CN105663070A - Medicine composition containing olmesartan medoxomi I and preparation method thereof - Google Patents
Medicine composition containing olmesartan medoxomi I and preparation method thereof Download PDFInfo
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- CN105663070A CN105663070A CN201410674793.5A CN201410674793A CN105663070A CN 105663070 A CN105663070 A CN 105663070A CN 201410674793 A CN201410674793 A CN 201410674793A CN 105663070 A CN105663070 A CN 105663070A
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Abstract
Provided is an olmesartan medoxomi I medicine composition. Through particle supporting method, active components are highly dispersed in a carrier in the composition. The medicine composition is low in cost and high in dissolution rate. In addition, a technical problem that highly-dispersed preparations are poor in stability is overcome. The invention also provides a method of preparing the olmesartan medoxomi I medicine composition. The method is carried out with common devices in the field, is reasonable in process steps, is simple and available and is suitable for large-scale production.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, especially, the preparation method that the present invention relates to a kind of pharmaceutical composition containing olmesartan medoxomil and said composition.
Background technology
Olmesartan medoxomil (OlmesartanMedoxomil), CAS:144689-63-4, is a kind of Angiotensin II (AT1) receptor blocking agent. Olmesartan medoxomil is developed by Sankyo Co. of Japan, and in 2002 at U.S.'s Initial Public Offering, trade name: Benicar (Chinese name: proud smooth). Compared with other tradition AT1 receptor blocking agent (such as losartan etc.), olmesartan medoxomil has the advantage such as long half time, dosage little, rapid-action, better tolerance, few side effects, after listing, market feedback is good, rises year by year in sales volume and market share.
Olmesartan medoxomil belongs to organic esters, there is the character of hydrophobic parent's ester, owing to its wettability, dissolubility in water are not good, cause its effective ingredient not easily dissolution when oral administration, medicine is made cannot effectively to be dissolved and disperse, thus affecting clinical therapeutic efficacy. It addition, as organic esters, olmesartan medoxomil is easily hydrolyzed, stability is not good. Therefore, being intended to exploitation olmesartan medoxomil oral formulations product, the dissolving out capability of preparation and the stability of preparation are firstly the need of the problem solved.
Current published method adopts the method reducing effective ingredient particle diameter (such as micronization) to improve preparation dissolution. Yuan Yan company discloses the pulverizing crystallization of a kind of olmesartan medoxomil at Chinese patent CN200880017194.9, and point out, when D90=75 μm, 30 minutes interior dissolution rates of its preparation are only 60%, it is unable to reach clinical application demand, as reached dissolution rate more than 80%, D90 need to be even lower at 39 μm. Olmesartan medoxomil powder body bulk density is little, is easily generated a large amount of dust when pulverizing, and the too small powder body of particle diameter is also easily not easily mixed homogeneously because of electrostatic effect when mix with adjuvant, affects and mixes the powder uniformity.
Chinese patent CN201010224565.X discloses a kind of olmesartan medoxomil tablet and preparation method thereof, the method reaches to improve the purpose of dissolution by olmesartan medoxomil and lactose being ground for a long time, the method technique is excessively complicated, and grinding easily makes effective ingredient degrade and produce impurity for a long time.
Chinese patent CN201210241253.9 discloses a kind of olmesartan medoxomil dispersible tablet and preparation method thereof, the method adopting micropill load, and olmesartan medoxomil first loads to lactose fine pellet core surface, then tabletting obtains after mixing homogeneously with other additional adjuvants.Gained dispersible tablet has good dissolving out capability, and its stability is also improved significantly. But the lactose micropill purchase cost used in this patent is higher, and not at the row of the pharmaceutic adjuvant of national registration. It addition, adopt micropill medicine carrying technique to there is greater loss rate, utilization ratio of drug is significantly lower than granule medicine carrying, and gained pharmaceutical composition also has the space of lifting further in dissolution and stability.
The present invention is from solving the deficiencies in the prior art, provide a kind of pharmaceutical composition containing olmesartan medoxomil, said composition adopts the method for particulate load, preparation technology is simple, raw material is easy to get, effective ingredient in gained olmesartan medoxomil pharmaceutical composition is highly dispersed in carrier granular, and relatively preparation disclosed in prior art has the advantages such as dissolution is higher, stability is better.
Summary of the invention
It is an object of the invention to overcome the deficiencies in the prior art, a kind of pharmaceutical composition containing olmesartan medoxomil is provided, said composition adopts the method for particulate load, by effective ingredient high degree of dispersion in the carrier, gained pharmaceutical composition has dissolution height, good stability, the advantage such as with low cost.
The above-mentioned purpose of the present invention is realized by techniques below means:
A kind of olmesartan medoxomil pharmaceutical composition, comprise olmesartan medoxomil particles, additional adjuvant: disintegrating agent, lubricant and filler, it is characterised in that described olmesartan medoxomil particles contains 1 mass parts olmesartan medoxomil, 6～10 mass parts filleies, 0.2～1.0 mass parts binding agent, 0.05～0.20 mass of surface activating agent and 0.2～0.5 mass parts disintegrating agent.
The technical advantages such as the dissolution of olmesartan medoxomil pharmaceutical composition of the present invention, stability, cost depend on the selection of the kind to adjuvant and mass ratio.
Concrete, the technical advantage such as the dissolution of olmesartan medoxomil pharmaceutical composition of the present invention, stability, cost is dependent firstly on the prescription of olmesartan medoxomil particles. For being loaded with the granule of olmesartan medoxomil, its kind that it is critical only that filler, disintegrating agent, surfactant and binding agent and consumption. More specifically, described filler mass parts is 6-10, preferably 7～8, described filler in lactose, microcrystalline Cellulose, starch, mannitol, dextrin, the pregelatinized Starch one or more with the mixture of arbitrary proportion mixing gained, the mixture of preferred lactose and microcrystalline Cellulose, more preferably lactose with microcrystalline Cellulose to mix the mixture of gained within the scope of mass ratio 0.8～2.0:1; Described binding agent mass parts is 0.2～1.0, preferably 0.3～0.5, described binding agent in hydroxypropyl methylcellulose, hydroxypropyl cellulose, the polyvinylpyrrolidone etc. one or more with the mixture of arbitrary proportion mixing gained, it is preferable that hydroxypropyl cellulose; Described surfactant qualities part is 0.05～0.20, it is preferable that 0.1～0.2, described surfactant in sodium lauryl sulphate, the poloxamer one or more with the mixture of arbitrary proportion mixing gained, it is preferable that poloxamer; Described disintegrating agent mass parts is 0.2～0.5, preferably 0.3～0.5, the described disintegrating agent one or more mixture in cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose etc., it is preferable that carboxymethyl starch sodium. When described granule prescription is in above-mentioned adjuvant and amount ranges, in gained olmesartan medoxomil particles, effective ingredient can realize farthest dispersed, enter internal after can realize rapid disintegrate rapidly dissolution, release completely, also ensure that effective ingredient is to disperse the optimal stability in the preparation technology of medicine carrying mode and product simultaneously.
For additional adjuvant disintegrating agent, filler and lubricant, wherein disintegrating agent is bigger for result of extraction and the stability influence of pharmaceutical composition of the present invention, concrete, for set interior phase granule prescription, too much disintegrating agent can increase the hygroscopicity of pharmaceutical composition, cause the easy moisture absorption of pharmaceutical composition, pharmaceutical composition disintegrate additionally also can be made too fast, thus affecting administering effect, very few disintegrating agent then makes pharmaceutical composition disintegrate cross slow and affect drug-eluting, described disintegrating agent mass parts is 0.2～0.5, described disintegrating agent is selected from cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone, carboxymethyl starch sodium, in low-substituted hydroxypropyl cellulose one or more with the mixture of arbitrary proportion mixing gained, preferably consistent with disintegrating agent with interior, more preferably carboxymethyl starch sodium, described filler mass parts is 0.5～1.0, preferably 0.5～0.6, described filler in lactose, microcrystalline Cellulose, starch, mannitol, dextrin, the pregelatinized Starch one or more with the mixture of arbitrary proportion mixing gained, it is preferable that microcrystalline Cellulose, described lubricant mass parts is 0.05～0.10, described lubricant in stearic acid, magnesium stearate, micropowder silica gel, the Pulvis Talci one or more with the mixture of arbitrary proportion mixing gained. by additional adjuvant so that additional, in the adjuvant that adds balance the character such as the hardness of pharmaceutical composition, rate of dissolution, disintegration rate further on the whole, comprehensively make the uniformity of olmesartan medoxomil pharmaceutical composition, dissolving out capability be in preferably level.
One optimal technical scheme of the present invention, described olmesartan medoxomil pharmaceutical composition prescription is as follows:
One optimal technical scheme of the present invention, described olmesartan medoxomil pharmaceutical composition prescription is as follows:
One optimal technical scheme of the present invention, described olmesartan medoxomil pharmaceutical composition prescription is as follows:
One optimal technical scheme of the present invention, described olmesartan medoxomil pharmaceutical composition prescription is as follows:
Another object of the present invention is to provide a kind of method preparing olmesartan medoxomil pharmaceutical composition of the present invention. The needs that described method is fully prepared in conjunction with the reality of aforementioned prescription and dosage form, including granulation, total mixed, tabletting three step, adopt fluidized bed process to granulate.
Wherein, pelletization adopts fluidized bed granulation method, uses the mode of powder medicine-feeding, and the method makes diameter of aspirin particle be able to very big reduction on the one hand, improves dissolving out capability; On the other hand effective ingredient evenly be dispersed in carrier material, also improve the stability of product. Finally carrying out fluidized granulation and improve mobility of particle, whole process completes in same Sealing Arrangement, and simple process is easy, and each processing step is arranged rationally, meets the requirement of industrialized production, decreases dust pollution simultaneously.
The method adopts this area conventional equipment, method simple possible, is suitable for large-scale production. Concrete, described method comprises the steps of:
1) surfactant solution is sprayed in recipe quantity filler, fluidized drying;
2) solution of olmesartan medoxomil of recipe quantity, fluidized drying are sprayed into;
3) add disintegrating agent, spray into binding agent fluidized drying after mixing and granulate;
4) after being mixed with all the other adjuvants by step 3 gained granule, tabletting obtains olmesartan medoxomil pharmaceutical composition.
In above-mentioned steps 1, described solution is aqueous solution or alcoholic solution, and in step 2, described solution of olmesartan medoxomil is acetone soln or alcoholic solution, it is preferred that described binder solution is aqueous solution, and described solution of olmesartan medoxomil is acetone soln.
Fluidized drying and the technological parameter of granulation step in above-mentioned preparation method defer to general knowledge known in this field, preferably, in the process (i.e. spray process) spraying into solution of olmesartan medoxomil of medicine-feeding step and above-mentioned steps 2: inlet temperature is set to 40 DEG C, temperature of charge is 30 DEG C, hydrojet speed 10mL/min, atomizing pressure 0.3Mpa;Inlet temperature 50 DEG C in dry run, temperature of charge 40 DEG C.
Described pharmaceutical composition can make further Cotton seeds, and described art for coating can be coating material commonly used in the art, adopts method commonly used in the art to carry out coating. Such as, described coating material can be hypromellose, polyvinyl alcohol, hydroxypropyl cellulose etc., it is possible to optionally adds the sweeting agent of necessity, opacifier, pigment etc.
The present invention compared with prior art has following prominent advantage and beneficial effect:
1, providing a kind of olmesartan medoxomil pharmaceutical composition, said composition adopts the method for particulate load, and by effective ingredient high degree of dispersion in the carrier, gained pharmaceutical composition has the advantages such as with low cost, dissolution is high; It addition, overcome the technical barrier that high degree of dispersion preparation stability is poor.
2, a kind of method preparing olmesartan medoxomil pharmaceutical composition of the present invention is provided, described method fully needs in conjunction with prescription reality and dosage form preparation, the method adopting powder medicine-feeding, make effective ingredient evenly be dispersed in carrier material, the method adopts this area conventional equipment, processing step arranges rationally, method simple possible, is suitable for large-scale production.
Detailed description of the invention
Below in conjunction with embodiment, the present invention is described in further detail, but the embodiment of invention is not limited to this.
Embodiment 1
Preparation technology:
1. microcrystalline Cellulose and lactose are placed in fluid bed, spray into Poloxamer solution, fluidized drying;
2. the olmesartan medoxomil of recipe quantity is added in acetone and dissolve, spray in step 1 gained mixture, fluidized drying. Wherein in spray process, inlet temperature is set to 40 DEG C, and temperature of charge is 30 DEG C, hydrojet speed 10mL/min, atomizing pressure 0.3Mpa; Inlet temperature 50 DEG C in dry run, temperature of charge 40 DEG C;
3. add with disintegrating agent, mixing in recipe quantity, and spray into binder solution granulation, fluidized drying;
4., by uniform to medicine-containing particle in step 3 and additional disintegrating agent, filler and mix lubricant, tabletting, sheet hardness is about 8kg.
Embodiment 2
Preparation technology:
1. microcrystalline Cellulose and lactose are placed in fluid bed, spray into sodium dodecyl sulfate solution, fluidized drying;
2. the olmesartan medoxomil of recipe quantity is added in acetone and dissolve, spray in step 1 gained mixture, fluidized drying. Wherein in spray process, inlet temperature is set to 40 DEG C, and temperature of charge is 30 DEG C, hydrojet speed 10mL/min, atomizing pressure 0.3Mpa; Inlet temperature 50 DEG C in dry run, temperature of charge 40 DEG C;
3. add with disintegrating agent, mixing in recipe quantity, and spray into binder solution granulation, fluidized drying;
4., by uniform to medicine-containing particle in step 3 and additional disintegrating agent, filler and mix lubricant, tabletting, sheet hardness is about 8kg.
Embodiment 3
Preparation technology:
1. microcrystalline Cellulose and lactose are placed in fluid bed, spray into Poloxamer solution, fluidized drying;
2. the olmesartan medoxomil of recipe quantity is added in acetone and dissolve, spray in step 1 gained mixture, fluidized drying. Wherein in spray process, inlet temperature is set to 40 DEG C, and temperature of charge is 30 DEG C, hydrojet speed 10mL/min, atomizing pressure 0.3Mpa; Inlet temperature 50 DEG C in dry run, temperature of charge 40 DEG C;
3. add with disintegrating agent, mixing in recipe quantity, and spray into binder solution granulation, fluidized drying;
4., by uniform to medicine-containing particle in step 3 and additional disintegrating agent, filler and mix lubricant, tabletting, sheet hardness is about 8kg.
Embodiment 4
Preparation technology:
1. starch and lactose are placed in fluid bed, spray into sodium dodecyl sulfate solution, fluidized drying;
2. the olmesartan medoxomil of recipe quantity is added in acetone and dissolve, spray in step 1 gained mixture, fluidized drying. Wherein in spray process, inlet temperature is set to 40 DEG C, and temperature of charge is 30 DEG C, hydrojet speed 10mL/min, atomizing pressure 0.3Mpa; Inlet temperature 50 DEG C in dry run, temperature of charge 40 DEG C;
3. add with disintegrating agent, mixing in recipe quantity, and spray into binder solution granulation, fluidized drying;
4., by uniform to medicine-containing particle in step 3 and additional disintegrating agent, filler and mix lubricant, tabletting, sheet hardness is about 8kg.
Comparative example 1
Preparation technology:
1. microcrystalline Cellulose and lactose are placed in fluid bed, the olmesartan medoxomil of recipe quantity are added in acetone and dissolves, spray in fluid bed substrate, fluidized drying. Wherein in spray process, inlet temperature is set to 40 DEG C, and temperature of charge is 30 DEG C, hydrojet speed 10mL/min, atomizing pressure 0.3Mpa; Inlet temperature 50 DEG C in dry run, temperature of charge 40 DEG C;
2. add with disintegrating agent, mixing in recipe quantity, and spray into binder solution granulation, fluidized drying;
3., by uniform to medicine-containing particle in step 2 and additional disintegrating agent, filler and mix lubricant, tabletting, sheet hardness is about 8kg.
Comparative example 2
Preparation technology:
1. microcrystalline Cellulose and lactose are placed in fluid bed, spray into Poloxamer solution, fluidized drying;
2. the olmesartan medoxomil of recipe quantity is added in acetone and dissolve, spray in step 1 gained mixture, fluidized drying. Wherein in spray process, inlet temperature is set to 40 DEG C, and temperature of charge is 30 DEG C, hydrojet speed 10mL/min, atomizing pressure 0.3Mpa; Inlet temperature 50 DEG C in dry run, temperature of charge 40 DEG C;
3. add with disintegrating agent, mixing in recipe quantity, and spray into binder solution granulation, fluidized drying;
4., by uniform to medicine-containing particle in step 3 and additional disintegrating agent, filler and mix lubricant, tabletting, sheet hardness is about 8kg.
Comparative example 3
Preparation technology:
1. microcrystalline Cellulose and lactose are placed in fluid bed, spray into Poloxamer solution, fluidized drying;
2. the olmesartan medoxomil of recipe quantity is added in acetone and dissolve, spray in step 1 gained mixture, fluidized drying. Wherein in spray process, inlet temperature is set to 40 DEG C, and temperature of charge is 30 DEG C, hydrojet speed 10mL/min, atomizing pressure 0.3Mpa; Inlet temperature 50 DEG C in dry run, temperature of charge 40 DEG C;
3. add with disintegrating agent, mixing in recipe quantity, and spray into binder solution granulation, fluidized drying;
4., by uniform to medicine-containing particle in step 3 and additional disintegrating agent, filler and mix lubricant, tabletting, sheet hardness is about 8kg.
Embodiment 5
Adopt 2010 editions annex XC dissolution determination the second methods of Chinese Pharmacopoeia, pH6.8 phosphate buffer (37 DEG C when detection embodiment 1～4, comparative example 1～3 gained olmesartan medoxomil pharmaceutical composition 0 day, dissolution medium 900mL, rotating speed 50rpm) in dissolution situation, respectively at 5min, 10min, 15min, 30min samples, and with determined by ultraviolet spectrophotometry, result is shown in following table:
| Project | 5min | 10min | 15min | 30min |
| Embodiment 1 | 75% | 92% | 96% | 100% |
| Embodiment 2 | 70% | 83% | 90% | 98% |
| Embodiment 3 | 72% | 86% | 91% | 99% |
| Embodiment 4 | 73% | 85% | 92% | 95% |
| Comparative example 1 | 55% | 73% | 78% | 82% |
| Comparative example 2 | 50% | 75% | 78% | 80% |
| Comparative example 3 | 45% | 64% | 68% | 75% |
It is seen from the above data that embodiment 1～4 gained olmesartan medoxomil pharmaceutical composition dissolution rate is very fast, in 15 minutes, dissolution can reach more than 85%, the nearly dissolution completely of accumulation in 30 minutes.
Reviewing comparative example, wherein comparative example 1 is not owing to using surfactant, and dissolution rate is significantly lower than embodiment 1-4. And comparative example 2 and 3, then owing to making consumption too low with disintegrating agent or disintegrating agent in not using, cause that dissolution is decreased obviously.
It addition, by compared with olmesartan medoxomil dispersible tablet disclosed in patent CN201210241253.9, embodiment 1-4 gained olmesartan medoxomil pharmaceutical composition is significantly faster than that patented product on dissolution rate, shows that 10min can realize the dissolution of more than 85%.
Embodiment 6
At 40 DEG C, when 75%RH, olmesartan medoxomil tablet 20 Example 1～4 preparation in the 0th, 10,30 days, finely ground, precision weighs in right amount (being approximately equivalent to 50mg olmesartan medoxomil) and puts in 50mL measuring bottle, adds acetonitrile-water (9:1) and dissolves, it is diluted to scale, shake up, centrifugal, take supernatant as need testing solution; Precision measures need testing solution 1mL, dilutes 100 times, as contrast solution. Take 10 μ L, inject chromatograph of liquid. Adopting C18 chromatographic column, with the potassium dihydrogen phosphate (pH3.4) (34:66) of acetonitrile-0.015mol/L for mobile phase, detection wavelength 249nm carries out the relevant substance-measuring of olmesartan medoxomil. Result is shown in following table:
Visible from the data above, at 40 DEG C, when 75%RH, olmesartan medoxomil tablet prepared by embodiment of the present invention 1-4 has the assorted and total assorted content increasing degree of the maximum list of related substance all less, it was shown that preparation stability is higher. Even if effective ingredient high degree of dispersion is in the carrier, the stability of olmesartan medoxomil pharmaceutical composition of the present invention is also significantly better than the particle surface load technology gained dispersible tablet formulation of patent disclosure.
Above-described embodiment is the present invention preferably embodiment; but embodiments of the present invention are also not restricted to the described embodiments; the change made under other any spirit without departing from the present invention and principle, modification, replacement, combination, simplification; all should be the substitute mode of equivalence, be included within protection scope of the present invention.
Claims (10)
1. an olmesartan medoxomil pharmaceutical composition, comprise olmesartan medoxomil particles, additional adjuvant: disintegrating agent, lubricant and filler, it is characterised in that described olmesartan medoxomil particles contains 1 mass parts olmesartan medoxomil, 6～10 mass parts filleies, 0.2～1.0 mass parts binding agent, 0.05～0.20 mass of surface activating agent and 0.2～0.5 mass parts disintegrating agent.
2. olmesartan medoxomil pharmaceutical composition according to claim 1, it is characterised in that in described olmesartan medoxomil particles: described filler be one or more in lactose, microcrystalline Cellulose, starch, mannitol, dextrin, pregelatinized Starch with the mixture of arbitrary proportion mixing gained; Described binding agent be one or more in hydroxypropyl methylcellulose, hydroxypropyl cellulose, polyvinylpyrrolidone with the mixture of arbitrary proportion mixing gained; Described surfactant be one or more in sodium lauryl sulphate, poloxamer with the mixture of arbitrary proportion mixing gained; Described disintegrating agent is one or more the mixture in cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose.
3. olmesartan medoxomil pharmaceutical composition according to claim 1 or 2 any one, it is characterised in that in described olmesartan medoxomil particles: described filler mass parts is 7～8;Described binding agent mass parts is 0.3～0.5; Described surfactant qualities part is 0.1～0.2; Described disintegrating agent mass parts is 0.3～0.5.
4. olmesartan medoxomil pharmaceutical composition according to claim 1-3 any one, it is characterised in that in described olmesartan medoxomil particles: described filler be lactose with microcrystalline Cellulose to mix the mixture of gained within the scope of mass ratio 0.8～2.0:1.
5. olmesartan medoxomil pharmaceutical composition according to claim 1-4 any one, it is characterised in that described additional adjuvant: described disintegrating agent be one or more in cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose with the mixture of arbitrary proportion mixing gained; Described filler be one or more in lactose, microcrystalline Cellulose, starch, mannitol, dextrin, pregelatinized Starch with the mixture of arbitrary proportion mixing gained; Described lubricant be one or more in stearic acid, magnesium stearate, micropowder silica gel, Pulvis Talci with the mixture of arbitrary proportion mixing gained.
6. olmesartan medoxomil pharmaceutical composition according to claim 1-5 any one, it is characterized in that described additional adjuvant: described disintegrating agent mass parts is 0.2～0.5, described filler mass parts is 0.5～1.0, and described lubricant mass parts is 0.05～0.10.
7. olmesartan medoxomil pharmaceutical composition according to claim 1-6 any one, it is characterised in that filler mass parts described in described additional adjuvant is 0.5～0.6.
8. olmesartan medoxomil pharmaceutical composition according to claim 1, it is characterised in that the prescription of described olmesartan medoxomil pharmaceutical composition is any one in following four prescription:
Prescription one
Prescription two
Prescription three
Prescription four
9. the preparation method of olmesartan medoxomil pharmaceutical composition described in a claim 1-8 any one, it is characterised in that described preparation method comprises the steps:
1) surfactant solution is sprayed in recipe quantity filler, fluidized drying;
2) solution of olmesartan medoxomil of recipe quantity, fluidized drying are sprayed into;
3) add disintegrating agent, spray into binding agent fluidized drying after mixing and granulate;
4) after being mixed with all the other adjuvants by step 3 gained granule, tabletting obtains olmesartan medoxomil pharmaceutical composition.
In above-mentioned steps 1, described solution is aqueous solution or alcoholic solution, and in step 2, described solution of olmesartan medoxomil is acetone soln or alcoholic solution.
10. preparation method according to claim 9, it is characterised in that in the process spraying into solution of olmesartan medoxomil of described step 2: inlet temperature is set to 40 DEG C, temperature of charge is 30 DEG C, hydrojet speed 10mL/min, atomizing pressure 0.3Mpa; Inlet temperature 50 DEG C in dry run, temperature of charge 40 DEG C.
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Cited By (1)
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| CN112691084A (en) * | 2019-10-23 | 2021-04-23 | 南京正大天晴制药有限公司 | Pharmaceutical composition and preparation method thereof |
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