CN109125427B - Penyanjing suppository and preparation method thereof - Google Patents
Penyanjing suppository and preparation method thereof Download PDFInfo
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- A61K36/185—Magnoliopsida (dicotyledons)
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Abstract
The invention belongs to the technical field of pharmaceutical engineering, and particularly relates to a pelvic inflammation cleaning suppository and a preparation method thereof, wherein the pelvic inflammation cleaning suppository is composed of a pelvic inflammation cleaning extract and auxiliary materials, wherein the pelvic inflammation cleaning extract accounts for 1-5 parts; the auxiliary material is at least one of 1-10 parts of glycerogelatin, 1-8 parts of polyoxyethylene (40) monostearate, 1-5 parts of poloxamer and 0.002-0.1 part of azone. The suppository is in a suppository form, is directly absorbed and quickly acts on a focus, can avoid the interaction of the medicament with digestive tracts such as stomach, intestine and the like to inactivate the medicament or stimulate the gastrointestinal tract by the medicament, can avoid the first pass effect of liver, is convenient to use and carry, can play a local treatment role and can be used for whole-body treatment, so the suppository has a unique effect on the treatment of diseases.
Description
Technical Field
The invention belongs to the technical field of pharmaceutical engineering, and particularly relates to a pelvic inflammation cleaning suppository and a preparation method thereof.
Background
Pelvic inflammation is a common and frequently encountered gynecological disease, the incidence rate is up to 30% -60%, and the health and the life quality of women are seriously affected. Penyanjing is an effective medicine for treating chronic pelvic inflammation. The pelvic inflammation curing agent currently on the market comprises tablets, capsules, granules, oral liquid and the like. The pelvic inflammation medicine is prepared by extracting eight medicinal materials of honeysuckle stem, suberect spatholobus stem, east Asian tree fern rhizome, dandelion, motherwort herb, plantain herb, red paeony root, Szechuan lovage rhizome and the like with water and precipitating with ethanol, and then adding a proper amount of auxiliary materials. These oral preparations enter the gastrointestinal tract such as the stomach and intestine through the oral cavity, and some of the drugs are inactivated by various substances in the gastrointestinal tract, or the drugs stimulate the gastrointestinal tract, and the drug effect is reduced by the "first pass effect" after the drugs are absorbed through the gastrointestinal tract. Years of clinical application tracking and collection show that some patients have adverse reactions such as nausea, diarrhea, pruritus, rash, vomit, headache and the like after the pelvic inflammation oral preparation is used, and the compliance of the patients is influenced, so that the treatment and the rehabilitation of the patients are influenced.
Disclosure of Invention
The invention aims to solve the defects of the prior art and provides a new, safe and effective product, namely the pelvic inflammation cleaning suppository.
The invention is realized by the following technical scheme:
a pelvic inflammation cleaning suppository is composed of a pelvic inflammation cleaning extract and auxiliary materials, wherein the pelvic inflammation cleaning extract accounts for 1-5 parts; the auxiliary material is at least one of 1-10 parts of glycerogelatin, 1-8 parts of polyoxyethylene (40) monostearate, 1-5 parts of poloxamer and 0.002-0.1 part of azone.
The preparation method of the Penyanjing extract comprises the following steps:
(1) taking the medicine: weighing 550g of honeysuckle stem, 550g of caulis spatholobi, 550g of rhizoma cibotii, 220g of dandelion, 220g of motherwort, 220g of plantain herb, 132g of red paeony root and 132g of ligusticum wallichii;
(2) decocting: adding 8 times of water into the medicinal materials weighed in the step (1), decocting twice for 2 hours each time, and mixing the decoctions;
(3) and (3) filtering: filtering the decoction to obtain filtrate;
(4) concentration: concentrating the filtrate to a relative density of 1.25 at 90 deg.C;
(5) adding ethanol: adding medicinal ethanol into the concentrated filtrate to make the alcohol content in the filtrate 65%;
(6) preparing clear paste: uniformly stirring the filtrate obtained in the step (5), standing for 12 hours, filtering to obtain a supernatant, and recovering ethanol to obtain a clear paste with the relative density of 1.30 at the temperature of 60-65 ℃;
(7) preparing a finished product: drying the obtained fluid extract and pulverizing to obtain PENYANJING extract.
The weight ratio of the glycerol to the gelatin to the water in the glycerol gelatin is 5-8: 1-4: 1-3.
The auxiliary material is preferably at least one of 1-9 parts of glycerogelatin, 1-6 parts of polyoxyethylene (40) monostearate, 1-4 parts of poloxamer and 0.002-0.08 part of azone.
A suppository for treating pelvic inflammation is prepared by the following steps:
a. crushing: pulverizing PENYANJING extract;
b. screening: sieving the crushed Penyanjing extract with a 80-mesh sieve, and taking the Penyanjing extract under the sieve;
c. dissolving auxiliary materials: and dissolving the auxiliary materials in a water bath at 45-65 ℃.
d. Gradually adding the Penyanjing extract obtained in the step b into the dissolved auxiliary material obtained in the step c at the temperature of 35-65 ℃, and stirring along with adding to disperse and completely mix the Penyanjing extract to obtain a mixture;
e. pouring a mold: d, pouring the mixture obtained in the step d into a plug mould coated with a small amount of liquid paraffin or vegetable oil at a proper speed (ensuring that bubbles are effectively extruded in the mould filling process), and pouring until a mould opening slightly overflows; cooling the mixture in an environment with the temperature of less than or equal to 10 ℃ for 30-50 minutes (min), taking out the mixture, scraping redundant parts, and taking out the pelvic inflammation suppository;
f. packaging: and e, packaging the pelvic inflammation eliminating suppository obtained in the step e to obtain a finished product.
A suppository for treating pelvic inflammation, vaginitis and cervicitis is disclosed.
Compared with the prior art, the invention has the following beneficial effects: 1. the invention provides a new, safe and effective product for patients, the product can replace the existing pelvic inflammation curing agent and is highly approved by both doctors and patients; 2 the invention adopts the form of suppository, because the suppository is directly absorbed, acts on the focus very fast, can avoid the interaction of the medicament and the digestive tracts such as stomach, intestines and the like to inactivate the medicament or stimulate the gastrointestinal tract by the medicament, can also avoid the first pass effect of liver, is convenient to use and carry, can play a local treatment role, and can be used for the whole body treatment, so the suppository has unique effect on the treatment of diseases; 3. compared with the products sold on the market at present, the Chinese medicinal composition has more remarkable treatment effect, and can be used for treating vaginitis, cervicitis and the like besides pelvic inflammation; 4. the invention selects the glycerogelatin and the like as the matrix of the suppository for treating pelvic inflammation and prepares the pelvic inflammation-treating suppository into the suppository, thereby improving the dosage form and overcoming the problems of irritation and the like of the traditional Chinese medicine external preparation.
Detailed Description
The present invention is further illustrated by the following examples, but the scope of the present invention is not limited by the examples.
Example 1
The composition of the pelvic inflammation cleaning extract and the auxiliary materials is preferably: 2 parts of Penyanjing extract, 3 parts of glycerogelatin, 1 part of polyoxyethylene (40) monostearate and 1 part of poloxamer.
Gradually adding the Penyanjing extract which is ground and sieved by a 80-mesh sieve into the dissolved auxiliary materials at the temperature of 45-55 ℃, stirring along with adding to completely and uniformly disperse the extract, filling the mixture into a plug mold (the additive is coated in the plug mold firstly) at a proper speed until a mold opening slightly overflows; cooling at below 10 deg.C for 30min, taking out, slightly scraping off excessive part, taking out the suppository, and packaging.
Example 2
The composition of the pelvic inflammation cleaning extract and the auxiliary materials is preferably: 5 parts of Penyanjing extract, 3 parts of glycerogelatin, 2 parts of polyoxyethylene (40) monostearate and 0.002 part of azone.
Gradually adding the Penyanjing extract which is ground and sieved by a 80-mesh sieve into the dissolved auxiliary materials at the temperature of 50-60 ℃, stirring along with adding to completely and uniformly disperse the extract, filling the mixture into a plug mold (the additive is coated in the plug mold firstly) at a proper speed of 6, and filling until a mold opening slightly overflows; cooling at below 10 deg.C for 50min, taking out, slightly scraping off excessive part, taking out the suppository, and packaging.
Test example 1: bacteriostasis test
The suppository of the invention is the pelvic inflammation eliminating suppository prepared in example 1, and the batch number is as follows: 20170912. the usage and dosage are as follows: applied externally, 3 times a day. Ofloxacin suppository.
Preparing a bacterial liquid: taking 1 single colony on a common agar slant culture medium of 6 test strains of pseudomonas aeruginosa, escherichia coli, staphylococcus aureus, candida albicans, streptococcus and sarcina, respectively inoculating the single colony to 10mL of broth culture medium, culturing the single colony at 37 ℃ for 24h, and diluting the single colony with sterile normal saline to the concentration of 1.5 multiplied by 108cfu/mL for later use.
Determination of Minimum Inhibitory Concentration (MIC): several small test tubes containing 1mL broth culture medium were diluted to a series of concentrations by a two-fold dilution method, 50 μ L of each strain diluent (diluted to 10-4 for use) was added to mix well, and cultured at 37 ℃ for 24h, and the minimum concentration of the clarified liquid in the test tubes was recorded, which is the minimum inhibitory concentration, and the results are shown in Table 1.
TABLE 1 MIC assay results for PENYANJING suppository against the following strains
Note: "+" indicates that growth was observed, and "-" indicates that no growth was observed.
The experimental result shows that the suppository for treating pelvic inflammation has an inhibiting effect on pseudomonas aeruginosa, escherichia coli, staphylococcus aureus, candida albicans, streptococcus and sarcina in vitro.
Test example 2: safety test
1. Acute toxicity test: the guinea pig is administered with 100 times of clinical daily dose in vagina, and is continuously observed for 7 days, so that all animals are kept healthy, and no abnormality is found in diet, activity, hair and excrement, and the abnormality is also not found in visual autopsy.
2. Long-term toxicity test: the large dose group, the medium dose group and the small dose group of the medicine in the vagina of the guinea pig are administrated for 4 weeks, so that the weight, hemogram, liver and kidney functions of the guinea pig are not affected, and pathological examination on heart, liver, spleen, lung, kidney and uterus is not obviously changed.
3. Mucosal irritation test: the white female rabbit is administrated once in the vagina for observation, and the result shows that the local part and the whole body do not have obvious reaction within 24 hours, and no pathological change is seen by naked eyes and under a microscope after the vagina mucosa is taken out of the sacrificed animal.
The results show that the pelvic inflammation cleaning suppository does not have toxic and side effects in acute toxicity and long-term toxicity tests and mucosa irritation tests, and is safe and reliable in clinical application.
Test example 3: clinical trial
1. General data: community hospital outpatient clinic from 9 months in 2017 to 12 months in 201772For example. The treatment group and the control group are randomly divided, wherein the treatment group comprises 42 cases, the control group comprises 30 cases, and the age, the disease course and the integration condition before treatment of the two groups have no statistical significance (P is more than 0.05) through statistical test (t test), and the data are all comparable.
2. Diagnostic criteria: according to the relevant contents in the standard of curative effect of diagnosis of clinical symptoms of traditional Chinese medicine, the following steps are drawn: (1) part of patients have a history of acute pelvic inflammatory disease; (2) a pain due to lower abdomen and distention or soreness of lumbosacral part, which is aggravated by fatigue, postcoital and menstrual periods, accompanied by low-grade fever, fatigue, irregular menstruation and leukorrhagia; (3) gynecological examination: the uterus is usually in the posterior position, limited in movement or fixed by adhesion, with tenderness. If the uterus is endometritis, the uterus is enlarged and tenderness is caused; if salpingitis is detected, the cord-like substance is touched on one side or two sides of uterus and slight tenderness is caused; in case of pelvic connective tissue inflammation, there is a thickening and tenderness on one or both sides of uterus. Or touching the mass on one side or both sides of the pelvic cavity. (4) Pelvic inflammatory mass or effusion is found through B-ultrasonic examination.
3. The treatment method comprises the following steps: the Chinese medicinal suppository for treating pelvic inflammation is externally used for a treatment group, 1 granule is taken every day, and 12 days are 1 course of treatment.
The control group orally takes Penyanjing granules 10g once 3 times a day. 12 days is 1 course of treatment.
4. Scoring criteria for local signs and symptoms: according to the standard of curative effect of diagnosis of clinical symptoms of traditional Chinese medicine: the relevant contents of < new medicine and traditional Chinese medicine clinical research guiding principles in the angle of the & ltsoup & gt are formulated.
5. The curative effect standard is as follows: the medicine is drawn up according to the relevant contents of New medicine and traditional Chinese medicine clinical research guiding principles in the Standard of curative Effect for diagnosing clinical symptoms of traditional Chinese medicine. And (3) curing: clinical symptoms all disappeared; the effect is shown: the symptoms disappear, the gynecological examination is obviously improved, and the tenderness of the uterus and the attachments is obviously improved; the method has the following advantages: the symptoms are obviously improved, and the tenderness of uterus and accessories in gynecological examination is relieved; and (4) invalidation: before and after treatment, the clinical symptoms and physical signs are not changed.
6. The treatment results are as follows: the local signs and symptoms of the two groups of cases before and after treatment are obviously improved, and the results are shown in table 2.
Table 2: comparison table of local signs and symptoms before and after treatment
Compared with the two groups, the clinical cure rate and the total effective rate of the treatment group to the pelvic inflammation are higher than those of the control group (P is less than 0.05).
Claims (4)
1. The suppository for treating pelvic inflammation is characterized by being prepared from a pelvic inflammation eliminating extract and auxiliary materials through the following steps:
a. crushing: pulverizing PENYANJING extract;
b. screening: sieving the crushed Penyanjing extract with a 80-mesh sieve, and taking the Penyanjing extract under the sieve;
c. dissolving auxiliary materials: dissolving the auxiliary materials in a water bath at 45-65 ℃;
d. gradually adding the Penyanjing extract obtained in the step b into the dissolved auxiliary materials obtained in the step c, and stirring along with adding to disperse and completely mix the Penyanjing extract to obtain a mixture;
e. pouring a mold: d, pouring the mixture obtained in the step d into a plug mold coated with a small amount of liquid paraffin or vegetable oil until a mold opening slightly overflows; cooling the mixture in an environment with the temperature of less than or equal to 10 ℃ for 30-50 min, taking out the mixture, scraping redundant parts, and taking out the pelvic inflammation cleaning suppository;
f. packaging: e, packaging the pelvic inflammation eliminating suppository obtained in the step e to obtain a finished product;
wherein the Penyanjing extract is 1-5 parts; the auxiliary material is at least one of 1-10 parts of glycerogelatin, 1-8 parts of polyoxyethylene 40 monostearate, 1-5 parts of poloxamer and 0.002-0.1 part of azone;
the preparation method of the Penyanjing extract comprises the following steps:
(1) taking the medicine: weighing 550g of honeysuckle stem, 550g of caulis spatholobi, 550g of rhizoma cibotii, 220g of dandelion, 220g of motherwort, 220g of plantain herb, 132g of red paeony root and 132g of ligusticum wallichii;
(2) decocting: adding 8 times of water into the medicinal materials weighed in the step (1), decocting twice for 2 hours each time, and mixing the decoctions;
(3) and (3) filtering: filtering the decoction to obtain filtrate;
(4) concentration: concentrating the filtrate to a relative density of 1.25 at 90 deg.C;
(5) adding ethanol: adding medicinal ethanol into the concentrated filtrate to make the alcohol content in the filtrate 65%;
(6) preparing clear paste: uniformly stirring the filtrate obtained in the step (5), standing for 12 hours, filtering to obtain a supernatant, and recovering ethanol to obtain a clear paste with the relative density of 1.30 at the temperature of 60-65 ℃;
(7) preparing a finished product: drying the obtained fluid extract and pulverizing to obtain PENYANJING extract.
2. The suppository for treating pelvic inflammation according to claim 1, wherein the weight ratio of glycerin to gelatin to water in glycerin gelatin is 5-8: 1-4: 1-3.
3. The suppository for treating pelvic inflammation according to claim 1, wherein the auxiliary material is at least one of 1-9 parts of glycerogelatin, 1-6 parts of polyoxyethylene 40 monostearate, 1-4 parts of poloxamer and 0.002-0.08 part of azone.
4. The suppository for pelvic inflammation according to any one of claims 1-3, wherein the suppository for pelvic inflammation is used for the treatment of pelvic inflammation, vaginitis and cervicitis when it is applied externally.
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CN101181361A (en) * | 2007-11-22 | 2008-05-21 | 姚俊华 | A kind of Penyanjing soft capsule and preparation method thereof |
CN101579306A (en) * | 2009-06-25 | 2009-11-18 | 王明 | Ciclopirox olamine pessary and preparation method thereof |
CN106511500A (en) * | 2016-11-24 | 2017-03-22 | 杨凌科森生物制药有限责任公司 | Composition for treating gynecological disease, agent containing composition and preparation method of composition |
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CN101181361A (en) * | 2007-11-22 | 2008-05-21 | 姚俊华 | A kind of Penyanjing soft capsule and preparation method thereof |
CN101579306A (en) * | 2009-06-25 | 2009-11-18 | 王明 | Ciclopirox olamine pessary and preparation method thereof |
CN106511500A (en) * | 2016-11-24 | 2017-03-22 | 杨凌科森生物制药有限责任公司 | Composition for treating gynecological disease, agent containing composition and preparation method of composition |
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