CN113398069A - Veterinary amoxicillin and sulfadiazine sodium suspension injection and preparation method and device thereof - Google Patents
Veterinary amoxicillin and sulfadiazine sodium suspension injection and preparation method and device thereof Download PDFInfo
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- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/425—Thiazoles
- A61K31/429—Thiazoles condensed with heterocyclic ring systems
- A61K31/43—Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula, e.g. penicillins, penems
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- A61K31/63—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide
- A61K31/635—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide having a heterocyclic ring, e.g. sulfadiazine
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- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
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- A61P1/12—Antidiarrhoeals
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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Abstract
The invention relates to the technical field of veterinary medicines, in particular to an amoxicillin and sulfadiazine sodium suspension injection for veterinary use and a preparation method and a preparation device thereof.
Description
Technical Field
The invention relates to the technical field of veterinary medicines, in particular to an amoxicillin and sulfadiazine sodium suspension injection for veterinary use, and a preparation method and a device thereof.
Background
The animal husbandry is well developed at present, but intestinal infections such as yellow scour, white scour and gastroenteritis of piglets and various diarrhea, bacillary dysentery and the like can occur in the process of breeding livestock.
Veterinary drugs such as amoxicillin and colistin sulfate exist in the market at present, but the production process is complex and the cost is high.
Disclosure of Invention
The invention aims to provide the veterinary amoxicillin and sulfadiazine sodium suspension injection with simple production process and low cost, and the preparation method and the device thereof.
In order to achieve the aim, the invention provides a veterinary amoxicillin and sulfadiazine sodium suspension injection, which comprises raw materials and auxiliary materials, wherein the raw materials comprise 100g of veterinary amoxicillin and 20g of sulfadiazine sodium, and the auxiliary materials comprise 20g of calcium stearate, 60g of ethyl oleate and 1200ml of soybean oil for injection.
The invention also provides a preparation method of the amoxicillin and sulfadiazine sodium suspension injection for livestock, which comprises the following steps:
adding 1200ml of soybean oil for injection and 20g of calcium stearate into a blending tank, and heating until the calcium stearate is completely dissolved;
adding 60g of ethyl oleate into a batching tank;
adding 100g of amoxicillin and 20g of sulfadiazine sodium for livestock into a mixing tank, and stirring to obtain a liquid medicine;
and placing the liquid medicine into a sterile homogenizing bag and homogenizing for multiple times by using a homogenizer to obtain the amoxicillin and sulfadiazine sodium suspension injection for the livestock.
Wherein, before the step of adding 1200ml of soybean oil for injection and 20g of calcium stearate into a proportioning tank for heating until the calcium stearate is completely dissolved, the method also comprises the following steps:
and sterilizing the raw materials and the auxiliary materials.
The method comprises the following specific steps of adding 1200ml of soybean oil for injection and 20g of calcium stearate into a blending tank, and heating until the calcium stearate is completely dissolved:
adding 1200ml of soybean oil for injection and 20g of calcium stearate into a batching tank;
heating the material mixing tank at 150 ℃;
stirring was carried out during heating to completely dissolve the calcium stearate.
The method comprises the following specific steps of adding 60g of ethyl oleate into a batching tank:
when the heating temperature is reduced to 110 ℃, 60g of ethyl oleate is added and stirred;
after stirring uniformly, the temperature was cooled to 60 ℃.
The method comprises the following specific steps of putting the liquid medicine into a sterile homogenizing bag, and homogenizing the liquid medicine for multiple times by using a homogenizer to obtain the amoxicillin and sulfadiazine sodium suspension injection for the livestock:
placing the liquid medicine into a sterile homogenizing bag and placing the bag in a homogenizer;
adjusting the pressure of the homogenizer to 300-400 bar, and homogenizing the liquid medicine for 5 times;
and (3) adjusting the pressure of the homogenizer to 1700-1900 bar, and homogenizing the liquid medicine for 12 times to obtain the amoxicillin and sulfadiazine sodium suspension injection for the livestock.
The invention also provides a device adopting the preparation method of the amoxicillin and sulfadiazine sodium suspension injection for livestock, which comprises a fixed base, a mixing tank, a heater and a homogenizer, wherein the heater is fixedly arranged inside the fixed base, the mixing tank is detachably connected with the base, the mixing tank is positioned above the heater, and the homogenizer is fixedly arranged on the fixed base.
The amoxicillin and sulfadiazine sodium suspension injection for livestock and the preparation method and the device have the advantages of simple production process and low production cost, and meet the relevant regulations of Chinese veterinary pharmacopoeia.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the drawings without creative efforts.
Fig. 1 is a flow chart of a preparation method of the amoxicillin and sulfadiazine sodium suspension injection for livestock provided by the invention.
Fig. 2 is a flow chart of a specific step S200 in the preparation method of the amoxicillin and sulfadiazine sodium suspension injection for livestock provided by the invention.
Fig. 3 is a flow chart of a specific step S300 in the preparation method of the amoxicillin and sulfadiazine sodium suspension injection for livestock provided by the invention.
Fig. 4 is a flow chart of a specific step S500 in the preparation method of the amoxicillin and sulfadiazine sodium suspension injection for livestock provided by the invention.
Fig. 5 is a structural diagram of the device adopting the preparation method of amoxicillin and sulfadiazine sodium suspension injection for livestock provided by the invention.
1-fixing a machine base, 11-installing grooves, 2-proportioning tanks, 3-heaters, 4-homogenizers, 5-fixing structures, 51-pressure springs, 52-supporting frames and 53-protective sheets.
Detailed Description
Reference will now be made in detail to embodiments of the present invention, examples of which are illustrated in the accompanying drawings, wherein like or similar reference numerals refer to the same or similar elements or elements having the same or similar function throughout. The embodiments described below with reference to the drawings are illustrative and intended to be illustrative of the invention and are not to be construed as limiting the invention.
In the description of the present invention, it is to be understood that the terms "length", "width", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", and the like, indicate orientations or positional relationships based on the orientations or positional relationships illustrated in the drawings, and are used merely for convenience in describing the present invention and for simplicity in description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed in a particular orientation, and be operated, and thus, are not to be construed as limiting the present invention. Further, in the description of the present invention, "a plurality" means two or more unless specifically defined otherwise.
Referring to fig. 1 to 4, the invention provides a veterinary amoxicillin and sulfadiazine sodium suspension injection, which comprises raw materials and auxiliary materials, wherein the raw materials comprise 100g of veterinary amoxicillin and 20g of sulfadiazine sodium, and the auxiliary materials comprise 20g of calcium stearate, 60g of ethyl oleate and 1200ml of soybean oil for injection.
The invention also provides a preparation method of the amoxicillin and sulfadiazine sodium suspension injection for livestock, which comprises the following steps:
s200: 1200ml of soybean oil for injection and 20g of calcium stearate are added into a proportioning tank 2 and heated until the calcium stearate is completely dissolved;
s300: adding 60g of ethyl oleate into the batching tank 2;
s400: adding 100g of amoxicillin and 20g of sulfadiazine sodium for livestock into a mixing tank 2, and stirring to obtain a liquid medicine;
s500: and placing the liquid medicine into a sterile homogenizing bag and homogenizing for multiple times by using a homogenizer 4 to obtain the amoxicillin and sulfadiazine sodium suspension injection for the livestock.
Further, before the step of adding 1200ml of soybean oil for injection and 20g of calcium stearate into the dosing tank 2 for heating until the calcium stearate is completely dissolved, the method also comprises the following steps:
s100: and sterilizing the raw materials and the auxiliary materials.
Further, the specific steps of adding 1200ml of soybean oil for injection and 20g of calcium stearate into the batching tank 2 and heating until the calcium stearate is completely dissolved are as follows:
s201: adding 1200ml of soybean oil for injection and 20g of calcium stearate into a batching tank 2;
s202: heating the material mixing tank 2 at 150 ℃;
s203: stirring was carried out during heating to completely dissolve the calcium stearate.
Further, the concrete steps of adding 60g of ethyl oleate into the batching tank 2 are as follows:
s301: when the heating temperature is reduced to 110 ℃, 60g of ethyl oleate is added and stirred;
s302: after stirring uniformly, the temperature was cooled to 60 ℃.
Further, the method comprises the following specific steps of putting the liquid medicine into a sterile homogenizing bag and homogenizing the liquid medicine for multiple times by using a homogenizer 4 to obtain the amoxicillin and sulfadiazine sodium suspension injection for the livestock:
s501: putting the liquid medicine into a sterile homogenizing bag and putting the bag into a homogenizer 4;
s502: adjusting the pressure of the homogenizer 4 to 300-400 bar, and homogenizing the liquid medicine for 5 times;
s503: and (3) adjusting the pressure of the homogenizer 4 to 1700-1900 bar, and homogenizing the liquid medicine for 12 times to obtain the amoxicillin and sulfadiazine sodium suspension injection for the livestock.
Example 1:
the preparation method of the amoxicillin and sulfadiazine sodium suspension injection for livestock comprises the following specific operations: the operator sterilizes the batching tank 2 and carries out drying treatment, the operator fills in the material receiving list according to the production instruction, and gets the raw and auxiliary materials in the warehouse, and the variety, batch number and quantity of the received materials are confirmed to be correct by checking the qualified state, code number, raw and auxiliary material name, production batch number, production manufacturer, quantity and the like of the inspection report list. Removing the outer package in a bag removing room, and wiping the inner package with 75% ethanol; placing the animal meat into a transfer cabinet, starting an ultraviolet lamp for sterilization for 30 minutes, taking out and transferring the animal meat to a weighing room, weighing 100g of amoxicillin, 20g of sulfadiazine sodium, 20g of calcium stearate and 60g of ethyl oleate according to the prescription amount by using a clean polyethylene bag or a clean barrel, rechecking the animal meat for two persons in the weighing process, adhering material marks outside the weighing bag, and transferring the weighed raw and auxiliary materials to a liquid preparation process; checking the raw materials and the auxiliary materials, including varieties, batch numbers, quantities, manufacturers and qualified states; weighing and rechecking. And cleaning and disinfecting the external package of the raw and auxiliary materials according to the standard operation rules of the materials entering and exiting a ten thousand-level clean area. The raw and auxiliary materials of the non-degerming filtering part in the process are sterile raw and auxiliary materials, the granularity meets the requirement, the equipment such as a liquid medicine pipeline, a measuring cylinder, a liquid storage barrel, a perfusion piston, a perfusion needle and the like which need to be used needs to be subjected to sterilization treatment for 50 minutes at 121 ℃ of a sterilization cabinet, wherein the transfusion hose does not fall particles, and the batching tank 2 is subjected to sterilization treatment: connecting the dosing tank 2 and a pure steam pipeline to form a closed loop, introducing steam to raise the temperature in the dosing tank 2 and the pipeline to a specified temperature, and maintaining for a specified time to finish sterilization; sterilizing calcium stearate, ethyl oleate and soybean oil for injection at 115 deg.C for 40 min by hot-pressing sterilization method, 1200ml of soybean oil for injection and 20g of calcium stearate are added into a batching tank 2, heating the material preparing tank 2 at 150 deg.C, stirring to completely dissolve calcium stearate, cooling to 110 deg.C, adding 60g ethyl oleate, stirring, cooling to 60 deg.C, then adding 100g of amoxicillin and 20g of sulfadiazine sodium for animals into a mixing tank 2, stirring to obtain a liquid medicine, finally placing the liquid medicine into a sterile homogenizing bag and a homogenizer 4, adjusting the pressure of the homogenizer 4 to 300bar, homogenizing the liquid medicine for 5 times, adjusting the pressure of a homogenizer 4 to 1700bar, and homogenizing the liquid medicine for 12 times to obtain the veterinary amoxicillin and sulfadiazine sodium suspension injection.
Example 2:
the preparation method of the amoxicillin and sulfadiazine sodium suspension injection for livestock comprises the following specific operations: the operator sterilizes the batching tank 2 and carries out drying treatment, the operator fills in the material receiving list according to the production instruction, and gets the raw and auxiliary materials in the warehouse, and the variety, batch number and quantity of the received materials are confirmed to be correct by checking the qualified state, code number, raw and auxiliary material name, production batch number, production manufacturer, quantity and the like of the inspection report list. Removing the outer package in a bag removing room, and wiping the inner package with 75% ethanol; placing the animal meat into a transfer cabinet, starting an ultraviolet lamp for sterilization for 30 minutes, taking out and transferring the animal meat to a weighing room, weighing 100g of amoxicillin, 20g of sulfadiazine sodium, 20g of calcium stearate and 60g of ethyl oleate according to the prescription amount by using a clean polyethylene bag or a clean barrel, rechecking the animal meat for two persons in the weighing process, adhering material marks outside the weighing bag, and transferring the weighed raw and auxiliary materials to a liquid preparation process; checking the raw materials and the auxiliary materials, including varieties, batch numbers, quantities, manufacturers and qualified states; weighing and rechecking. And cleaning and disinfecting the external package of the raw and auxiliary materials according to the standard operation rules of the materials entering and exiting a ten thousand-level clean area. The raw and auxiliary materials of the non-degerming filtering part in the process are sterile raw and auxiliary materials, the granularity meets the requirement, the equipment such as a liquid medicine pipeline, a measuring cylinder, a liquid storage barrel, a perfusion piston, a perfusion needle and the like which need to be used needs to be subjected to sterilization treatment for 50 minutes at 121 ℃ of a sterilization cabinet, wherein the transfusion hose does not fall particles, and the batching tank 2 is subjected to sterilization treatment: connecting the dosing tank 2 and a pure steam pipeline to form a closed loop, introducing steam to raise the temperature in the dosing tank 2 and the pipeline to a specified temperature, and maintaining for a specified time to finish sterilization; sterilizing calcium stearate, ethyl oleate and soybean oil for injection at 115 deg.C for 40 min by hot-pressing sterilization method, 1200ml of soybean oil for injection and 20g of calcium stearate are added into a batching tank 2, heating the material preparing tank 2 at 150 deg.C, stirring to completely dissolve calcium stearate, cooling to 110 deg.C, adding 60g ethyl oleate, stirring, cooling to 60 deg.C, then adding 100g of amoxicillin and 20g of sulfadiazine sodium for animals into a mixing tank 2, stirring to obtain a liquid medicine, finally placing the liquid medicine into a sterile homogenizing bag and a homogenizer 4, adjusting the pressure of the homogenizer 4 to 350bar, homogenizing the liquid medicine for 5 times, adjusting the pressure of a homogenizer 4 to 1800bar, and homogenizing the liquid medicine for 12 times to obtain the veterinary amoxicillin and sulfadiazine sodium suspension injection.
Example 3:
the preparation method of the amoxicillin and sulfadiazine sodium suspension injection for livestock comprises the following specific operations: the operator sterilizes the batching tank 2 and carries out drying treatment, the operator fills in the material receiving list according to the production instruction, and gets the raw and auxiliary materials in the warehouse, and the variety, batch number and quantity of the received materials are confirmed to be correct by checking the qualified state, code number, raw and auxiliary material name, production batch number, production manufacturer, quantity and the like of the inspection report list. Removing the outer package in a bag removing room, and wiping the inner package with 75% ethanol; placing the animal meat into a transfer cabinet, starting an ultraviolet lamp for sterilization for 30 minutes, taking out and transferring the animal meat to a weighing room, weighing 100g of amoxicillin, 20g of sulfadiazine sodium, 20g of calcium stearate and 60g of ethyl oleate according to the prescription amount by using a clean polyethylene bag or a clean barrel, rechecking the animal meat for two persons in the weighing process, adhering material marks outside the weighing bag, and transferring the weighed raw and auxiliary materials to a liquid preparation process; checking the raw materials and the auxiliary materials, including varieties, batch numbers, quantities, manufacturers and qualified states; weighing and rechecking. And cleaning and disinfecting the external package of the raw and auxiliary materials according to the standard operation rules of the materials entering and exiting a ten thousand-level clean area. The raw and auxiliary materials of the non-degerming filtering part in the process are sterile raw and auxiliary materials, the granularity meets the requirement, the equipment such as a liquid medicine pipeline, a measuring cylinder, a liquid storage barrel, a perfusion piston, a perfusion needle and the like which need to be used needs to be subjected to sterilization treatment for 50 minutes at 121 ℃ of a sterilization cabinet, wherein the transfusion hose does not fall particles, and the batching tank 2 is subjected to sterilization treatment: connecting the dosing tank 2 and a pure steam pipeline to form a closed loop, introducing steam to raise the temperature in the dosing tank 2 and the pipeline to a specified temperature, and maintaining for a specified time to finish sterilization; sterilizing calcium stearate, ethyl oleate and soybean oil for injection at 115 deg.C for 40 min by hot-pressing sterilization method, 1200ml of soybean oil for injection and 20g of calcium stearate are added into a batching tank 2, heating the material preparing tank 2 at 150 deg.C, stirring to completely dissolve calcium stearate, cooling to 110 deg.C, adding 60g ethyl oleate, stirring, cooling to 60 deg.C, then adding 100g of amoxicillin and 20g of sulfadiazine sodium for animals into a mixing tank 2, stirring to obtain a liquid medicine, finally placing the liquid medicine into a sterile homogenizing bag and a homogenizer 4, adjusting the pressure of the homogenizer 4 to 400bar, homogenizing the liquid medicine for 5 times, adjusting the pressure of a homogenizer 4 to 1900bar, and homogenizing the liquid medicine for 12 times to obtain the veterinary amoxicillin and sulfadiazine sodium suspension injection.
Referring to fig. 5, the present invention further provides a device for preparing veterinary amoxicillin and sulfadiazine sodium suspension injection, including a fixed base 1, a dosing tank 2, a heater 3 and a homogenizer 4, wherein the heater 3 is fixedly installed inside the fixed base 1, the dosing tank 2 is detachably connected to the base, the dosing tank 2 is located above the heater 3, and the homogenizer 4 is fixedly installed on the fixed base 1.
In this embodiment, the fixed frame 1 is used for fixing various parts, the batching jar 2 is used for preparing veterinary amoxicillin and sulfadiazine sodium, the 3 models of heater is RYT-GD intelligent heater 3, but intelligent control temperature to heat batching jar 2, the 4 models of isotropic symmetry is APV-60 high pressure isotropic symmetry 4, in order to carry out the homogeneity to the liquid medicine.
Further, a mounting groove 11 is formed in the top of the fixed base 1, and the size of the mounting groove 11 is matched with that of the batching tank 2;
a fixing structure 5 is arranged on the inner side surface of the mounting groove 11, the fixing structure 5 comprises a pressure spring 51 and a support frame 52, two ends of the pressure spring 51 are respectively fixedly connected with the fixed base 1 and the support frame 52, and the support frame 52 is slidably connected with the fixed base 1;
fixed knot constructs 5 still includes protection piece 53, protection piece 53 with support frame 52 fixed connection, protection piece 53 with the laminating mutually of batching jar 2.
In this embodiment, will batching jar 2 is placed into in the mounting groove 11, it is convenient for right batching jar 2 is fixed, pressure spring 51 is in the compression state and has the restoring force, it is right to support frame 52 under pressure spring 51's the effect batching jar 2 supports and holds, thereby will batching jar 2 is fixed, just be provided with on batching jar 2 the protection plate 53, the protection plate 53 is made by rubber, it is right to support frame 52 when batching jar 2 supports and holds, the protection plate 53 with batching jar 2 direct contact, thereby it is right batching jar 2 protects.
While the invention has been described with reference to a preferred embodiment, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the invention as defined by the appended claims.
Claims (7)
1. An amoxicillin and sulfadiazine sodium suspension injection for animals, which is characterized in that,
the amoxicillin and sulfadiazine sodium suspension injection for livestock comprises raw materials and auxiliary materials, wherein the raw materials comprise 100g of amoxicillin and 20g of sulfadiazine sodium for livestock, and the auxiliary materials comprise 20g of calcium stearate, 60g of ethyl oleate and 1200ml of soybean oil for injection.
2. The preparation method of amoxicillin and sulfadiazine sodium suspension injection for livestock according to claim 1, which comprises the following steps:
adding 1200ml of soybean oil for injection and 20g of calcium stearate into a blending tank, and heating until the calcium stearate is completely dissolved;
adding 60g of ethyl oleate into a batching tank;
adding 100g of amoxicillin and 20g of sulfadiazine sodium for livestock into a mixing tank, and stirring to obtain a liquid medicine;
and placing the liquid medicine into a sterile homogenizing bag and homogenizing for multiple times by using a homogenizer to obtain the amoxicillin and sulfadiazine sodium suspension injection for the livestock.
3. The preparation method of amoxicillin and sulfadiazine sodium suspension injection for livestock according to claim 2, which is characterized in that,
before the step of adding 1200ml of soybean oil for injection and 20g of calcium stearate into a proportioning tank for heating until the calcium stearate is completely dissolved, the method also comprises the following steps:
and sterilizing the raw materials and the auxiliary materials.
4. The preparation method of amoxicillin and sulfadiazine sodium suspension injection for livestock according to claim 3, which is characterized in that the specific steps of adding 1200ml of soybean oil for injection and 20g of calcium stearate into a dosing tank and heating until the calcium stearate is completely dissolved are as follows:
adding 1200ml of soybean oil for injection and 20g of calcium stearate into a batching tank;
heating the material mixing tank at 150 ℃;
stirring was carried out during heating to completely dissolve the calcium stearate.
5. The preparation method of amoxicillin and sulfadiazine sodium suspension injection for livestock according to claim 4, characterized in that the specific steps of adding 60g of ethyl oleate into a dosing tank are as follows:
when the heating temperature is reduced to 110 ℃, 60g of ethyl oleate is added and stirred;
after stirring uniformly, the temperature was cooled to 60 ℃.
6. The method for preparing the amoxicillin and sulfadiazine sodium suspension injection for the veterinary use as claimed in claim 5, wherein the specific steps of placing the liquid medicine into a sterile homogenizing bag and homogenizing the liquid medicine with a homogenizer for a plurality of times to obtain the amoxicillin and sulfadiazine sodium suspension injection for the veterinary use are as follows:
placing the liquid medicine into a sterile homogenizing bag and placing the bag in a homogenizer;
adjusting the pressure of the homogenizer to 300-400 bar, and homogenizing the liquid medicine for 5 times;
and (3) adjusting the pressure of the homogenizer to 1700-1900 bar, and homogenizing the liquid medicine for 12 times to obtain the amoxicillin and sulfadiazine sodium suspension injection for the livestock.
7. A device adopting the preparation method of amoxicillin and sulfadiazine sodium suspension injection for livestock as claimed in claim 6,
including fixed frame, batching jar, heater and isotropic symmetry, the heater fixed mounting be in the inside of fixed frame, the batching jar with the frame is dismantled and is connected, the batching jar is located the top of heater, isotropic symmetry fixed mounting be in on the fixed frame.
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