CN105168154A - Phenobarbital oral freeze-dried powder preparation and preparation method thereof - Google Patents
Phenobarbital oral freeze-dried powder preparation and preparation method thereof Download PDFInfo
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- CN105168154A CN105168154A CN201510650425.1A CN201510650425A CN105168154A CN 105168154 A CN105168154 A CN 105168154A CN 201510650425 A CN201510650425 A CN 201510650425A CN 105168154 A CN105168154 A CN 105168154A
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Abstract
The invention relates to a phenobarbital oral freeze-dried powder preparation and a preparation method thereof. The oral freeze-dried powder is prepared from phenobarbital and freeze-dried skeleton agents. The phenobarbital oral freeze-dried powder obtained by adopting a freeze drying technology is high in dissolution rate and accurate in dosage and is used for treating diseases such as neonatal jaundice.
Description
Technical field
The invention belongs to chemical pharmacy field, be specifically related to oral freeze-dried powder of a kind of phenobarbital and preparation method thereof.
Background technology
Medically non-full moon (being born in 28 days) neonatal jaundice, be referred to as neonatal jaundice, neonatal jaundice refers to non-neonate, because bilirubin metabolism is abnormal, blood mesobilirubin level is caused to raise, and to come across skin, mucosa and sclera jaundice be the disease of feature, primary disease have physiological and pathologic point.Physiologic jaundice occurs after birth for 2 ~ 3 days, and within 4 ~ 6 days, peak, within 7 ~ 10 days, disappear, premature infant's persistent period is longer, apart from outside slight inappetence, without other clinical symptoms.If within latter 24 hours, namely occur jaundice raw, every day, serum bilirubin increased to over 5mg/dl or >0.5mg/dl per hour; Persistent period is long, and in term infant >2 week, premature infant >4 week does not still move back, even continue intensification increase the weight of repeat after disappearing or raw after just start to occur jaundice in thoughtful several weeks, be pathological jaundice.Pathological jaundice is quite different, and it is because the various cause of disease causes.Some disease remains serious, and can injure the life of children's.Neonatal hemolytic is modal Jaundice disease, and it is blood group incompatibility due to neonate and mother and causes FE coagulation to destroy to occur haemolysis, cause anemia, edema, hepatosplenomegaly, hyperbilirubinemia.If bilirubin a large amount of in body invades the axoneure core of people, its jaundice occurred is just relatively more serious, and be medically referred to as bilirubin encephalopathy, its case fatality rate is higher, and easily leaves sequela.Modal treatment way is change-blood.Mild can adopt phototherapy, is blue light illumination again, and the method for this method for taking stopgap measures, can not effect a permanent cure.Therefore, phototherapy can not replace change-blood, but can reduce the number of times of change-blood.The main manifestations of neonatal hepatitis is jaundice, usually appears at neonatal period, and because physiologic jaundice is persistent and medical, after inspection is made a definite diagnosis, the patient through certain treatment 60-70% can cure, and prognosis is better.When the patient of congenital biliary atresia is born, appearance is all normal, after raw latter 11 weeks, starts to occur xanthochromia, and increases the weight of gradually, and its yellow is comparatively dark, slightly brown-green.Doctor trained in Western medicine is referred to as green jaundice, and the traditional Chinese medical science is thought and belonged to YIN jaundice category, its feces to be canescence be its another large feature.Due to the restriction of surgery operating technology, some patients is only had to adopt operative treatment.Can adopt hormonotherapy in addition, but primary disease prognosis is poor, youngster is after 3 months, and liver starts sclerosis, 6 months to 2 years old endogenous cause of ill hepatic failure and dead, and only small number of patients is survived longer.
Phenobarbital is Liver enzyme inducer, can the MC drug metabolism enzyme of inducing hepatocyte, promotes bilirubinic metabolism, reduces the concentration of blood mesobilirubin, jaundice is disappeared.Glucose is monosaccharide molecule in addition, directly can be utilized by human body and absorption enters blood circulation, glucose is again crystalline solid, enter blood circulation can form transient blood volume increase and cause osmotic diuresis, thus add the osmotic diuresis effect of kidney, the bilirubin too much produced in blood and the fragment that is not true to type thereof are excreted from glomerular filtration by the induced effect of osmotic pressure, thus its part reduces jaundice effect.Another effect of glucose is hepatoprotective effect, certain blood sugar concentration is very important to hepatocellular moist effect, various metabolic enzymes in liver mostly are glycoprotein molecule, glucose molecule is all needed to participate in, only have the maturation of liver enzyme that liver just can be made to transform bilirubin and make its metabolism Sum decomposition, reduce serum bilirubin level, jaundice situation is reduced.
Neonate administering mode and dosage accurately become the problem that people pay close attention to.Neonate is had any problem to Tablet and Capsula of swallowing, and have impact on the compliance of Drug therapy; Ordinary preparation is as inaccurate in oral liquid metering, cause that neonate dosage is inadequate or dosage is bigger than normal, and oral freeze-dried powder adds a small amount of water dissolution, neonate oral cavity is put into by child's medicine-feeding utensil, digestive tract is entered with swallowing act, without mucosa absorption in oral cavity, body absorption, metabolic process are consistent with conventional tablet, just can address this problem.Compared with ordinary preparation, dosage accurately, absorption is fast, bioavailability is high, to advantages such as alimentary canal mucous membrane zest are little, be subject to extensive concern.Therefore, develop the oral freeze-dried powder of a kind of phenobarbital, will there is important market value and social benefit.
Summary of the invention
One object of the present invention is to provide a kind of phenobarbital oral freeze-dried powder, and the composition simple and stable of this lyophilized powder is good, can the storage of long period.
Another object of the present invention is the preparation method providing the oral freeze-dried powder of a kind of phenobarbital, and the obtained oral freeze-dried opaque ground of phenobarbital of the method loosens, and can dissolve rapidly and recover the primary characteristic of medicinal liquid after adding water.
The oral freeze-dried powder of the phenobarbital provided of the present invention is made up of phenobarbital, glucose.Described phenobarbital and the weight ratio of glucose are 1:2-1:20, preferred 1:3-1:10, with preferred 1:3-1:5.
From prescription, the selection of adjuvant is analyzed, and the principle that the present inventor follows is, do not affecting under medicine stability, the prerequisite of product that meets clinical needs, the composition of adjuvant is more simple better.The composition of adjuvant is simpler, and preparation greatly can simplify batching step in production technology, and meanwhile, adjuvant can be avoided the to be divided into side effect being difficult to expect that complexity brings, therefore, the present invention only selects a kind of adjuvant of glucose.
Glucose is monosaccharide molecule in addition, directly can be utilized by human body and absorption enters blood circulation, glucose is again crystalline solid, enter blood circulation can form transient blood volume increase and cause osmotic diuresis, thus add the osmotic diuresis effect of kidney, the bilirubin too much produced in blood and the fragment that is not true to type thereof are excreted from glomerular filtration by the induced effect of osmotic pressure, thus its part reduces jaundice effect.Another effect of glucose is hepatoprotective effect, certain blood sugar concentration is very important to hepatocellular moist effect, various metabolic enzymes in liver mostly are glycoprotein molecule, glucose molecule is all needed to participate in, only have the maturation of liver enzyme that liver just can be made to transform bilirubin and make its metabolism Sum decomposition, reduce serum bilirubin level, jaundice situation is reduced.Therefore, select glucose as the agent of oral freeze-dried powder skeleton, phenobarbital treatment neonatal jaundice can be assisted again.
In order to the present invention that solves the problem discloses the oral freeze-dried powder, preparation method thereof of a kind of phenobarbital, the oral freeze-dried powder of phenobarbital is made up of phenobarbital, glucose, wherein the weight ratio of phenobarbital and skeleton agent is 1:2-1:20, preferred 1:3-1:10, with preferred 1:3-1:5.Prepared by following steps:
(1) phenobarbital of recipe quantity is joined in water for injection, be heated to 40 DEG C, then in above-mentioned solution, add skeleton agent, stirring and dissolving, with sodium hydroxide or hydrochloric acid conditioning solution pH6-7, add sterilized water for injection to full dose;
(2) add active carbon in the solution prepared in step (1), the consumption of active carbon is the 0.1g/mL of liquor capacity, filters;
(3) filtrate that step (2) obtains is placed in lowers the temperature in the household freezer of-20 DEG C, tentatively freezing 3 hours, and then dropped to-50 DEG C, evacuation, in 10 hours, be warming up to-8 ~-6 DEG C, and maintain 6 hours, then be warming up to 22-30 DEG C in 7-10 hour, and maintain 6 hours, namely obtain the oral freeze-dried powder of phenobarbital.
Technical solution of the present invention compared with prior art, has following beneficial effect:
Phenobarbital lyophilized powder dosage of the present invention is accurate, and enter a small amount of water dissolution, put into neonate oral cavity, enter digestive tract with swallowing act by child's medicine-feeding utensil, without mucosa absorption in oral cavity, body absorption, metabolic process are consistent with conventional tablet.Compliance is good, suitable especially neonate, steady quality, and onset is rapid; Solve Kotabarb and capsule onset slow, take inconvenience, oral liquid carries inconvenience, the unfavorable shortcoming such as quantitatively to take.In phenobarbital lyophilized powder of the present invention, supplementary product consumption is little, and preparation technology is simple, has considerable economic and social benefit.
Detailed description of the invention
Further describe the present invention below in conjunction with specific embodiment, advantage and disadvantage of the present invention will be more clear along with description.It should be understood that described embodiment is only exemplary, any restriction is not formed to scope of the present invention.It will be understood by those skilled in the art that and can modify to the details of technical solution of the present invention and form or replace down without departing from the spirit and scope of the present invention, but these amendments or replacement all fall into protection scope of the present invention.
Embodiment 1
Every bottle contains phenobarbital 7.5mg, consisting of of 1000 bottles of phenobarbital oral cavity disintegration tablets:
(1) phenobarbital of recipe quantity is joined in water for injection, be heated to 40 DEG C, then in above-mentioned solution, add skeleton agent, stirring and dissolving, regulate pH value of solution 6-7, add sterilized water for injection to full dose;
(2) add active carbon in the solution prepared in step (1), the consumption of active carbon is the 0.1g/mL of liquor capacity, filters;
(3) filtrate that step (2) obtains is placed in lowers the temperature in the household freezer of-20 DEG C, tentatively freezing 3 hours, and then dropped to-50 DEG C, evacuation, in 10 hours, be warming up to-8 ~-6 DEG C, and maintain 6 hours, then be warming up to 22-30 DEG C in 7-10 hour, and maintain 6 hours, namely obtain the oral freeze-dried powder of phenobarbital.
Embodiment 2
Every bottle contains phenobarbital 10mg, consisting of of 1000 bottles of phenobarbital oral cavity disintegration tablets:
(1) phenobarbital of recipe quantity is joined in water for injection, be heated to 40 DEG C, then in above-mentioned solution, add skeleton agent, stirring and dissolving, regulate pH value of solution, add sterilized water for injection to full dose;
(2) add active carbon in the solution prepared in step (1), the consumption of active carbon is the 0.1g/mL of liquor capacity, filters;
(3) filtrate that step (2) obtains is placed in lowers the temperature in the household freezer of-20 DEG C, tentatively freezing 3 hours, and then dropped to-50 DEG C, evacuation, in 10 hours, be warming up to-8 ~-6 DEG C, and maintain 6 hours, then be warming up to 22-30 DEG C in 7-10 hour, and maintain 6 hours, namely obtain the oral freeze-dried powder of phenobarbital.
Embodiment 3
Every bottle contains phenobarbital 7.5mg, consisting of of 1000 bottles of phenobarbital oral cavity disintegration tablets:
(1) phenobarbital of recipe quantity is joined in water for injection, be heated to 40 DEG C, then in above-mentioned solution, add skeleton agent, stirring and dissolving, regulate pH value of solution 6-7, add sterilized water for injection to full dose;
(2) add active carbon in the solution prepared in step (1), the consumption of active carbon is the 0.1g/mL of liquor capacity, filters;
(3) filtrate that step (2) obtains is placed in lowers the temperature in the household freezer of-20 DEG C, tentatively freezing 3 hours, and then dropped to-50 DEG C, evacuation, in 10 hours, be warming up to-8 ~-6 DEG C, and maintain 6 hours, then be warming up to 22-30 DEG C in 7-10 hour, and maintain 6 hours, namely obtain the oral freeze-dried powder of phenobarbital.
Embodiment 4
Every bottle contains phenobarbital 10mg, consisting of of 1000 bottles of phenobarbital oral cavity disintegration tablets:
(1) phenobarbital of recipe quantity is joined in water for injection, be heated to 40 DEG C, then in above-mentioned solution, add skeleton agent, stirring and dissolving, regulate pH value of solution, add sterilized water for injection to full dose;
(2) add active carbon in the solution prepared in step (1), the consumption of active carbon is the 0.1g/mL of liquor capacity, filters;
(3) filtrate that step (2) obtains is placed in lowers the temperature in the household freezer of-20 DEG C, tentatively freezing 3 hours, and then dropped to-50 DEG C, evacuation, in 10 hours, be warming up to-8 ~-6 DEG C, and maintain 6 hours, then be warming up to 22-30 DEG C in 7-10 hour, and maintain 6 hours, namely obtain the oral freeze-dried powder of phenobarbital.
Embodiment 5
Every bottle contains phenobarbital 7.5mg, consisting of of 1000 bottles of phenobarbital oral cavity disintegration tablets:
(1) phenobarbital of recipe quantity is joined in water for injection, be heated to 40 DEG C, then in above-mentioned solution, add skeleton agent, stirring and dissolving, regulate pH value of solution 6-7, add sterilized water for injection to full dose;
(2) add active carbon in the solution prepared in step (1), the consumption of active carbon is the 0.1g/mL of liquor capacity, filters;
(3) filtrate that step (2) obtains is placed in lowers the temperature in the household freezer of-20 DEG C, tentatively freezing 3 hours, and then dropped to-50 DEG C, evacuation, in 10 hours, be warming up to-8 ~-6 DEG C, and maintain 6 hours, then be warming up to 22-30 DEG C in 7-10 hour, and maintain 6 hours, namely obtain the oral freeze-dried powder of phenobarbital.
Embodiment 6
Every bottle contains phenobarbital 10mg, consisting of of 1000 bottles of phenobarbital oral cavity disintegration tablets:
(1) phenobarbital of recipe quantity is joined in water for injection, be heated to 40 DEG C, then in above-mentioned solution, add skeleton agent, stirring and dissolving, regulate pH value of solution, add sterilized water for injection to full dose;
(2) add active carbon in the solution prepared in step (1), the consumption of active carbon is the 0.1g/mL of liquor capacity, filters;
(3) filtrate that step (2) obtains is placed in lowers the temperature in the household freezer of-20 DEG C, tentatively freezing 3 hours, and then dropped to-50 DEG C, evacuation, in 10 hours, be warming up to-8 ~-6 DEG C, and maintain 6 hours, then be warming up to 22-30 DEG C in 7-10 hour, and maintain 6 hours, namely obtain the oral freeze-dried powder of phenobarbital.
Embodiment 7
Every bottle contains phenobarbital 7.5mg, consisting of of 1000 bottles of phenobarbital oral cavity disintegration tablets:
(1) phenobarbital of recipe quantity is joined in water for injection, be heated to 40 DEG C, then in above-mentioned solution, add skeleton agent, stirring and dissolving, regulate pH value of solution 6-7, add sterilized water for injection to full dose;
(2) add active carbon in the solution prepared in step (1), the consumption of active carbon is the 0.1g/mL of liquor capacity, filters;
(3) filtrate that step (2) obtains is placed in lowers the temperature in the household freezer of-20 DEG C, tentatively freezing 3 hours, and then dropped to-50 DEG C, evacuation, in 10 hours, be warming up to-8 ~-6 DEG C, and maintain 6 hours, then be warming up to 22-30 DEG C in 7-10 hour, and maintain 6 hours, namely obtain the oral freeze-dried powder of phenobarbital.
Embodiment 8
Every bottle contains phenobarbital 7.5mg, consisting of of 1000 bottles of phenobarbital oral cavity disintegration tablets:
(1) phenobarbital of recipe quantity is joined in water for injection, be heated to 40 DEG C, then in above-mentioned solution, add skeleton agent, stirring and dissolving, regulate pH value of solution, add sterilized water for injection to full dose;
(2) add active carbon in the solution prepared in step (1), the consumption of active carbon is the 0.1g/mL of liquor capacity, filters;
(3) filtrate that step (2) obtains is placed in lowers the temperature in the household freezer of-20 DEG C, tentatively freezing 3 hours, and then dropped to-50 DEG C, evacuation, in 10 hours, be warming up to-8 ~-6 DEG C, and maintain 6 hours, then be warming up to 22-30 DEG C in 7-10 hour, and maintain 6 hours, namely obtain the oral freeze-dried powder of phenobarbital.
Embodiment 9
Every bottle contains phenobarbital 10mg, consisting of of 1000 bottles of phenobarbital oral cavity disintegration tablets:
(1) phenobarbital of recipe quantity is joined in water for injection, be heated to 40 DEG C, then in above-mentioned solution, add skeleton agent, stirring and dissolving, regulate pH value of solution 6-7, add sterilized water for injection to full dose;
(2) add active carbon in the solution prepared in step (1), the consumption of active carbon is the 0.1g/mL of liquor capacity, filters;
(3) filtrate that step (2) obtains is placed in lowers the temperature in the household freezer of-20 DEG C, tentatively freezing 3 hours, and then dropped to-50 DEG C, evacuation, in 10 hours, be warming up to-8 ~-6 DEG C, and maintain 6 hours, then be warming up to 22-30 DEG C in 7-10 hour, and maintain 6 hours, namely obtain the oral freeze-dried powder of phenobarbital.
Embodiment 10
Every bottle contains phenobarbital 7.5mg, consisting of of 1000 bottles of phenobarbital oral cavity disintegration tablets:
(1) phenobarbital of recipe quantity is joined in water for injection, be heated to 40 DEG C, then in above-mentioned solution, add skeleton agent, stirring and dissolving, regulate pH value of solution, add sterilized water for injection to full dose;
(2) add active carbon in the solution prepared in step (1), the consumption of active carbon is the 0.1g/mL of liquor capacity, filters;
(3) filtrate that step (2) obtains is placed in lowers the temperature in the household freezer of-20 DEG C, tentatively freezing 3 hours, and then dropped to-50 DEG C, evacuation, in 10 hours, be warming up to-8 ~-6 DEG C, and maintain 6 hours, then be warming up to 22-30 DEG C in 7-10 hour, and maintain 6 hours, namely obtain the oral freeze-dried powder of phenobarbital.
Claims (3)
1. the oral freeze-dried powder, preparation method thereof of phenobarbital, is characterized in that, the oral freeze-dried powder of described phenobarbital is made up of phenobarbital, the agent of lyophilizing skeleton, is prepared by following steps:
(1) phenobarbital of recipe quantity is joined in water for injection, be heated to 40 DEG C, then in above-mentioned solution, add skeleton agent, stirring and dissolving, regulate pH value of solution 6-7, add sterilized water for injection to full dose;
(2) add active carbon in the solution prepared in step (1), the consumption of active carbon is the 0.1g/mL of liquor capacity, filters;
(3) filtrate that step (2) obtains is placed in lowers the temperature in the household freezer of-20 DEG C, tentatively freezing 3 hours, and then dropped to-50 DEG C, evacuation, in 10 hours, be warming up to-8 ~-6 DEG C, and maintain 6 hours, then be warming up to 22-30 DEG C in 7-10 hour, and maintain 6 hours, namely obtain the oral freeze-dried powder of phenobarbital.
2. the oral freeze-dried powder of phenobarbital according to claim 1, is characterized in that, the weight ratio of described phenobarbital and skeleton agent is 1:2-1:20, and preferred 1:3-1:10, with preferred 1:3-1:5.
3. the oral freeze-dried powder of phenobarbital according to claim 1, is characterized in that, described skeleton agent is one or both in glucose, mannitol, dextran, lactose, maltose, fructose, preferred glucose.
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| CN201510650425.1A CN105168154A (en) | 2015-09-30 | 2015-09-30 | Phenobarbital oral freeze-dried powder preparation and preparation method thereof |
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| CN201510650425.1A CN105168154A (en) | 2015-09-30 | 2015-09-30 | Phenobarbital oral freeze-dried powder preparation and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109651204A (en) * | 2019-01-18 | 2019-04-19 | 山东新华制药股份有限公司 | A method of 2- phenyl butyryl urea is isolated and purified from phenobarbital production activated carbon waste residue |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH06234649A (en) * | 1993-02-12 | 1994-08-23 | Kotarou Kanpou Seiyaku Kk | Anticonvulsant |
| CN105147625A (en) * | 2015-09-30 | 2015-12-16 | 合肥华方医药科技有限公司 | Oral phenobarbital freeze-dried powder preparation and preparation method thereof |
-
2015
- 2015-09-30 CN CN201510650425.1A patent/CN105168154A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH06234649A (en) * | 1993-02-12 | 1994-08-23 | Kotarou Kanpou Seiyaku Kk | Anticonvulsant |
| CN105147625A (en) * | 2015-09-30 | 2015-12-16 | 合肥华方医药科技有限公司 | Oral phenobarbital freeze-dried powder preparation and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| MALGORZATA SZNITOWSKA ET AL: "THE PHYSICAL CHARACTERISTICS OF LYOPHILIZED TABLETS CONTAINING A MODEL DRUG IN DIFFERENT CHEMICAL FORMS AND CONCENTRATIONS", 《ACTA POLONIAE PHARMACEUTICA-DRUG RESEARCH》 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109651204A (en) * | 2019-01-18 | 2019-04-19 | 山东新华制药股份有限公司 | A method of 2- phenyl butyryl urea is isolated and purified from phenobarbital production activated carbon waste residue |
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Application publication date: 20151223 |
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