CN1813887A - Process for preparing fresh motherwort formulation - Google Patents
Process for preparing fresh motherwort formulation Download PDFInfo
- Publication number
- CN1813887A CN1813887A CN 200510004940 CN200510004940A CN1813887A CN 1813887 A CN1813887 A CN 1813887A CN 200510004940 CN200510004940 CN 200510004940 CN 200510004940 A CN200510004940 A CN 200510004940A CN 1813887 A CN1813887 A CN 1813887A
- Authority
- CN
- China
- Prior art keywords
- fresh
- herba leonuri
- juice
- preparation technology
- temperature
- 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.)
- Granted
Links
- 241000207925 Leonurus Species 0.000 title claims abstract description 19
- 235000000604 Chrysanthemum parthenium Nutrition 0.000 title claims description 15
- 235000000802 Leonurus cardiaca ssp. villosus Nutrition 0.000 title claims description 15
- 239000000203 mixture Substances 0.000 title claims description 14
- 238000009472 formulation Methods 0.000 title claims description 11
- 238000004519 manufacturing process Methods 0.000 title description 5
- 238000002360 preparation method Methods 0.000 claims abstract description 31
- 239000008187 granular material Substances 0.000 claims abstract description 28
- 235000011389 fruit/vegetable juice Nutrition 0.000 claims abstract description 23
- 238000001694 spray drying Methods 0.000 claims abstract description 12
- 239000000843 powder Substances 0.000 claims description 40
- 238000005516 engineering process Methods 0.000 claims description 20
- 239000007921 spray Substances 0.000 claims description 20
- 238000000034 method Methods 0.000 claims description 16
- 239000000243 solution Substances 0.000 claims description 14
- 239000002775 capsule Substances 0.000 claims description 8
- 238000007908 dry granulation Methods 0.000 claims description 7
- 230000008569 process Effects 0.000 claims description 7
- 238000005469 granulation Methods 0.000 claims description 6
- 230000003179 granulation Effects 0.000 claims description 6
- 239000007924 injection Substances 0.000 claims description 5
- 238000002347 injection Methods 0.000 claims description 5
- 239000007788 liquid Substances 0.000 claims description 5
- 239000003826 tablet Substances 0.000 claims description 5
- 239000006187 pill Substances 0.000 claims description 4
- 239000004744 fabric Substances 0.000 claims description 3
- 238000013467 fragmentation Methods 0.000 claims description 3
- 238000006062 fragmentation reaction Methods 0.000 claims description 3
- 239000012141 concentrate Substances 0.000 abstract description 5
- 238000001035 drying Methods 0.000 abstract description 2
- 238000007873 sieving Methods 0.000 abstract 2
- 238000013112 stability test Methods 0.000 description 14
- 238000012856 packing Methods 0.000 description 12
- 238000012360 testing method Methods 0.000 description 10
- 229920001353 Dextrin Polymers 0.000 description 8
- 239000004375 Dextrin Substances 0.000 description 8
- 235000019425 dextrin Nutrition 0.000 description 8
- 230000007774 longterm Effects 0.000 description 8
- 238000003556 assay Methods 0.000 description 7
- 230000008719 thickening Effects 0.000 description 7
- 239000011248 coating agent Substances 0.000 description 6
- 238000000576 coating method Methods 0.000 description 6
- 230000000813 microbial effect Effects 0.000 description 6
- 239000000047 product Substances 0.000 description 6
- 238000002474 experimental method Methods 0.000 description 5
- DUNMULOWUUIQIL-RGMNGODLSA-N (2s)-1,1-dimethylpyrrolidin-1-ium-2-carboxylic acid;chloride Chemical compound Cl.C[N+]1(C)CCC[C@H]1C([O-])=O DUNMULOWUUIQIL-RGMNGODLSA-N 0.000 description 4
- 238000001514 detection method Methods 0.000 description 4
- 239000003814 drug Substances 0.000 description 4
- 238000007689 inspection Methods 0.000 description 4
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 4
- 238000002156 mixing Methods 0.000 description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 4
- 244000025254 Cannabis sativa Species 0.000 description 3
- 238000004140 cleaning Methods 0.000 description 3
- 239000000463 material Substances 0.000 description 3
- 239000002245 particle Substances 0.000 description 3
- 238000005070 sampling Methods 0.000 description 3
- 238000003756 stirring Methods 0.000 description 3
- 239000002671 adjuvant Substances 0.000 description 2
- 229910052782 aluminium Inorganic materials 0.000 description 2
- 239000007864 aqueous solution Substances 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- NNBFNNNWANBMTI-UHFFFAOYSA-M brilliant green Chemical compound OS([O-])(=O)=O.C1=CC(N(CC)CC)=CC=C1C(C=1C=CC=CC=1)=C1C=CC(=[N+](CC)CC)C=C1 NNBFNNNWANBMTI-UHFFFAOYSA-M 0.000 description 2
- 230000002950 deficient Effects 0.000 description 2
- 238000010410 dusting Methods 0.000 description 2
- 238000005265 energy consumption Methods 0.000 description 2
- 239000007941 film coated tablet Substances 0.000 description 2
- 239000000706 filtrate Substances 0.000 description 2
- 230000008676 import Effects 0.000 description 2
- 238000011835 investigation Methods 0.000 description 2
- 235000021579 juice concentrates Nutrition 0.000 description 2
- 238000011068 loading method Methods 0.000 description 2
- 239000002932 luster Substances 0.000 description 2
- 235000019359 magnesium stearate Nutrition 0.000 description 2
- -1 mixing Substances 0.000 description 2
- 238000012946 outsourcing Methods 0.000 description 2
- 238000004806 packaging method and process Methods 0.000 description 2
- 239000000825 pharmaceutical preparation Substances 0.000 description 2
- 238000005498 polishing Methods 0.000 description 2
- 230000001737 promoting effect Effects 0.000 description 2
- 238000012552 review Methods 0.000 description 2
- 238000007789 sealing Methods 0.000 description 2
- 229920006300 shrink film Polymers 0.000 description 2
- 238000004088 simulation Methods 0.000 description 2
- 239000011734 sodium Substances 0.000 description 2
- 230000001954 sterilising effect Effects 0.000 description 2
- 238000004659 sterilization and disinfection Methods 0.000 description 2
- 239000002951 street drug Substances 0.000 description 2
- 238000010998 test method Methods 0.000 description 2
- FTLYMKDSHNWQKD-UHFFFAOYSA-N (2,4,5-trichlorophenyl)boronic acid Chemical compound OB(O)C1=CC(Cl)=C(Cl)C=C1Cl FTLYMKDSHNWQKD-UHFFFAOYSA-N 0.000 description 1
- 235000003826 Artemisia Nutrition 0.000 description 1
- 235000003261 Artemisia vulgaris Nutrition 0.000 description 1
- 240000006891 Artemisia vulgaris Species 0.000 description 1
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 1
- 241000196324 Embryophyta Species 0.000 description 1
- 206010030113 Oedema Diseases 0.000 description 1
- 241000590428 Panacea Species 0.000 description 1
- 208000004880 Polyuria Diseases 0.000 description 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 1
- 229930006000 Sucrose Natural products 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 235000009052 artemisia Nutrition 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 229910052799 carbon Inorganic materials 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 238000004939 coking Methods 0.000 description 1
- 238000005520 cutting process Methods 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 239000012153 distilled water Substances 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 230000035619 diuresis Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000007888 film coating Substances 0.000 description 1
- 238000009501 film coating Methods 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 235000012907 honey Nutrition 0.000 description 1
- 230000001939 inductive effect Effects 0.000 description 1
- 230000005906 menstruation Effects 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 239000003507 refrigerant Substances 0.000 description 1
- 229940085605 saccharin sodium Drugs 0.000 description 1
- 239000011265 semifinished product Substances 0.000 description 1
- 238000005507 spraying Methods 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 230000017423 tissue regeneration Effects 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
- 230000007704 transition Effects 0.000 description 1
- 239000008215 water for injection Substances 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
The present invention discloses a preparation process of fresh leonurus preparation. Said preparation process includes the following steps: breaking fresh leonurus, pressing to make juice, collecting juice, sieving to obtain fresh leonurus juice, concentrating fresh leonurus juice at 45 plus or minus 5 deg.C, spray-drying the obtained concentrate whose relative density is 1.04-1.06, granulating, sieving, drying and finishing granules so as to obtain the invented product.
Description
Technical field
The present invention relates to a kind of preparation technology of fresh motherwort formulation.
Background technology
Fresh Herba Leonuri has another name called Herba Leonuri Artemisia, Herba Leonuri etc., is the fresh or dry aerial parts of labiate fresh Herba Leonuri Leonurns japonicusHoutt.The function that promoting blood flow to regulate menstruation, promoting tissue regeneration by removing blood stasis, inducing diuresis to remove edema are arranged is described as " gynecological's panacea ".
The report of existing relevant fresh motherwort formulation in the prior art, for example, document CN1456253A discloses a kind of preparation method of fresh Herba Leonuri sheet, mainly may further comprise the steps: get the fresh Herba Leonuri fragmentation, squeeze the juice, filter, being concentrated into relative density is 1.05～1.15 (60 ℃), and spray drying adds right amount of auxiliary materials, mixing, granulate tabletting, coating.Fresh Herba Leonuri juice concentrates under 60 ℃ temperature in this method, can destroy the organic components such as marennin in the Herba Leonuri, the color burn that causes the Herba Leonuri concentrated solution, by green transition is brown, cause spray to do a part color and do not meet standard-required (it is green that standard code motherwort powder color should be), and the oven dry that after granulation, there is no need in this method, sieve, the granulate step, can cause granule humidity to increase, it is bad flowability to occur, and the phenomenon of caking is difficult to standard compliant technological procedure.
Document CN1055011C discloses a kind of preparation method of bright motherwort preparation, mainly may further comprise the steps: the aquatic foods product Herba Leonuri homogenate that will spend early stage, centrifugal filtration, add dextrin, stir evenly, be spray dried to medicated powder, make medicament with the pharmaceutical methods of routine again.Before spray drying, add dextrin in this method and can increase humidity, can produce caking phenomenon, and can cause spray powder content defective, in addition, this method is not recognized the spissated benefit of carrying out fresh Herba Leonuri juice in certain temperature range, do not recognize after granulation yet should dry, sieve, necessity of granulate step.
Summary of the invention
Technical problem to be solved by this invention is to avoid above-mentioned deficiency of the prior art, and proposes a kind of preparation technology of improved bright motherwort preparation, the product conformance with standard requirement that makes according to the method, and stability is high.
Technical scheme provided by the present invention is: this technology includes following steps
Get the fresh Herba Leonuri fragmentation, squeeze the juice, collect juice, sieve, get fresh Herba Leonuri juice;
Fresh Herba Leonuri juice is concentrated, get concentrated solution;
Concentrated solution is carried out spray drying, get spray powder;
With the spray powder dry granulation, sieve;
Granule is dried, is sieved, granulate,
Described being concentrated in carried out in 45 ± 5 ℃ the temperature range.
Further, the relative density of described concentrated solution is 1.04～1.06.
Further, described spray-dired process conditions are: inlet temperature is 195 ℃～205 ℃, and outlet temperature is 95 ℃～105 ℃.
Further, the process conditions of described dry granulation are: humidity is made as 45%RH～50%RH, and main frame pressure is 4Mpa, and engine speed is 600r/min, and feed voltage is 120v, and the granulation screen cloth is 30 orders.
Further, to sieve be 20 orders～60 orders to described granule.
Further, the process conditions of described oven dry are: bake out temperature is made as 67 ℃～69 ℃, and the time is 5h, thickness H≤0.5cm.
Further, described preparation is: pill, tablet, capsule, granule, oral liquid and injection.
The present invention has following advantage: step is simple, and processing ease is saved operation, reduces adjuvant, has reduced product cost; The product color conformance with standard requirement that obtains according to the method, and stability is high.
Description of drawings
Fig. 1 is a process chart of the present invention.
The specific embodiment
Describe the present invention in detail below in conjunction with specific embodiment.
Embodiment 1 preparation fresh Herba Leonuri capsule
1.1 squeeze the juice: get fresh Herba Leonuri, remove the foreign material weeds, wash one's hair cleaning machine and clean up, chaffcutter cutting after the vibration water-strainer dewaters, crusher in crushing through stirring pendulum-type cleaning machine, high-pressure spraying cleaning machine, bubble.Squeeze the juice, discard residue, collect juice.Fresh Herba Leonuri juice filters through 60 eye mesh screens.
1.2 fresh Herba Leonuri juice concentrates: concentrate in the suction haplo-effect concentrator, thickening temperature is controlled at below 50 ℃, is concentrated into relative density 1.04～1.06 (45 ± 5 ℃).
1.3 spray drying: get concentrated solution and carry out spray drying, the control parameter is: inlet temperature is 200 ± 5 ℃, and outlet temperature is 100 ± 5 ℃.Collect dry powder, weighing and bagging.The intermediate check contains moisture≤8.0%, and assay should be not less than 23mg/g in stachydrine hydrochloride.
1.4 dry granulation: get spray powder and sieve in (40 order), mix dry granulation.Dry granulation parameter: humidity 45%RH～50%RH, main frame pressure 4MPa, engine speed 600r/min, feed voltage 120v, granulation screen cloth 30 orders.The granule that makes is crossed 20 orders and 60 mesh sieves, the fine powder and the caking of the back gained that sieves are granulated once more.
1.5 oven dry: get granule and put into the oven dry of constant pressure and dry case, control parameter: 67～69 ℃ of temperature, 5 hours time, thickness H≤0.5cm.
1.6 sieve, always mix: get the granule of dry and cross 60 mesh sieves, add magnesium stearate (granule heavy 0.2%) mixing 10 minutes in multidirectional movement mixer.Midbody particle check: moisture≤5.0%, stachydrine hydrochloride content 〉=23.0mg/g.
1.7 fill: get qualified granule and adopt No. 1 capsule to fill, the control parameter: temperature≤25 ℃, humidity≤50%RH, loading amount 0.37g-0.43g.Per 15 minutes loading amounts of survey also keep a record, and populated capsule is delivered to lamp inspection chamber lamp inspection, note humidity≤50%RH.Lamp inspection finishes and delivers to polishing room's polishing.The inspection of semifinished product: moisture≤6.0%.
1.8 aluminium-plastic bubble plate packing: get qualified capsule aluminium-plastic bubble plate packing, control parameter: 150 ℃ of integrated temperatures, on seal 100 ℃ of temperature, 100 ℃ of lower seal temperature.
1.9 outer package: the capsule that aluminium-plastic bubble plate packing is good is delivered to outsourcing from pass-through box, and placed pillow type column device of full automatic packaging is aluminum-plastic packaged, dress box, coding, cover heat shrink films, case, put packing list, joint sealing, packing.
Embodiment 2 preparation Herba Leonuri tablets
Basic technology is identical with the capsular preparation of fresh Herba Leonuri among the embodiment 1, and step 1.1～1.5 are the same;
1.6 sieve, always mix: get the granule of dry and cross 60 mesh sieves, adding CMC-Na (granule heavy 8%) and magnesium stearate (granule heavy 0.2%) mixing 10 minutes in multidirectional movement mixer.Midbody particle check: moisture≤5.0%, stachydrine hydrochloride content 〉=23.0mg/g.
1.7 tabletting: get qualified granule rotary tablet machine tabletting, the control parameter: temperature≤25 ℃, humidity≤50%RH, the heavy 0.38g～0.42g of sheet.It is heavy and keep a record to survey once sheet in per 15 minutes.
1.8 coating: get qualified plain sheet and put in the efficient film coating machine, being preheated to the label temperature is 45 ℃, and the aqueous solution of the Opadry with 3% is made the coating material coating.The coating parameter: inlet temperature is 120 ℃, and intake is 10m
3/ min, spray gun height 120mm sprays fast 40g/min, expulsion pressure 6bar, coating pan rotating speed 45r/min.
1.9 aluminium-plastic bubble plate packing: get qualified Film coated tablets aluminium-plastic bubble plate packing, control parameter: 150 ℃ of integrated temperatures, on seal 100 ℃ of temperature, 100 ℃ of lower seal temperature.
1.10 outer package: the Film coated tablets that aluminium-plastic bubble plate packing is good is delivered to outsourcing from pass-through box, and placed pillow type column device of full automatic packaging is aluminum-plastic packaged, dress box, coding, cover heat shrink films, case, put packing list, joint sealing, packing.
The preparation of embodiment 3 Herba Leonuri granule agent
Basic technology is identical with the capsular preparation of fresh Herba Leonuri among the embodiment 1, only step 1.4 is changed into
1.4 sieve, total mixing: spray powder is crossed 40 mesh sieves, adds after 3% saccharin sodium mixes, and adds the 1%CMC-Na aqueous solution, granulate, and drying, granulate was got part that No. 1 sieve can not cross No. 4 sieves promptly.
The preparation of embodiment 4 fresh Herba Leonuri balls
Basic technology is identical with the capsular preparation of fresh Herba Leonuri among the embodiment 1, and only step 1.4 is changed into 1.4 pills: every 100g spray powder adds refined honey 120g and makes big honeyed pills promptly.
The preparation of embodiment 5 fresh Herba Leonuri oral liquids
Basic technology is identical with the capsular preparation of fresh Herba Leonuri among the embodiment 1, only be controlled at below 50 ℃ from thickening temperature, being concentrated into relative density 1.04～1.06 (45 ± 5 ℃) concentrated solution filters, in filtrate, add an amount of sucrose and add distilled water to relative density 1.04～1.06, transfer pH value, filter embedding, sterilization, promptly.
The preparation of embodiment 6 fresh Herba Leonuri injections
Basic technology is identical with the capsular preparation of fresh Herba Leonuri among the embodiment 1, only crosses 40 mesh sieves for spray powder is dissolved with an amount of water for injection from spray powder, regulates pH value, adds proper amount of active carbon and stirs evenly, and filters, and filtrate adds the injection water again to ormal weight.Embedding, sterilization promptly.
Experimental example one: contrast test
1. temperature experiment: fresh Herba Leonuri juice of the present invention is stored in the basin of chuck before concentrating, and refrigerant is a water in the chuck, and Herba Leonuri grass juice factor temperature remains on 3～10 ℃, can guarantee the Herba Leonuri grass juice factor quality of dusting like this.If fresh Herba Leonuri juice temperature surpasses 40 ℃, the color of dusting is bad.In time concentrated, thickening temperature can not surpass 50 ℃, concentrates back relative density 1.04～1.06 (45 ± 5 ℃ of temperature), can guarantee dried part of color conformance with standard requirement of spray like this.After granulation, carried out necessary oven dry, sieved, the granulate step, reduced granule humidity, guaranteed good mobile and prevent the generation of caking phenomenon, conformance with standard technological procedure.In addition, import during spray drying, outlet temperature control all have very big influence to the color and luster humidity of spray powder, the import and export temperature of strict control spray dryer within the scope of the invention, can control the color and luster of spray powder well, improve the particle size distribution of spray powder, make it reach standard-required, be the textual criticism thickening temperature, concentrate relative density, out temperature etc. may influence the factor of opaque amount when whether adding dextrin and spray drying, we have done relevant contrast test, and situation is as follows.
Show 1. thickening temperature and concentrated solution color and powder color
| Temperature (℃) | The concentrated solution color | The powder color |
| 35 | Emerald green | Green |
| 40 | Emerald green | Green |
| 45 | Green | Green |
| 50 | Green | Green |
| 55 | Brown-green | Brown-green |
| 60 | Brown-green | Brown |
| 65 | Brown | Brown |
By table 1. as can be seen, temperature is obvious to the influence of fresh motherwort powder quality, when temperature is higher than 50 ℃, darkens, so the control temperature is being essential below 50 ℃.In theory, thickening temperature be lower than 40 ℃ also feasible, but consider energy consumption and production efficiency, so best thickening temperature is decided to be 40 ± 5 ℃.
2. spray drying: if adopt unconcentrated medicinal liquid to carry out spray drying, then the powder delivery yield only is 1.5～2.0kg/h, adopt concentrated solution carry out spray drying then the powder yield rise to 6～7kg/h, concentrating capacity is about 1000L/h.(remarks: above data are relevant with bright herbaceous stem amount and concentrated solution relative density) concentrates and spray is done and can be carried out simultaneously, shortened the production cycle greatly, reduced energy consumption.
Show 2. concentrated solution relative density and powdery attitude situation
| Relative density | The powdery condition | Relative density | The powdery condition |
| Unconcentrated Herba Leonuri grass juice factor | Caking is arranged | 1.05 | Do not have caking, mealiness is good |
| 1.01 | Caking is arranged | 1.06 | Do not have caking, mealiness is good |
| 1.02 | Caking is arranged | 1.07 | Nozzle easily stops up |
| 1.03 | Caking is arranged | 1.08 | Nozzle easily stops up |
| 1.04 | Do not have caking, mealiness is good | 1.09 | Nozzle easily stops up |
By table 2. as can be seen, relative density is clearly for the influence of the state of powder, and relative density is low excessively, then be prone to caking, too high then can plug nozzle, therefore, it is essential concentrating and controlling relative density, by finding out that best relative density is 1.04～1.06 in the table.
Add dextrin and opaque magnitude relation:
| Add the dextrin amount | The powder appearance character | Stachydrine hydrochloride content mg/g | |||
| ① | ② | ③ | On average | ||
| 50％ | Powder has caking, and breeze is arranged, and the powder moisture-sensitive darkens | 17.4 | 16.8 | 16.5 | 16.9 |
| 40％ | Powder has caking, and breeze is arranged, and the powder moisture-sensitive darkens | 19.3 | 20.2 | 19.9 | 19.8 |
| 30％ | Powder has caking, and breeze is arranged, and the powder moisture-sensitive darkens | 22.8 | 23.7 | 21.9 | 22.8 |
| 20％ | Powder has caking, and breeze is arranged, and the powder moisture-sensitive darkens | 25.4 | 26.9 | 27.1 | 26.5 |
| 10％ | Powder has caking, and a little breeze is arranged, and the powder moisture-sensitive darkens | 28.9 | 30.6 | 29.4 | 29.6 |
| 5％ | Powder has caking, and a little breeze is arranged, and the powder moisture-sensitive darkens | 30.2 | 31.9 | 32.5 | 31.5 |
| 1％ | A little breeze is arranged, and the powder moisture-sensitive darkens | 32.8 | 33.4 | 32.0 | 32.7 |
| 0％ | Do not have caking, color even is difficult for the moisture absorption | 34.1 | 33.6 | 33.9 | 33.9 |
Can cause the powder caking phenomenon by adding dextrin as can be seen in showing 3., and moisture-sensitive, the easy coking of dextrin produces breeze, and is also influential to product colour, and can cause powder content defective (23mg/g).Do not add dextrin, then powder directly is evenly distributed, color even, and moisture-sensitive not, and do not have caking and breeze phenomenon.The opaque amount is easy to control, and saves operation, reduces adjuvant, has reduced product cost.
Experimental example two: accelerated stability test
According to " pharmaceutical preparation accelerated test detailed rules and regulations under two appendix XIXC of Chinese pharmacopoeia version in 2000 " medicine stability examination guideline " are carried out accelerated stability test.The fresh Herba Leonuri capsule that we produce our company, the fresh Herba Leonuri sheet, the fresh Herba Leonuri granule, fresh Herba Leonuri oral liquid, fresh Herba Leonuri injection, fresh Herba Leonuri ball etc. has carried out stability test, each preparation is through 6 months accelerated stability test and 24 months long-term stable experiment, and the result shows that the fresh Herba Leonuri sheet was being placed 6 months under the accelerated stability test condition and placed 24 months under long-time stability strip spare, every index and 0 month detection data compare, and sample is stable.At duration of test, its character of sample, discriminating, assay, disintegration, microbial limit is all up to specification.Be the example explanation now with the fresh Herba Leonuri sheet.
Experimental condition: simulation street drug packing (plastic-aluminum bubble-cap+carton), 40 ℃ ± 2 ℃ of temperature, relative humidity 75% ± 5%.
Test method: by the three batch samples (lot number: 020301,020302,020303) of producing prescription, technology trial production, under the commercially available back condition, in 40 ℃ ± 2 ℃ of temperature, placed 6 months under relative humidity 75% ± 5% condition, respectively at 1st month, the 2nd month, the 3rd month and the 6th the end of month sampling and measuring, detect (character, discriminating, assay, disintegration by stable high spot reviews project, microbial limit) every index and 0 month detection data are relatively investigated its sample stability.
Investigation project: character, discriminating, disintegration, assay, microbial limit.
Result of the test sees Table 1,2,3.
Experimental example three: long-term stable experiment
According to " pharmaceutical preparation long term test detailed rules and regulations under two appendix XIXC of Chinese pharmacopoeia version in 2000 " medicine stability examination guideline " are carried out long-term stable experiment.。
Experimental condition: simulation street drug packing (plastic-aluminum bubble-cap+carton)
25 ℃ ± 2 ℃ of temperature, relative humidity 60% ± 10%
Test method: by producing prescription, three batch samples (the lot number: 020301 of technology trial production, 020302,020303), under the commercially available back condition, in 25 ℃ ± 2 ℃ of temperature, placed 12 months under relative humidity 60% ± 10% condition, respectively at 3rd month, 6th month, 9th month and the 12nd the end of month sampling and measuring, detect (character by stable high spot reviews project, differentiate, assay, disintegration, microbial limit) after 12 month, still need continue to investigate, respectively at 18th month, 24th month sampling and measuring, every index and 0 month detection data are relatively investigated its sample stability, to determine the effect duration of medicine.
Investigation project: character, discriminating, disintegration, assay, microbial limit.
Result of the test sees Table 4,5,6.
The stability test conclusion:
The fresh Herba Leonuri sheet is through 6 months accelerated stability test and 24 months long-term stable experiment, the result shows, the fresh Herba Leonuri sheet was being placed 6 months under the accelerated stability test condition and was being placed 24 months under long-time stability strip spare, every index and 0 month detection data are relatively investigated its sample stability.At duration of test, its character of sample, discriminating, assay, disintegration, microbial limit is all up to specification, so fresh Herba Leonuri tablet stability result of the test shows that the fresh Herba Leonuri sheet is at the duration of test steady quality.
Table 1, fresh Herba Leonuri sheet accelerated stability test result ()
Sample title: fresh Herba Leonuri sheet lot number: 020301
Table 2, fresh Herba Leonuri sheet accelerated stability test result (two)
Sample title: fresh Herba Leonuri sheet lot number: 020302
Table 3, fresh Herba Leonuri sheet accelerated stability test result (three)
Sample title: fresh Herba Leonuri sheet lot number: 020303
Table 4, the long-term stability test result of fresh Herba Leonuri sheet ()
Sample title: fresh Herba Leonuri sheet lot number: 020301
Table 5, the long-term stability test result of fresh Herba Leonuri sheet (two)
Sample title: fresh Herba Leonuri sheet lot number: 020302
Table 6, the long-term stability test result of fresh Herba Leonuri sheet (three)
Sample title: fresh Herba Leonuri sheet lot number: 020303
Claims (7)
1, a kind of preparation technology of fresh motherwort formulation, this technology includes following steps
Get the fresh Herba Leonuri fragmentation, squeeze the juice, collect juice, sieve, get fresh Herba Leonuri juice;
Fresh Herba Leonuri juice is concentrated, get concentrated solution;
Concentrated solution is carried out spray drying, get spray powder;
With the spray powder dry granulation, sieve;
Granule is dried, is sieved, granulate,
It is characterized in that: described being concentrated in carried out in 45 ± 5 ℃ the temperature range.
2, the preparation technology of fresh motherwort formulation according to claim 1 is characterized in that: the relative density of described concentrated solution is 1.04～1.06.
3, the preparation technology of fresh motherwort formulation according to claim 1 is characterized in that: described spray-dired process conditions are: inlet temperature is 195 ℃～205 ℃, and outlet temperature is 95 ℃～105 ℃.
4, the preparation technology of fresh motherwort formulation according to claim 1, it is characterized in that: the process conditions of described dry granulation are: humidity is made as 45%RH～50%RH, and main frame pressure is 4Mpa, and engine speed is 600r/min, feed voltage is 120v, and the granulation screen cloth is 30 orders.
5, the preparation technology of fresh motherwort formulation according to claim 1 is characterized in that: it is 20 orders～60 orders that described granule sieves.
6, the preparation technology of fresh motherwort formulation according to claim 1 is characterized in that: the process conditions of described oven dry are: bake out temperature is made as 67 ℃～69 ℃, and the time is 5h, thickness H≤0.5cm.
7, the preparation technology of fresh motherwort formulation according to claim 1 is characterized in that: described preparation is: pill, tablet, capsule, granule, oral liquid and injection.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100049409A CN100441204C (en) | 2005-01-31 | 2005-01-31 | Process for preparing fresh motherwort formulation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100049409A CN100441204C (en) | 2005-01-31 | 2005-01-31 | Process for preparing fresh motherwort formulation |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1813887A true CN1813887A (en) | 2006-08-09 |
| CN100441204C CN100441204C (en) | 2008-12-10 |
Family
ID=36906319
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2005100049409A Active CN100441204C (en) | 2005-01-31 | 2005-01-31 | Process for preparing fresh motherwort formulation |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN100441204C (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101007053B (en) * | 2007-01-09 | 2012-05-02 | 浙江大德药业集团有限公司 | Capsule for treating gynecological diseases and preparation method and quality-control method |
| CN106668141A (en) * | 2015-11-06 | 2017-05-17 | 庞锦霞 | Motherwort herb syrup |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1569096A (en) * | 2003-07-16 | 2005-01-26 | 浙江大德制药有限公司 | Method for preparing fresh leonurus heterophyllus powder |
-
2005
- 2005-01-31 CN CNB2005100049409A patent/CN100441204C/en active Active
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101007053B (en) * | 2007-01-09 | 2012-05-02 | 浙江大德药业集团有限公司 | Capsule for treating gynecological diseases and preparation method and quality-control method |
| CN106668141A (en) * | 2015-11-06 | 2017-05-17 | 庞锦霞 | Motherwort herb syrup |
Also Published As
| Publication number | Publication date |
|---|---|
| CN100441204C (en) | 2008-12-10 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN101057925A (en) | Preparation technology for 'jieguqili' capsule and its quality control method | |
| CN1813887A (en) | Process for preparing fresh motherwort formulation | |
| CN1813860A (en) | Naoxinqing Chinese medicine dispersible tablet and its preparing process | |
| CN1850167A (en) | Thirsty-relieving blood-sugar-reducing dropping pills and preparing method | |
| CN1657093A (en) | Preparation method of granular agent for raising leucocyte and its quality control method | |
| CN1813888A (en) | Process for preparing fresh motherwort powder | |
| CN1369306A (en) | 'Huajuhong' preparation and its preparing process | |
| CN101036739A (en) | Chinese medicine preparation for treating stomach-ache and its preparation process | |
| CN1709419A (en) | Basis-reinforcing eyesight-improving dropping pill for treating eye disease and its preparing method | |
| CN1775266A (en) | Qianjin cough-relieving preparation and new preparing method | |
| CN1668320A (en) | Tablet composition containing chinese orthodox medicine extract and process for producing the same | |
| CN100345534C (en) | Yinzhi huang capsule, its preparation method and use | |
| CN1698822A (en) | 'Gansu' dripping pills for treating hepatitis and its preparation method | |
| CN1824078A (en) | Green biota body cleaning effervescent particle preparation | |
| CN1883644A (en) | Chinese medicinal tablet for treating gynecological disease and preparation process thereof | |
| CN1660364A (en) | 'Lianzhi' anti inflammation drop pill in use for clearing away heat and toxic material and preparation method | |
| CN1259099C (en) | Prepared traditional Chinese drug Liangfu drop pills for treating epigastric pain | |
| CN1733272A (en) | Pulean pharmaceutical preparation for treating urinary system diseases and process for preparing the same | |
| CN1660372A (en) | Oral drop pill in use for clearing sway heat and toxic material, relieving inflammation and dysentery, and preparation method | |
| CN1559527A (en) | Compound stemona cough stopping medicine and its preparation method | |
| CN1695713A (en) | Medication for treating diabetes and preparation method | |
| CN1559525A (en) | Red tangerine peel medicine for treating sputum cough and its preparation method | |
| CN1660267A (en) | 'Yankening' pharmaceutical preparation and preparing method | |
| CN1307981C (en) | Xuening dripping pill having hemostatic function and its preparing method | |
| CN1686339A (en) | Compound cynomorium drip pill and its preparation method |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: Preparation process of fresh motherwort preparations Effective date of registration: 20231222 Granted publication date: 20081210 Pledgee: CITIC Bank Co.,Ltd. Yiwu Branch Pledgor: ZHEJIANG DADE PHARMACEUTICAL GROUP Co.,Ltd. Registration number: Y2023330003084 |
|
| PE01 | Entry into force of the registration of the contract for pledge of patent right |