CN113144180B - Application of ulinastatin in preparing medicine for treating novel coronavirus pneumonia - Google Patents
Application of ulinastatin in preparing medicine for treating novel coronavirus pneumonia Download PDFInfo
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Abstract
The invention belongs to the technical field of medicines, and particularly relates to application of ulinastatin in preparing a medicine for treating novel coronavirus pneumonia. Clinical tests show that the ulinastatin has an obvious treatment effect on the novel coronavirus pneumonia and has a certain treatment effect on myocardial damage caused by the novel coronavirus.
Description
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to application of ulinastatin in preparing a medicine for treating novel coronavirus pneumonia.
Background
Coronavirus is a large group of viruses widely existing in nature, 6 kinds of coronavirus capable of infecting human are discovered before 2019, namely HCoV-229E, HCoV-OC43, HCoV-NL63, HCoV-HKU1, SARS-CoV and MERS-CoV, and the coronavirus causing epidemic situation is named as novel coronavirus (SARS-CoV-2) after being separated and confirmed. According to the existing research, the common symptoms of the onset of the novel coronavirus infected patients are fever, cough and myalgia or fatigue; all patients had pneumonia, and chest CT examination revealed abnormalities; complications include acute respiratory distress syndrome, myocardial injury and secondary infections. In 41 patients diagnosed by Huang et al by day 1 and 2 of 2020, 5 cases (12%) of virus-induced acute myocardial injury were observed in statistics of COVID-19 patients. Of the 138 COVID-19 patients counted in the southern Hospital at Wuhan university, 7.2% of the patients developed troponin, i.e., exhibited myocardial injury.
At present, the treatment of myocardial damage caused by the novel coronavirus comprises antiviral treatment, and antiviral drugs such as Reineckvir, chloroquine, lopinavir/ritonavir, and abidol have good effects of treating the novel coronavirus pneumonia, but are also found to cause heart damage. Meanwhile, the method also comprises the treatment of myocarditis and heart failure, traditional Chinese medicine treatment and the like.
Ulinastatin is a trypsin inhibitor, and a large-dose broad-spectrum protease inhibitor such as ulinastatin is suggested to be used for reducing pulmonary interstitial inflammation and pulmonary lesions in the consensus of 2019 CoV disease comprehensive treatment experts in Shanghai city, but whether ulinastatin can play a certain positive role in treating novel coronavirus pneumonia needs to be further researched.
The existing of the original basic cardiovascular diseases increases the treatment difficulty of patients with the novel coronavirus pneumonia, and published cases of the patients with the novel coronavirus pneumonia show that severe cases or death cases of the patients with the novel coronavirus pneumonia are mostly old people with chronic basic diseases such as cardiovascular diseases, which shows that the myocardial damage caused by the novel coronavirus further accelerates the disease progress, so that important research is carried out on whether ulinastatin can treat the myocardial damage caused by the novel coronavirus pneumonia while treating the novel coronavirus pneumonia.
Disclosure of Invention
The invention aims to provide application of ulinastatin in preparing a medicine for treating novel coronavirus pneumonia.
In order to achieve the purpose, the invention adopts the following technical scheme:
the application of ulinastatin in preparing a medicine for treating novel coronavirus pneumonia is characterized in that the single administration dosage of ulinastatin is 10-1000 ten thousand units.
Preferably, the single administration dosage of the ulinastatin is 30-500 ten thousand units.
Preferably, the novel coronavirus pneumonia is a disease caused by a novel coronavirus SARS-CoV-2.
Preferably, the medicament comprises ulinastatin and geniposidic acid.
Preferably, the medicament comprises ulinastatin, geniposide and isosorbide mononitrate.
Preferably, the medicament is a freeze-dried powder injection, an injection, a spray preparation or an atomized preparation.
Preferably, the medicament comprises the following components:
10-1000 ten thousand units of ulinastatin;
0.5-1.5 g of geniposide;
15-30 mg of isosorbide mononitrate;
2-5 g of cysteine;
3-8 g of sodium hyaluronate;
10-30 g of carrier;
preferably, the carrier is lactose or/and mannitol.
Preferably, the preparation method of the medicament comprises the following steps:
s1) dissolving ulinastatin, cysteine, sodium hyaluronate and 1/4 prescription amount of carrier with water for injection, adjusting pH to 6.8-7.2, performing sterile filtration, performing spray freeze drying, fully mixing with 1/4 prescription amount of carrier according to a progressive dilution method, and sieving with a 60-mesh sieve to obtain a mixture A;
s2) dissolving geniposide, isosorbide mononitrate and 1/4 prescription amount of carrier with water for injection, carrying out sterile filtration, carrying out spray freeze drying, fully mixing with 1/4 prescription amount of carrier according to a progressive dilution method, and sieving with a 60-mesh sieve to obtain a mixture B;
s3) fully mixing the mixture A and the mixture B obtained in the steps S1 and S2, and sieving the mixture with a 60-mesh sieve to obtain the compound.
Preferably, the incremental dilution method is: the vehicle was added in the order of 5%, 15%, 25% and 55% of the prescribed amount.
Ulinastatin belongs to a successfully industrialized medicine, and has a therapeutic effect on novel coronavirus SARS-CoV-2.
According to the clinical manifestations of the treatment process of patients with COVID-19, the novel coronavirus SARS-CoV-2 can cause myocardial damage, especially the myocardial damage of the old, although ulinastatin can play a certain role in treating the myocardial damage caused by the novel coronavirus, clinical tests show that the combined use of ulinastatin, geniposide and isosorbide mononitrate can play a significant role in treating the myocardial damage caused by the novel coronavirus, which is probably because ulinastatin belongs to a broad-spectrum protease inhibitor and can interfere the synthesis of RNA polymerase in SARS-CoV-2 virus, thereby inhibiting the replication of SARS-CoV-2 virus and achieving the purpose of resisting the new coronary pneumonia caused by SARS-CoV-2 virus infection. Meanwhile, the ulinastatin can inhibit various enzymes participating in inflammatory reaction to reduce the degree of organ inflammatory reaction and the symptom of myocardial injury, and the effect of the ulinastatin is enhanced after the ulinastatin is combined with the geniposide and the isosorbide mononitrate.
Compared with the prior art, the invention has the following beneficial effects:
(1) clinical tests show that ulinastatin can be used for treating novel coronavirus pneumonia and treating myocardial damage caused by the novel coronavirus.
(2) Clinical tests show that the treatment effect of the combined drug for treating group B is superior to that of group A, group C and group D, and the treatment effect of the combined drug for treating group B is higher than that of the combined drug for treating group A, group C and group D, which indicates that the combined drug for treating group B can enhance the treatment effect of the combined drug for treating myocardial damage caused by the novel coronavirus.
Detailed Description
The present invention will be described in further detail with reference to the following examples. It should not be understood that the scope of the above-described subject matter of the present invention is limited to the following examples.
Example 1 pharmaceutical compositions containing ulinastatin
Taking 10000 units of ulinastatin after filtration and sterilization, adding 20g of mannitol and 10g of sodium chloride for dissolution, adjusting the pH value to 6.8, supplementing the volume to 1500mL with water for injection, performing sterile filtration, and subpackaging in 1000 cillin bottles to obtain the product.
Example 2 pharmaceutical compositions containing ulinastatin
Taking 10000 million units of filtered and sterilized ulinastatin, adding 20g of glucose and 5g of sodium chloride for dissolving, adjusting the pH to 7.1, supplementing the volume to 1500mL with water for injection, performing sterile filtration, and subpackaging in 1000 cillin bottles to obtain the injection.
Example 3 pharmaceutical compositions containing ulinastatin
The medicine is an atomized preparation and comprises the following components:
ulinastatin 80 ten thousand units;
0.5g of geniposide;
isosorbide mononitrate 20 mg;
3g of cysteine;
5g of sodium hyaluronate;
20g of mannitol;
the preparation method of the medicine comprises the following steps:
s1) dissolving ulinastatin, cysteine, sodium hyaluronate and 1/4 prescription amount of mannitol with water for injection, adjusting pH to 6.8, performing sterile filtration, performing spray freeze drying, fully mixing with 1/4 prescription amount of mannitol according to a progressive dilution method, and sieving with a 60-mesh sieve to obtain a mixture A;
s2) dissolving geniposide, isosorbide mononitrate and 1/4 prescription amount of mannitol with water for injection, performing sterile filtration, spray freeze drying, fully mixing with 1/4 prescription amount of mannitol according to a progressive dilution method, and sieving with a 60-mesh sieve to obtain a mixture B;
s3) fully mixing the mixture A and the mixture B obtained in the steps S1 and S2, and sieving the mixture with a 60-mesh sieve to obtain the compound.
Wherein, the progressive dilution method comprises the following steps: mannitol was added in the order of 5%, 15%, 25% and 55% of the prescribed amount.
Example 4 pharmaceutical compositions containing ulinastatin
The medicine is an atomized preparation and comprises the following components:
500 ten thousand units of ulinastatin;
0.7g of geniposide;
isosorbide mononitrate 22 mg;
cysteine 3. g;
5g of sodium hyaluronate;
25g of mannitol;
the preparation method of the medicine comprises the following steps:
s1) dissolving ulinastatin, cysteine, sodium hyaluronate and 1/4 prescription amount of mannitol with water for injection, adjusting pH to 7.1, performing sterile filtration, performing spray freeze drying, fully mixing with 1/4 prescription amount of mannitol according to a progressive dilution method, and sieving with a 60-mesh sieve to obtain a mixture A;
s2) dissolving geniposide, isosorbide mononitrate and 1/4 prescription amount of mannitol with water for injection, performing sterile filtration, spray freeze drying, fully mixing with 1/4 prescription amount of mannitol according to a progressive dilution method, and sieving with a 60-mesh sieve to obtain a mixture B;
s3) fully mixing the mixture A and the mixture B obtained in the steps S1 and S2, and sieving the mixture with a 60-mesh sieve to obtain the compound.
Preferably, the incremental dilution method is: mannitol was added in the order of 5%, 15%, 25% and 55% of the prescribed amount.
Comparative example 1 medicament containing ulinastatin
Compared with example 3, the distinguishing feature is that no genipin nucleotide is added.
Comparative example 2 medicament containing ulinastatin
In comparison with example 3, the difference is that isosorbide mononitrate is not added.
Experiment I, clinical trial of novel coronavirus pneumonia
1.1 methods of treatment: 100 patients who have diagnosed the novel coronavirus pneumonia are randomly divided into 25 patients of a treatment group A, a treatment group B and a control group, and both the two groups of patients are subjected to basic treatment such as anti-infection and symptomatic support treatment after admission and are subjected to oxygen inhalation or noninvasive ventilator treatment according to the illness state of the patients.
Patients in the control group were treated for 5 days using standard treatment protocols (conventional antiviral, anti-inflammatory, adjuvant immunopotentiator and supportive therapy);
treatment group A was treated by intravenous drip with 0.9% sodium chloride injection 100ml combined with 80 ten thousand units of ulinastatin based on the control group (conventional antiviral, anti-inflammatory, adjuvant immunopotentiator and supportive treatment). Once for 8 hours. The treatment is continued for 5 days;
treatment group B100 ml i.v. instillation of 0.9% sodium chloride injection was added in example 3 based on controls (conventional anti-viral, anti-inflammatory, adjuvant immune potentiator and supportive therapy). Once for 8 hours. The treatment was continued for 5 days.
Treatment group C100 ml i.v. instillation of 0.9% sodium chloride injection was added to comparative example 1 based on controls (conventional antiviral, anti-inflammatory, adjuvant immunopotentiator and supportive therapy). Once for 8 hours. The treatment was continued for 5 days.
Treatment group D100 ml intravenous drip of 0.9% sodium chloride injection was added to comparative example 2 based on controls (conventional antiviral, anti-inflammatory, adjuvant immunopotentiator and supportive therapy). Once for 8 hours. The treatment was continued for 5 days.
1.2 Observation index
(1) The body temperature, respiratory rate RR and oxygen saturation at rest before and after treatment were compared among five groups of patients.
(2) The clinical efficacy of five groups of patients was compared.
And (3) curing: after treatment, the patient breathes stably, the respiratory rate RR is 10-20 times/min, the oxygen saturation is more than 95%, the CDC throat swab novel coronavirus nucleic acid is negative, and the chest CT shows that the inflammation is absorbed earlier;
the method has the following advantages: the respiratory rate RR of the patient after treatment is 21-28 times/min, the oxygen saturation is more than 95%, the novel coronavirus nucleic acid of CDC throat swab is negative, and the chest CT shows that most of inflammation is absorbed before;
and (4) invalidation: after treatment, patients have shortness of breath, the respiratory rate RR is more than 28 times/min, the oxygen saturation is less than 95%, the CDC throat swab novel coronavirus nucleic acid is positive, and chest CT shows that the inflammation is not absorbed or slightly absorbed before.
(3) Discharge criteria were performed in accordance with "diagnosis and treatment of novel coronavirus pneumonia" (seventh trial).
1.3 observations
TABLE 1 comparison of gender and age of patients
As can be seen from Table 1, the differences between the treatment groups A, B, C and D were not statistically significant and comparable to the control group.
TABLE 2 comparison of analytical indices before treatment between the treated group and the control group
TABLE 3 comparison of analytical indices after treatment of group A and control
As can be seen from tables 2 and 3, after treatment of group A, group B, group C and group D in combination with ulinastatin for 5 days on the basis of the treatment of the control group, the body temperature, respiratory rate and oxygen saturation were significantly improved, and the patient's coronavirus nucleic acids were turned negative. Treatment group B was superior to treatment group a, treatment group C and treatment group D compared to the control group.
Experiment two, clinical test of myocardial damage caused by novel coronavirus
The treatment method comprises the following steps: 100 patients who confirmed the new coronavirus pneumonia and the myocardial damage caused by the new coronavirus infection were randomly divided into 25 patients of treatment group A, treatment group B, treatment group C and control group, and both patients were admitted to the hospital and given basic treatments such as anti-infection and symptomatic support treatment, and were given oxygen inhalation or noninvasive ventilator treatment according to the patients' condition.
Patients in the control group were treated for 5 days using standard treatment protocols (conventional antiviral, anti-inflammatory, adjuvant immunopotentiator and supportive therapy);
treatment group A was treated with ulinastatin 80 ten thousand units based on the control group (conventional antiviral, anti-inflammatory, adjuvant immunopotentiator and supportive therapy). Once for 8 hours. The treatment is continued for 5 days;
treatment group B treatment was performed in example 3 on the basis of control groups (conventional antiviral, anti-inflammatory drugs, adjuvant immunopotentiators and supportive therapy). Once for 8 hours. The treatment was continued for 5 days.
Treatment group C was treated in comparative example 1 on the basis of controls (conventional antiviral, anti-inflammatory, adjuvant immunopotentiator and supportive therapy). Once for 8 hours. The treatment was continued for 5 days.
Treatment group D was treated in comparative example 2 on the basis of control groups (conventional antiviral, anti-inflammatory, adjuvant immunopotentiator and supportive therapy). Once for 8 hours. The treatment was continued for 5 days.
1.2 observation indexes:
the clinical efficacy of five groups of patients was compared:
the method has the following advantages:
(1) markers of myocardial injury: hs-cTnI <28pg/mg, troponin >6.125 pg/ml;
(2) the CDC throat swab novel coronavirus nucleic acid is negative;
(3) chest CT showed earlier absorption of inflammation.
And (4) invalidation:
(1) markers of myocardial injury: hs-cTnI >28pg/mg, troponin <6.125 pg/ml;
(2) the CDC throat swab novel coronavirus nucleic acid is positive;
(3) chest CT showed that the inflammation was not or slightly absorbed earlier.
TABLE 4 observations
As can be seen from Table 4, the treatment of group B had a better therapeutic effect on patients with the novel coronavirus pneumonia and myocardial damage caused by the novel coronavirus infection.
The foregoing embodiments are merely illustrative of the principles and utilities of the present invention and are not intended to limit the invention. Any person skilled in the art can modify or change the above-mentioned embodiments without departing from the spirit and scope of the present invention. Accordingly, it is intended that all equivalent modifications or changes which can be made by those skilled in the art without departing from the spirit and technical spirit of the present invention be covered by the claims of the present invention.
Claims (6)
1. The application of ulinastatin in preparing the medicine for treating the novel coronavirus pneumonia is characterized in that the medicine comprises the following components:
10-1000 ten thousand units of ulinastatin;
0.5-1.5 g of geniposide;
15-30 mg of isosorbide mononitrate;
2-5 g of cysteine;
3-8 g of sodium hyaluronate;
10-30 g of carrier.
2. Use according to claim 1, characterized in that the novel coronavirus pneumonia is initiated by the novel coronavirus SARS-CoV-2.
3. The use of claim 1, wherein the medicament is a lyophilized powder for injection, an injection, a spray formulation or an atomized formulation.
4. Use according to claim 1, characterized in that the carrier is lactose or/and mannitol.
5. Use according to claim 1, characterized in that the process for the preparation of the medicament comprises the following steps:
s1) dissolving ulinastatin, cysteine, sodium hyaluronate and 1/4 prescription amount of carrier with water for injection, adjusting pH to 6.8-7.2, performing sterile filtration, performing spray freeze drying, fully mixing with 1/4 prescription amount of carrier according to a progressive dilution method, and sieving with a 60-mesh sieve to obtain a mixture A;
s2) dissolving geniposide, isosorbide mononitrate and 1/4 prescription amount of carrier with water for injection, carrying out sterile filtration, carrying out spray freeze drying, fully mixing with 1/4 prescription amount of carrier according to a progressive dilution method, and sieving with a 60-mesh sieve to obtain a mixture B;
s3) fully mixing the mixture A and the mixture B obtained in the steps S1 and S2, and sieving the mixture with a 60-mesh sieve to obtain the compound.
6. Use according to claim 5, wherein the incremental dilution method is: the vehicle was added in the order of 5%, 15%, 25% and 55% of the prescribed amount.
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| CN111991554A (en) * | 2020-09-25 | 2020-11-27 | 广东天普生化医药股份有限公司 | Use of ulinastatin in preparing medicine for treating viral diseases |
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