CN110859801A - Amoxicillin potassium clavulanate dry suspension and preparation method thereof - Google Patents
Amoxicillin potassium clavulanate dry suspension and preparation method thereof Download PDFInfo
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Abstract
The invention discloses an amoxicillin and clavulanate potassium dry suspension and a preparation method thereof, wherein the amoxicillin and clavulanate potassium dry suspension is composed of the following raw materials in parts by mass: 16-18 parts of amoxicillin, 10-12 parts of amoxicillin and potassium clavulanate mixed powder, 70-85 parts of sucrose, 1-9 parts of xanthan gum, 2-10 parts of hydroxypropyl methylcellulose, 2-3 parts of aspartame, 1-12 parts of silicon dioxide and 1-2 parts of fruit milk essence; wherein the mass ratio of amoxicillin to potassium clavulanate in the amoxicillin and potassium clavulanate mixed powder is 2: 1. The dry suspension is prepared by directly filling powder, the dissolution rate in a buffer solution with the pH value of 5.0 is more than 85 percent or F2 is more than 50 percent, and the viscosity of a reference preparation and a self-grinding sample is considered to reduce the BE risk.
Description
Background
Amoxicillin (Amoxicillin CAS number: 61336-70-7) chemical name: (2S,5R,6R) -3, 3-dimethyl-6- [ (R) - (-) -2-amino-2- (4-hydroxyphenyl) acetylamino]-7-oxo-4-thia-1-azaBicyclo [3.2.0]Heptane-2-carboxylic acid trihydrate, of the molecular formula: 419.46, the chemical formula is:
chemical name of Potassium clavulanate (Potasidum clavulanate CAS number: 61177-45-5): (Z) - (2S, 5R) -3- (2-hydroxyethylidene) -7-oxo-4-oxa-1-azabicyclo-3.2.0-heptane-2-carboxylic acid potassium salt of formula: 237.25, chemical structural formula:
amoxicillin is white or white-like crystalline powder, belongs to BCS classification 1 variety under the maximum dose of 875mg, is slightly soluble in water and methanol, is extremely slightly soluble in ethanol, has obvious pH value dependence (pH1.2, pH4.0, pH6.8, water solubility of 30.7, 3.8, 4.9 and 3.6mg/ml respectively), and clavulanate potassium is white to yellowish crystalline powder, is smelly and is easy to absorb moisture, belongs to BCS 3 variety under the maximum dose of 125mg, is easy to dissolve in water, is slightly soluble in ethanol, has no pH value dependence (pH1.2, pH4.0, pH6.8 and water solubility of 2.5 g/ml). Amoxicillin and clavulanate potassium are poor in acid-base stability and stable in pH6.0 medium, and is suitable for producing β -Haemophilus influenzae and Moraxella catarrhalis, lower respiratory tract infection, otitis media and nasosinusitis caused by Escherichia coli, β -producing staphylococcus and Escherichia coli, and can be used for treating skin infection caused by light enterococcus and other bacteria such as light enterococcus infection and intestinal infection.
AUGMENTIN produced by Puerarin SckerTMBID is researched, and the production process is found to be that powder is directly filled, the product specification shows that auxiliary materials used by the product are xanthan gum, aspartame, hydroxypropyl methylcellulose, silicon dioxide, colloidal silicon dioxide and composite essence, and the product is multi-dose and is inconvenient to take and difficult to control dosage.
Disclosure of Invention
Aiming at the problems, in order to facilitate the taking of the product, better control the dosage and reduce the waste, the invention provides the amoxicillin and clavulanate potassium dry suspension and the preparation method thereof, which change the multi-dosage product into single dosage, improve the stability of the product, avoid the degradation of active substances and improve the bioavailability of the dry suspension.
In order to achieve the above purpose, the invention adopts the following technical scheme:
the amoxicillin and clavulanate potassium dry suspension is composed of the following raw materials in parts by mass:
16-18 parts of amoxicillin, 10-12 parts of amoxicillin and potassium clavulanate mixed powder, 70-85 parts of sucrose, 1-9 parts of xanthan gum, 2-10 parts of hydroxypropyl methylcellulose, 2-3 parts of aspartame, 1-12 parts of silicon dioxide and 1-2 parts of fruit milk essence; the mass ratio of amoxicillin to potassium clavulanate in the amoxicillin and potassium clavulanate mixed powder is 2: 1.
Preferably, the amoxicillin and clavulanate potassium dry suspension is composed of the following raw materials in parts by mass: 16.58 parts of amoxicillin, 10.06 parts of amoxicillin and clavulanate potassium mixed powder, 77.4 parts of sucrose, 1.2 parts of xanthan gum, 6.8 parts of hydroxypropyl methylcellulose, 2.4 parts of aspartame, 2.4 parts of silicon dioxide and 1.2 parts of fruit milk essence.
The invention also provides a preparation method of the amoxicillin and clavulanate potassium dry suspension, which comprises the following steps: mixing the above materials, and packaging.
The single potassium clavulanate raw material is difficult to store, so the amoxicillin potassium clavulanate mixed powder (2:1) which is easier to store is used. Sucrose is extracted from sugar crops such as sugar beet or sugar cane. Therefore, the cane sugar is natural food, is harmless to human bodies even if being used frequently, is cheap, has low hygroscopicity, and is selected as a filler. Aspartame is used as sweetener, has high sweetness, can reach higher sweetness by using less amount, has bitter amoxicillin taste, and can increase the compliance of patients by adding the sweetener. The fruit milk essence is used for covering the odor of amoxicillin and potassium clavulanate and increasing the compliance of patients. Hypromellose is a non-ionic cellulose derivative. Has good thermoplasticity, film-forming property, caking property, latex stability and dispersibility, and is a better suspending agent. Silica is a submicron sized silica gel, a lightweight, loose, white, odorless, tasteless, gritty, amorphous powder, and can be used to improve powder flowability, suspension of the solution, and also to prevent agglomeration of the powder. The xanthan gum is white or light yellow powder, can be quickly dissolved in water, has good water solubility, excellent thickening property, suspension property, emulsifying property and water solubility, and good heat and acid-base stability, and has the suspending and thickening effects in the amoxicillin and clavulanate potassium dry suspension.
The invention has the beneficial effects that:
the invention adopts a process of directly filling powder to prepare the amoxicillin and clavulanate potassium dry suspension, and the raw materials comprise amoxicillin, amoxicillin and clavulanate potassium mixed powder (2:1), sucrose, hydroxypropyl methylcellulose, aspartame, xanthan gum, silicon dioxide and fruit milk essence, wherein the sucrose is a filling agent, the hydroxypropyl methylcellulose and the xanthan gum are suspending agents, and the aspartame and the fruit milk essence are flavoring agents. The process is simple, the steps of preparation and the like are reduced, and the prepared amoxicillin and clavulanate potassium dry suspension is qualified in quality and stable in property. Improves the stability in the storage period, avoids the degradation of active substances and also improves the bioavailability of the dry suspension.
Detailed Description
The present invention will be further described with reference to specific examples to assist understanding of the invention.
Example one
The amoxicillin and clavulanate potassium dry suspension in the embodiment is composed of the following raw materials by mass: 16g of amoxicillin, 10.0g of amoxicillin and clavulanate potassium mixed powder, 70g of sucrose, 9g of xanthan gum, 10g of hydroxypropyl methylcellulose, 2g of aspartame, 1g of silicon dioxide and 1g of fruit milk essence.
The preparation method comprises the following steps: pulverizing sucrose, drying aspartame and fruit milk essence at 40 deg.C under normal pressure for 5 hr, drying sucrose, silicon dioxide, xanthan gum and hypromellose at 80 deg.C under normal pressure for 5 hr, weighing the dried adjuvants and amoxicillin and clavulanate potassium mixed powder according to the prescription proportion, mixing, and packaging.
The preparation environment is as follows: the temperature is 27-28 ℃, and the humidity is 33-36%. The prepared sample is dissolved in a medium with the pH value of 5.0, the sample is difficult to sink into the bottom of a dissolving cup on the dissolving liquid level and dissolve, the viscosity of the sample is high, the sample is placed at the high temperature of 60 ℃ for 10 days, and the sample has white-like powder which is changed into light yellow powder.
Example two
The amoxicillin and clavulanate potassium dry suspension in the embodiment is prepared from the following raw materials in parts by mass: 18g of amoxicillin, 12g of amoxicillin and clavulanate potassium mixed powder, 85g of sucrose, 5g of xanthan gum, 2g of hydroxypropyl methylcellulose, 3g of aspartame, 12g of silicon dioxide and 2g of fruit milk essence.
The preparation method comprises the following steps: pulverizing sucrose, drying aspartame and fruit milk essence at 40 deg.C under normal pressure for 5 hr, drying sucrose, aspartame, silicon dioxide, xanthan gum and hypromellose at 80 deg.C under normal pressure for 5 hr, weighing the dried adjuvants and amoxicillin and clavulanate potassium mixed powder according to the prescription ratio, mixing, and packaging.
The preparation environment is as follows: the temperature is 27-28 ℃, and the humidity is 33-36%. The prepared sample is dissolved in a medium with the pH value of 5.0, the amoxicillin has better similarity compared with the original grinding, the clavulanic acid is slowly dissolved out compared with the original grinding, the viscosity of the clavulanic acid is higher, and the sample is placed at the high temperature of 60 ℃ for 10 days and is changed from white-like powder to light yellow powder.
EXAMPLE III
The amoxicillin and clavulanate potassium dry suspension in the embodiment is prepared from the following raw materials in parts by mass: 16.5g of amoxicillin, 10.0g of amoxicillin and clavulanate potassium mixed powder, 77.8g of sucrose, 1g of xanthan gum, 4.4g of hydroxypropyl methylcellulose, 2.4g of aspartame, 2.4g of silicon dioxide and 1.2g of fruit milk essence.
The preparation method comprises the following steps: pulverizing sucrose, drying aspartame and fruit milk essence at 40 deg.C under normal pressure for 5 hr, drying sucrose, aspartame, silicon dioxide, xanthan gum and hypromellose at 80 deg.C under normal pressure for 5 hr, weighing the dried adjuvants and amoxicillin and clavulanate potassium mixed powder according to the prescription ratio, mixing, and packaging.
The preparation environment is as follows: the temperature is 27-28 ℃, and the humidity is 33-36%. The prepared sample is dissolved out in a medium with the pH value of 5.0, the similarity of amoxicillin and the original research is better, the dissolution of the clavulanic acid is more consistent with the original research, and the viscosity of the clavulanic acid is lower than that of a reference preparation. The sample was left at a high temperature of 60 ℃ for 10 days to change from a white-like powder to a yellowish powder.
Example four
The amoxicillin and clavulanate potassium dry suspension in the embodiment is prepared from the following raw materials in parts by mass: 16.58g of amoxicillin, 10.06g of amoxicillin and clavulanate potassium mixed powder, 77.4g of sucrose, 1.2g of xanthan gum, 6.8g of hydroxypropyl methylcellulose, 2.4g of aspartame, 2.4g of silicon dioxide and 1.2g of fruit milk essence.
The preparation method comprises the following steps: pulverizing sucrose, drying aspartame and fruit milk essence at normal pressure at 40 deg.C for 5 hr, drying sucrose, silicon dioxide, xanthan gum and hypromellose at normal pressure at 80 deg.C for 5 hr, weighing the dried adjuvants, amoxicillin and amoxicillin potassium clavulanate mixed powder according to the prescription ratio, mixing, and packaging.
The preparation environment is as follows: the temperature is 13-18 ℃, and the humidity is 12-20%.
The prepared sample is dissolved out in a medium with the pH value of 5.0, the amoxicillin has better similarity compared with the original grinding, the clavulanic acid is dissolved out more consistently compared with the original grinding, the viscosity of the clavulanic acid is consistent with that of a reference preparation, the clavulanic acid is placed at the high temperature of 60 ℃ for 10 days, and the sample is white-like powder and is not changed.
Examples one to four examples the blend-in and viscosity ratio of the dry suspension of amoxicillin and clavulanate potassium prepared is shown in tables 1 and 2:
table 1:
table 2:
| sample (I) | Reference formulation | Example one | Example two | EXAMPLE III | Example four |
| Viscosity mPa.S | 536.0 | 1585.0 | 1051.5 | 427.0 | 524.6 |
As can be seen from the above table, the dissolution of the third and fourth examples in the medium with pH5.0 is consistent with that of the reference preparation, the dissolution amount of amoxicillin in 15 minutes is more than 85%, and the dissolution amount of clavulanic acid in 5 minutes is more than 90%. The embodiment has the optimal square proportion.
EXAMPLE five
This example illustrates the screening of the amount of silica.
The amounts of the respective raw materials used are shown in table 3.
Table 3:
formulas 1-3 amoxicillin and clavulanate potassium dry suspension was prepared according to the preparation method in example four, wherein 2% silica was used for formula 1, 5% silica was used for formula 2, and 10% silica was used for formula 3, samples were kept at high temperature of 60 ℃ for 10 days and at accelerated temperature (40 ℃ and humidity of 75%) for 30 days, and the content of amoxicillin and clavulanic acid and the content of related substances were measured, and the results are shown in tables 4 and 5.
Table 4:
table 5:
as can be seen from the table above, the content of the reserved sample in the formulas 1-3 is not obviously changed, the related substances of the reserved sample tend to increase along with the increase of the silicon dioxide dosage in the formulas, and compared with the content of the silicon dioxide, the related substances of the sample in the formula 1 are better, and the sample stability is good.
EXAMPLE six
And (3) preparing production batch samples according to a preferable prescription and a preferable process, carrying out stability inspection on the production batch samples, and detecting the contents of amoxicillin and clavulanic acid and the contents of related substances, wherein the results are shown in tables 6 and 7.
Table 6:
| sample retention time | Day 0 | Accelerating for 1 month | Accelerated for 2 months | Accelerated for 3 months | Accelerated for 6 months |
| AmomuContent of penicillin% | 100.8 | 101.4 | 100.7 | 100.4 | 99.9 |
| The content of clavulanic acid% | 101.5 | 102.8 | 102.6 | 102.5 | 101.2 |
Table 7:
| sample retention time | Impurity D% | Impurity C% | Impurity J% | Not known as single hetero% | Total miscellaneous% |
| Day 0 | 0.12 | 0.04 | 0.16 | 0.15 | 0.77 |
| Accelerating for 1 month | 0.11 | 0.04 | 0.17 | 0.16 | 0.78 |
| Accelerated for 2 months | 0.16 | 0.02 | 0.13 | 0.15 | 0.80 |
| Accelerated for 3 months | 0.13 | 0.04 | 0.16 | 0.16 | 0.81 |
| Accelerated for 6 months | 0.07 | 0.05 | 0.17 | 0.17 | 0.83 |
From the stability data in the table above, it can be known that the contents of amoxicillin and clavulanic acid of the sample are basically unchanged under the condition of accelerated sample retention, the related substances are not obviously changed, and the total impurities are only increased by 0.06%, so that the sample prepared by the formula and the process is stable.
Claims (6)
1. The amoxicillin and clavulanate potassium dry suspension is characterized by comprising the following raw materials in parts by mass:
16-18 parts of amoxicillin, 10-12 parts of amoxicillin and potassium clavulanate mixed powder, 70-85 parts of sucrose, 1-9 parts of xanthan gum, 2-10 parts of hydroxypropyl methylcellulose, 2-3 parts of aspartame, 1-12 parts of silicon dioxide and 1-2 parts of fruit milk essence; the mass ratio of amoxicillin to potassium clavulanate in the amoxicillin and potassium clavulanate mixed powder is 2: 1.
2. The amoxicillin and clavulanate potassium dry suspension as claimed in claim 1, which is characterized by comprising the following raw materials in parts by mass:
16.58 parts of amoxicillin, 10.06 parts of amoxicillin and clavulanate potassium mixed powder, 77.4 parts of sucrose, 1.2 parts of xanthan gum, 6.8 parts of hydroxypropyl methylcellulose, 2.4 parts of aspartame, 2.4 parts of silicon dioxide and 1.2 parts of fruit milk essence.
3. The amoxicillin and clavulanate potassium dry suspension as claimed in claim 1, which is characterized by comprising the following raw materials in parts by mass:
16.5 parts of amoxicillin, 10 parts of amoxicillin and clavulanate potassium mixed powder, 79.5 parts of sucrose, 1.2 parts of xanthan gum, 6.8 parts of hydroxypropyl methylcellulose, 2.4 parts of aspartame, 2.4 parts of silicon dioxide and 1.2 parts of fruit milk essence.
4. The amoxicillin and clavulanate potassium dry suspension as claimed in claim 1, which is characterized by comprising the following raw materials in parts by mass:
16.5 parts of amoxicillin, 10 parts of amoxicillin and clavulanate potassium mixed powder, 75.9 parts of sucrose, 1.2 parts of xanthan gum, 6.8 parts of hydroxypropyl methylcellulose, 2.4 parts of aspartame, 6 parts of silicon dioxide and 1.2 parts of fruit milk essence.
5. The amoxicillin and clavulanate potassium dry suspension as claimed in claim 1, which is characterized by comprising the following raw materials in parts by mass:
16.5 parts of amoxicillin, 10 parts of amoxicillin and clavulanate potassium mixed powder, 77.8 parts of sucrose, 1 part of xanthan gum, 4.4 parts of hydroxypropyl methylcellulose, 2.4 parts of aspartame, 2.4 parts of silicon dioxide and 1.3 parts of fruit milk essence.
6. A preparation method of the amoxicillin and clavulanate potassium dry suspension as claimed in claims 1-5, which is characterized in that the preparation method comprises the following steps: mixing the above materials, and packaging.
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| CN114432241A (en) * | 2021-12-21 | 2022-05-06 | 上海奥全生物医药科技有限公司 | Suspending aid composition capable of being rapidly dispersed, preparation method and application thereof |
| CN114432241B (en) * | 2021-12-21 | 2023-07-14 | 上海奥全生物医药科技有限公司 | Rapidly-dispersed suspension composition, preparation method and application thereof |
| CN116327760A (en) * | 2022-12-26 | 2023-06-27 | 南京臣功制药股份有限公司 | Amoxicillin and clavulanate potassium sustained-release dry suspension and preparation method thereof |
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