CN101317971B - Complete-gastrodia tuber soft capsule and preparation method thereof - Google Patents
Complete-gastrodia tuber soft capsule and preparation method thereof Download PDFInfo
- Publication number
- CN101317971B CN101317971B CN2008103025043A CN200810302504A CN101317971B CN 101317971 B CN101317971 B CN 101317971B CN 2008103025043 A CN2008103025043 A CN 2008103025043A CN 200810302504 A CN200810302504 A CN 200810302504A CN 101317971 B CN101317971 B CN 101317971B
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- Prior art keywords
- soft capsule
- gastrodia tuber
- diluent
- rhizoma gastrodiae
- complete
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
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- 239000007901 soft capsule Substances 0.000 title claims abstract description 53
- 238000002360 preparation method Methods 0.000 title claims abstract description 19
- 239000003085 diluting agent Substances 0.000 claims abstract description 34
- 239000000843 powder Substances 0.000 claims abstract description 24
- 239000000203 mixture Substances 0.000 claims abstract description 11
- 230000001954 sterilising effect Effects 0.000 claims abstract description 11
- 238000004659 sterilization and disinfection Methods 0.000 claims abstract description 11
- 238000000227 grinding Methods 0.000 claims abstract description 5
- 238000002156 mixing Methods 0.000 claims abstract description 4
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 78
- 229920002565 Polyethylene Glycol 400 Polymers 0.000 claims description 29
- JLFNLZLINWHATN-UHFFFAOYSA-N pentaethylene glycol Chemical compound OCCOCCOCCOCCOCCO JLFNLZLINWHATN-UHFFFAOYSA-N 0.000 claims description 16
- 230000036760 body temperature Effects 0.000 claims description 9
- 239000000084 colloidal system Substances 0.000 claims description 8
- 239000002202 Polyethylene glycol Substances 0.000 claims description 7
- 229920001223 polyethylene glycol Polymers 0.000 claims description 7
- 238000000034 method Methods 0.000 abstract description 6
- 238000003825 pressing Methods 0.000 abstract description 6
- 239000008157 edible vegetable oil Substances 0.000 abstract description 5
- 230000000694 effects Effects 0.000 abstract description 4
- 206010019233 Headaches Diseases 0.000 abstract description 3
- 201000010099 disease Diseases 0.000 abstract description 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 abstract description 3
- 208000002173 dizziness Diseases 0.000 abstract description 3
- 231100000869 headache Toxicity 0.000 abstract description 3
- 238000003860 storage Methods 0.000 abstract description 3
- 210000002435 tendon Anatomy 0.000 abstract description 3
- 241000305492 Gastrodia Species 0.000 abstract 6
- ULWHHBHJGPPBCO-UHFFFAOYSA-N propane-1,1-diol Chemical compound CCC(O)O ULWHHBHJGPPBCO-UHFFFAOYSA-N 0.000 abstract 2
- 230000007547 defect Effects 0.000 abstract 1
- 230000032798 delamination Effects 0.000 abstract 1
- 238000011049 filling Methods 0.000 abstract 1
- 239000002245 particle Substances 0.000 abstract 1
- 239000007788 liquid Substances 0.000 description 15
- 229940068918 polyethylene glycol 400 Drugs 0.000 description 13
- 239000002775 capsule Substances 0.000 description 8
- 239000003814 drug Substances 0.000 description 7
- 229940079593 drug Drugs 0.000 description 5
- 238000005516 engineering process Methods 0.000 description 3
- 238000010348 incorporation Methods 0.000 description 3
- 235000015112 vegetable and seed oil Nutrition 0.000 description 3
- 239000008158 vegetable oil Substances 0.000 description 3
- 238000010521 absorption reaction Methods 0.000 description 2
- 239000002671 adjuvant Substances 0.000 description 2
- 238000000151 deposition Methods 0.000 description 2
- 239000000835 fiber Substances 0.000 description 2
- 239000008187 granular material Substances 0.000 description 2
- 230000007774 longterm Effects 0.000 description 2
- 238000005498 polishing Methods 0.000 description 2
- 206010009346 Clonus Diseases 0.000 description 1
- 239000013543 active substance Substances 0.000 description 1
- 230000003064 anti-oxidating effect Effects 0.000 description 1
- 239000007766 cera flava Substances 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 238000004945 emulsification Methods 0.000 description 1
- 230000002708 enhancing effect Effects 0.000 description 1
- 206010015037 epilepsy Diseases 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 230000003834 intracellular effect Effects 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 239000004576 sand Substances 0.000 description 1
- 235000012424 soybean oil Nutrition 0.000 description 1
- 239000003549 soybean oil Substances 0.000 description 1
- 239000007921 spray Substances 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
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- Medicinal Preparation (AREA)
Abstract
The present invention provides a complete gastrodia tuber soft capsule and a preparation method thereof, which solves the defects of the prior art that the refined gastrodia tuber powder is hardly dissolved in edible oil, easily congregated into particles, delaminated and unevenly dispersed after placement. Calculated by weight portions, the present invention includes the following procedures: taking one portion of gastrodia tuber and grinding the gastrodia tuber into 120 meshes; adding 0.5 to 3 portions of polyglycol400 and propanediol accounting for 8% of the amount of polyglycol400 after sterilization; then evenly mixing, filling and pressing the mixture into soft capsules. Compared with the prior art, the present invention takes polyglycol400 as the diluting agent so that the refined gastrodia tuber powder can be better dispersed. In addition, the present invention has no delamination after placement and excellent stability and can better increase the biological utilization of the soft capsule preparation. The addition of propanediol into the diluting agent can prevent the soft capsule shell from hardening and the disintegration time limit from prolonging in storage. The complete gastrodia tuber soft capsule has obvious curative effect on headache and dizziness, numb limbs and tense tendons, hieronosus and hyperspasmia and other diseases.
Description
Technical field
The present invention relates to a kind of whole day fiber crops preparation and preparation method thereof, particularly relate to a kind of complete-gastrodia tuber soft capsule preparation and preparation method thereof.
Background technology
Diseases such as Rhizoma Gastrodiae is dizzy for headache, numb limbs and tense tendons have reasonable curative effect, but directly result of use is undesirable, be that Rhizoma Gastrodiae is made into QUANTIANMA JIAONANG or Rhizoma Gastrodiae slice in the prior art, but they are in manufacturing process, just Rhizoma Gastrodiae powder is broken into general fine powder (fineness is 80～100 orders), in incapsulating after the sterilization or add the compacting of suitable adjuvant and make in flakes.This quasi drugs stable poor, the very easily moisture absorption, and bioavailability is low, effect is bad.
The former dosage form of whole day fiber crops is a capsule, because there is above-mentioned problem in capsule, so the marketability of commodity is not strong.Can consider to make soft capsule into former dose.Soft capsule contained drug error is little, and drug release is very fast, and bioavailability is good.In addition, soft capsule has plasticity and elasticity, can moistureproof, anti-oxidation, lucifuge, improve stability of drug; Carry, easy to use; Exquisite appearance is subject to patient and accepts; Also can improve the marketability of this product greatly, increase economic benefit.
Application number is that the patent application of CN03117242.3 discloses a kind of " complete-gastrodia tuber soft capsule and preparation method thereof ", and it is prepared from as diluent with edible oil and Cera Flava.The applicant finds in practice, and Rhizoma Gastrodiae fine powder is difficult for dissolving and disperses in edible oil, can be gathered into granule, and place the back layering, disperses inhomogeneously, can't make soft capsule.
Summary of the invention
Technical problem to be solved by this invention is the defective that overcomes prior art, and a kind of complete-gastrodia tuber soft capsule stable, quality controllable, taking convenience that is uniformly dispersed is provided, and this preparation of soft capsule method is provided simultaneously.
In order to solve the problems of the technologies described above, the present invention adopts following technical scheme:
According to listed as parts by weight, complete-gastrodia tuber soft capsule is to be prepared from for 0.5～3 part by 1 part in Rhizoma Gastrodiae and diluent, wherein contains the propylene glycol of 6～10% (volumes) in the diluent, and all the other are PEG400.
Preferably, according to listed as parts by weight, it is to be prepared from for 1.4～1.7 parts by 1 part in Rhizoma Gastrodiae and diluent, wherein contains the propylene glycol of 7～9% (volumes) in the diluent, and all the other are PEG400.
Further, it is to be prepared from for 1.6 parts by 1 part in Rhizoma Gastrodiae and diluent, wherein contains the propylene glycol of 8% (volume) in the diluent, and all the other are PEG400.
Rhizoma Gastrodiae in the aforementioned complete-gastrodia tuber soft capsule is that granularity is 120 purpose fine powders.Can make easier effective stripping of the intracellular active substance of Rhizoma Gastrodiae and absorption like this, improve the therapeutic effect of its bioavailability, enhancing Rhizoma Gastrodiae.
The preparation method of aforementioned complete-gastrodia tuber soft capsule: get Rhizoma Gastrodiae powder and be broken into 120 purpose fine powders, the sterilization back adds PEG400 and propylene glycol, and mixing, fill are pressed into soft capsule promptly.
Concrete, the preparation method of complete-gastrodia tuber soft capsule is: be ground into 120 purpose fine powders after getting the Rhizoma Gastrodiae oven dry, carry out the low temperature discontinuous sterilization 3 times at 75～80 ℃, each 12 hours, add Polyethylene Glycol and propylene glycol then, grinding 10 minutes mix homogeneously in colloid mill, is fill under 42～46 ℃ the condition in the sprinkler body temperature, is pressed into soft capsule promptly.
The inventor is as follows to the prescription of complete-gastrodia tuber soft capsule and preparation technology's exploration:
One, the selection of diluent
The selection of diluent is the important step of soft capsule preparation, should be able to guarantee the accuracy and the stability of formulation of drug content, and diluent commonly used has soybean oil, Polyethylene Glycol-400 (PEG-400) etc.
Through overtesting, the inventor finds: with vegetable oil or edible oil is diluent, and it is difficult for dissolving and disperses in vegetable oil or edible oil, be gathered into granule, places the back layering, disperses inhomogeneously, can't make soft capsule; With PEG-400 is diluent, and it can disperse in PEG-400 preferably, and intersolubility is better, not stratified after placing, good stability.Simultaneously, because of PEG-400 has good water-solubility, can improve the bioavailability of preparation, be diluent so determine to select for use PEG-400.
The selection of table 1 diluent kind
| Diluent | The medicinal liquid situation |
| Vegetable oil | Extractum is difficult for disperseing, and is easily agglomerating, places layering |
| PEG-400 | Extractum is uniformly dispersed, and intersolubility is good, place not stratified, but the easy hardening of softgel shell |
The inventor finds again in experimentation, because PEG-400 easily absorbs the moisture in the softgel shell, makes the softgel shell hardening, causes prolong disintegration.In capsule liquid prescription, add propylene glycol, substitute the PEG-400 of part, but the moisture between the balance capsule shell fluid then suppress capsule liquid and absorb moisture in the softgel shell, after the placement, disintegration basic no change, the hardening phenomenon does not appear in softgel shell.
By above result of the test as can be known, capsule liquid prescription for well, with the alternative PEG-400 partly of the propylene glycol of 8% (volume) amount, can guarantee that the soft capsule long-term storage is stable with PEG-400, not hardening of softgel shell, and disintegration is up to specification.So determine in the prescription of soft capsule with PEG-400 to be diluent, wherein contain the propylene glycol of 8% (volume), prevent soft capsule hardening and prolonging disintegration in depositing process.
Two, the diluent consumption is selected
The consumption of diluent directly has influence on the loading amount and the content uniformity of soft capsule: ratio is low excessively, and then mobile bad, content uniformity is big; Ratio is excessive, and then consumption increases, the inconvenience of taking medicine.Therefore screen the diluent of different proportion, thereby determined optimal proportion.Get Rhizoma Gastrodiae fine powder 50g, add not commensurability PEG-400 (comprising 8% propylene glycol) respectively, fully mix, observe its state after colloid mill ground 10 minutes, and compacting fill capsule, the results are shown in Table 2.
The selection result of the test of table 2 diluent ratio
| Diluent: Rhizoma Gastrodiae fine powder | The medicinal liquid situation | The fill situation | Content uniformity |
| 1.2∶1 | Medicinal liquid is than thickness, and is mobile bad | The fill difficulty, sprinkler body easily stops up | Up to specification |
| 1.4∶1 | Medicinal liquid is than thickness, and flowability is good slightly | The fill difficulty, sprinkler body has clogging | Up to specification |
| 1.6∶1 | Medicinal liquid is even, denseness is suitable, good fluidity | Fill is smooth, and sprinkler body does not have clogging | Up to specification |
| 1.8∶1 | Medicinal liquid evenly, rarer, good fluidity | Fill is smooth, and sprinkler body does not have clogging | Up to specification |
By above result as can be known, when the ratio of diluent and Rhizoma Gastrodiae fine powder is 1.6: 1 and 1.8: 1, the flowability of medicinal liquid can satisfy the requirement of soft capsule pressing, but ratio is 1.8: 1 o'clock, the consumption of adjuvant is big, it is bigger to take volume, so determine that the optimal proportion of diluent and Rhizoma Gastrodiae fine powder is 1.6: 1.
Three, the selection of incorporation time
The content of soft capsule is wanted sufficient mix homogeneously, otherwise easily layering in compacting or put procedure, influences the accuracy of medicine loading amount.General mixing apparatus adopts colloid mill or dispersing emulsification machine.This product adopts the colloid mill polishing, has compared the situation of medicinal liquid after grinding different time, the results are shown in Table 3.
The selection result of the test table of table 3 incorporation time
| Incorporation time | The medicinal liquid situation |
| 5 minutes | Medicinal liquid has grains of sand sense, mixes inhomogeneous |
| 10 minutes | Medicinal liquid is even, the feel exquisiteness |
| 15 minutes | Medicinal liquid is even, the feel exquisiteness |
By above result as can be known, with the colloid mill polishing, ground 10 minutes and 15 minutes material situation zero differences, but all be better than grinding 5 minutes.So determine to grind 10 minutes with colloid mill.
Four, the selection of sprinkler body temperature
In the pressing process of soft capsule, the sprinkler body temperature is the key factor that influences soft capsule content uniformity and yield rate: temperature is low excessively, and the capsule pressing is bad, leakage easily; Temperature is too high, influences the outward appearance of soft capsule.So this product has been investigated under different sprinkler body temperature, the pressing situation and the yield rate of soft capsule the results are shown in Table 4.
Table 4 sprinkler body temperature is selected result of the test
| The sprinkler body temperature | Make the soft capsule situation |
| 38～42℃ | Pressing is bad, leakage easily |
| 42～46℃ | The yield rate height, loading amount is up to specification |
| 46～50℃ | The soft capsule appearance poor, the out-of-flatness of pressing position |
As seen from the experiment, the sprinkler body temperature should be controlled at 42～46 ℃ and is advisable.
Compared with prior art, the present invention is diluent with the PEG400, and interpolation propylene glycol, intersolubility between Rhizoma Gastrodiae fine powder and the PEG400 is better, make Rhizoma Gastrodiae fine powder can better be dispersed in the diluent, and it is not stratified to place the back, has good stability, and, the water solublity of PEG400 is good, can better improve the bioavailability of soft capsule preparation, adds propylene glycol in diluent, also guarantee the stability of soft capsule long-term storage, prevented soft capsule softgel shell hardening and prolongation disintegration in depositing process.Diseases such as the complete-gastrodia tuber soft capsule preparation is dizzy to having a headache, numb limbs and tense tendons, epilepsy clonus have obvious curative effects.
The specific embodiment
Embodiment 1: Rhizoma Gastrodiae 1kg, PEG400 1.4kg, propylene glycol 200g
Be ground into 120 purpose fine powders after getting the Rhizoma Gastrodiae oven dry, carry out the low temperature discontinuous sterilization 3 times at 75～80 ℃ then, each 12 hours, add Polyethylene Glycol and propylene glycol then, grind 10 minutes mix homogeneously in colloid mill, the sprinkler body temperature is set at 44 ℃, and the spray fill becomes 4000 of soft capsules.
Usage and dosage: oral, one time 4～12,3 times on the one.
Embodiment 2: Rhizoma Gastrodiae 1kg, PEG400 1.7kg, propylene glycol 138g
Be ground into 120 purpose fine powders after getting the Rhizoma Gastrodiae oven dry, carry out the low temperature discontinuous sterilization 3 times at 75～80 ℃ then, each 12 hours, add Polyethylene Glycol and propylene glycol then, mix homogeneously, fill are pressed into 4000 of soft capsules.
Usage and dosage: oral, one time 4～12,3 times on the one.
Embodiment 3: Rhizoma Gastrodiae 1kg, PEG400 500g, propylene glycol 40g
Be ground into 120 purpose fine powders after getting the Rhizoma Gastrodiae oven dry, carry out the low temperature discontinuous sterilization 3 times at 75～80 ℃ then, each 12 hours, add Polyethylene Glycol and propylene glycol then, mix homogeneously, fill are pressed into 4000 of soft capsules.
Usage and dosage: oral, one time 4～12,3 times on the one.
Embodiment 4: Rhizoma Gastrodiae 1kg, PEG400 3kg, propylene glycol 240g
Be ground into 120 purpose fine powders after getting the Rhizoma Gastrodiae oven dry, carry out the low temperature discontinuous sterilization 3 times at 75～80 ℃ then, each 12 hours, add Polyethylene Glycol and propylene glycol then, mix homogeneously, fill are pressed into 4000 of soft capsules.
Usage and dosage: oral, one time 4～12,3 times on the one.
Embodiment 5: Rhizoma Gastrodiae 1kg, PEG400 2kg, propylene glycol 160g
Be ground into 120 purpose fine powders after getting the Rhizoma Gastrodiae oven dry, carry out the low temperature discontinuous sterilization 3 times at 75～80 ℃ then, each 12 hours, add Polyethylene Glycol and propylene glycol then, mix homogeneously, fill are pressed into 4000 of soft capsules.
Usage and dosage: oral, one time 4～12,3 times on the one.
Claims (6)
1. complete-gastrodia tuber soft capsule is characterized in that: according to listed as parts by weight, it is to be prepared from for 1.4～1.7 parts by 1 part in Rhizoma Gastrodiae and diluent, wherein contains the propylene glycol of 6～10% (volumes) in the diluent, and all the other are PEG400.
2. according to the described complete-gastrodia tuber soft capsule of claim 1, it is characterized in that: according to listed as parts by weight, it is to be prepared from for 1.4～1.7 parts by 1 part in Rhizoma Gastrodiae and diluent, wherein contains the propylene glycol of 7～9% (volumes) in the diluent, and all the other are PEG400.
3. according to the described complete-gastrodia tuber soft capsule of claim 2, it is characterized in that: according to listed as parts by weight, it is to be prepared from for 1.6 parts by 1 part in Rhizoma Gastrodiae and diluent, wherein contains the propylene glycol of 8% (volume) in the diluent, and all the other are PEG400.
4. according to the arbitrary described complete-gastrodia tuber soft capsule of claim 1-3, it is characterized in that: described Rhizoma Gastrodiae is that granularity is 120 purpose fine powders.
5. the preparation method of the arbitrary described complete-gastrodia tuber soft capsule of claim 1-4 is characterized in that: get Rhizoma Gastrodiae powder and be broken into 120 purpose fine powders, the sterilization back adds PEG400 and propylene glycol, and mixing, fill are pressed into soft capsule promptly.
6. according to the preparation method of the described complete-gastrodia tuber soft capsule of claim 5, it is characterized in that: be ground into 120 purpose fine powders after getting the Rhizoma Gastrodiae oven dry, carry out the low temperature discontinuous sterilization 3 times at 75～80 ℃, each 12 hours, add Polyethylene Glycol and propylene glycol then, grinding 10 minutes mix homogeneously in colloid mill, is fill under 42～46 ℃ the condition in the sprinkler body temperature, is pressed into soft capsule promptly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2008103025043A CN101317971B (en) | 2008-07-02 | 2008-07-02 | Complete-gastrodia tuber soft capsule and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2008103025043A CN101317971B (en) | 2008-07-02 | 2008-07-02 | Complete-gastrodia tuber soft capsule and preparation method thereof |
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| Publication Number | Publication Date |
|---|---|
| CN101317971A CN101317971A (en) | 2008-12-10 |
| CN101317971B true CN101317971B (en) | 2011-07-20 |
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| CN2008103025043A Expired - Fee Related CN101317971B (en) | 2008-07-02 | 2008-07-02 | Complete-gastrodia tuber soft capsule and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102416031A (en) * | 2011-11-07 | 2012-04-18 | 江苏鹏鹞药业有限公司 | Rhodiola wallichiana soft capsule and preparation method thereof |
| CN112426489A (en) * | 2020-11-17 | 2021-03-02 | 孙红梅 | Process for producing gastrodia tuber capsule |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1136446A (en) * | 1995-05-25 | 1996-11-27 | 张仁保 | Soft capsule of gynostemma pentaphylla total glycoside and its preparing technology |
| CN1875949A (en) * | 2006-07-04 | 2006-12-13 | 邵爱霞 | Soft gastrodine capsule and preparation method thereof |
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2008
- 2008-07-02 CN CN2008103025043A patent/CN101317971B/en not_active Expired - Fee Related
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1136446A (en) * | 1995-05-25 | 1996-11-27 | 张仁保 | Soft capsule of gynostemma pentaphylla total glycoside and its preparing technology |
| CN1875949A (en) * | 2006-07-04 | 2006-12-13 | 邵爱霞 | Soft gastrodine capsule and preparation method thereof |
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| CN101317971A (en) | 2008-12-10 |
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Denomination of invention: Complete-gastrodia tuber soft capsule and preparation method thereof Effective date of registration: 20120903 Granted publication date: 20110720 Pledgee: Agricultural Bank of China Limited by Share Ltd. Guiyang Huaxi branch Pledgor: Guizhou Eakan Pharmaceutical Co.,Ltd. Registration number: 2012990000490 |
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Denomination of invention: Complete-gastrodia tuber soft capsule and preparation method thereof Effective date of registration: 20131017 Granted publication date: 20110720 Pledgee: Agricultural Bank of China Limited by Share Ltd. Guiyang Huaxi branch Pledgor: Guizhou Eakan Pharmaceutical Co.,Ltd. Registration number: 2013990000752 |
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