CN115721607B - Levofloxacin lactate injection and preparation method thereof - Google Patents
Levofloxacin lactate injection and preparation method thereof Download PDFInfo
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Abstract
The application relates to the technical field of medicines, and in particular discloses a levofloxacin lactate injection and a preparation method thereof. The levofloxacin lactate injection comprises the following raw materials: the preparation method of the levofloxacin lactate crude drug, hydroxylated lecithin, oleic acid, cosolvent, glucose aqueous solution, cytidine disodium triphosphate and lidocaine carbonate aqueous solution comprises the following steps: s1, mixing the crude drug with oleic acid, and stirring until the crude drug is completely dissolved; s2, adding glucose aqueous solution and hydroxylated lecithin, and performing high-shear treatment by using a high-shear emulsifier; s3, adding a cosolvent, cytidine disodium triphosphate and lidocaine carbonate aqueous solution, and then continuously stirring and mixing for 5-15min; s4: carrying out 2-4 times of ultra-high pressure nano homogenization treatment. The levofloxacin lactate injection prepared in the application has mild, rapid and effective action, and is suitable for people with weak body or high drug sensitivity who need to treat infectious diseases.
Description
Technical Field
The application relates to the technical field of medicines, in particular to a levofloxacin lactate injection and a preparation method thereof.
Background
The levofloxacin lactate can be used for treating the systemic infections such as urogenital system infection, respiratory tract infection, gastrointestinal tract infection, typhoid, bone and joint infection, skin soft tissue infection, septicemia and the like caused by sensitive bacteria, has the characteristics of wide antibacterial spectrum and strong antibacterial effect, and is widely used at present, but the levofloxacin lactate belongs to the category of fluoroquinolone antibiotics, once incorrect administration or anaphylaxis is generated, irreversible damage to organs is most likely to be caused, and along with the increase of the application range of the medicine, reports on various side effects of the medicine are also increasingly increased, including liver toxicity, central nerve and peripheral nerve abnormality and abnormal blood sugar change which are irrelevant to anaphylaxis, serious discomfort can appear when the organism is injected under the condition of high sensitivity of the medicine, so the prevention and reduction of the occurrence of the levofloxacin adverse reaction becomes an important problem to be solved in clinical treatment.
Disclosure of Invention
In order to reduce the possibility of irritation to human bodies caused by adverse reactions of levofloxacin lactate and reduce side effects of medicines, the application provides a levofloxacin lactate injection and a preparation method thereof.
In a first aspect, the present application provides a levofloxacin lactate injection, which adopts the following technical scheme:
the levofloxacin lactate injection comprises the following raw materials in parts by weight: 0.4-0.6 part of lactic acid levofloxacin technical, 5-8 parts of hydroxylation lecithin, 10-12 parts of oleic acid, 2-5 parts of cosolvent, 25-35 parts of glucose aqueous solution, 0.4-0.8 part of cytidine disodium triphosphate and 0.1-0.3 part of lidocaine aqueous solution.
By adopting the technical scheme, the indissolvable drug levofloxacin lactate can be completely dissolved in an oil phase, so that the drug can be fully dissolved in the indissolvable drug levofloxacin lactate by adopting oleic acid, and then the indissolvable drug levofloxacin lactate is combined to form an oil-in-water emulsion by adopting hydroxylated lecithin and adding glucose aqueous solution capable of controlling osmotic pressure of an injection; the oil-in-water emulsion has good hydrophobic drug carrying capacity, strong blood brain barrier permeation capacity, and targeting affinity of the emulsion to lymphatic system, so that the drug has high bioavailability, and the stimulation to other cells of the body is minimized, the drug is controlled to be released in a large amount in blood, the increase of blood concentration is slowed down, the phenomenon of ascending is avoided, the texture fluidity of the oil-in-water is good, no obvious pain is caused, and the oil-in-water emulsion can be rapidly mixed with glucose aqueous solution; the possibility of some neurotoxic side effects of people with drug sensitive physique is reduced by adding cytidine disodium triphosphate, the brain and the nervous system are nourished, and the immunity and the restoring force of the brain and the nervous system are improved, so that the stimulation of the drug to the nervous system is reduced, and the drug administration risk is reduced; the lidocaine carbonate aqueous solution is adopted, the pain of sensitive people when the emulsion is injected can be relieved through the lidocaine medicine, the irritation to the skin is relieved, and the expansion effect and the targeting effect of the lidocaine medicine on blood vessels are combined, so that the injection can more rapidly go to the lymphatic system to exert the efficacy, and the lymphomegaly caused by infection is relieved.
Preferably, the HLB value of the hydroxylated lecithin is 10 to 12.
By adopting the technical scheme, the hydroxylated lecithin is injected into a human body, so that the effects of protecting the heart, regulating the activation degree of brain cells, emulsifying and removing blood fat and the like can be achieved, and the hydroxylated lecithin with the HLB value within the range of 10-12 is adopted, so that the oil-in-water emulsion injection with good fluidity can be formed by utilizing the characteristic of good hydrophilic property of the hydroxylated lecithin.
Preferably, the cosolvent comprises polyethylene glycol and ethanol in a weight ratio of 1:1.
Preferably, the lidocaine aqueous solution is a lidocaine carbonate aqueous solution prepared by lidocaine hydrochloride and sodium bicarbonate solution under the condition of carbon dioxide saturation.
By adopting the technical scheme, the ph of lidocaine hydrochloride is adjusted through reaction with alkaline sodium bicarbonate, so that the ph of the injection reaches corresponding standards, and the neutralization acidity enables the injection system to be the same as the weakly alkaline blood system environment, so that the injection is mild and does not irritate.
Preferably, the concentration of glucose in the aqueous glucose solution is 5-8wt%.
By adopting the technical scheme, the osmotic pressure of the injection system can be regulated and controlled by adding glucose, so that the concentration in blood and the equilibrium of osmotic pressure indexes are maintained; and when abnormal blood sugar changes occur in quinolone injection, blood sugar is normally abnormally reduced three days before injection, and at the moment, glucose in the injection can play a role in compensation, so that severe hypoglycemia is avoided.
In a second aspect, the present application provides a preparation method of levofloxacin lactate injection, which adopts the following technical scheme:
a preparation method of levofloxacin lactate injection comprises the following steps:
s1, mixing a raw material medicine with oleic acid, and stirring until the raw material medicine is completely dissolved to obtain an oil phase;
s2, adding glucose aqueous solution and hydroxylated lecithin into the oil phase, and performing high-shear treatment by using a high-shear emulsifier to obtain levofloxacin lactate colostrum;
s3, adding a cosolvent, cytidine disodium triphosphate and lidocaine carbonate aqueous solution, and then continuously stirring and mixing for 5-15min to obtain the levofloxacin lactate injection.
Preferably, the high shearing operation performed in step S2 is shearing at a rotational speed of 24000-26000 rpm.
By adopting the technical scheme, the oil phase is sheared and broken into tiny oil drops which are invisible to naked eyes through high shearing treatment, and compared with the traditional mixed shearing, the oil drops are broken more finely, the shearing effect is good, and a large amount of mixed shearing time is saved.
Preferably, the preparation method of the levofloxacin lactate injection further comprises the step S4: and carrying out 2-4 times of ultrahigh pressure nano homogenization treatment on the obtained levofloxacin lactate injection.
By adopting the technical scheme, the oil drops are homogenized, so that the size and the volume of the oil drops are similar, uneven drug release caused by different sizes of the oil drops is avoided, and finally the phenomenon of unstable blood concentration after injection is caused.
In summary, the present application has the following beneficial effects:
1. the oil-in-water emulsion injection is prepared, so that the injection has good medicine carrying capacity of hydrophobic medicines, good fluidity of the injection, no obvious pain in the injection process, small damage to other cells of a human body due to the targeting affinity of a lymphatic system, small medicine release amount of the emulsion injection in blood, and less part of medicines participating in liver and intestine circulation, so that the stimulation to viscera is reduced.
2. The characteristics of the lidocaine carbonate aqueous solution and the oil-in-water emulsion injection are matched, and the emulsion injection can expand blood vessels to accelerate the circulation and dispersion of medicines due to the fact that the speed of the emulsion injection penetrating through the blood brain barrier of a human body is higher, the dosage form effectively reduces the medicine quantity participating in liver and intestine circulation of the human body and relieves the metabolic burden for viscera, so that the levofloxacin lactate injection prepared in the application has mild, rapid and effective effects, and is suitable for people with weak bodies or high sensitivity to medicines, which need to treat infectious diseases.
3. According to the method, the cytidine disodium triphosphate is matched with lecithin, so that brain cells and nerve cells can be nourished, the resistance and the restoring force of a brain nervous system can be improved, the stimulation of a medicine to neurons can be reduced, and the brain nervous system is milder to a human body.
Detailed Description
The present application is further described in detail with reference to the following examples, which are specifically described: the following examples, in which no specific conditions are noted, are conducted under conventional conditions or conditions recommended by the manufacturer, and the raw materials used in the following examples are commercially available from ordinary sources except for the specific descriptions.
The lidocaine carbonate aqueous solution described in this application is a music product sold by Jiangsu Jichuan pharmaceutical Co., ltd.
Examples
Example 1
The levofloxacin lactate injection comprises the following raw materials: 0.4g of levofloxacin lactate, 5g of hydroxylated lecithin, 10g of oleic acid, 1g of polyethylene glycol, 1g of ethanol, 25g of 5wt% glucose aqueous solution, 0.4g of cytidine disodium triphosphate and 0.1g of lidocaine carbonate aqueous solution.
A preparation method of levofloxacin lactate injection comprises the following steps:
s1, mixing a lactic acid levofloxacin technical product with oleic acid, and stirring until the mixture is completely dissolved to obtain an oil phase;
s2, adding glucose aqueous solution and hydroxylated lecithin into the oil phase, and carrying out high-shear treatment on the mixed water phase, oil phase and hydroxylated lecithin components for 10S by using a high-shear emulsifying machine at the rotating speed of 24000rpm to obtain lactic acid levofloxacin colostrum;
s3, adding polyethylene glycol, ethanol, cytidine disodium triphosphate and lidocaine carbonate aqueous solution, and then continuously stirring and mixing for 5min to obtain levofloxacin lactate injection;
s4, treating the levofloxacin lactate injection for 2 times by using an ultrahigh-pressure nano homogenizer, wherein the pressure is 1400bar.
Example 2
The levofloxacin lactate injection comprises the following raw materials: 0.5g of levofloxacin lactate, 6.5g of hydroxylated lecithin, 11g of oleic acid, 2g of polyethylene glycol, 1.5g of ethanol, 30g of 6.5wt% glucose aqueous solution, 0.6g of cytidine disodium triphosphate and 0.2g of lidocaine carbonate aqueous solution.
A preparation method of levofloxacin lactate injection comprises the following steps:
s1, mixing a raw material medicine with oleic acid, and stirring until the raw material medicine is completely dissolved to obtain an oil phase;
s2, adding a 6.5wt% glucose aqueous solution and hydroxylated lecithin into the oil phase, and carrying out high-shear treatment on the mixed water-oil two phases for 12.5S by using a high-shear emulsifying machine at the rotating speed of 25000rpm to obtain lactic acid levofloxacin colostrum;
s3, adding polyethylene glycol, ethanol, cytidine disodium triphosphate and lidocaine carbonate aqueous solution, and then continuously stirring and mixing for 10min to obtain levofloxacin lactate injection;
s4, treating for 3 times by using an ultrahigh pressure nano homogenizer, wherein the pressure is 1500bar.
Example 3
The levofloxacin lactate injection comprises the following raw materials: 0.6g of levofloxacin lactate, 8g of hydroxylated lecithin, 12g of oleic acid, 3g of polyethylene glycol, 2g of ethanol, 35g of glucose aqueous solution, 0.8g of cytidine disodium triphosphate and 0.3g of lidocaine carbonate aqueous solution.
A preparation method of levofloxacin lactate injection comprises the following steps:
s1, mixing a raw material medicine with oleic acid, and stirring until the raw material medicine is completely dissolved to obtain an oil phase;
s2, adding glucose aqueous solution and hydroxylated lecithin into the oil phase, and carrying out high-shear treatment on the mixed water-oil two phases by using a high-shear emulsifying machine for 15S at the rotating speed of 26000rpm to obtain levofloxacin lactate colostrum;
s3, adding a cosolvent, cytidine disodium triphosphate and lidocaine carbonate aqueous solution, and then continuously stirring and mixing for 15min to obtain levofloxacin lactate injection;
s4, treating for 4 times by using an ultrahigh pressure nano homogenizer, wherein the pressure is 1600bar.
Example 4
Levofloxacin lactate injection is carried out according to the method in example 1, except that in step S3, lidocaine carbonate aqueous solution is replaced by lidocaine hydrochloride aqueous solution in equal amount.
Example 5
Levofloxacin lactate injection is carried out according to the method in example 1, except that high shear is not used in step S2, and low-rotation ordinary shear at 8000rpm is used and the shearing time is prolonged to 15min.
Example 6
Levofloxacin lactate injection is carried out according to the method in example 1, except that the homogenization treatment in step S4 is not performed 3 times.
Comparative example
Comparative example 1
Levofloxacin lactate injection, performed according to the method of example 1, is different in that: the aqueous glucose solution in the raw material is replaced with pure water in equal amount.
Comparative example 2
Levofloxacin lactate injection, performed according to the method of example 1, is different in that: and (3) adding no cytidine disodium triphosphate raw material, namely adding no cytidine disodium triphosphate in the step S3.
Comparative example 3
Levofloxacin lactate injection, performed according to the method of example 1, is different in that: the raw materials are not added with lidocaine carbonate aqueous solution.
Comparative example 4
Levofloxacin lactate injection, performed according to the method of example 1, is different in that: soybean oil is used as the oil phase.
Performance test
1. Blood concentration variation
2. Adverse reaction experiment
PH detection
Detection method/test method
1. Change in blood concentration: after healthy mice are put into a test box and fed for 3d, 50 microliters of levofloxacin lactate injection prepared in the application is injected into the mice, and the blood concentration of the mice is detected at 0.5h, 1h, 4h, 12h, 24h and 48h respectively.
2. Adverse reaction experiment: after 10 healthy mice were placed in a test box and fed with the same amount of food for 3d, 50 microliters of levofloxacin lactate injection prepared in the present application was injected into each mouse, the reaction of the mice was observed, and the blood glucose content was measured once a day, and the measurement results are shown in table 1.
PH detection: the PH values of the levofloxacin lactate injections prepared in examples and comparative examples were measured using a PH meter, and the measurement results are shown in table 2.
The levofloxacin lactate injection prepared in example 1 was injected into mice, and the blood concentration thereof was: 3.07. Mu.g/ml at 0.5h, 1.83. Mu.g/ml at 1h, 0.66. Mu.g/ml at 4h, 0.55. Mu.g/ml at 12h, 0.52. Mu.g/ml at 24h, and 0.33. Mu.g/ml at 48 h.
The levofloxacin lactate injection prepared in example 2 was injected into mice, and the blood concentration thereof was: 3.08. Mu.g/ml at 0.5h, 1.85. Mu.g/ml at 1h, 0.68. Mu.g/ml at 4h, 0.53. Mu.g/ml at 12h, 0.51. Mu.g/ml at 24h, and 0.35. Mu.g/ml at 48 h.
The levofloxacin lactate injection prepared in example 3 was injected into mice, and the blood concentration thereof was: 3.06 μg/ml at 0.5h, 1.79 μg/ml at 1h, 0.67 μg/ml at 4h, 0.54 μg/ml at 12h, 0.52 μg/ml at 24h, and 0.34 μg/ml at 48 h.
The levofloxacin lactate injection prepared in example 4 was injected into mice, and the blood concentration thereof was: 3.12. Mu.g/ml at 0.5h, 1.88. Mu.g/ml at 1h, 0.63. Mu.g/ml at 4h, 0.56. Mu.g/ml at 12h, 0.53. Mu.g/ml at 24h, and 0.37. Mu.g/ml at 48 h.
The levofloxacin lactate injection prepared in example 5 was injected into mice, and the blood concentration thereof was: 4.62. Mu.g/ml at 0.5h, 1.83. Mu.g/ml at 1h, 0.78. Mu.g/ml at 4h, 0.53. Mu.g/ml at 12h, 0.52. Mu.g/ml at 24h, and 0.33. Mu.g/ml at 48 h.
The levofloxacin lactate injection prepared in example 6 was injected into mice, and the blood concentration thereof was: 3.32. Mu.g/ml at 0.5h, 0.89. Mu.g/ml at 1h, 0.66. Mu.g/ml at 4h, 0.55. Mu.g/ml at 12h, 0.50. Mu.g/ml at 24h, and 0.35. Mu.g/ml at 48 h.
The levofloxacin lactate injection prepared in comparative example 1 was injected into mice, and the blood concentration thereof was: 3.03. Mu.g/ml at 0.5h, 1.78. Mu.g/ml at 1h, 0.65. Mu.g/ml at 4h, 0.52. Mu.g/ml at 12h, 0.50. Mu.g/ml at 24h, 48h 0.31. Mu.g/ml.
The levofloxacin lactate injection prepared in comparative example 2 was injected into mice, and the blood concentration thereof was: 3.09. Mu.g/ml at 0.5h, 1.87. Mu.g/ml at 1h, 0.65. Mu.g/ml at 4h, 0.53. Mu.g/ml at 12h, 0.51. Mu.g/ml at 24h, and 0.33. Mu.g/ml at 48 h.
The levofloxacin lactate injection prepared in comparative example 3 was injected into mice, and the blood concentration thereof was: 2.65. Mu.g/ml at 0.5h, 3.00. Mu.g/ml at 1h, 0.97. Mu.g/ml at 4h, 0.55. Mu.g/ml at 12h, 0.52. Mu.g/ml at 24h, 48h 0.33. Mu.g/ml.
The levofloxacin lactate injection prepared in comparative example 4 was injected into mice, and the blood concentration thereof was: 3.02 μg/ml at 0.5h, 1.83 μg/ml at 1h, 0.65 μg/ml at 4h, 0.54 μg/ml at 12h, 0.50 μg/ml at 24h, 48h0.32 μg/ml.
Table 1:
pH value detection result:
as can be seen from the combination of the detection results of example 1 and example 4 and the ph detection results, when lidocaine hydrochloride aqueous solution was used, the ph meter detection did not meet the injection requirement, and the ph value after sodium bicarbonate reaction was closer to the ph of blood, and was milder.
As can be seen from the performance detection results of the embodiment 1 and the embodiment 5, the obtained emulsion injection adopts a common mixing shearing method, tiny oil drops can be seen under naked eyes, the emulsion injection is in inclusion with uneven size under a microscope, the inclusion in the embodiment 1 has similar size, can be uniformly distributed in a water phase, is favorable for maintaining the stability of blood concentration, and can control the blood concentration to be between the minimum toxic concentration and the minimum effective concentration, so that abnormal fluctuation is reduced.
As can be seen from the performance test results of example 1 and comparative example 1, 2 mice in the comparative example were intolerant to the pharmaceutical preparation, and the phenomenon of hypoglycemia occurred on the first and second days of injection, but only 1 mouse in example 1 had a slight decrease in blood glucose on the third day and had little influence on daily activities of the mice.
As can be seen from the performance test results of example 1 and comparative example 2, 3 mice were hyperexcitable and 1 mouse was sporadically twitched without adding cytidine disodium triphosphate, and only 1 mouse in example one was hyperexcitable, thus it was found that the degree and possibility of occurrence of tics can be slowed down for the injection of the present application for mice.
As can be seen from the results of the performance tests of example 1 and comparative example 3, the increase in blood concentration was slow, about 0.5 to 1 hour, without adding the drug, and the utilization rate was increased after the addition.
As can be seen from the results of the performance tests of example 1 and comparative example 4, the fluidity of the emulsion of the injection prepared with other oil-phase matrix such as soybean oil and the like was inferior to that of the emulsion prepared with oleic acid as the matrix, resulting in the phenomena of thickening of blood of mice after injection, gradual lassitude and slow movement of mice after injection.
The present embodiment is merely illustrative of the present application and is not intended to be limiting, and those skilled in the art, after having read the present specification, may make modifications to the present embodiment without creative contribution as required, but is protected by patent laws within the scope of the claims of the present application.
Claims (8)
1. The levofloxacin lactate injection is characterized by comprising the following raw materials in parts by weight: levofloxacin lactate
0.4-0.6 part of raw medicine, 5-8 parts of hydroxylated lecithin, 10-12 parts of oleic acid, 2-5 parts of cosolvent, 25-35 parts of glucose aqueous solution, 0.4-0.8 part of cytidine disodium triphosphate and 0.1-0.3 part of lidocaine aqueous solution;
the preparation method comprises the following steps:
s1, mixing a lactic acid levofloxacin technical product with oleic acid, and stirring until the mixture is completely dissolved to obtain an oil phase;
s2, adding glucose aqueous solution and hydroxylated lecithin into the oil phase, and performing high-shear treatment by using a high-shear emulsifier to obtain levofloxacin lactate colostrum;
s3, adding a cosolvent, cytidine disodium triphosphate and lidocaine carbonate aqueous solution, and then continuously stirring and mixing for 5-15min to obtain the levofloxacin lactate injection.
2. The levofloxacin lactate injection according to claim 1, wherein: the HLB value of the hydroxylation lecithin is 10-12.
3. The levofloxacin lactate injection according to claim 1, wherein: the cosolvent comprises polyethylene glycol and ethanol in a weight ratio of 1:1.
4. The levofloxacin lactate injection according to claim 1, wherein: the lidocaine aqueous solution is a lidocaine carbonate aqueous solution prepared by lidocaine hydrochloride and sodium bicarbonate solution under the condition of carbon dioxide saturation.
5. The levofloxacin lactate injection according to claim 1, wherein: the concentration of the glucose in the glucose aqueous solution is 5-8wt%.
6. A method for preparing levofloxacin lactate injection according to any one of claims 1-5, comprising the steps of:
s1, mixing a lactic acid levofloxacin technical product with oleic acid, and stirring until the mixture is completely dissolved to obtain an oil phase;
s2, adding glucose aqueous solution and hydroxylated lecithin into the oil phase, and performing high-shear treatment by using a high-shear emulsifying machine to obtain levofloxacin lactate colostrum;
s3, adding a cosolvent, cytidine disodium triphosphate and lidocaine carbonate aqueous solution, and then continuously stirring and mixing for 5-15min to obtain the levofloxacin lactate injection.
7. The method for preparing levofloxacin lactate injection according to claim 6, wherein the method comprises the following steps: the high shear operation performed in step S2 is performed at a rotational speed of 24000-26000 rpm.
8. The method for preparing levofloxacin lactate injection according to claim 6, wherein the method comprises the following steps: the preparation method of the levofloxacin lactate injection further comprises the step S4: carrying out 2-4 times of ultrahigh pressure nano homogenization treatment on the obtained levofloxacin lactate injection, wherein the pressure of an ultrahigh pressure nano homogenizer is set to 1400-1600bar.
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| CN108892676A (en) * | 2018-08-06 | 2018-11-27 | 华夏生生药业(北京)有限公司 | A kind of synthetic method of Ofloxacin and lavo-ofloxacin |
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| JPH0881360A (en) * | 1994-07-13 | 1996-03-26 | Wakamoto Pharmaceut Co Ltd | Stable fat emulsion |
| US5693337A (en) * | 1994-07-13 | 1997-12-02 | Wakamoto Pharmaceutical Co., Ltd. | Stable lipid emulsion |
| US6720001B2 (en) * | 1999-10-18 | 2004-04-13 | Lipocine, Inc. | Emulsion compositions for polyfunctional active ingredients |
| CN1274308C (en) * | 2005-06-14 | 2006-09-13 | 舒尊鹏 | Prostatic atrophy antiphlogistic injection liquid |
| CN101467987B (en) * | 2007-12-26 | 2012-02-22 | 上海复星医药（集团）股份有限公司 | Method for preparing lidocaine carbonate injection |
| CN101642434B (en) * | 2009-06-08 | 2011-07-20 | 邓菊娟 | Levofloxacin lactate liposome sodium chloride injection and preparation method thereof |
| CN101690713B (en) * | 2009-09-28 | 2011-12-28 | 普莱柯生物工程股份有限公司 | Preparation method for carbostyril injection |
| CN101703776B (en) * | 2009-09-28 | 2012-07-11 | 洛阳惠中兽药有限公司 | Method for preparing anti-infective agent long-acting injection |
| CN102078290B (en) * | 2009-11-26 | 2014-01-15 | 华北制药集团制剂有限公司 | Method for preparing carbonate lidocaine injection |
| CN102119923B (en) * | 2011-02-25 | 2013-07-17 | 湖南农业大学 | Antibiotic oil-water double suspension type injection emulsion for livestock and preparation method thereof |
| ES2640572T3 (en) * | 2011-04-28 | 2017-11-03 | Platform Brightworks Two, Ltd. | Enhanced parenteral formulations of lipophilic pharmaceutical agents and methods of preparation and use thereof |
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