CN110882275A - Preparation process of pig gall powder for treating gynecological vaginitis - Google Patents

Preparation process of pig gall powder for treating gynecological vaginitis Download PDF

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CN110882275A
CN110882275A CN201911135026.6A CN201911135026A CN110882275A CN 110882275 A CN110882275 A CN 110882275A CN 201911135026 A CN201911135026 A CN 201911135026A CN 110882275 A CN110882275 A CN 110882275A
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CN110882275B (en
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黄艳萍
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Beijing Baoniantang (heze) Pharmaceutical Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/02Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10Antimycotics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/20Antivirals for DNA viruses
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    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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Abstract

The invention provides a preparation process of pig gall powder for treating gynecological vaginitis, which comprises the following steps: (1) concentrating fel Sus Domestica under reduced pressure, stopping concentrating when the relative density of fel Sus Domestica reaches 1.12-1.19, and cooling to room temperature to obtain concentrated fel Sus Domestica; (2) subpackaging the concentrated pig bile in glass bottles, and placing in a freeze dryer; firstly, adjusting the temperature in a freeze drying chamber to-20 +/-2 ℃, and pre-freezing for 60-90 min; then adjusting the temperature in the freeze drying chamber to-40 +/-2 ℃, and preserving the temperature for 3-4 h; (3) vacuumizing, and when the vacuum degree reaches below 20Pa, starting to heat to-15 +/-2 ℃, and keeping for 15-20 h; then heating to-2 +/-2 ℃, and keeping for 3-5 h; (4) heating to 8 +/-2 ℃, and keeping for 3-5 h; heating to 35 + -2 deg.C, and maintaining for 3-4 h; and (5) closing the freeze dryer, adjusting the pressure to normal pressure, then pressing and plugging, and discharging. The pig gall powder prepared by the invention has good appearance, good re-dissolubility, high safety of clinical medication, good effect on treating gynecological vaginitis and good effect of resisting HPV virus.

Description

Preparation process of pig gall powder for treating gynecological vaginitis
Technical Field
The invention relates to the technical field of traditional Chinese medicines, in particular to a preparation process of pig gall powder for treating gynecological vaginitis.
Background
The fel Sus Domestica powder is dried product of fel Sus Domestica of pig family, and is yellow or gray yellow powder. Slight fishy smell, bitter taste and easy moisture absorption. It has effects in promoting digestion, relieving cough and asthma, relieving inflammation and allergy, resisting pathogenic microorganism, and resisting tumor. In the prior art, the pig gall powder is generally obtained by directly drying fresh pig gall after filtering. Because pig bile contains components such as bile acids, bile pigments, mucin and the like, the biological organic matters are generally sensitive to temperature and oxygen. If the temperature is not well controlled in the processing process of the pig gall powder, the deterioration of effective components in the pig gall is easily caused, and the actual use value of the pig gall powder is reduced. Therefore, it is necessary to develop a new process for preparing the pig gall powder with excellent and stable performance.
Vaginitis is a common multiple gynecological disease and is a latent disease which often troubles women, and according to different causes, the vaginitis comprises staphylococcus aureus, beta hemolytic streptococcus, candida albicans, escherichia coli, trichomonas, gonococcus, chlamydia, papilloma virus and other pathogenic bacteria. At present, most of the medicines used for treating the gynecological diseases are various antibiotic medicines, and have strong pertinence and large toxic and side effects. Therefore, much attention has been paid to the treatment with the use of Chinese herbs. The pig gall powder is one of the traditional Chinese medicines capable of treating gynecological diseases, but the pig gall powder is not reported to be used as a medicament for treating vaginitis.
Disclosure of Invention
The invention aims to provide a preparation process of pig gall powder for treating gynecological vaginitis, and the prepared pig gall powder has good appearance, good redissolution property, high safety of clinical medication, good effect on treating gynecological vaginitis and good effect on resisting HPV (human papillomavirus).
In order to achieve the purpose, the invention is realized by the following technical scheme:
a preparation process of pig gall powder for treating gynecological vaginitis comprises the following steps:
(1) concentrating fel Sus Domestica under reduced pressure, stopping concentrating when the relative density of fel Sus Domestica reaches 1.12-1.19, and discharging when the fel Sus Domestica is cooled to room temperature to obtain concentrated fel Sus Domestica;
(2) subpackaging the concentrated pig bile obtained in the step (1) into glass bottles, and then placing the glass bottles into a freeze dryer; firstly, adjusting the temperature in a freeze drying chamber to-20 +/-2 ℃, and pre-freezing for 60-90 min; then adjusting the temperature in the freeze drying chamber to-40 +/-2 ℃, and preserving the temperature for 3-4 h;
(3) vacuumizing the freeze drying chamber, and when the vacuum degree reaches below 20Pa, starting to heat to-15 +/-2 ℃, and keeping for 15-20 h; then heating to-2 +/-2 ℃, and keeping for 3-5 h;
(4) then heating to 8 +/-2 ℃, and keeping for 3-5 h; then heating to 35 plus or minus 2 ℃ and keeping for 3-4 h; and (5) closing the freeze dryer, adjusting the pressure in the freeze drying chamber to normal pressure, then plugging, and discharging.
Preferably, in the step (1), the vacuum degree is 0.04-0.06MPa and the temperature is 55-60 ℃ when the concentration under reduced pressure is carried out.
Preferably, in the step (2), the temperature in the freeze drying chamber is firstly adjusted to-20 +/-2 ℃ at the rate of 3-5 ℃/10 min; the temperature in the freeze drying chamber was adjusted to-40 + -2 deg.C at a rate of 3-5 deg.C/10 min.
Preferably, in the step (3), the temperature is increased to-15 +/-2 ℃ at the rate of 0.5-1 ℃/10 min; heating to-2 +/-2 ℃ at the speed of 1-1.5 ℃/10 min.
Preferably, in the step (4), the temperature is raised to 8 +/-2 ℃ at the speed of 0.8-1.5 ℃/h, and the temperature is raised to 35 +/-2 ℃ at the speed of 2-3 ℃/10 min.
The pig gall powder prepared by the preparation process is applied to preparing the medicine for treating gynecological vaginitis. The gynecological vaginitis can be bacterial vaginitis and fungal vaginitis.
The invention has the beneficial effects that:
1. when the pig gall powder is prepared, the pig gall powder is firstly subjected to reduced pressure concentration and then is subjected to freeze drying, and the temperature and time of each stage in the freeze drying process are reasonably controlled, so that the obtained freeze-dried pig gall powder has good appearance, good re-solubility and high safety of clinical medication. The obtained pig gall powder has high content of taurolihyodeoxycholic acid, good anti-inflammatory effect,
2. the pig gall powder prepared by the invention has high quality, can be used for directly treating vaginitis, and particularly has good effect on bacterial vaginitis and mycotic vaginitis.
3. The freeze-dried pig gall powder prepared by the invention is sealed and packaged by adopting the glass bottle, so that the storage time of the pig gall powder is prolonged, the pig gall powder is not polluted in the storage process, and the pig gall powder is safer and more effective in treating gynecological vaginitis.
4. The pig gall powder prepared by the invention has good effect of resisting HPV.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the embodiments of the present invention, and it is obvious that the described embodiments are some embodiments of the present invention, but not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Example 1:
a preparation process of pig gall powder for treating gynecological vaginitis comprises the following steps:
(1) concentrating fel Sus Domestica under reduced pressure at 55 deg.C under 0.04 MPa; stopping concentrating when the relative density of fel Sus Domestica reaches 1.15, and collecting after fel Sus Domestica is cooled to room temperature to obtain concentrated fel Sus Domestica;
(2) subpackaging the concentrated pig bile obtained in the step (1) into glass bottles, and then placing the glass bottles into a freeze dryer; firstly, adjusting the temperature in a freeze drying chamber to-20 +/-2 ℃ at the speed of 4 ℃/10min, and pre-freezing for 80 min; adjusting the temperature in the freeze drying chamber to-40 +/-2 ℃ at the speed of 4 ℃/10min, and preserving the temperature for 3.5 h;
(3) vacuumizing the freeze drying chamber, and when the vacuum degree reaches below 20Pa, starting to heat to-15 +/-2 ℃ at the speed of 0.8 ℃/10min, and keeping for 18 h; then heating to-2 +/-2 ℃ at the speed of 1.2 ℃/10min, and keeping for 4 h;
(4) then heating to 8 +/-2 ℃ at the speed of 1 ℃/h, and keeping for 5 h; then heating to 35 +/-2 ℃ at the speed of 3 ℃/10min, and keeping for 4 h; and (5) closing the freeze dryer, adjusting the pressure in the freeze drying chamber to normal pressure, then plugging, and discharging.
Example 2:
a preparation process of pig gall powder for treating gynecological vaginitis comprises the following steps:
(1) concentrating fel Sus Domestica under reduced pressure at 60 deg.C under 0.04 MPa; stopping concentrating when the relative density of fel Sus Domestica reaches 1.18, and collecting the fel Sus Domestica after the fel Sus Domestica is cooled to room temperature to obtain concentrated fel Sus Domestica;
(2) subpackaging the concentrated pig bile obtained in the step (1) into glass bottles, and then placing the glass bottles into a freeze dryer; firstly, adjusting the temperature in a freeze drying chamber to-20 +/-2 ℃ at the speed of 3.5 ℃/10min, and pre-freezing for 70 min; adjusting the temperature in the freeze drying chamber to-40 +/-2 ℃ at the speed of 4 ℃/10min, and preserving the temperature for 4 h;
(3) vacuumizing the freeze drying chamber, and when the vacuum degree reaches below 20Pa, starting to heat to-15 +/-2 ℃ at the speed of 0.8 ℃/10min, and keeping for 18 h; then heating to-2 +/-2 ℃ at the speed of 1.5 ℃/10min, and keeping for 5 h;
(4) then heating to 8 +/-2 ℃ at the speed of 1.2 ℃/h, and keeping for 5 h; then heating to 35 +/-2 ℃ at the speed of 3 ℃/10min, and keeping for 3 h; and (5) closing the freeze dryer, adjusting the pressure in the freeze drying chamber to normal pressure, then plugging, and discharging.
Example 3:
a preparation process of pig gall powder for treating gynecological vaginitis comprises the following steps:
(1) concentrating fel Sus Domestica under reduced pressure at 55 deg.C under 0.05 MPa; stopping concentrating when the relative density of fel Sus Domestica reaches 1.13, and discharging when the fel Sus Domestica is cooled to room temperature to obtain concentrated fel Sus Domestica;
(2) subpackaging the concentrated pig bile obtained in the step (1) into glass bottles, and then placing the glass bottles into a freeze dryer; firstly, adjusting the temperature in a freeze drying chamber to-20 +/-2 ℃ at the speed of 4.5 ℃/10min, and pre-freezing for 90 min; adjusting the temperature in the freeze drying chamber to-40 +/-2 ℃ at the speed of 4.5 ℃/10min, and preserving the temperature for 3 h;
(3) vacuumizing the freeze drying chamber, and when the vacuum degree reaches below 20Pa, starting to heat to-15 +/-2 ℃ at the speed of 1 ℃/10min, and keeping for 20 h; then heating to-2 +/-2 ℃ at the speed of 1.2 ℃/10min, and keeping for 5 h;
(4) then heating to 8 +/-2 ℃ at the speed of 1 ℃/h, and keeping for 4 h; then heating to 35 plus or minus 2 ℃ at the speed of 2.5 ℃/10min, and keeping for 4 h; and (5) closing the freeze dryer, adjusting the pressure in the freeze drying chamber to normal pressure, then plugging, and discharging.
Example 4:
a preparation process of pig gall powder for treating gynecological vaginitis comprises the following steps:
(1) concentrating fel Sus Domestica under reduced pressure at 60 deg.C under 0.06 MPa; stopping concentrating when the relative density of fel Sus Domestica reaches 1.15, and collecting after fel Sus Domestica is cooled to room temperature to obtain concentrated fel Sus Domestica;
(2) subpackaging the concentrated pig bile obtained in the step (1) into glass bottles, and then placing the glass bottles into a freeze dryer; firstly, adjusting the temperature in a freeze drying chamber to-20 +/-2 ℃ at the speed of 3.5 ℃/10min, and pre-freezing for 60 min; adjusting the temperature in the freeze drying chamber to-40 +/-2 ℃ at the speed of 5 ℃/10min, and preserving the temperature for 4 h;
(3) vacuumizing the freeze drying chamber, and when the vacuum degree reaches below 20Pa, starting to heat to-15 +/-2 ℃ at the speed of 1 ℃/10min, and keeping for 18 h; then heating to-2 +/-2 ℃ at the speed of 1 ℃/10min, and keeping for 4 h;
(4) then heating to 8 +/-2 ℃ at the speed of 1.5 ℃/h, and keeping for 4 h; then heating to 35 +/-2 ℃ at the speed of 3 ℃/10min, and keeping for 3.5 h; and (5) closing the freeze dryer, adjusting the pressure in the freeze drying chamber to normal pressure, then plugging, and discharging.
Example 5:
a preparation process of pig gall powder for treating gynecological vaginitis comprises the following steps:
(1) concentrating fel Sus Domestica under reduced pressure at 55 deg.C under 0.04 MPa; stopping concentrating when the relative density of fel Sus Domestica reaches 1.19, and discharging when the fel Sus Domestica is cooled to room temperature to obtain concentrated fel Sus Domestica;
(2) subpackaging the concentrated pig bile obtained in the step (1) into glass bottles, and then placing the glass bottles into a freeze dryer; firstly, adjusting the temperature in a freeze drying chamber to-20 +/-2 ℃ at the speed of 3 ℃/10min, and pre-freezing for 90 min; adjusting the temperature in the freeze drying chamber to-40 +/-2 ℃ at the speed of 3 ℃/10min, and preserving the temperature for 3 h;
(3) vacuumizing the freeze drying chamber, and when the vacuum degree reaches below 20Pa, starting to heat to-15 +/-2 ℃ at the speed of 0.5 ℃/10min, and keeping for 15 h; then heating to-2 +/-2 ℃ at the speed of 1.5 ℃/10min, and keeping for 5 h;
(4) then heating to 8 +/-2 ℃ at the speed of 0.8 ℃/h, and keeping for 3 h; then heating to 35 +/-2 ℃ at the speed of 3 ℃/10min, and keeping for 3 h; and (5) closing the freeze dryer, adjusting the pressure in the freeze drying chamber to normal pressure, then plugging, and discharging.
Example 6:
a preparation process of pig gall powder for treating gynecological vaginitis comprises the following steps:
(1) concentrating fel Sus Domestica under reduced pressure at 58 deg.C under 0.05 MPa; stopping concentrating when the relative density of fel Sus Domestica reaches 1.12, and discharging when the fel Sus Domestica is cooled to room temperature to obtain concentrated fel Sus Domestica;
(2) subpackaging the concentrated pig bile obtained in the step (1) into glass bottles, and then placing the glass bottles into a freeze dryer; firstly, adjusting the temperature in a freeze drying chamber to-20 +/-2 ℃ at the speed of 5 ℃/10min, and pre-freezing for 70 min; adjusting the temperature in the freeze drying chamber to-40 +/-2 ℃ at the speed of 4 ℃/10min, and preserving the temperature for 3.5 h;
(3) vacuumizing the freeze drying chamber, and when the vacuum degree reaches below 20Pa, starting to heat to-15 +/-2 ℃ at the speed of 0.8 ℃/10min, and keeping for 20 h; then heating to-2 +/-2 ℃ at the speed of 1.2 ℃/10min, and keeping for 3 h;
(4) then heating to 8 plus or minus 2 ℃ at the speed of 0.8-1.5 ℃/h, and keeping for 3-5 h; then heating to 35 plus or minus 2 ℃ at the speed of 2 ℃/10min, and keeping for 4 h; and (5) closing the freeze dryer, adjusting the pressure in the freeze drying chamber to normal pressure, then plugging, and discharging.
The swine bile powder obtained in examples 1 to 6 was examined, and the details are shown in table 1.
Table 1:
Figure BDA0002279361920000061
Figure BDA0002279361920000071
the clinical curative effect is as follows:
the swine bile powder is used for treating vaginitis, and the specific treatment mode is as follows: the pig gall powder is directly pushed into the vagina by using a booster for treatment. Vaginitis is mainly bacterial vaginitis and mycotic vaginitis.
The pig gall powder in the embodiment 1 is used for treating bacterial vaginitis, 50 patients with bacterial vaginitis confirmed are selected, the dosage of each patient is 3g, the patient is treated once/day, the treatment lasts for 7 days, and the curative effect result is counted.
The curative effect standard is as follows: and (3) curing: after the product is used, the discomfort symptom disappears; the method has the following advantages: after the product is used, discomfort symptoms basically disappear; and (4) invalidation: after the product is used, discomfort symptoms are unchanged. The specific therapeutic results are shown in table 2.
Table 2:
clinical curative effect Cure rate High efficiency Inefficiency of
Pig gall powder of example 1 80% 12% 8%
As can be seen from Table 2, the swine gall powder prepared by the embodiment of the invention has a very good effect on treating bacterial vaginitis.
The above examples are only intended to illustrate the technical solution of the present invention, but not to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; and such modifications or substitutions do not depart from the spirit and scope of the corresponding technical solutions of the embodiments of the present invention.

Claims (7)

1. A preparation process of pig gall powder for treating gynecological vaginitis is characterized by comprising the following steps:
(1) concentrating fel Sus Domestica under reduced pressure, stopping concentrating when the relative density of fel Sus Domestica reaches 1.12-1.19, and discharging when the fel Sus Domestica is cooled to room temperature to obtain concentrated fel Sus Domestica;
(2) subpackaging the concentrated pig bile obtained in the step (1) into glass bottles, and then placing the glass bottles into a freeze dryer; firstly, adjusting the temperature in a freeze drying chamber to-20 +/-2 ℃, and pre-freezing for 60-90 min; then adjusting the temperature in the freeze drying chamber to-40 +/-2 ℃, and preserving the temperature for 3-4 h;
(3) vacuumizing the freeze drying chamber, and when the vacuum degree reaches below 20Pa, starting to heat to-15 +/-2 ℃, and keeping for 15-20 h; then heating to-2 +/-2 ℃, and keeping for 3-5 h;
(4) then heating to 8 +/-2 ℃, and keeping for 3-5 h; then heating to 35 plus or minus 2 ℃ and keeping for 3-4 h; and (5) closing the freeze dryer, adjusting the pressure in the freeze drying chamber to normal pressure, then plugging, and discharging.
2. The process for preparing swine bile powder for treating gynecological vaginitis according to claim 1, wherein in the step (1), the vacuum degree is 0.04-0.06MPa and the temperature is 55-60 ℃ when the concentration under reduced pressure is performed.
3. The process for preparing swine bile powder for treating gynecological vaginitis according to claim 1, wherein in the step (2), the temperature in the freeze-drying chamber is adjusted to-20 ± 2 ℃ at a rate of 3-5 ℃/10 min; the temperature in the freeze drying chamber was adjusted to-40 + -2 deg.C at a rate of 3-5 deg.C/10 min.
4. The process for preparing swine bile powder for treating gynecological vaginitis according to claim 1, wherein in the step (3), the temperature is raised to-15 ± 2 ℃ at the rate of 0.5-1 ℃/10 min; heating to-2 +/-2 ℃ at the speed of 1-1.5 ℃/10 min.
5. The process for preparing swine bile powder for treating gynecological vaginitis according to claim 1, wherein in the step (4), the temperature is raised to 8 ± 2 ℃ at a rate of 0.8-1.5 ℃/h, and the temperature is raised to 35 ± 2 ℃ at a rate of 2-3 ℃/10 min.
6. The application of the pig gall powder prepared by the preparation process according to any one of claims 1 to 5 in preparing a medicament for treating gynecological vaginitis.
7. Use according to claim 6, characterized in that the gynaecological vaginitis is bacterial vaginitis and mycotic vaginitis.
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Inventor after: Feng Zeju

Inventor after: Huang Yanping

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