CN103385868A - Application of sodium pyruvate in preparing medicine for treating chronic obstructive pulmonary disease - Google Patents
Application of sodium pyruvate in preparing medicine for treating chronic obstructive pulmonary disease Download PDFInfo
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- CN103385868A CN103385868A CN2013103355699A CN201310335569A CN103385868A CN 103385868 A CN103385868 A CN 103385868A CN 2013103355699 A CN2013103355699 A CN 2013103355699A CN 201310335569 A CN201310335569 A CN 201310335569A CN 103385868 A CN103385868 A CN 103385868A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/06—Antiasthmatics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P39/00—General protective or antinoxious agents
- A61P39/02—Antidotes
Abstract
The invention provides an application of sodium pyruvate in preparing a medicine for treating chronic obstructive pulmonary disease. The invention provides an inhalant composition capable of treating the chronic obstructive pulmonary disease, which comprises sodium pyruvate, sodium chloride and water, wherein in the inhalant composition, the mass molarity of the sodium pyruvate is 0.5-6mmol/kg, and the mass percent of the sodium chloride is 0.85-0.95%. Compared with the traditional treatment on the chronic obstructive pulmonary disease, the inhalant composition provided by the invention has the advantages that (1) the inhalant composition is better targeted by directly acting on the focus part of the lung, and does not participate in the metabolism of the whole body; (2) the toxic and side effects are small, the safety is higher, and the medicine is stable; and (3) the sodium pyruvate serving as an antioxidant is different from antibiotics, expectorants and steroid medicines, and realizes more comprehensive effect and better effect.
Description
Technical field
The present invention relates to the purposes of Sodium Pyruvate at preparation treatment chronic obstructive pulmonary disease, belong to field of medical technology.
Background technology
Chronic obstructive pulmonary disease claims again obstructive emphysema, is that terminal bronchiole distal portions (comprising respiratory bronchioles, alveolar duct, alveolar sac and alveolar) expands, and with the destruction of air cavity wall.Obstructive emphysema is that terminal bronchiole distal portions (comprising respiratory bronchioles, alveolar duct, alveolar sac and alveolar) expands, and with the destruction of air cavity wall.And often with gastric ulcer, respiratory failure, spontaneous pneumothorax, sleep disordered breathing, chronic pulmonary heart disease and right heart failure.Nearly recent decades, the sickness rate of obstructive emphysema significantly increased, and this is because chronic bronchitis is brought out in atmospheric pollution, smoking and pulmonary's chronic infection etc., further develops into primary disease.According to China more than 6,000 ten thousand people's generaI investigation, the chronic bronchitis prevalence is to reach 15% or more more than 3.9%, 50 years old.The prevalence whole nation of obstructive emphysema is inconsistent, and minimum is 0.6%, is up to 4.3%.Primary disease is chronic disease, and the course of disease is long, and unhealthful and labour force brings massive losses for social production and economy., take the U.S. as example,, due to the medical expense of obstructive emphysema and the economic loss such as absent from duty, reach multi-million dollar every year.
Chronic obstructive pulmonary disease is general main takes the circumstances into consideration to use antibacterials, expectorant and bronchodilator to be used for the treatment of according to the cause of disease.These traditional treatments are mainly alleviated the complication that pulmonary and bronchial obstruction cause, from fundamental significance, do not get on to diminish inflammation.
Sodium Pyruvate generally is used as the alternative carbon source in cell culture fluid, is a kind of energy substrate, and is minimum to the toxic and side effects of human body.Sodium Pyruvate has had been found that a variety of purposes at present.
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Summary of the invention
The object of the present invention is to provide a method that can be used for the treatment of chronic obstructive pulmonary disease, i.e. the purposes of Sodium Pyruvate in preparation treatment chronic obstructive pulmonary disease.
The invention provides the purposes of Sodium Pyruvate in preparation treatment chronic obstructive pulmonary disease.
The invention provides a kind of inhalant compositions for the treatment of chronic obstructive pulmonary disease, comprise following constituent: Sodium Pyruvate, sodium chloride and water, the molality of described Sodium Pyruvate is 0.5-6mMol/kg, and the mass percent of sodium chloride is 0.85-0.95%.
Preferably,
Can treat the inhalant compositions of slight chronic obstructive pulmonary disease or preventing chronic obstructive pulmonary disease, comprise following constituent: Sodium Pyruvate, sodium chloride and water, in described inhalant compositions, the molality of Sodium Pyruvate is 0.5-1.5mMol/kg, and the mass percent of sodium chloride is 0.85-0.95%.
The present invention, in order to allow medicine fully enter the human lung deep, realizes by the dosage form that is prepared into the ultrasonic atomization inhalant.
The preparation method that can treat the inhalant compositions of chronic obstructive pulmonary disease of the present invention is: the Sodium Pyruvate of recipe quantity and sodium chloride are added respectively in 95% surplus purified water after stirring and add 5% surplus purified water to stir again.Carry out sterile filling after aseptic filtration, packing both obtained.
Using method: use 5ml liquid at every turn, liquid is poured in nebulizer and produced water smoke, the general breathing by pulmonary's power sucks pulmonary with water smoke, uses 5 minutes at every turn.Observe a course for the treatment of for patients with chronic obstructive pulmonary diseases, pulmonary's mucus obviously weakens, and infection site obviously reduces, and patient respiratory is more unobstructed, and do not find other drug with complication.
The present invention has with respect to traditional treatment chronic obstructive pulmonary disease advantage:
1, directly act on the pulmonary lesions position and have more targeting, do not participate in general metabolism.
2, toxic and side effects is less, and safety is higher, medicine is stable.
3, Sodium Pyruvate, as antioxidant, is different from antibiotic, expectorant, steroid medicine, and effect is more comprehensive, effect is better.
Description of drawings
Fig. 1 percentage ratio that FEV1 measures after asthmatic subjects is taken normal saline and 0.5mMol/kg Sodium Pyruvate changes comparison diagram;
Fig. 2 percentage ratio that FEV1 measures after asthmatic subjects is taken normal saline and 1.5mMol/kg Sodium Pyruvate changes comparison diagram;
Fig. 3 percentage ratio that FEV1 measures after asthmatic subjects is taken normal saline and 2.5mMol/kg Sodium Pyruvate changes comparison diagram;
Fig. 4 percentage ratio that FEV1 measures after asthmatic subjects is taken normal saline and 5mMol/kg Sodium Pyruvate changes comparison diagram;
Fig. 5 is that asthmatic subjects is taken the percentage ratio that PEF measures after normal saline and 0.5mMol/kg Sodium Pyruvate and changed comparison diagram;
Fig. 6 is that asthmatic subjects is taken the percentage ratio that PEF measures after normal saline and 1.5mMol/kg Sodium Pyruvate and changed comparison diagram;
Fig. 7 is that asthmatic subjects is taken the percentage ratio that PEF measures after normal saline and 2.5mMol/kg Sodium Pyruvate and changed comparison diagram;
Fig. 8 is that asthmatic subjects is taken the percentage ratio that PEF measures after normal saline and 5mMol/kg Sodium Pyruvate and changed comparison diagram;
Fig. 9 is the concentration level comparison diagram of the H2O2 of contrast experimenter and asthmatic patient.
The specific embodiment
Embodiment 1
0.5mMol/kg the preparation (1000) of Sodium Pyruvate inhalant
Prescription
Technique: the Sodium Pyruvate of recipe quantity and sodium chloride are added respectively in 95% surplus purified water after stirring and add again 5% surplus purified water to stir.Carry out sterile filling after aseptic filtration, packing had both obtained the Sodium Pyruvate inhalant of 0.5mMol/kg.
To treating slight chronic obstructive pulmonary disease, good curative effect is arranged by clinical research this product.
1.0mMol/kg the preparation (1000) of Sodium Pyruvate inhalant
Prescription
Technique: the Sodium Pyruvate of recipe quantity and sodium chloride are added respectively in 95% surplus purified water after stirring and add again 5% surplus purified water to stir.Carry out sterile filling after aseptic filtration, packing had both obtained the Sodium Pyruvate inhalant of 1.0mMol/kg.
To treating slight chronic obstructive pulmonary disease, good curative effect is arranged by clinical research this product.
Embodiment 3
1.5mMol/kg the preparation (1000) of Sodium Pyruvate inhalant
Prescription
Technique: the Sodium Pyruvate of recipe quantity and sodium chloride are added respectively in 95% surplus purified water after stirring and add again 5% surplus purified water to stir.Carry out sterile filling after aseptic filtration, packing had both obtained the Sodium Pyruvate inhalant of 1.5mMol/kg.
To treating slight chronic obstructive pulmonary disease, good curative effect is arranged by clinical research this product.
2.5mMol/kg the preparation (1000) of Sodium Pyruvate inhalant
Prescription
Technique: the Sodium Pyruvate of recipe quantity and sodium chloride are added respectively in 95% surplus purified water after stirring and add again 5% surplus purified water to stir.Carry out sterile filling after aseptic filtration, packing had both obtained the Sodium Pyruvate inhalant of 2.5mMol/kg.
To treating slight chronic obstructive pulmonary disease, certain curative effect is arranged by clinical research this product, more multiplex in the treatment of severe chronic obstructive pulmonary disease.
Embodiment 5
3.0mMol/kg the preparation (1000) of Sodium Pyruvate inhalant
Prescription
Technique: the Sodium Pyruvate of recipe quantity and sodium chloride are added respectively in 95% surplus purified water after stirring and add again 5% surplus purified water to stir.Carry out sterile filling after aseptic filtration, packing had both obtained the Sodium Pyruvate inhalant of 3.0mMol/kg.
By clinical research this product, treatment severe chronic obstructive pulmonary disease there is certain curative effect.
4.0mMol/kg the preparation (1000) of Sodium Pyruvate inhalant
Prescription
Technique: the Sodium Pyruvate of recipe quantity and sodium chloride are added respectively in 95% surplus purified water after stirring and add again 5% surplus purified water to stir.Carry out sterile filling after aseptic filtration, packing had both obtained the Sodium Pyruvate inhalant of 4.0mMol/kg.
By clinical research this product, treatment severe chronic obstructive pulmonary disease there is certain curative effect.
Embodiment 7
5.0mMol/kg the preparation (1000) of Sodium Pyruvate inhalant
Prescription
Technique: the Sodium Pyruvate of recipe quantity and sodium chloride are added respectively in 95% surplus purified water after stirring and add again 5% surplus purified water to stir.Carry out sterile filling after aseptic filtration, packing had both obtained the Sodium Pyruvate inhalant of 5.0mMol/kg.
By clinical research this product, treatment severe chronic obstructive pulmonary disease there is good curative effect.
5.5mMol/kg the preparation (1000) of Sodium Pyruvate inhalant
Prescription
Technique: the Sodium Pyruvate of recipe quantity and sodium chloride are added respectively in 95% surplus purified water after stirring and add again 5% surplus purified water to stir.Carry out sterile filling after aseptic filtration, packing had both obtained the Sodium Pyruvate inhalant of 5.5mMol/kg.
By clinical research this product, treatment severe chronic obstructive pulmonary disease there is good curative effect.
Embodiment 9
6.0mMol/kg the preparation (1000) of Sodium Pyruvate inhalant
Prescription
Technique: the Sodium Pyruvate of recipe quantity and sodium chloride are added respectively in 95% surplus purified water after stirring and add again 5% surplus purified water to stir.Carry out sterile filling after aseptic filtration, packing had both obtained the Sodium Pyruvate inhalant of 6.0mMol/kg.
By clinical research this product, treatment severe chronic obstructive pulmonary disease there is good curative effect.
Embodiment 2-9 relates to inhalant and uses 5ml liquid at every turn, and liquid is poured in nebulizer and produced water smoke, and the general breathing by pulmonary's power sucks pulmonary with water smoke, uses 5 minutes at every turn.
The present embodiment is part acetone acid sodium clinical research data.
Purpose: (1) detect the Sodium Pyruvate inhalant in slight chronic obstructive pulmonary disease individuality safety and the effectiveness for the treatment of; (2) measure the Sodium Pyruvate inhalant and whether can reduce the concentration of the hydrogen peroxide of these experimenter's expired gass.
Method: the Sodium Pyruvate of having studied three kinds of concentration; 0.5mMol/kg, 1.5mMol/kg, 2.5mMol/kg and 5.0mMol/kg.80 contrast individualities that the experimenter has completed to study 20 non-asthma, 60 slight chronic obstructive pulmonary diseases by name are individual.The contrast individuality of non-asthma is divided into 4 groups, every group of 5 experimenters; Every group of Sodium Pyruvate of accepting respectively three kinds of concentration.Slight chronic obstructive pulmonary disease individuality is divided into 4 groups, every group of 15 experimenters; Every group of Sodium Pyruvate of accepting respectively four kinds of concentration.Originally every experimenter sucks the normal saline of single dose, returns to the Sodium Pyruvate that sucks the 5.0mL concentration of single dose while following up a case by regular visits to.Suck front 1h and rear 1h collection expired gas at normal saline or Sodium Pyruvate.15min, 30min, 1h, 2h and 4h after baseline and Sodium Pyruvate or normal saline suction carry out Pulmonary Evaluation and monitor vital sign.
Usually be used as clinically the sensitive indicator of chronic obstructive pulmonary disease with FEV1 and two kinds of indexs of PEF, PEF be forced expiration peak flow, FEV1 be one second FEC.
Patients with chronic obstructive pulmonary diseases is due to the deficiency of the intake of oxygen, the oxidation material that the macrophage that air flue and pulmonary raise produces can obviously increase, as free radical (HO), hydrogen peroxide (H2O2), nitric oxide (NO), active oxygen (ROS) etc., this is clinical uses the variation of hydrogen peroxide (H2O2) of pulmonary and reflects as chronic obstructive pulmonary disease treatment situation.
Result:
1) percentage ratio that FEV1 measures after asthmatic subjects sucks normal saline placebo or Sodium Pyruvate changes, data are in Table 1,0.5mMol/kg Fig. 1 is seen in pyruvate research, 1.5mMol/kg Fig. 2 is seen in pyruvate research, 2.5mMol/kg Fig. 3 is seen in pyruvate research, Fig. 4 is seen in the research of 5mMol/kg pyruvate.
2) percentage ratio that PEF measures after asthmatic subjects sucks normal saline placebo or Sodium Pyruvate changes, data are in Table 2,0.5mMol/kg Fig. 5 is seen in pyruvate research, 1.5mMol/kg Fig. 6 is seen in pyruvate research, 2.5mMol/kg Fig. 7 is seen in pyruvate research, Fig. 8 is seen in the research of 5mMol/kg pyruvate.
3) Fig. 9 is seen in the concentration level research of the H2O2 of medicine of the present invention (0.5mMol/kg) contrast experimenter and asthmatic patient.
All do not observe serious adverse events in any experimenter of research.After Sodium Pyruvate sucked, the physiological change of termination did not all occur can cause studying in any participant.In addition, suck and compare with normal saline, 0.5mMol/kg, the 1.5mMol/kg Sodium Pyruvate suck after 15min, 30min, 1h and 2h, the percentage ratio that can be observed FEV1 and PEF in slight chronic obstructive pulmonary disease changes be significantly improved statistically (greater than 10%).Suck the Sodium Pyruvate of 2.5mMol/kg or 5.0mMol/kg, the FEV1 of slight chronic obstructive pulmonary disease experimenter after suction that observes do not have significant change.Compare with the contrast individuality of non-asthma, can be observed the expired gas concentration of hydrogen peroxide and significantly raise in slight chronic obstructive pulmonary disease experimenter.In addition, with sucking normal saline, compare, slight chronic obstructive pulmonary disease experimenter after sucking the 2.5mMol/kg Sodium Pyruvate, can be observed the H2O2 concentration significantly decline (p＜0.02) statistically of expired gas.Compare with sucking normal saline, slight chronic obstructive pulmonary disease experimenter is after sucking 0.5mMol/kg or 5.0mMol/kg Sodium Pyruvate, and we can't detect the significant change of H2O2 concentration in expired gas.
Table 1: the percentage ratio that after normal saline placebo or Sodium Pyruvate, FEV1 measures
Table 2: the percentage ratio that after normal saline placebo or Sodium Pyruvate, PEF measures
Conclusion:
A. safety: in all experimenters, the suction of Sodium Pyruvate all can be well tolerable.All do not observe in any experimenter because Sodium Pyruvate sucks serious adverse events and the physiological change that needs to stop research.
B. effectiveness: have the improvement of clinical meaning and remarkable improvement statistically according to the variation of FEV1, Sodium Pyruvate except having antiinflammatory property, also may have bronchiectatic activity.The Sodium Pyruvate of 0.5mMol/kg-1.5mMol/kg is also found in clinical research in addition,, by the atomization pulmonary administration, is preventing and treating slight chronic obstructive pulmonary disease that significant curative effect is arranged.4.5mMol/kg-5.5mMol/kg Sodium Pyruvate,, by the atomization pulmonary administration, in treatment severe chronic obstructive pulmonary disease, significant curative effect is arranged.
Embodiment 11
Sodium Pyruvate inhalant stability study
Prescription is in Table 3
Table 3: Sodium Pyruvate inhalant prescription
With the inhalant of prescription 1～12 preparation, put into respectively the acceleration test in 6 months of 40 ℃, the results are shown in Table 4
Table 4: stability related data
Conclusion:
The stability that can prove Sodium Pyruvate 0.5mMol/kg～6mMol/kg from table 2 is better.
Claims (4)
1. Sodium Pyruvate is in the purposes for preparing in treating chronic obstructive pulmonary disease.
2. the inhalant compositions that can treat chronic obstructive pulmonary disease, it is characterized in that, comprise following constituent: Sodium Pyruvate, sodium chloride and water, in described inhalant compositions, the molality of Sodium Pyruvate is 0.5-6 mMol/kg, and the mass percent of sodium chloride is 0.85-0.95%.
3. the inhalant compositions that can treat slight chronic obstructive pulmonary disease or preventing chronic obstructive pulmonary disease, it is characterized in that, comprise following constituent: Sodium Pyruvate, sodium chloride and water, in described inhalant compositions, the molality of Sodium Pyruvate is 0.5-1.5 mMol/kg, and the mass percent of sodium chloride is 0.85-0.95%.
4. the preparation method of inhalant compositions as claimed in claim 2 or claim 3, it is characterized in that, comprise the following steps: Sodium Pyruvate and sodium chloride are added respectively in 95% surplus purified water after stirring and adds 5% surplus purified water to stir again, carry out sterile filling after aseptic filtration, packing both obtained.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2013103355699A CN103385868A (en) | 2013-08-02 | 2013-08-02 | Application of sodium pyruvate in preparing medicine for treating chronic obstructive pulmonary disease |
| CN201410032871.1A CN103720682A (en) | 2013-08-02 | 2014-01-23 | Pyruvic acid medicinal composition and application thereof in preparation of medicament for treating chronic obstructive pulmonary diseases |
| CN201410175073.4A CN103948578A (en) | 2013-08-02 | 2014-04-28 | Pyruvic acid medicine composition for stabilizing osmotic pressure, and detoxification function thereof in healthy people and patients with lung diseases |
| PCT/CN2014/082185 WO2015014209A1 (en) | 2013-08-02 | 2014-07-15 | Pyruvate pharmaceutical compositions for osmotic stability and detoxification effect thereof in healthy human beings and lung disease patients |
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| CN2013103355699A CN103385868A (en) | 2013-08-02 | 2013-08-02 | Application of sodium pyruvate in preparing medicine for treating chronic obstructive pulmonary disease |
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| CN201410032871.1A Pending CN103720682A (en) | 2013-08-02 | 2014-01-23 | Pyruvic acid medicinal composition and application thereof in preparation of medicament for treating chronic obstructive pulmonary diseases |
| CN201410175073.4A Pending CN103948578A (en) | 2013-08-02 | 2014-04-28 | Pyruvic acid medicine composition for stabilizing osmotic pressure, and detoxification function thereof in healthy people and patients with lung diseases |
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| CN201410175073.4A Pending CN103948578A (en) | 2013-08-02 | 2014-04-28 | Pyruvic acid medicine composition for stabilizing osmotic pressure, and detoxification function thereof in healthy people and patients with lung diseases |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2015014209A1 (en) * | 2013-08-02 | 2015-02-05 | 江苏长泰药业有限公司 | Pyruvate pharmaceutical compositions for osmotic stability and detoxification effect thereof in healthy human beings and lung disease patients |
| WO2021115156A1 (en) * | 2019-12-10 | 2021-06-17 | 周方强 | Composition containing sodium pyruvate and use thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN106727320A (en) * | 2017-01-13 | 2017-05-31 | 江苏长泰药业有限公司 | A kind of composition for repairing schneiderian membrane, reducing allergic reaction, antiinflammatory action |
| CN109771398B (en) * | 2019-02-25 | 2019-09-20 | 广州南鑫药业有限公司 | A kind of Peramivir solution-type inhalant and preparation method thereof |
| CN109806224B (en) * | 2019-03-15 | 2021-05-28 | 江苏长泰药业有限公司 | Olopatadine composition and preparation method thereof |
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| CN101164530B (en) * | 2006-10-18 | 2010-10-20 | 周方强 | Aqueous solution containing stable sodium pyrouvate and preparing method and use thereof |
| CN102657611B (en) * | 2012-03-02 | 2015-01-14 | 江苏长泰药业有限公司 | Sodium pyruvate nasal spray and preparation method thereof |
| CN103385868A (en) * | 2013-08-02 | 2013-11-13 | 江苏长泰药业有限公司 | Application of sodium pyruvate in preparing medicine for treating chronic obstructive pulmonary disease |
| CN103610671A (en) * | 2013-12-10 | 2014-03-05 | 江苏长泰药业有限公司 | Pyruvic acid medicinal composition and application thereof in preparing medicament for treating lung cancer |
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2014
- 2014-01-23 CN CN201410032871.1A patent/CN103720682A/en active Pending
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2015014209A1 (en) * | 2013-08-02 | 2015-02-05 | 江苏长泰药业有限公司 | Pyruvate pharmaceutical compositions for osmotic stability and detoxification effect thereof in healthy human beings and lung disease patients |
| WO2021115156A1 (en) * | 2019-12-10 | 2021-06-17 | 周方强 | Composition containing sodium pyruvate and use thereof |
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| CN103948578A (en) | 2014-07-30 |
| CN103720682A (en) | 2014-04-16 |
| WO2015014209A1 (en) | 2015-02-05 |
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