CN1785237A - Duyiwei dripping pill prepn. and its preparing method - Google Patents
Duyiwei dripping pill prepn. and its preparing method Download PDFInfo
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- CN1785237A CN1785237A CN 200410081401 CN200410081401A CN1785237A CN 1785237 A CN1785237 A CN 1785237A CN 200410081401 CN200410081401 CN 200410081401 CN 200410081401 A CN200410081401 A CN 200410081401A CN 1785237 A CN1785237 A CN 1785237A
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- radix lamiophlomidis
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Abstract
A Chinese medicine in the form of dripping pills is prepared from lamiophomis herb and polyethandiol through extracting and shaping. Its advantages are sure curative effect and high safety.
Description
Technical field
The present invention relates to the pharmaceutical technology field, relate in particular to a kind of dropping pill formulation made from the Chinese medicine Radix Lamiophlomidis Rotatae and preparation method thereof.
Background technology
Radix Lamiophlomidis Rotatae is the dry herb of labiate Radix Lamiophlomidis Rotatae Lamiophlomis rotata (Benth.) Kudo., records in first 73 pages of the Sanitation Ministry medicine standard Tibetan medicines.
Radix Lamiophlomidis Rotatae is national folk medical herbs such as Tibetan, illiteracy, Nahsi, Tibetan language claims " big bus " " to beat the cloth crust ", be stated from Tibetan medicine's masterpiece Four-Volume Medical Code, " month king's medicine is examined " the earliest, Radix Lamiophlomidis Rotatae has promoting blood circulation and stopping pain, change silt hemostatic function, be used for the edge of a knife pain, hemorrhage behind the multiple surgical operation clinically, exogenous injury, muscles and bones is sprained, rheumatic arthralgia and metrorrhagia, dysmenorrhea, gingival swelling and pain, hemorrhage etc.
The therapeutical effect of Radix Lamiophlomidis Rotatae is pain relieving, hemostasis, needs the characteristics of performance quick acting, with very fast releasing patient's misery.But existing common lamiophlomis root preparation is capsule and tablet, because its disintegration time generally about 18-20 minute, fails to embody the characteristics of quick acting, does not give full play of the treatment advantage of Radix Lamiophlomidis Rotatae, and therefore its weak point is arranged.And Radix Lamiophlomidis Rotatae capsule and tablet are all with the reference substance of rutin as quality control, but itself does not contain rutin in the Radix Lamiophlomidis Rotatae medical material, just in its hydrolyzate, exist, this method does not have the effective ingredient at medicine, do not have specificity, can not directly reflect and control the quality of common lamiophlomis root preparation.
Summary of the invention
Purpose of the present invention just provides a kind of Duyiwei dripping pill preparation, and this dropping pill formulation determined curative effect, safety is good, onset is very fast, taking convenience, and the quality of the pharmaceutical preparations is convenient to control.
Another object of the present invention provides a kind of preparation method of above-mentioned Duyiwei dripping pill preparation.
The technical solution adopted for the present invention to solve the technical problems is: a kind of Duyiwei dripping pill preparation, it contains Radix Lamiophlomidis Rotatae extract and mean molecule quantity at the Polyethylene Glycol more than 2000, wherein, Radix Lamiophlomidis Rotatae extract is for following the example of with water extraction method or alcohol extraction from the Chinese crude drug Radix Lamiophlomidis Rotatae or decoction and alcohol sedimentation technique or organic solvent extraction method are extracted the material of the glycoside derivant that contains luteolin and/or luteolin that obtains.
The total weight percentage of glycoside derivant of luteolin and/or luteolin is calculated as more than 0.2% by luteolin in the above-mentioned Radix Lamiophlomidis Rotatae extract.
The preferred weight proportioning of component of the present invention is: 1 part of Radix Lamiophlomidis Rotatae extract, 0.8-9 part Macrogol 4000 or 6000.More preferably weight proportion is: 1 part of Radix Lamiophlomidis Rotatae extract, 1-5 part Macrogol 4000 or 6000.Further the preferred weight proportioning is: 1 part of Radix Lamiophlomidis Rotatae extract, 1.5-3 part Macrogol 4000 or 6000.The optimum weight proportioning is: 1 part of Radix Lamiophlomidis Rotatae extract, 2.33 parts of Macrogol 4000s or 6000.
Above-mentioned Duyiwei dripping pill preparation can also contain other component, comprising other medicines composition and/or other pharmaceutic adjuvant.The other medicines composition is for being used for the treatment of with the Radix Lamiophlomidis Rotatae extract compatibility or the pharmaceutically acceptable material of health purpose such as Rhizoma Curcumae Longae extract, turmeric oil, Oleum menthae, Pollen Tyjphae extract, Fructus Tribuli extract etc.; Other pharmaceutic adjuvant is for preparation dropping pill formulation available adjuvant commonly used, as surfactant poloxamer, Tween 80, span series etc., and and for example suspending agent Cera Flava, lecithin, gelatin etc.
The concrete extracting method of above-mentioned Radix Lamiophlomidis Rotatae extract is as follows:
The concrete practice of water extraction method is: gets the Radix Lamiophlomidis Rotatae medical material, adds 6-10 times of water gaging and soaked 0.5-2 hour, and more than the decoction once, each 0.5-2 hour, filter, it is 1.20-1.40 that filtrate is concentrated into relative density, dry below 90 ℃, promptly.
The concrete practice that alcohol extraction is followed the example of is: get the Radix Lamiophlomidis Rotatae medical material, add 6-10 and doubly measure Different concentrations of alcohol solution, soaked 0.5-2 hour, more than decocting once, each 0.5-2 hour, filter, filtrate is concentrated or reclaims to be concentrated into relative density behind the ethanol be 1.20-1.40, dry below 90 ℃, promptly.
The concrete practice of decoction and alcohol sedimentation technique is: gets the Radix Lamiophlomidis Rotatae medical material, adds 6-10 times of water gaging and soaked 0.5-2 hour, and more than the decoction once, each 0.5-2 hour, filter, it is 1.10-1.30 that filtrate is concentrated into relative density; Add alcoholic solution 90% or more and contain the alcohol amount to the solution and reach 60-80%, staticly settle more than 12 hours, filter, collect filtrate and also reclaim ethanol, reconcentration to relative density is 1.20-1.40, in drying below 90 ℃, promptly.
The concrete practice of organic solvent extraction method is: gets the Radix Lamiophlomidis Rotatae medical material, adds organic solvent extraction more than 1 time, and each 1-2 hour, filter, with filtrate and reclaim organic solvent and be concentrated into driedly, get final product.Wherein organic solvent is selected from any one or more than one the mixture in acetone, ethyl acetate, the dichloromethane.
The preparation method of above-mentioned Duyiwei dripping pill preparation, its practice is: earlier the Radix Lamiophlomidis Rotatae extract of described proportioning is pulverized, added the Polyethylene Glycol of described proportioning again, go into the drop pill machine behind the mix homogeneously and make drop pill, get final product.
Compared with prior art, the invention has the beneficial effects as follows: (1) this dropping pill formulation extracts at the effective ingredient of medicine, can improve content of effective, and determined curative effect also can reduce dose, taking convenience; (2) with the glycoside derivant of the effective ingredient luteolin that contains really in the Radix Lamiophlomidis Rotatae medical material and/or luteolin as quality control index, more scientific and reasonable, the quality of the pharmaceutical preparations can access directly effectively control; (3) it is little, safe to learn its toxic and side effects of evidence by pharmacological toxicology.(4) adopted solid dispersion technology, show after deliberation, the Radix Lamiophlomidis Rotatae capsule disintegration time is about 18 minutes, the Radix Lamiophlomidis Rotatae disintegration of tablet time is about 20 minutes, medicine Duyiwei dripping pill preparation disintegration time of the present invention is about 8 minutes, so the molten diffusing speed of medicine Duyiwei dripping pill preparation of the present invention is fast, medicine is discharged as early as possible, thereby onset is rapid.
For showing that curative effect of medication of the present invention is definite, onset is very fast, and drug safety, quality controllable, the inventor has carried out many-sided investigating such as pharmacodynamics, toxicology, dissolve scattered time limit, active constituent content control.The research method and the result of the test that are adopted are as follows:
(1) the analgesia test of pesticide effectiveness
Test method: Kunming mouse, complete male, 18-22g, be divided into 6 groups at random, every group 10, be respectively model control group (being the normal saline group), Duyiwei dripping pill (medicine of the present invention, together following) and small dose group (the 0.49g Duyiwei dripping pill/kg), dosage group in the Duyiwei dripping pill (the 0.98g Duyiwei dripping pill/kg), ((0.45g Radix Lamiophlomidis Rotatae capsule/kg) and tramadol (Beijing Sihuan Medicine Science and Technology Co., Ltd's product) are organized (40mg/kg) to the heavy dose of group of Duyiwei dripping pill for 1.97g Duyiwei dripping pill/kg) and positive drug Radix Lamiophlomidis Rotatae capsule (Gansu Duyiwei Biological Pharmaceutical Co., Ltd's productions) group, press table 1 dosage gastric infusion 1 time, each treated animal 60min after administration, lumbar injection 0.7% acetum 0.2ml/ are only.With the abdominal part indent, arm is raised, and stretches hind leg for turning round the body index, observes the interior writhing response number of times of injection back 15min and the time (incubation period) of body occurs turning round for the first time, and be calculated as follows the analgesia rate, the results are shown in Table 1.
The analgesic activity of table 1 Duyiwei dripping pill (writhing method) (x ± SD)
| Group | Dosage (g/kg) | Mus number (only) | Turn round body incubation period (sec) | Turn round the body number of times (inferior/15min) | Analgesia rate (%) |
| Dosage Duyiwei dripping pill low dose in the heavy dose of Duyiwei dripping pill of matched group tramadol group Radix Lamiophlomidis Rotatae capsule Duyiwei dripping pill | - 40mg 0.45 0.49 0.98 1.97 | 10 10 10 10 10 10 | 309.70±184.95 716.80±238.05*** 320.00±120.85 650.00±154.59*** 544.50±150.89** 484.80±97.36 | 8.90±5.47 0.80±1.14*** 4.60±3.67 2.20±1.69** 3.10±2.50* 3.50±3.53 | - 91.01 48.31 75.28 65.17 60.67 |
Annotate: each administration group with compare * P＜0.05 * * P＜0.01 * * * P＜0.001
Table 1 result shows that Duyiwei dripping pill and capsule all can obviously reduce the mouse writhing number of times due to the acetic acid, all can prolong the incubation period of pain outbreak.Wherein the Duyiwei dripping pill curative effect obviously is better than Radix Lamiophlomidis Rotatae capsule, turns round body incubation period longer (P＜0.01 and P＜0.001), illustrates that onset is rapider; Duyiwei dripping pill analgesic effect is better than Radix Lamiophlomidis Rotatae capsule (P＜0.01), and the highest analgesia rate can reach 75.28%.
(2) the hemostasis test of pesticide effectiveness
Test method: Kunming mouse, male and female half and half, 18-22g, be divided into 6 groups at random, every group 10, be respectively model control group (being the normal saline group), the Duyiwei dripping pill small dose group (the 0.49g Duyiwei dripping pill/kg), dosage group in the Duyiwei dripping pill (the 0.98g Duyiwei dripping pill/kg), ((0.45g Radix Lamiophlomidis Rotatae capsule/kg) and YUNNAN BAIYAO group (Yunnan Paiyao Group Corp., Ltd's production) are organized (40mg/kg) to the heavy dose of group of Duyiwei dripping pill for 1.97g Duyiwei dripping pill/kg) and positive drug Radix Lamiophlomidis Rotatae capsule (Gansu Duyiwei Biological Pharmaceutical Co., Ltd's productions) group, press table 2 dosed administration, every day 1 time, for three days on end.Each is organized the administration volume and is 0.2ml/10g, and after time administration 60 minutes, mice is fixed, cut with profit mouse tail point 3mm place is cut off, treat that blood overflows voluntarily to pick up counting, inhale to dehematize with filter paper every 30S and drip 1 time, until stopped bleeding, the calculating bleeding time.The results are shown in Table 2.
The anastalsis of table 2 Duyiwei dripping pill (x ± SD)
| Group | Dosage (g/kgd) | Mus number (only) | Bleeding time (sec) |
| Dosage Duyiwei dripping pill low dose in the heavy dose of Duyiwei dripping pill of matched group YUNNAN BAIYAO group Radix Lamiophlomidis Rotatae capsule Duyiwei dripping pill | - 0.34×3 0.45×3 0.49×3 0.98×3 1.97×3 | 10 10 10 10 10 10 | 385.0±65.9 175.8±38.1*** 314.2±65.5 188.2±54.9*** 201.5±44.8** 255.8±57.6* |
Annotate: each administration group with compare * P＜0.05 * * P＜0.01 * * * P＜0.001
Table 2 result shows that Duyiwei dripping pill and capsule all can obviously reduce the bleeding time.Wherein the Duyiwei dripping pill curative effect obviously is better than Radix Lamiophlomidis Rotatae capsule (P＜0.01 and P＜0.001).
Table 1 and table 2 result of the test show: Duyiwei dripping pill preparation of the present invention all is being better than existing Radix Lamiophlomidis Rotatae capsule preparation aspect analgesia and the anastalsis, and onset is very fast, and curative effect is better.
(3) toxicity test
The inventor has carried out the acute toxicity test investigation with mice to Duyiwei dripping pill preparation, the result: it is 59.02g/kg that mice is once irritated stomach LD50, is about 590 times of the daily dosage of human body (about 0.1g/Kg).Therefore, the toxicity of Duyiwei dripping pill preparation of the present invention is very little, and is safer.
(4) investigation of dissolve scattered time limit
Test method: get Duyiwei dripping pill and Radix Lamiophlomidis Rotatae capsule, tablet, shine the dissolving time limit and the disintegration time of an appendix XII of Chinese Pharmacopoeia version in 2000 A three batches of Duyiwei dripping pills of inspection technique disintegration inspection and Radix Lamiophlomidis Rotatae capsule, tablet, the results are shown in Table 3.
Table 3 drop pill dissolve scattered time limit is table as a result
| Project | Lot number | ||
| 011220 | 011221 | 011222 | |
| Dissolve scattered time limit (minute) | 6 | 7 | 8 |
Result of the test: (regulation should be not more than 30 minutes under an appendix XII of Chinese Pharmacopoeia version in 2000 the A item) all up to specification.
Capsule, disintegration of tablet time see Table 4.
Table 4 capsule, disintegration of tablet time limit be table as a result
| Project | Radix Lamiophlomidis Rotatae capsule | The Radix Lamiophlomidis Rotatae tablet |
| Dissolve scattered time limit (minute) | 18 | 20 |
By above result, the Duyiwei dripping pill dissolve scattered time limit can illustrate to a great extent that far away faster than Radix Lamiophlomidis Rotatae capsule and tablet the Duyiwei dripping pill onset is faster than Radix Lamiophlomidis Rotatae capsule and tablet as can be known.
(5) content of effective control
Luteolin and/or its glycoside derivant etc. are active chemical wherein in the Radix Lamiophlomidis Rotatae, have multiple pharmacological effect such as analgesia, antibiotic, antiinflammatory, spasmolytic, enhancing blood flow volume, hemostasis, cure mainly relevant with this preparation function, so select the index components of luteolin as control this product quality, adopt reversed phase high-performance liquid chromatography-UV-detector, pressing luteolin calculates, luteolin and/or its glycoside derivant are carried out quantitative analysis, this method good separating effect, sensitivity, accurate, content of effective in may command Radix Lamiophlomidis Rotatae extract and the preparation thereof.After measured, press luteolin and calculate, the weight percentage of the glycoside derivant of luteolin and/or luteolin is more than 0.2% in the Radix Lamiophlomidis Rotatae extract that the present invention mentions.
The specific embodiment
The present invention is described in further detail below in conjunction with the specific embodiment.
Embodiment one
The present embodiment medicine is made up of 1 part of Radix Lamiophlomidis Rotatae extract and 2.33 parts of Macrogol 4000s.
Embodiment two
The present embodiment medicine is made up of 1 part of Radix Lamiophlomidis Rotatae extract and 0.8 part of polyethylene glycol 6000.
Embodiment three
The present embodiment medicine is made up of 1 part of Radix Lamiophlomidis Rotatae extract and 9 parts of Macrogol 4000s.
Embodiment four
The present embodiment medicine is made up of 1 part of Radix Lamiophlomidis Rotatae extract and 5 parts of polyethylene glycol 6000s.
Embodiment five
The present embodiment medicine is made up of 1 part of Radix Lamiophlomidis Rotatae extract and 1 part of Macrogol 4000.
Embodiment six
The present embodiment medicine is made up of 1 part of Radix Lamiophlomidis Rotatae extract and 1.5 parts of polyethylene glycol 6000s.
Embodiment seven
The present embodiment medicine is made up of 1 part of Radix Lamiophlomidis Rotatae extract and 3 parts of Macrogol 4000s.
More than the preparation method of each embodiment medicine be: get the Radix Lamiophlomidis Rotatae extract of described proportioning, pulverize the Polyethylene Glycol that the back adds described proportioning, go into the drop pill machine behind the mix homogeneously and make drop pill, get final product.
Embodiment eight
The present embodiment medicine is made up of 1 part of Radix Lamiophlomidis Rotatae extract, 0.1 part of lecithin and 4 parts of Macrogol 2000s.
The preparation method of present embodiment medicine is: get the Radix Lamiophlomidis Rotatae extract of described proportioning, pulverize lecithin and Macrogol 2000 that the back adds described proportioning, go into the drop pill machine behind the mix homogeneously and make drop pill, get final product.
Embodiment nine
The present embodiment medicine is made up of 1 part of Radix Lamiophlomidis Rotatae extract, 0.5 part of turmeric oil and 7 parts of Macrogol 4000s.
The preparation method of present embodiment medicine is: get the Radix Lamiophlomidis Rotatae extract of described proportioning, pulverize turmeric oil and Macrogol 4000 that the back adds described proportioning, go into the drop pill machine behind the mix homogeneously and make drop pill, get final product.
Embodiment ten
The present embodiment medicine is made up of 1 part of Radix Lamiophlomidis Rotatae extract, 1 part of turmeric oil, 0.2 part of Tween 80 and 8 parts of Macrogol 4000s.
The preparation method of present embodiment medicine is: get the Radix Lamiophlomidis Rotatae extract of described proportioning, pulverize turmeric oil, Tween 80 and Macrogol 4000 that the back adds described proportioning, go into the drop pill machine behind the mix homogeneously and make drop pill, get final product.
The Tween 80 of the lecithin of embodiment eight and embodiment ten is a pharmaceutic adjuvant, can also select other pharmaceutic adjuvant such as poloxamer, span series, Cera Flava, gelatin etc. when implementing for use.
Embodiment nine and ten turmeric oil are ingredient, can also select other medicines composition such as Rhizoma Curcumae Longae extract, Oleum menthae, Pollen Tyjphae extract, Fructus Tribuli extract etc. when implementing for use.
Radix Lamiophlomidis Rotatae extract of the present invention is for following the example of with water extraction method or alcohol extraction from the Chinese crude drug Radix Lamiophlomidis Rotatae or decoction and alcohol sedimentation technique or organic solvent extraction method are extracted the material of the glycoside derivant that contains luteolin and/or luteolin that obtains.The total weight percentage of glycoside derivant of luteolin and/or luteolin is calculated as more than 0.2% by luteolin in the Radix Lamiophlomidis Rotatae extract.
The concrete practice of water extraction method is: gets the Radix Lamiophlomidis Rotatae medical material, adds 6-10 times of water gaging and soaked 0.5-2 hour, and more than the decoction once, each 0.5-2 hour, filter, it is 1.20-1.40 that filtrate is concentrated into relative density, dry below 90 ℃, promptly.
The concrete practice that alcohol extraction is followed the example of is: get the Radix Lamiophlomidis Rotatae medical material, add 6-10 and doubly measure Different concentrations of alcohol solution, soaked 0.5-2 hour, more than decocting once, each 0.5-2 hour, filter, filtrate is concentrated or reclaims to be concentrated into relative density behind the ethanol be 1.20-1.40, dry below 90 ℃, promptly.
The concrete practice of decoction and alcohol sedimentation technique is: gets the Radix Lamiophlomidis Rotatae medical material, adds 6-10 times of water gaging and soaked 0.5-2 hour, and more than the decoction once, each 0.5-2 hour, filter, it is 1.10-1.30 that filtrate is concentrated into relative density; Add alcoholic solution 90% or more and contain the alcohol amount to the solution and reach 60-80%, staticly settle more than 12 hours, filter, collect filtrate and also reclaim ethanol, reconcentration to relative density is 1.20-1.40, in drying below 90 ℃, promptly.
The concrete practice of organic solvent extraction method is: gets the Radix Lamiophlomidis Rotatae medical material, adds organic solvent extraction more than 1 time, and each 1-2 hour, filter, with filtrate and reclaim organic solvent and be concentrated into driedly, get final product.Wherein organic solvent is selected from any one or more than one the mixture in acetone, ethyl acetate, the dichloromethane.
Claims (10)
1, a kind of Duyiwei dripping pill preparation, it contains Radix Lamiophlomidis Rotatae extract and mean molecule quantity at the Polyethylene Glycol more than 2000, it is characterized in that: described Radix Lamiophlomidis Rotatae extract extracts the material of the glycoside derivant that contains luteolin and/or luteolin that obtains for to follow the example of or decoction and alcohol sedimentation technique or organic solvent extraction method with water extraction method or alcohol extraction from the Chinese crude drug Radix Lamiophlomidis Rotatae.
2, Duyiwei dripping pill preparation according to claim 1 is characterized in that: the total weight percentage of glycoside derivant of luteolin and/or luteolin is calculated as more than 0.2% by luteolin in the described Radix Lamiophlomidis Rotatae extract.
3, Duyiwei dripping pill preparation according to claim 1 is characterized in that: the weight proportion of described Radix Lamiophlomidis Rotatae extract and Polyethylene Glycol component is: 1 part of Radix Lamiophlomidis Rotatae extract, 0.8-9 part Macrogol 4000 or 6000.
4, Duyiwei dripping pill preparation according to claim 3 is characterized in that: the weight proportion of described component is: 1 part of Radix Lamiophlomidis Rotatae extract, 1-5 part Macrogol 4000 or 6000.
5, Duyiwei dripping pill preparation according to claim 4 is characterized in that: the weight proportion of described component is: 1 part of Radix Lamiophlomidis Rotatae extract, 1.5-3 part Macrogol 4000 or 6000.
6, Duyiwei dripping pill preparation according to claim 5 is characterized in that: the weight proportion of described component is: 1 part of Radix Lamiophlomidis Rotatae extract, 2.33 parts of Macrogol 4000s or 6000.
7, Duyiwei dripping pill preparation according to claim 1 is characterized in that: the organic solvent extraction method of described Radix Lamiophlomidis Rotatae extract is: get the Radix Lamiophlomidis Rotatae medical material, add organic solvent extraction once more than, each 1-2 hour, filter, filtrate is reclaimed be concentrated into behind the organic solvent driedly, get final product.
8, Duyiwei dripping pill preparation according to claim 7 is characterized in that: described organic solvent is selected from any one or more than one the mixture in acetone, ethyl acetate, the dichloromethane.
9, Duyiwei dripping pill preparation according to claim 1 is characterized in that: it also contains other component, comprising other medicines composition and/or other medicinal thing adjuvant.
10, a kind of method for preparing the described Duyiwei dripping pill preparation of claim 1, its practice is: earlier the Radix Lamiophlomidis Rotatae extract of described proportioning is pulverized, added the Polyethylene Glycol of described proportioning again, go into the drop pill machine behind the mix homogeneously and make drop pill, get final product.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110721216A (en) * | 2019-12-09 | 2020-01-24 | 遂成药业股份有限公司 | Sugar-free lamiophlomis rotata oral liquid preparation and preparation method thereof |
| CN111067930A (en) * | 2019-12-31 | 2020-04-28 | 江西杏林白马药业股份有限公司 | Lamiophlomis rotate (Benth.) kudo extract nanometer preparation and preparation method thereof |
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2004
- 2004-12-06 CN CN 200410081401 patent/CN1785237A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110721216A (en) * | 2019-12-09 | 2020-01-24 | 遂成药业股份有限公司 | Sugar-free lamiophlomis rotata oral liquid preparation and preparation method thereof |
| CN111067930A (en) * | 2019-12-31 | 2020-04-28 | 江西杏林白马药业股份有限公司 | Lamiophlomis rotate (Benth.) kudo extract nanometer preparation and preparation method thereof |
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Open date: 20060614 |