, and the consumption of Cortex Moutan is 2.03 weight portions, the consumption of Radix Paeoniae Rubra is 2.03 weight portions, the consumption of Fructus Toosendan is 2.03 weight portions, and the consumption of Rhizoma Corydalis (system) is 2.03 weight portions, and the consumption of Radix Et Rhizoma Rhei (system) is 1.35 weight portions;
Press WS
3The method of-B-1541-93 standard code makes the extract extract powder of above-mentioned medical material;
Used pharmaceutic adjuvant is selected from any one or a few in starch, sucrose, microcrystalline Cellulose, the dextrin etc.
2, fule micro pill according to claim 1 is characterized in that pharmaceutic adjuvant is a microcrystalline Cellulose; Perhaps by microcrystalline Cellulose be selected from sucrose, starch, the dextrin any one or a few and formed;
The percentage by weight of each component is in the pharmaceutic adjuvant:
Microcrystalline Cellulose 10%～100%, sucrose, starch, dextrin are respectively 0～90%.
3, the preparation method of fule micro pill according to claim 1 and 2 is characterized in that the extract extract powder of FULE CHONGJI standard prescription medical material is mixed with pharmaceutic adjuvant; Add adhesive, any one method of select centrifugal lamination method, general method for making, stirring-granulating method, coating pan spheronization for use, extruding in the spheronization is made micropill.
4, according to the preparation method of claim 3, it is characterized in that adopting centrifugal lamination method: every 4.4g extract powder adds the 0.6g adjuvant; Adjuvant is microcrystalline Cellulose and sucrose mixture; The weight ratio of microcrystalline Cellulose and sucrose is 3: 2 in this mixture; Extract powder and auxiliary materials and mixing; Getting an amount of mixed powder, is adhesive with water, and 20 mesh sieves are granulated, drying; Sieve is got 30-40 order granule as the ball core, and is standby after clout drying, the pulverizing;
Getting 30-40 order granule and put in right amount on the rotation disc, start rotation disc, is that adhesive sprays into the ball wicking surface again with water, is sprinkled into mixed powder, continues this long ball process to ball and directly meets the requirements, and takes out drying, and sieve is got 10-30 order part promptly.
5, according to the preparation method of claim 3, it is characterized in that adopting general method for making: every 4.4g extract powder adds the 5.6g adjuvant; Adjuvant is microcrystalline Cellulose and starch mixture; The weight ratio of microcrystalline Cellulose and starch is 3: 2 in this mixture; Extract powder and auxiliary materials and mixing; Getting an amount of mixed powder, is adhesive with water, plays female and general routinely method for making operation, continues this operation, and sieve is got 10-30 order part, drying, promptly.
6, according to the preparation method of claim 3, it is characterized in that adopting the coating pan spheronization: every 4.4g extract powder adds the 5.6g adjuvant; Adjuvant is microcrystalline Cellulose and starch mixture; The weight ratio of microcrystalline Cellulose and starch is 3: 2 in this mixture; Extract powder and auxiliary materials and mixing; Getting an amount of mixed powder, is adhesive with water, plays female and general routinely method for making operation, continues this operation, and sieve is got 10-30 order part, drying, promptly.
7, according to the preparation method of claim 3, it is characterized in that adopting the stirring-granulating method: every 4.4g extract powder adds the 3.6g adjuvant; Adjuvant is microcrystalline Cellulose, starch, dextrin mixture; The weight ratio of microcrystalline Cellulose and starch, dextrin is 3: 2: 1 in this mixture; Extract powder and auxiliary materials and mixing; Getting an amount of mixed powder and put in the stirring granulating machine, is adhesive with the suitable quantity of water, starts stirring arm, and rotating speed is that per minute 800 changes; Rotated 5 minutes; Reducing rotating speed to rotating speed then is that per minute 100 changes; Alternately add binding agent and mixed powder, continue this operating process to whole mixed powders and only add; Drying, sieve is got 10-30 order part, promptly.
8, according to the preparation method of claim 3, it is characterized in that adopting and extrude spheronization: every 4.4g extract powder adds the 5.6g adjuvant; Adjuvant is microcrystalline Cellulose and starch mixture, and the weight ratio of microcrystalline Cellulose and starch is 3: 2 in this mixture; Extract powder and auxiliary materials and mixing; Is 100: 17 ratio mixing with mixed powder and water according to weight ratio, and in the input banded extruder, the aperture is 1mm, extrudes the bar shaped cylinder and puts into high speed centrifuge, opens centrifuge, and rotating speed is that per minute 1000 changes, and rotates 5～10 minutes; Take out, drying, sieve is got 10-30 order part, promptly.
9, fule micro pill according to claim 1 and 2, it is characterized in that being every bag by the fule micro pill unit dose package, to contain extract powder be 4.4g.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN 200610113219 CN1931250A (en) | 2006-09-19 | 2006-09-19 | Fule micro pill and its prepn process |
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| CN 200610113219 CN1931250A (en) | 2006-09-19 | 2006-09-19 | Fule micro pill and its prepn process |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102205130A (en) * | 2011-05-18 | 2011-10-05 | 杭州高成生物营养技术有限公司 | Low-friability medicinal micro-pill core and preparation method thereof |
| CN105770795A (en) * | 2016-03-03 | 2016-07-20 | 章敏 | Puerperal conditioning instant medicine and preparation method thereof |
| CN106266422A (en) * | 2015-06-10 | 2017-01-04 | 马金叶 | A kind of woman takes happy ball and preparation method thereof |
-
2006
- 2006-09-19 CN CN 200610113219 patent/CN1931250A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102205130A (en) * | 2011-05-18 | 2011-10-05 | 杭州高成生物营养技术有限公司 | Low-friability medicinal micro-pill core and preparation method thereof |
| CN106266422A (en) * | 2015-06-10 | 2017-01-04 | 马金叶 | A kind of woman takes happy ball and preparation method thereof |
| CN105770795A (en) * | 2016-03-03 | 2016-07-20 | 章敏 | Puerperal conditioning instant medicine and preparation method thereof |
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Assignee: Taiyangshi (Tangshan) Pharm Ind Co., Ltd. Assignor: Han Zhiqiang Contract fulfillment period: 2007.09.05 to 2015.06.22 Contract record no.: Contract filing No. 2007990000037 Denomination of invention: Invented name fule pill micro pellet and preparation method thereof Granted publication date: Unauthorized authorization day License type: Exclusive license Record date: 20070912 |
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Assignee: Taiyangshi (Tangshan) Pharm Ind Co., Ltd. Assignor: Han Zhiqiang Contract fulfillment period: 2009.10.20 to 2014.10.19 contract change Contract record no.: 2009990001300 Denomination of invention: Pellets of fule pill and preparation method thereof License type: General permission Record date: 20091130 Assignee: Taiyangshi (Tangshan) Pharm Ind Co., Ltd. Assignor: Han Zhiqiang Contract fulfillment period: 2009.12.16 to 2026.5.30 contract change Contract record no.: 2009990001331 Denomination of invention: Pellets of fule pill and preparation method thereof License type: Exclusive license Record date: 20091217 |
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