CN104856965B - A kind of freeze drying process of injection thymic peptide - Google Patents

A kind of freeze drying process of injection thymic peptide Download PDF

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CN104856965B
CN104856965B CN201510288309.XA CN201510288309A CN104856965B CN 104856965 B CN104856965 B CN 104856965B CN 201510288309 A CN201510288309 A CN 201510288309A CN 104856965 B CN104856965 B CN 104856965B
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temperature
injection
sample
freeze
peptide solution
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CN104856965A (en
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李全学
廖孝曙
逯佩荣
刘志军
余泽勇
廖国栋
荣超
刘思川
程志鹏
万阳浴
葛均友
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Hunan Kelun Pharmaceutical Co Ltd
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Abstract

The present invention provides a kind of freeze drying process of injection thymic peptide, include the following steps:By the greenhouse cooling of thymus peptide solution sample to the first temperature, first temperature≤35 DEG C;Under conditions of first temperature, by thymus peptide solution sample pre-freeze under vacuum;After vacuum degree less than after 500ubar, the thymus peptide solution sample after pre-freeze is warming up to second temperature, the second temperature is higher than 15 DEG C;The temperature of thymus peptide solution sample is down to third temperature by the second temperature again, the third temperature is not higher than 40 DEG C;Thymus peptide solution sample is warming up to the 4th temperature by the third temperature again, is kept the temperature under conditions of four temperature, injection thymic peptide sample is obtained, the 4th temperature is not less than 40 DEG C.Compared with prior art, the injection thymic peptide sample that the present invention obtains has preferable solubility, and it is 3s that the time is averagely redissolved in embodiment 1, and it is 2s that the time is averagely redissolved under the conditions of shaking up.

Description

A kind of freeze drying process of injection thymic peptide
Technical field
The present invention relates to technical field of pharmaceuticals more particularly to a kind of freeze drying process of injection thymic peptide.
Background technology
Thymic peptide also known as thymosin extrasin or thymic factor are less than by the molecular weight extracted in health pig or calf thymus tissue The polypeptide with physiological activity of 5000 dalton, the Thymosin alpha 1 that thymic peptide main active is made of 28 amino acid (Tα1)。
Clinically thymic peptide is used to treat various primary or secondary T cell defect is sick, certain autoimmune diseases, The auxiliary treatment of the low disease of various cellular immune functions and tumour specifically includes various serious hepatitis, chronic active liver Scorching, chronic persistant hepatitis and hepatic sclerosis etc.;Herpes zoster, genital herpes, condyloma acuminatum etc.;3. bronchitis, bronchus Asthma, pulmonary tuberculosis, prevention infection of the upper respiratory tract etc.;Various malignant tumour early periods and chemotherapy, radiotherapy, which shares, to be used in combination;Lupus erythematosus, Rheumatic and atrophic diseases, ankylosing spondylitis, Guillain Barre syndrome etc.;Alpastic anemia, leukaemia, blood are small Plate reduces disease etc.;7. viral keratitis, viral conjunctivitis, allergic rhinitis etc.;Senile early ageing, Woman climacteric synthesis Sign etc.;Multiple furuncle and skin of face acne etc., psoriasis, lichen planus, squamous cell carcinoma and epithelium seborrheic keratosis etc.;Children Congenital immune deficiency disease etc..
Existing thymic peptide administering mode includes subcutaneously or intramuscularly injecting and taking orally.Injection thymic peptide is usually by being lyophilized Thymus peptide solution obtains, and injection thymic peptide lyophilized technique includes in the prior art:The glass bottle for being loaded with liquid is pushed into vacuum In freeze drier;Products temperature is down to -40 DEG C or less to start to vacuumize, pre-freeze about 240min;Wait for that vacuum degree is less than 150ubar rises to 40 DEG C from -40 DEG C or less, period about 1800min with the speed of 3 DEG C/h;About 400min is kept the temperature at 40 DEG C;It closes Vacuum pump is closed, vacuum, tamponade, outlet are stopped.The injection thymic peptide finished product solubility that this lyophilized technique obtains is poor, 20mg's Sample is lyophilized, the average redissolution time of 2mL waters for injection is added as 72s, the redissolution time under the conditions of shaking up is 48s.
Invention content
The purpose of the present invention is to provide a kind of freeze drying process of injection thymic peptide, method provided by the invention is lyophilized It is good that the injection thymic peptide finished product arrived redissolves performance.
The present invention provides a kind of freeze drying process of injection thymic peptide, include the following steps:
By the greenhouse cooling of thymus peptide solution sample to the first temperature, first temperature≤- 35 DEG C;
Under conditions of first temperature, by thymus peptide solution sample pre-freeze under vacuum;
After vacuum degree less than after 500ubar, the thymus peptide solution sample after pre-freeze is warming up to second temperature, described second Temperature is higher than -15 DEG C;
The temperature of thymus peptide solution sample is down to third temperature by the second temperature again, the third temperature is not high In -40 DEG C;
Thymus peptide solution sample is warming up to the 4th temperature by the third temperature again, is protected under conditions of four temperature Temperature, obtains injection thymic peptide sample, and the 4th temperature is not less than 40 DEG C.
Preferably, the time of the pre-freeze is 120min~180min.
Preferably, the vacuum degree of the pre-freeze is 50~150ubar.
Preferably, the heating rate for being warming up to second temperature is 3 DEG C/h~7 DEG C/h.
Preferably, the second temperature is -15 DEG C~0 DEG C.
Preferably, the time that the second temperature is down to third temperature is preferably 300min~600min.
Preferably, the third temperature is -50 DEG C~-40 DEG C.
Preferably, the time that the third temperature is warming up to the 4th temperature is 800~1000min.
Preferably, the 4th temperature is 40 DEG C~50 DEG C.
Preferably, the time of the heat preservation is 120 DEG C~180 DEG C.
The present invention provides a kind of freeze drying process of injection thymic peptide, include the following steps:By thymus peptide solution sample Greenhouse cooling to the first temperature, first temperature≤- 35 DEG C;Under conditions of first temperature, by thymus peptide solution Sample pre-freeze under vacuum;After vacuum degree less than after 500ubar, the thymus peptide solution sample after pre-freeze is warming up to second Temperature, the second temperature are higher than -15 DEG C;The temperature of thymus peptide solution sample is down to third temperature by the second temperature again Degree, the third temperature are not higher than -40 DEG C;Thymus peptide solution sample is warming up to the 4th temperature by the third temperature again, It is kept the temperature under conditions of 4th temperature, obtains injection thymic peptide sample, the 4th temperature is not less than 40 DEG C.With prior art phase Than the injection thymic peptide sample that method provided by the invention obtains has preferable solubility, the experiment of the embodiment of the present invention The result shows that the time of averagely being redissolved under conditions of not shaking for the injection thymic peptide sample that the present invention obtains is 3s, shake up Under the conditions of averagely redissolve the time be 2s.
Moreover, injection thymic peptide sample no sample atrophy phenomenon that method provided by the invention obtains and cellular sample Occur, ensure that the quality of product in the term of validity.Method provided by the invention makes injection thymic peptide medication safer, suitable Industrial mass production.
Specific implementation mode
The present invention provides a kind of freeze drying process of injection thymic peptide, include the following steps:
By the greenhouse cooling of thymus peptide solution sample to the first temperature, first temperature≤- 35 DEG C;
Under conditions of first temperature, by thymus peptide solution sample pre-freeze under vacuum;
After vacuum degree less than after 500ubar, the thymus peptide solution sample after pre-freeze is warming up to second temperature, described second Temperature is higher than -15 DEG C;
The temperature of thymus peptide solution sample is down to third temperature by the second temperature again, the third temperature is not high In -40 DEG C;
Thymus peptide solution sample is warming up to the 4th temperature by the third temperature again, is protected under conditions of four temperature Temperature, obtains injection thymic peptide sample, and the 4th temperature is not less than 40 DEG C.
Compared with prior art, the injection thymic peptide sample that method provided by the invention obtains has preferable redissolve Property.Moreover, injection thymic peptide sample no sample atrophy phenomenon and cellular sample that method provided by the invention obtains occur, It ensure that the quality of product in the term of validity.Method provided by the invention makes injection thymic peptide medication safer, suitable for industry Change and produces in enormous quantities.
The temperature of thymus peptide solution sample is down to the first temperature, first temperature≤- 35 DEG C by the present invention.In the present invention Embodiment in, specifically thymus peptide solution sample can be lyophilized in vacuum freeze drier, prepare injection thymic peptide Finished product.In the present invention, first temperature is preferably -50 DEG C~-35 DEG C, more preferably -45 DEG C~-40 DEG C.In the present invention In, the mass concentration of the thymus peptide solution is preferably 5mg/mL~20mg/mL, and more preferably 8mg/mL~15mg/mL is optimal It is selected as 10mg/mL~15mg/mL.The present invention does not have the source of the thymus peptide solution special limitation, using this field skill Thymus peptide solution known to art personnel.In the present invention, the rate of temperature fall for being cooled to the first temperature be preferably 13~ 17℃/h。
After being cooled to the first temperature, the present invention is under conditions of first temperature, by thymus peptide solution sample in vacuum Under the conditions of pre-freeze.In an embodiment of the present invention, after being cooled to the first temperature, it can specifically open vacuum pump and start to vacuumize, Carry out pre-freeze.In the present invention, the vacuum degree of the pre-freeze is preferably 800ubar;The time of the pre-freeze is preferably 120min ~180min, more preferably 135min~165min, most preferably 145min~155min.In an embodiment of the present invention, exist During pre-freeze, preferably continue to cool down with above-mentioned rate of temperature fall, until pre-freeze process terminates.
After vacuum degree less than after 500ubar, the thymus peptide solution sample after pre-freeze is warming up to second temperature, described second Temperature is higher than -15 DEG C.The present invention is preferably when vacuum degree is down to 200ubar~500ubar, by the thymus peptide solution sample after pre-freeze Product are warming up to second temperature, more preferably 300ubar~450ubar, more preferably 350ubar~400ubar.In the present invention In, the second temperature is preferably -15 DEG C~0 DEG C, more preferably -10 DEG C~-5 DEG C;The heating for being warming up to second temperature Rate is preferably 3 DEG C/h~7 DEG C/h, more preferably 4 DEG C/h~6 DEG C/h, most preferably 5 DEG C/h.In the present invention, the heating Time to second temperature is preferably 500min~700min, more preferably 550min~650min, most preferably 600min.
After being warming up to second temperature, the temperature of thymus peptide solution sample is down to third by the present invention by the second temperature again Temperature, the third temperature are not higher than -40 DEG C.In the present invention, the third temperature is preferably -50 DEG C~-40 DEG C, more preferably For -48 DEG C~-42 DEG C, most preferably -45 DEG C;The time that the second temperature is cooled to third temperature be preferably 300min~ 600min, more preferably 320min~500min, most preferably 350min~400min.In the present invention, the second temperature During being cooled to third temperature, vacuum degree is preferably smaller than 800ubar.
After being cooled to third temperature, thymus peptide solution sample is warming up to the 4th temperature by the present invention by the third temperature again Degree, keeps the temperature under conditions of four temperature, obtains injection thymic peptide sample, and the 4th temperature is not less than 40 DEG C.In this hair In bright, during the third temperature is warming up to the 4th temperature, vacuum degree is preferably smaller than 200ubar.In the present invention, described 4th temperature is preferably 40 DEG C~50 DEG C, more preferably 42 DEG C~48 DEG C, most preferably 45 DEG C;The third temperature is warming up to The time of four temperature is preferably 600~800min.In the present invention, the time of the heat preservation is preferably 120min~180min, More preferably 135min~165min, most preferably 140min~150min;The vacuum degree of the heat preservation is preferably 50~ 150ubar。
The present invention provides a kind of freeze drying process of injection thymic peptide, include the following steps:By thymus peptide solution sample Greenhouse cooling to the first temperature, first temperature≤- 35 DEG C;Under conditions of first temperature, by thymus peptide solution Sample pre-freeze under vacuum;After vacuum degree less than after 500ubar, the thymus peptide solution sample after pre-freeze is warming up to second Temperature, the second temperature are higher than -15 DEG C;The temperature of thymus peptide solution sample is down to third temperature by the second temperature again Degree, the third temperature are not higher than -40 DEG C;Thymus peptide solution sample is warming up to the 4th temperature by the third temperature again, It is kept the temperature under conditions of 4th temperature, obtains injection thymic peptide sample, the 4th temperature is not less than 40 DEG C.With prior art phase Than the injection thymic peptide sample that method provided by the invention obtains has preferable solubility, the experiment of the embodiment of the present invention The result shows that the time of averagely being redissolved under conditions of not shaking for the injection thymic peptide sample that the present invention obtains is 3s, shake up Under the conditions of averagely redissolve the time be 2s.
Moreover, injection thymic peptide sample no sample atrophy phenomenon that method provided by the invention obtains and cellular sample Occur, ensure that the quality of product in the term of validity.Method provided by the invention makes injection thymic peptide medication safer, suitable Industrial mass production.
In order to further illustrate the present invention, with reference to embodiment to the freeze-drying side of injection thymic peptide provided by the invention Method is described in detail, but cannot they be interpreted as limiting the scope of the present invention.
Embodiment 1
By the thymus peptide solution of prepared a concentration of 10mg/mL filling 1000, loading amount 2.0mL, half tamponade;
By in the glass bottle push-in vacuum freeze drier for filling liquid, products temperature is down to -35 DEG C, starts to vacuumize Vacuum degree is less than 800ubar, pre-freeze 120min;
After vacuum degree less than after 500ubar, products temperature is risen to -15 DEG C from -35 DEG C with the heating rate of 3 DEG C/h, week Phase about 350min;
Products temperature is down to -40 DEG C again, cool down used time about 350min;
Products temperature is finally warming up to 40 DEG C, 120min is kept the temperature under conditions of 40 DEG C;
After the completion of heat preservation, vacuum pump is closed, stops vacuum tamponade, outlet, obtains injection thymic peptide finished product.
The quality for the injection thymic peptide finished product that the present invention detects, observation sample have the ratio of atrophy, sample appearance There is cellular ratio, the average redissolution time of addition 2mL waters for injection and injection 2mL waters for injection shake up into sample The time is averagely redissolved, the results are shown in Table 1, and table 1 is the embodiment of the present invention and the experimental result that comparative example obtains.
Embodiment 2
By the thymus peptide solution of prepared a concentration of 10mg/mL filling 1000, loading amount 2.0mL, half tamponade;
By in the glass bottle push-in vacuum freeze drier for filling liquid, products temperature is down to -35 DEG C, starts to vacuumize Vacuum degree is less than 800ubar, pre-freeze 180min;
After vacuum degree less than after 500ubar, products temperature is risen to -15 DEG C from -35 DEG C with the heating rate of 7 DEG C/h, week Phase about 172min;
Products temperature is down to -40 DEG C again, cool down used time about 500min;
Products temperature is finally warming up to 45 DEG C, 150min is kept the temperature under conditions of 45 DEG C;
After the completion of heat preservation, vacuum pump is closed, stops vacuum tamponade, outlet, obtains injection thymic peptide finished product.
The quality for the injection thymic peptide finished product that the present invention detects, observation sample have the ratio of atrophy, sample appearance There is cellular ratio, the average redissolution time of addition 2mL waters for injection and injection 2mL waters for injection shake up into sample The time is averagely redissolved, the results are shown in Table 1, and table 1 is the embodiment of the present invention and the experimental result that comparative example obtains.
Embodiment 3
By the thymus peptide solution of prepared a concentration of 10mg/mL filling 1000, loading amount 2.0mL, half tamponade;
By in the glass bottle push-in vacuum freeze drier for filling liquid, products temperature is down to -35 DEG C, starts to vacuumize small In 800ubar, pre-freeze 150min;
After vacuum degree less than after 500ubar, products temperature is risen to -15 DEG C from -35 DEG C with the heating rate of 5 DEG C/h, week Phase about 240min;
Products temperature is down to -40 DEG C again, cool down used time about 600min;
Products temperature is finally warming up to 42 DEG C, 180min is kept the temperature under conditions of 45 DEG C;
After the completion of heat preservation, vacuum pump is closed, stops vacuum tamponade, outlet, obtains injection thymic peptide finished product.
The quality for the injection thymic peptide finished product that the present invention detects, observation sample have the ratio of atrophy, sample appearance There is cellular ratio, the average redissolution time of addition 2mL waters for injection and injection 2mL waters for injection shake up into sample The time is averagely redissolved, the results are shown in Table 1, and table 1 is the embodiment of the present invention and the experimental result that comparative example obtains.
Comparative example
By the thymus peptide solution of prepared a concentration of 10mg/mL filling 1000, loading amount 2.0mL, half tamponade;
It will be loaded in the glass bottle push-in vacuum freeze drier of liquid, products temperature be down to -40 DEG C hereinafter, starting to take out Vacuum, pre-freeze about 240min;
It waits for that vacuum degree is less than 150ubar, rises to 40 DEG C from -40 DEG C or less with the heating rate of 3 DEG C/h, the period is about 1800min;
About 400min is kept the temperature at 40 DEG C, vacuum pump is closed after heat preservation, stops vacuum, tamponade, outlet obtain injection thymus gland Peptide finished product.
The quality for the injection thymic peptide finished product that the present invention detects, observation sample have the ratio of atrophy, sample appearance There is cellular ratio, the average redissolution time of addition 2mL waters for injection and injection 2mL waters for injection shake up into sample The time is averagely redissolved, the results are shown in Table 1, and table 1 is the embodiment of the present invention and the experimental result that comparative example obtains.
The experimental result that 1 embodiment of the present invention of table and comparative example obtain
Inspection item Comparative example Embodiment 1 Embodiment 2 Embodiment 3
Sample number after freeze-drying 1000 1000 1000 1000
There is the sample size of atrophy 72 0 0 0
Appearance has cellular sample size 421 0 0 0
Averagely redissolve the time (second) 72 3 8 5
The average redissolution time under the conditions of shaking up 48 2 5 3
As can be seen from Table 1, the injection thymic peptide finished product that method provided by the invention obtains without atrophy, without cellular sample Product, and averagely the redissolution time substantially reduces.
As can be seen from the above embodiments, the present invention provides a kind of freeze drying process of injection thymic peptide, including it is following Step:By the greenhouse cooling of thymus peptide solution sample to the first temperature, first temperature≤- 35 DEG C;In first temperature Under conditions of, by thymus peptide solution sample pre-freeze under vacuum;After vacuum degree is less than 500ubar, by the chest after pre-freeze Gland peptide solution sample is warming up to second temperature, and the second temperature is higher than -15 DEG C;Again by the temperature of thymus peptide solution sample by institute It states second temperature and is down to third temperature, the third temperature is not higher than -40 DEG C;Again by thymus peptide solution sample by the third temperature Degree is warming up to the 4th temperature, is kept the temperature under conditions of four temperature, obtains injection thymic peptide sample, the 4th temperature is not low In 40 DEG C.Compared with prior art, the injection thymic peptide sample that method provided by the invention obtains has preferable solubility, No sample atrophy phenomenon and cellular sample occur in obtained injection thymic peptide finished product, ensure that the matter of product in the term of validity Amount.Method provided by the invention makes injection thymic peptide medication safer, suitable for industrial mass production.
The above is only a preferred embodiment of the present invention, it is noted that for the ordinary skill people of the art For member, various improvements and modifications may be made without departing from the principle of the present invention, these improvements and modifications are also answered It is considered as protection scope of the present invention.

Claims (1)

1. a kind of freeze drying process of injection thymic peptide, includes the following steps:
By the greenhouse cooling of thymus peptide solution sample to the first temperature, first temperature is -50 DEG C~-35 DEG C;
Under conditions of first temperature, by thymus peptide solution sample, pre-freeze, the time of the pre-freeze are under vacuum 120min~180min;
After vacuum degree less than after 500 μ bar, the thymus peptide solution sample after pre-freeze is warming up to second temperature, it is described to be warming up to the The heating rate of two temperature is 3 DEG C/h~7 DEG C/h;The second temperature is -15 DEG C~0 DEG C;
The temperature of thymus peptide solution sample is down to third temperature by the second temperature again, the second temperature is down to third temperature The time of degree is 300min~600min;The third temperature is -50 DEG C~-40 DEG C;
Thymus peptide solution sample is warming up to the 4th temperature by the third temperature again, keeps the temperature, obtains under conditions of four temperature To injection thymic peptide sample, the time that the third temperature is warming up to the 4th temperature is 800~1000min;4th temperature Degree is 40 DEG C~50 DEG C;The time of the heat preservation is 120min~180min.
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