CN114984084B - Traditional Chinese medicine composition and traditional Chinese medicine preparation for treating hemorrhoid anorectal diseases and preparation method and application thereof - Google Patents
Traditional Chinese medicine composition and traditional Chinese medicine preparation for treating hemorrhoid anorectal diseases and preparation method and application thereof Download PDFInfo
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- CN114984084B CN114984084B CN202210775568.5A CN202210775568A CN114984084B CN 114984084 B CN114984084 B CN 114984084B CN 202210775568 A CN202210775568 A CN 202210775568A CN 114984084 B CN114984084 B CN 114984084B
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Abstract
The invention discloses a traditional Chinese medicine composition for treating hemorrhoids anorectal diseases, a traditional Chinese medicine preparation, a preparation method and application thereof. The traditional Chinese medicine composition comprises 0.1-10 parts of artificial musk, 0.1-10 parts of artificial bezoar, 5-50 parts of dried alum, 50-150 parts of schizonepeta charcoal, 50-150 parts of fried pagodatree pod, 10-70 parts of borneol and 5-30 parts of borax, and the traditional Chinese medicine preparation is prepared from the traditional Chinese medicine composition and auxiliary materials. The traditional Chinese medicine preparation provided by the invention has good anti-inflammatory, analgesic and hemostatic effects, is suitable for anorectal diseases such as hemorrhoids and anal fissure with various symptoms of fecal hemorrhage, has good safety and has high product value; meanwhile, the preparation process of the traditional Chinese medicine preparation provided by the invention is simple, strong in controllability, good in product stability and wide in market application prospect.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicine compositions, and in particular relates to a traditional Chinese medicine composition for treating hemorrhoids anorectal diseases, an external preparation containing the traditional Chinese medicine composition, and a preparation method and application thereof.
Background
Hemorrhoid anorectal diseases belong to a common and multiple disease in clinic, and are commonly hemorrhoids, anal fissure, fecal hemorrhage or pain or falling sense, perianal eczema and the like. The most widely applied medicine in clinic at present is a skin external preparation, the market of external medicine for treating hemorrhoids anorectal diseases takes Chinese patent medicines as the main medicine and occupies more than 80 percent of market share, and the Chinese patent medicine has obvious curative effect for treating hemorrhoids anorectal diseases and low toxic and side effects, thus being popular with experts and patients.
At present, the Chinese patent medicines for treating hemorrhoids anorectal diseases are various, such as anal-Tai ointment, ma Ying Longshu hemorrhoids ointment, jiu Hua ointment, beijing Wan hong hemorrhoids ointment, bear gall hemorrhoids ointment and the like. The prior art also discloses a plurality of external preparations for treating hemorrhoids anorectal diseases, for example, patent document CN1209118C discloses a medicament for treating hemorrhoids anorectal diseases, which is prepared from seven traditional Chinese medicines of amber, borneol, borax, pearl, calamine, bezoar and musk, and has better anti-inflammatory and analgesic effects.
Patent documents CN100536881C and CN113521166B disclose a medicament for treating hemorrhoid anorectal diseases, which is prepared from nine traditional Chinese medicines of amber, borneol, borax, beautyberry, pearl, calamine, artificial bezoar, catechu and artificial musk, and pharmacodynamic experiments show that compared with the traditional hemorrhoid medicament, the medicament has better antibacterial, anti-inflammatory and analgesic effects, but the stability of the product is difficult to control after a large amount of carbonate mineral calamine is added, and industrial mass production and sales of the product are difficult to realize.
Therefore, the medicine for treating hemorrhoids anorectal diseases, which has good curative effect and good stability and is suitable for mass production and sale, is necessary.
Disclosure of Invention
In order to solve the defects existing in the prior art, one of the purposes of the invention is to provide a traditional Chinese medicine composition for treating hemorrhoids anorectal diseases, and the traditional Chinese medicine composition has good curative effect and good stability through the optimization of the formula types.
The invention also aims to provide a traditional Chinese medicine preparation containing the traditional Chinese medicine composition, and the traditional Chinese medicine composition is prepared into a common traditional Chinese medicine preparation, so that the traditional Chinese medicine preparation is convenient to use.
The invention also aims at providing a preparation method of the traditional Chinese medicine preparation, which has simple process and controllable operation.
The final object of the invention is to provide an application of the traditional Chinese medicine composition in preparing external preparations for treating hemorrhoids anorectal diseases.
In order to achieve the above purpose, the present invention adopts the following technical scheme:
a traditional Chinese medicine composition for treating hemorrhoids anorectal diseases is prepared from the following raw materials in parts by weight:
musk is a monarch drug for detumescence and resolving hard mass, has the functions of opening orifices, dredging channels and collaterals, penetrating bones and muscles, removing malignant boil, removing putrefaction and promoting tissue regeneration, has strong permeability, enables skin pores to be opened and expanded by pungent temperature fragrance, leads the drugs to reach the affected parts, can be used for treating sores and ulcers, swelling and toxin due to blood stasis, swelling and pain due to blood stasis and traumatic injury, and has the antibacterial and anti-inflammatory effects which are six times of that of hydrocortisone as proved by modern pharmacological researches.
The dried alum is calcined by alum, and the main component is aqueous aluminum potassium sulfate, the alum is cold in nature, sour and astringent in taste, enters lung, spleen, liver and large intestine channels, has the effects of eliminating phlegm, drying dampness, stopping bleeding and relieving diarrhea, can detoxify and kill parasites, dry dampness and relieve itching when being externally used, and is mainly used for astringing dampness and astringing sores, stopping bleeding and resolving putrefaction. Traditionally, alum can reduce the property of acid cold after being calcined, weaken the effect of antiemetic, and strengthen the effects of astringing dampness and healing sores, stopping bleeding and resolving decay. Modern researches have shown that after the alum is calcined into dried alum, the antibacterial, anti-inflammatory and hemostatic effects are enhanced, and the external energy reacts with protein to generate substances which are difficult to dissolve in water to precipitate, so that the exudates on the sore surface are reduced to play a role in promoting granulation and protecting.
Bezoar has the effects of relieving spasm, inducing resuscitation, clearing heat and detoxicating, and also has the effects of exciting and inhibiting smooth muscle, resisting inflammation and resisting infection, and can be used for treating skin sore and furuncle due to fetal toxin and all sores and ulcers, and can be matched with Alumen to strengthen the effect of monarch drug, so as to play roles of clearing heat and detoxicating, detumescence and relieving pain, astringing and promoting granulation together.
The fried pagodatree pod has the effects of clearing heat and purging fire, cooling blood and stopping bleeding, and is used for treating intestinal heat hematochezia, hemorrhoids and hemorrhage, liver heat headache, dizziness and conjunctival congestion. The main active ingredients in the fried pagodatree pod are flavonoid compounds, isoflavone compounds, saponin compounds and pagodatree polysaccharide, and modern pharmacological researches show that the fried pagodatree pod has better functions of stopping bleeding, blood coagulation, anti-inflammatory and detumescence.
The schizonepeta charcoal has slightly warm nature, pungent and astringent taste, enters lung and liver meridians, has the effects of astringing and stopping bleeding, and is used for hematochezia, metrorrhagia and metrostaxis and postpartum anemic fainting.
Boron is a growth element necessary for human bodies, animals and plants, and mainly exists in the forms of boric acid, borax and the like, wherein the chemical component of borax is sodium tetraborate, is weak base and has weak antibacterial effect; borax has the effects of preserving and protecting skin mucous membrane, and can be used for washing ulcers and abscesses clinically, and is often used for treating skin mucous membrane and some tinea pedis, and has the effects of clearing heat, dissolving phlegm, detoxifying and preserving.
Borneol, pungent and bitter in taste and slightly cold in nature; has the effects of inducing resuscitation, refreshing mind, clearing heat, relieving pain, and subsiding swelling, and can be used for treating sore pain, sore, carbuncle, infantile hemorrhoids, and unhealed ulcer. The borneol is easy to absorb through mucous membrane and subcutaneous tissue, is discharged from the body after being combined with glucuronic acid in the body, is applied to the local part to slightly stimulate the sensory nerve, and has certain analgesic and mild antiseptic effects.
In the formula of the invention, musk is fragrant and flees, and is a monarch drug for activating collaterals, relieving swelling, resolving masses and relieving pain. The calculus bovis factitius has the effects of clearing heat and detoxicating, relieving swelling and pain, and the dried alum has the effects of eliminating dampness and promoting wound healing, and stopping bleeding and resolving decay, and is taken as ministerial drug. The schizonepeta charcoal has the effects of astringing to stop bleeding, borax has the effects of detoxification and corrosion prevention, and the fried pagodatree pod has the effects of clearing heat and stopping bleeding, and the borneol has the effects of clearing heat and detoxicating, promoting tissue regeneration and relieving pain, and is taken as an adjuvant drug. The whole prescription is used together to play the roles of clearing heat and drying dampness, activating blood and relieving swelling, astringing and stopping bleeding, removing necrotic tissue and promoting granulation, and is used for various hemorrhoids, anal fissure and symptoms, such as fecal hemorrhage, pain and falling sense caused by damp-heat stasis; also can be used for perianal eczema.
Preferably, the traditional Chinese medicine composition for treating hemorrhoids anorectal diseases is prepared from the following raw materials in parts by weight:
preferably, the traditional Chinese medicine composition for treating hemorrhoids anorectal diseases is prepared from the following raw materials in parts by weight:
preferably, the traditional Chinese medicine composition for treating hemorrhoids anorectal diseases is prepared from the following raw materials in parts by weight:
the invention also discloses a traditional Chinese medicine preparation which is prepared from the traditional Chinese medicine composition for treating hemorrhoids anorectal diseases and auxiliary materials.
Preferably, the Chinese medicinal preparation can be any pharmaceutically acceptable external preparation, and can be one or more of ointment, cream, gel, suppository, spray, film, paste, powder mist, solution, lotion and liniment.
Preferably, when the traditional Chinese medicine composition is prepared into the traditional Chinese medicine preparation, pharmaceutically acceptable auxiliary materials can be optionally added. The pharmaceutically acceptable auxiliary materials are not particularly limited, and auxiliary materials well known to those skilled in the art, such as common drug matrixes, antioxidants, bacteriostats, thickeners, wetting agents and the like, are adopted.
More preferably, the auxiliary materials comprise 700-800 parts of vaseline, 20-60 parts of lanoline and 40-80 parts of propylene glycol.
Meanwhile, the invention also provides a preparation method of the traditional Chinese medicine preparation, which comprises the following steps:
(1) Pulverizing Moschus, artificial calculus bovis, borax, and Alumen, and mixing to obtain crude powder;
(2) Extracting schizonepeta charcoal with ethanol solution to obtain a first extract; concentrating the first extract under reduced pressure to obtain a first concentrated solution; the first concentrated solution is subjected to spray drying and airflow crushing treatment to obtain fine powder of schizonepeta charcoal dry paste; extracting the fried sophora fruit with an aqueous solution to obtain a second extracting solution; concentrating the second extract under reduced pressure to obtain a second concentrated solution; the second concentrated solution is subjected to spray drying and air flow crushing treatment to obtain fried locust bean dry extract fine powder;
(3) Dispersing the fried sophora japonica linn dry paste fine powder and the schizonepeta charcoal dry paste fine powder obtained in the step (2) in propylene glycol to obtain dispersion liquid;
(4) Pulverizing Borneolum Syntheticum, and sieving to obtain Borneolum Syntheticum fine powder;
(5) Heating and melting vaseline and lanoline, and cooling to obtain ointment matrix;
(6) Adding the borneol fine powder obtained in the step (4) into the ointment base obtained in the step (5) and uniformly stirring; and (3) sequentially adding the traditional Chinese medicine raw powder obtained in the step (1) and the dispersion liquid obtained in the step (3) under the condition of homogenization, and cooling to form paste, thus obtaining the traditional Chinese medicine preparation.
Meanwhile, the invention also claims the application of the traditional Chinese medicine composition in preparing external preparations for treating hemorrhoids anorectal diseases.
Compared with the prior art, the invention has the following beneficial effects:
(1) The invention provides a traditional Chinese medicine composition for treating hemorrhoids anorectal diseases, which is reasonably compatible, is composed of musk, bezoar, dried alum, schizonepeta charcoal, fried pagodatree pod, borneol and borax, and modern pharmacological researches show that the traditional Chinese medicine preparation prepared from the traditional Chinese medicine composition has better anti-inflammatory, analgesic and hemostatic effects, further improves the hemostatic effects of products compared with traditional hemorrhoids medicines, is especially suitable for various hemorrhoids with bleeding of stool, anal fissure and other anorectal diseases, has good safety and has higher product value.
(2) The invention provides a traditional Chinese medicine preparation for treating hemorrhoids anorectal diseases, which is prepared by selecting a specific traditional Chinese medicine composition provided by the invention and adding common auxiliary materials, has remarkable anti-inflammatory and analgesic effects for treating hemorrhoids anorectal diseases by external application, and further improves the hemostatic effect of the product.
(3) The preparation method of the traditional Chinese medicine preparation provided by the invention has the advantages of simple process, controllable operation and good product stability, and is suitable for large-scale production.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention will be described in further detail with reference to the following examples. Of course, the specific embodiments described herein are for purposes of illustration only and are not intended to limit the invention.
Although the steps of the present invention are arranged by reference numerals, the order of the steps is not limited, and the relative order of the steps may be adjusted unless the order of the steps is explicitly stated or the execution of a step requires other steps as a basis. It is to be understood that the term "and/or" as used herein relates to and encompasses any and all possible combinations of one or more of the associated listed items.
Unless otherwise specified, the raw materials in the invention are all purchased from market.
Example 1
A Chinese medicinal composition for treating hemorrhoid anorectal diseases is prepared from the following raw materials in part by weight:
example 2
A Chinese medicinal composition for treating hemorrhoid anorectal diseases is prepared from the following raw materials in part by weight:
example 3
A Chinese medicinal preparation for treating hemorrhoid anorectal diseases is prepared from the following raw materials in part by weight:
in this embodiment, a preparation method of the above Chinese medicinal preparation for treating hemorrhoid anorectal diseases is provided, which includes the following steps:
(1) Pulverizing Moschus, artificial calculus bovis, borax and Alumen by jet mill, and mixing to obtain crude powder;
(2) Extracting charred herba Schizonepetae with 10 times of 60% ethanol solution for 3 times, mixing filtrates, and filtering to obtain first extractive solution; concentrating the first extract under reduced pressure to a relative density of about 1.2 (60deg.C) to obtain a first concentrate; the first concentrated solution is subjected to spray drying and airflow crushing treatment and is sieved by a 200-mesh sieve to obtain fine powder of schizonepeta charcoal dry paste; extracting parched fructus Sophorae with 10 times of water solution for 3 times, mixing filtrates, and filtering to obtain second extractive solution; concentrating the second extract under reduced pressure to a relative density of about 1.2 (60deg.C) to obtain a second concentrate; the second concentrated solution is subjected to spray drying and air flow crushing treatment and is sieved by a 200-mesh sieve to obtain fried sophora japonica linn dry paste fine powder;
(3) Dispersing the fried sophora japonica linn dry paste fine powder and the schizonepeta charcoal dry paste fine powder obtained in the step (2) in propylene glycol to obtain dispersion liquid;
(4) Pulverizing Borneolum Syntheticum, and sieving with 60 mesh sieve to obtain Borneolum Syntheticum fine powder;
(5) Heating yellow vaseline and lanolin in 80deg.C water bath to melt, stirring to obtain yellow transparent liquid, cooling to 60deg.C to obtain ointment matrix, and maintaining the temperature;
(6) Adding the borneol fine powder obtained in the step (4) into the ointment base obtained in the step (5) and stirring uniformly (about 5 min); sequentially adding the traditional Chinese medicine raw powder obtained in the step (1) and the dispersion liquid obtained in the step (3) under a homogenizing condition, homogenizing for about 3min, and then cooling to 40 ℃ while stirring to form a paste, thus obtaining the traditional Chinese medicine preparation;
(7) And (3) pouring the traditional Chinese medicine preparation obtained in the step (6) into a composite tube, adopting a sealing machine to carry out tail sealing treatment, setting the temperature of the sealing machine to 250 ℃, and preparing the ointment with the specification of 10 g/branch.
Example 4
A Chinese medicinal composition for treating hemorrhoid anorectal diseases is prepared from the following raw materials in part by weight:
in this embodiment, a preparation method of the above Chinese medicinal preparation for treating hemorrhoid anorectal diseases is provided, which includes the following steps:
(1) Pulverizing Moschus, artificial calculus bovis, borax and Alumen by jet mill, and mixing to obtain crude powder;
(2) Extracting charred herba Schizonepetae with 10 times of 60% ethanol solution for 3 times, mixing filtrates, and filtering to obtain first extractive solution; concentrating the first extract under reduced pressure to a relative density of about 1.2 (60deg.C) to obtain a first concentrate; the first concentrated solution is subjected to spray drying and airflow crushing treatment and is sieved by a 200-mesh sieve to obtain fine powder of schizonepeta charcoal dry paste; extracting parched fructus Sophorae with 10 times of water solution for 3 times, mixing filtrates, and filtering to obtain second extractive solution; concentrating the second extract under reduced pressure to a relative density of about 1.2 (60deg.C) to obtain a second concentrate; the second concentrated solution is subjected to spray drying and air flow crushing treatment and is sieved by a 200-mesh sieve to obtain fried sophora japonica linn dry paste fine powder;
(3) Dispersing the fried sophora japonica linn dry paste fine powder and the schizonepeta charcoal dry paste fine powder obtained in the step (2) in propylene glycol to obtain dispersion liquid;
(4) Pulverizing Borneolum Syntheticum, and sieving with 60 mesh sieve to obtain Borneolum Syntheticum fine powder;
(5) Heating yellow vaseline and lanolin in 80deg.C water bath to melt, stirring to obtain yellow transparent liquid, cooling to 60deg.C to obtain ointment matrix, and maintaining the temperature;
(6) Adding the borneol fine powder obtained in the step (4) into the ointment base obtained in the step (5) and stirring uniformly (about 5 min); sequentially adding the traditional Chinese medicine raw powder obtained in the step (1) and the dispersion liquid obtained in the step (3) under a homogenizing condition, homogenizing for about 3min, and then cooling to 40 ℃ while stirring to form a paste, thus obtaining the traditional Chinese medicine preparation;
(7) And (3) pouring the traditional Chinese medicine preparation obtained in the step (6) into a composite tube, adopting a sealing machine to carry out tail sealing treatment, setting the temperature of the sealing machine to 250 ℃, and preparing the ointment with the specification of 10 g/branch.
Example 5
A Chinese medicinal composition for treating hemorrhoid anorectal diseases is prepared from the following raw materials in part by weight:
in this embodiment, a preparation method of the above Chinese medicinal preparation for treating hemorrhoid anorectal diseases is provided, which includes the following steps:
(1) Pulverizing Moschus, artificial calculus bovis, borax and Alumen by jet mill, and mixing to obtain crude powder;
(2) Extracting charred herba Schizonepetae with 10 times of 60% ethanol solution for 3 times, mixing filtrates, and filtering to obtain first extractive solution; concentrating the first extract under reduced pressure to a relative density of about 1.2 (60deg.C) to obtain a first concentrate; the first concentrated solution is subjected to spray drying and airflow crushing treatment and is sieved by a 200-mesh sieve to obtain fine powder of schizonepeta charcoal dry paste; extracting parched fructus Sophorae with 10 times of water solution for 3 times, mixing filtrates, and filtering to obtain second extractive solution; concentrating the second extract under reduced pressure to a relative density of about 1.2 (60deg.C) to obtain a second concentrate; the second concentrated solution is subjected to spray drying and air flow crushing treatment and is sieved by a 200-mesh sieve to obtain fried sophora japonica linn dry paste fine powder;
(3) Dispersing the fried sophora japonica linn dry paste fine powder and the schizonepeta charcoal dry paste fine powder obtained in the step (2) in propylene glycol to obtain dispersion liquid;
(4) Pulverizing Borneolum Syntheticum, and sieving with 60 mesh sieve to obtain Borneolum Syntheticum fine powder;
(5) Heating yellow vaseline and lanolin in 80deg.C water bath to melt, stirring to obtain yellow transparent liquid, cooling to 60deg.C to obtain ointment matrix, and maintaining the temperature;
(6) Adding the borneol fine powder obtained in the step (4) into the ointment base obtained in the step (5) and stirring uniformly (about 5 min); sequentially adding the traditional Chinese medicine raw powder obtained in the step (1) and the dispersion liquid obtained in the step (3) under a homogenizing condition, homogenizing for about 3min, and then cooling to 40 ℃ while stirring to form a paste, thus obtaining the traditional Chinese medicine preparation;
(7) And (3) pouring the traditional Chinese medicine preparation obtained in the step (6) into a composite tube, adopting a sealing machine to carry out tail sealing treatment, setting the temperature of the sealing machine to 250 ℃, and preparing the ointment with the specification of 10 g/branch.
Example 6
A Chinese medicinal composition for treating hemorrhoid anorectal diseases is prepared from the following raw materials in part by weight:
in this embodiment, a preparation method of the above Chinese medicinal preparation for treating hemorrhoid anorectal diseases is provided, which includes the following steps:
(1) Pulverizing Moschus, artificial calculus bovis, borax and Alumen by jet mill, and mixing to obtain crude powder;
(2) Extracting charred herba Schizonepetae with 10 times of 60% ethanol solution for 3 times, mixing filtrates, and filtering to obtain first extractive solution; concentrating the first extract under reduced pressure to a relative density of about 1.2 (60deg.C) to obtain a first concentrate; the first concentrated solution is subjected to spray drying and airflow crushing treatment and is sieved by a 200-mesh sieve to obtain fine powder of schizonepeta charcoal dry paste; extracting parched fructus Sophorae with 10 times of water solution for 3 times, mixing filtrates, and filtering to obtain second extractive solution; concentrating the second extract under reduced pressure to a relative density of about 1.2 (60deg.C) to obtain a second concentrate; the second concentrated solution is subjected to spray drying and air flow crushing treatment and is sieved by a 200-mesh sieve to obtain fried sophora japonica linn dry paste fine powder;
(3) Dispersing the fried sophora japonica linn dry paste fine powder and the schizonepeta charcoal dry paste fine powder obtained in the step (2) in propylene glycol to obtain dispersion liquid;
(4) Pulverizing Borneolum Syntheticum, and sieving with 60 mesh sieve to obtain Borneolum Syntheticum fine powder;
(5) Heating yellow vaseline and lanolin in 80deg.C water bath to melt, stirring to obtain yellow transparent liquid, cooling to 60deg.C to obtain ointment matrix, and maintaining the temperature;
(6) Adding the borneol fine powder obtained in the step (4) into the ointment base obtained in the step (5) and stirring uniformly (about 5 min); sequentially adding the traditional Chinese medicine raw powder obtained in the step (1) and the dispersion liquid obtained in the step (3) under a homogenizing condition, homogenizing for about 3min, and then cooling to 40 ℃ while stirring to form a paste, thus obtaining the traditional Chinese medicine preparation;
(7) And (3) pouring the traditional Chinese medicine preparation obtained in the step (6) into a composite tube, adopting a sealing machine to carry out tail sealing treatment, setting the temperature of the sealing machine to 250 ℃, and preparing the ointment with the specification of 10 g/branch.
Comparative example 1
A Chinese medicinal preparation for treating hemorrhoid anorectal diseases is prepared from the following raw materials in part by weight:
specifically, about 20g of dry paste powder obtained by extracting 100g of schizonepeta charcoal is obtained, and the catechu is in powder form in the invention.
In the comparative example, a preparation method of the traditional Chinese medicine preparation for treating hemorrhoids anorectal diseases is provided, which comprises the following steps:
(1) Pulverizing Moschus, artificial calculus bovis, borax and Alumen by jet mill, and mixing to obtain crude powder;
(2) Extracting parched fructus Sophorae with 10 times of water solution for 3 times, mixing filtrates, and filtering to obtain second extractive solution; concentrating the second extract under reduced pressure to a relative density of about 1.2 (60deg.C) to obtain a second concentrate; the second concentrated solution is subjected to spray drying and air flow crushing treatment and is sieved by a 200-mesh sieve to obtain fried sophora japonica linn dry paste fine powder;
(3) Pulverizing Catechu by air flow, sieving with 200 mesh sieve, and dispersing together with the parched fructus Sophorae dry extract fine powder obtained in step (2) in propylene glycol to obtain dispersion;
(4) Pulverizing Borneolum Syntheticum, and sieving with 60 mesh sieve to obtain Borneolum Syntheticum fine powder;
(5) Heating yellow vaseline and lanolin in 80deg.C water bath to melt, stirring to obtain yellow transparent liquid, cooling to 60deg.C to obtain ointment matrix, and maintaining the temperature;
(6) Adding the borneol fine powder obtained in the step (4) into the ointment base obtained in the step (5) and stirring uniformly (about 5 min); sequentially adding the traditional Chinese medicine raw powder obtained in the step (1) and the dispersion liquid obtained in the step (3) under a homogenizing condition, homogenizing for about 3min, and then cooling to 40 ℃ while stirring to form a paste, thus obtaining the traditional Chinese medicine preparation;
(7) And (3) pouring the traditional Chinese medicine preparation obtained in the step (6) into a composite tube, adopting a sealing machine to carry out tail sealing treatment, setting the temperature of the sealing machine to 250 ℃, and preparing the ointment with the specification of 10 g/branch.
Test example 1
1. Purpose of test
Pharmacological tests are utilized to research the effects of analgesia, anti-inflammatory, hemostasis and the like of the ointment prepared by the invention.
2. Test method
The analgesic effect of the ointment of the invention is studied by adopting a formalin plantar inflammatory pain rat model; the anti-inflammatory effect of the ointment is researched by adopting a rat anus swelling model caused by the bala oil and a rat anus ulcer model caused by the acetic acid; the hemostatic effect of the ointments of the invention was studied by using an experimental rabbit skin excision model.
3. Test materials
(1) Test article
The ointment prepared in example 3 was used as group a; the ointment prepared in example 4 was used as group b; the ointment prepared in example 5 was used as group c; the ointment prepared in example 6 was used as group d; the ointment prepared in comparative example 1 was used as group e.
(2) Positive control
Mark dragon musk hemorrhoids ointment, lot number: 210929/210625; the content is as follows: 10% -20%, character: ointments served as positive control.
4. Test method and results
(1) Effects on formalin plantar inflammatory pain rat model
1) Grouping and administration
80 male SD rats are selected, the weight of the male SD rats is 180-220 g, the male SD rats are randomly divided into 8 groups according to the weight, and the normal control group, the model control group, the positive control group and the test sample group (a group, b group, c group, d group and e group) are respectively selected, and 10 male SD rats are selected from each group. After grouping, the right hind feet of rats of each administration group are respectively smeared with each tested object except the normal control group and the model control group, and the administration dose is 0.25 g/rat, 2 times per day; cutting the oil-separating paper into 1.5cm and attaching the oil-separating paper to the administration part after the medicine is applied, and winding a medical adhesive tape. Each dose was administered at 8h intervals, for 5 days continuously, and after the last dose was administered 1 time, the plantar skin of each rat except the normal control group was injected with 5% formalin at a volume of 0.1 mL/dose. The pain response of the rats was observed at 1, 5, 15, 30, 45, 60, 90min after injection, respectively.
2) Detection index
Number of foot licks in rats: after the last dose, the number of licks in rats was recorded for 30 min.
Rat foot pain response: pain response in rats was observed 1, 5, 15, 30, 45, 60, 90min after injection of the molding composition, foot pain grading criteria, scoring criteria: 0 point: formalin injection is carried out, one side hindfoot and the opposite side hindfoot are contacted with the bottom surface, and walking is free; 1, the method comprises the following steps: both hind feet contact the bottom surface, but the injection side is slightly claudified while walking; 2, the method comprises the following steps: the hind feet at both sides are contacted with the bottom surface, but the gravity center of the body is at the healthy side, and the injection side obviously lameness is caused when walking; 3, the method comprises the following steps: the injection side hind feet slightly contact the bottom surface, but do not dare to bear weight, and lift up when walking; 4, the following steps: the foot is lifted after injecting formalin on one side, and does not contact any surface; 5, the method comprises the following steps: rats lick, bite, shake and inject formalin into the hind paw.
3) Detection result
The results of measuring the number of licks in the rat are shown in Table 1, and the results of measuring the pain response in the foot of the rat are shown in Table 2.
TABLE 1 Effect of the ointments of the invention on the number of licking feet in ratsn＝10)/>
Note that: p.ltoreq.0.05, p.ltoreq.0.01 compared to the model control group
The pain phase of the formalin SD rat toe pain model can be divided into two types, one is the acute pain phase (0-10 min) and the other is the inflammatory pain phase (10-30 min). As can be seen from Table 1, the positive control group and the test samples a, b, c and d were significantly reduced in the number of licks within 1 to 10min and 10 to 30min (P.ltoreq.0.05 or P.ltoreq.0.01) as compared with the model control group. Therefore, the musk hemorrhoids ointment and the ointment of the invention have obvious analgesic effects in the acute pain stage and the inflammatory pain stage and have better analgesic effects.
TABLE 2 Effect of the ointments of the invention on the grade scores of pain in the toes of rats [ (]n＝10)
Note that: p.ltoreq.0.05, p.ltoreq.0.01 compared to the model control group
As can be seen from Table 2, compared with the model control group, the pain level scores of the positive control group and the test articles a, b, c and d are obviously reduced (P is less than or equal to 0.05 or P is less than or equal to 0.01) after 45min of administration, the pain level score is reduced to 0 after 90min of administration, and the pain sensation is completely eliminated; again, it is proved that both the musk hemorrhoids ointment and the ointment of the invention have better analgesic effect.
(2) Effect on model of rat anal swelling with croton oil
1) Grouping and administration
80 male SD rats are selected, and the weight of the male SD rats is 180-220 g, and the male SD rats are randomly divided into 8 groups according to the weight, namely a normal control group, a model control group, a positive control group and test products (group a, group b, group c, group d and group e). Each dosing group was dosed rectally, at a dose of 0.25 g/dose, 2 times daily, at 8h intervals, for 5 consecutive days. The gelatin sponge embolism method is adopted to prolong the drug contact time. Before the administration on the 5 th day, distilled water, pyridine, diethyl ether and croton oil are prepared into a mixed solution according to the ratio of 1:4:5:10, the mixed solution is contacted with a rectal mucosa except for a normal control group for 10s for molding, the therapeutic drug is administered 1 time through a rectal route after the rectal mucosa is contacted with the mixed solution, and animals are sacrificed after the administration for 6 hours.
2) Detection index
Anal swelling rate: after 6 hours from the last dose, the animals were sacrificed and the rectum was immediately cut 15mm long from the edge of the anus coat, the wet weight was weighed after trimming the surrounding connective tissue, then the sample was placed in a dry box at 80 ℃ for 16 hours and the dry weight was weighed, and the severity of swelling was expressed as the rectal-anus swelling rate (= (rectal-anus wet weight-rectal-anus dry weight)/rectal-anus wet weight×100).
3) Detection result
The results of measuring the anus swelling rate of the rats are shown in Table 3.
TABLE 3 Effect of the ointments of the invention on the rate of rectal anal swelling in ratsn＝10)
Note that: p.ltoreq.0.05, p.ltoreq.0.01 compared to the model control group.
As shown in Table 3, after 5 days of administration, compared with the model control group, the rectal and anal swelling rates of the positive control group, the test article a group, the test article b group, the test article c group and the test article d group are obviously reduced (P is less than or equal to 0.05 or P is less than or equal to 0.01), so that the musk hemorrhoids ointment and the musk hemorrhoids ointment of the invention can well inhibit the rectal and anal swelling of rats, and have better anti-inflammatory and detumescence effects.
(3) Influence on acetic acid-induced rat anal ulcer model
1) Grouping and administration
80 male SD rats are selected, the weight of the male SD rats is 180-220 g, 10 rats are taken as a normal control group, and acetic acid (99%) is adopted for the rest rats to establish an anal ulcer model. The method comprises the following steps: the saturated acetic acid solution is dipped into the filter paper with the diameter of 6mm to be tightly contacted with the perianal skin and mucous membrane, and the filter paper is changed for 1 time every 1min after each pasting for 0.5 min. The degree of ulcers was observed and the area of ulcers calculated on day 2 after molding, and the weight was randomly divided into 7 groups according to the area of anal ulcers: model control group, positive control group, test article (group a, group b, group c, group d, group e), 10 each. Each test group was administered rectally, with the exception of the normal control group, at a dose of 0.25 g/dose of 2 times per day, at 8h intervals, for 14 days. The gelatin sponge embolism method is adopted to prolong the drug contact time.
2) Detection index
Anal ulcer area: after molding and on days 1, 4, 7, 10, and 14 of administration, the healing of anal ulcers was observed in each group, and the ulcer area was calculated (ulcer area=pi (d/2) 2 D is the ulcer area diameter).
3) Detection result
The results of the area of anal ulcers in rats are shown in Table 4.
TABLE 4 Effect of the ointments of the invention on the area of anal ulcers in rats [ (]n＝10)
Note that: p.ltoreq.0.05, p.ltoreq.0.01 compared to the model control group.
As shown in Table 4, compared with the model control group, the positive control group, the test article a group, the test article b group, the test article c group, the test article D group and the test article e group have obviously reduced perianal ulcer areas (P is less than or equal to 0.01) after D10 and D14 days after the administration, so that the musk hemorrhoids ointment and the musk hemorrhoids ointment can better promote the healing of anal ulcers of rats, and have better ulcer healing promoting effect. In addition, compared with the test article a, the test article d increases the dosage of the dried alum, but the area of the anal ulcer of the rat is increased, the dried alum is taken as an aluminum-containing raw material, has slight toxicity, and can be taken orally only in a small amount, and the heart and lung can be damaged by multiple purposes, so the traditional Chinese medicine composition of the invention preferably adopts the dried alum with low dosage.
(4) Effect on hemostasis of experimental rabbit skin excision model
1) Grouping and administration
Selecting 28 qualified New Zealand rabbits, wherein the weight of the rabbits is 2.0-2.5 kg, and the rabbits are randomly divided into 7 groups according to sex and weight, namely a model control group, a positive control group and test products (group a, group b, group c, group d and group e), and 4 of the test products are respectively selected from each group. The new zealand rabbit is subjected to a skin excision surface bleeding model, 4 wound surfaces are cut by each new zealand rabbit, each wound surface is a full-circle skin excision wound surface with the diameter of 1.5cm, and the excision positions are ensured to be the same as far as possible by deep reaching a myometrium membrane. After skin excision, each test object is smeared on the wound surface, each administration group is 0.5 g/each test object, and the bleeding time after the test objects are administered is recorded.
2) Detection index
Hemostasis time: the post-dosing hemostatic time was recorded for each group of experimental rabbits.
3) Detection result
The results of testing the hemostatic time after administration of the experimental rabbits are shown in Table 5.
TABLE 5 hemostatic Effect of the ointments of the invention on New Zealand rabbit hemorrhage modeln＝4)
Note that: p.ltoreq.0.05, p.ltoreq.0.01 compared to the model control group.
As can be seen from Table 5, the hemostasis time of the positive control group, the test article a group, b group, c group, d group and e group is significantly reduced (P.ltoreq.0.01) compared with the model control group; compared with the positive control group, the hemostasis time of the test sample a group, the test sample b group, the test sample c group and the test sample d group is obviously reduced, and the hemostasis time of the test sample e group is relatively increased. Compared with the traditional hemorrhoids medicine, the tested product e group ointment prepared by the comparative example has insignificant improvement on the hemostatic effect, which is probably due to unstable content of catechu in the prescription of dried alum and difficult dispersion in the oil phase, thus affecting the hemostatic effect of the product.
Test example 2
The stability study was carried out for 6 months (investigation conditions: 30 ℃ C.+ -. 2 ℃ C., relative humidity 65%.+ -. 5%) on the ointment (specification: 10 g/min; package: composite tube) prepared in example 3 (lot: S2110003) and comparative example according to the requirements of the "Chinese pharmacopoeia", and the specific results are shown in Table 6.
TABLE 6 accelerated stability test results for ointments of the present invention
As can be seen from Table 6, the stability of the ointment prepared in example 3 of the present invention after 6 months of acceleration meets the quality standard requirements, while the stability of the ointment prepared in comparative example after 6 months of acceleration is poor, and the stability of the ointment does not meet the quality standard requirements, which indicates that the prescription components of comparative example may have mutual influence, and the stability of the prescription is poor.
Test example 3
1. Purpose of trial
The ointment prepared in the embodiment 3 of the invention is tested, so that the effectiveness and safety of the product for treating internal hemorrhoids, external hemorrhoids, mixed hemorrhoids, red swelling, pain and bleeding of anal fissure are evaluated accurately, objectively and truly.
2. Trial method
Trial population: the trial population with internal hemorrhoids, external hemorrhoids, mixed hemorrhoids and anal fissure is selected, the sample size of the trial population is 30 people, the age range is 18-65 years, and the male and female are not limited.
Trial method and dosage: the medicine is applied for 7 days after washing anus before being applied 2 times a day and 1 time a day in the morning and evening. For external hemorrhoids and anal fissure patients: directly applying the ointment to the affected part; aiming at patients with internal hemorrhoids and mixed hemorrhoids: the injector is sleeved on the orifice of the ointment tube, after the injector is screwed up, the injector is inserted into anus, and after a proper amount of ointment is extruded, the injector is discarded.
3. Efficacy observation index
And (3) healing: symptoms and signs disappear or disappear basically, the integral value is reduced by more than or equal to 95 percent, and the related physicochemical indexes are normal or basically normal.
The effect is shown: the symptoms and the physical signs are obviously improved, the integral value is reduced by more than or equal to 70 percent, and the related physicochemical indexes are obviously improved.
The method is effective: the symptoms and signs are improved, the integral value is reduced by more than or equal to 30 percent, and the related physicochemical indexes are obviously improved.
Invalidation: the symptoms and signs are not improved, the integral value is reduced by <30 percent, and the related physicochemical indexes are not improved.
The grading of the hemorrhoid symptoms is shown in Table 7.
TABLE 7 hierarchical quantization table for hemorrhoid symptoms
4. Trial results
(1) Product availability
Anal bleeding conditions: among the trial population, 13 (43.3%) had a hemostatic effect 2-3 days after trial and 17 (56.7%) had a hemostatic effect 4-5 days after trial. After the trial is finished, 9 people (30%) have no anal bleeding symptoms, 14 people (46.7%) have obviously reduced anal bleeding symptoms, and 7 people (23.3%) have slightly reduced bleeding symptoms, and the total effective rate of the ointment for improving the anal bleeding condition is up to 100%.
Anal pain conditions: after the trial is finished, 6 (20%) anus pain conditions disappear, 11 (36.7%) anus pain symptoms are obviously relieved, 12 (40%) anus pain symptoms are slightly relieved, 1 (3.3%) anus pain symptoms are not greatly changed, and the total effective rate of the ointment for improving anus pain conditions is up to 96.7%.
The anus is weighed down and swelled: after trial, 8 (26.7%) anus distension symptoms disappear, 16 (53.3%) anus distension symptoms are obviously relieved, and 6 (20%) anus distension symptoms are slightly relieved, and the total effective rate of the ointment for improving anus distension condition is up to 100%.
In conclusion, the ointment has the advantages of quick hemostatic effect time, extremely remarkable hemostatic effect, better relief of anus pain and anus swelling symptoms of hemorrhoids and anal fissure patients, and higher clinical effectiveness.
(2) Product security
In the trial population, 30 (100%) had feedback that there was a cooling sensation after the trial and no discomfort symptoms were present. In conclusion, the ointment of the invention does not have any local irritation and anaphylactic reaction, and has higher safety in clinical trial.
The technical idea of the present invention is described by the above embodiments, but the present invention is not limited to the above embodiments, that is, it does not mean that the present invention must be implemented depending on the above embodiments. It should be apparent to those skilled in the art that any modification of the present invention, equivalent substitution of individual raw materials for the product of the present invention, addition of auxiliary components, selection of specific modes, etc., falls within the scope of the present invention and the scope of disclosure.
Claims (9)
1. A Chinese medicinal composition for external use for treating hemorrhoid anorectal diseases is characterized by being prepared from the following raw materials in parts by weight:
raw materials in parts by weight
0.1-3 parts of artificial musk
0.1-3 parts of artificial bezoar
10-20 parts of dried alum
70-130 parts of schizonepeta charcoal
70-130 parts of fried sophora fruit
30-50 parts of borneol
5-15 parts of borax.
2. The external traditional Chinese medicine composition for treating hemorrhoids anorectal diseases according to claim 1, which is characterized by being prepared from the following raw materials in parts by weight:
raw materials in parts by weight
0.5-2 parts of artificial musk
0.5-2 parts of artificial bezoar
10-20 parts of dried alum
80-120 parts of schizonepeta charcoal
80-120 parts of fried sophora fruit
40-50 parts of borneol
5-15 parts of borax.
3. An external traditional Chinese medicine preparation for treating hemorrhoids anorectal diseases is characterized by being prepared from the external traditional Chinese medicine composition and auxiliary materials according to any one of claims 1-2.
4. The external traditional Chinese medicine preparation according to claim 3, wherein the external traditional Chinese medicine preparation is one of cream, gel, suppository, spray, film, paste, powder, lotion and liniment.
5. The external traditional Chinese medicine preparation according to claim 3, wherein the external traditional Chinese medicine preparation is an ointment, a powder spray or a solution.
6. The external traditional Chinese medicine preparation according to claim 4, wherein the auxiliary materials comprise one or more of a medicine matrix, an antioxidant, a bacteriostat, a thickener or a wetting agent.
7. The external traditional Chinese medicine preparation according to claim 6, wherein the auxiliary materials comprise 700-800 parts of Vaseline, 20-60 parts of lanolin and 40-80 parts of propylene glycol.
8. A method for preparing the external traditional Chinese medicine preparation according to claim 7, which is characterized by comprising the following steps:
(1) Pulverizing Moschus, artificial calculus bovis, borax, and Alumen, and mixing to obtain crude powder;
(2) Extracting schizonepeta charcoal with ethanol solution to obtain a first extract; concentrating the first extract under reduced pressure to obtain a first concentrated solution; the first concentrated solution is subjected to spray drying and airflow crushing treatment to obtain fine powder of schizonepeta charcoal dry paste; extracting the fried sophora fruit with an aqueous solution to obtain a second extracting solution; concentrating the second extract under reduced pressure to obtain a second concentrated solution; the second concentrated solution is subjected to spray drying and air flow crushing treatment to obtain fried locust bean dry extract fine powder;
(3) Dispersing the fried sophora japonica linn dry paste fine powder and the schizonepeta charcoal dry paste fine powder obtained in the step (2) in propylene glycol to obtain dispersion liquid;
(4) Pulverizing Borneolum Syntheticum, and sieving to obtain Borneolum Syntheticum fine powder;
(5) Heating and melting vaseline and lanoline, and cooling to obtain ointment matrix;
(6) Adding the borneol fine powder obtained in the step (4) into the ointment base obtained in the step (5) and uniformly stirring; and (3) sequentially adding the traditional Chinese medicine raw powder obtained in the step (1) and the dispersion liquid obtained in the step (3) under the condition of homogenization, and cooling to form paste, thereby obtaining the external traditional Chinese medicine preparation.
9. The use of the external traditional Chinese medicine composition according to any one of claims 1-2 in preparing external preparations for treating hemorrhoids anorectal diseases.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1194848A (en) * | 1997-04-01 | 1998-10-07 | 何元钟 | Haemorrhoidolysis powder |
| CN106727686A (en) * | 2017-03-01 | 2017-05-31 | 苟小军 | A kind of Chinese medicine fuming-lotion for treating anal disease |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1194848A (en) * | 1997-04-01 | 1998-10-07 | 何元钟 | Haemorrhoidolysis powder |
| CN106727686A (en) * | 2017-03-01 | 2017-05-31 | 苟小军 | A kind of Chinese medicine fuming-lotion for treating anal disease |
Non-Patent Citations (1)
| Title |
|---|
| 冯建春.《用药如用兵 中药配伍应用》.中国中医药出版社,2018,(第第1版版),第608页第10段——第609页第4段. * |
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