CN115887599B - Pharmaceutical composition for treating herpes zoster and preparation method and application thereof - Google Patents
Pharmaceutical composition for treating herpes zoster and preparation method and application thereof Download PDFInfo
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Abstract
The invention relates to the technical field of medicines, in particular to a pharmaceutical composition for treating herpes zoster and a preparation method and application thereof. The medicine has the effects of clearing heat and detoxicating, resolving hard mass and detumescence, promoting qi circulation and relieving pain, is used for treating early herpes zoster, is an external good medicine for treating herpes zoster, and has wide application value.
Description
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to a pharmaceutical composition for treating herpes zoster as well as a preparation method and application thereof.
Background
Herpes zoster is a skin disease caused by varicella-zoster virus infection and is called "herpes zoster", "spider sore" in traditional Chinese medicine. The clinical manifestation of herpes zoster is slight fever before onset, tiredness and discomfort, and then local irregular erythema appears, mung bean size cluster blisters are arranged on the erythema, the blister has a red halo and the nerves are distributed in a single side and strip shape. It is often distributed in intercostal nerves such as dorsal chest. The pain is severe, once the acute phase herpes zoster is diagnosed, if the treatment is not timely and thorough, the pain can develop into postherpetic neuralgia, and the life quality and physical and mental health of patients are seriously affected.
Western medicine is mainly used for treating the disease by adopting medicaments such as antiviral medicaments, vegetative nerve and the like. Western medicines can generate certain side effects on patients in the clinical application process, for example, famciclovir is a 2 nd generation ring-opening nucleoside antiviral drug, and has the characteristics of high bioavailability, long half-life and lasting effect, but can cause adverse reactions such as fever, headache and the like, mecobalamin is coenzyme of methionine synthetase, has important value in the aspects of maintaining cell functions, in vivo metabolism, nerve functions and the like, but can generate adverse reactions such as rash, diarrhea and the like. In addition, because western medicines are taken for a long time, the economic burden of a patient is increased, and the postherpetic neuralgia is often caused. At present, no obvious and effective treatment method exists, but traditional Chinese medicine is a national treasure, and the method for searching the traditional Chinese medicine is one of effective ways for treating herpes zoster.
The invention takes the traditional Chinese medicine as the main component, and researches and experiments prove that the medicine composition for treating the herpes zoster is developed and consists of snake reversing, rheum officinale, alum, turmeric, snake slough, centella asiatica, bitter gall, liquorice and borneol; snake reversing and Rumex madaio are monarch drugs, alum is used for clearing heat and detoxicating, cooling blood and removing stasis, and detumescence and pain relieving, and turmeric is pungent, bitter and warm in nature, enters liver and spleen channels, breaks blood and promotes qi circulation, relieves pain, clears menstruation and relieves swelling, and the medicines are ministerial medicines. The snake slough, the centella and the elephantopus are used for dispelling wind and removing dampness, clearing heat and detoxicating and relieving swelling, and especially for treating the refractory skin itch caused by herpes zoster, liquorice and borneol are used as guiding drugs for purging pathogenic fire and removing toxin, clearing heat and drying dampness, and the drugs are used together to play roles of clearing heat and removing toxin, and relieving swelling and pain. The external preparation prepared by the invention has better spreadability and stability, high drug absorption rate, and shorter bullae stopping time, pain relieving time and crusting time than the prior treatment technology.
Disclosure of Invention
In order to solve the problems, the invention develops a pharmaceutical composition for treating herpes zoster, which consists of snake reversing, rheum officinale, alum, turmeric, snake slough, centella asiatica, elephantopus scaber, liquorice and borneol.
The invention aims to provide a pharmaceutical composition for treating herpes zoster;
another object of the present invention is to provide a method for preparing a pharmaceutical composition for treating shingles;
another object of the invention is to provide the use of a pharmaceutical composition for the preparation of a medicament for the treatment of shingles;
the invention relates to a pharmaceutical composition for treating herpes zoster, which consists of 10-30 parts of snake reversing, 10-30 parts of rheum officinale, 10-30 parts of alum, 10-30 parts of turmeric, 10-30 parts of snake slough, 10-30 parts of centella asiatica, 6-14 parts of georgia, 2-18 parts of liquorice, 1-5 parts of borneol, 80-100 parts of white vaseline, 5-15 parts of light liquid paraffin and 1-3 parts of azone.
Further, the pharmaceutical composition comprises 15-25 parts of snake retrograde, 15-25 parts of rheum emodi, 15-25 parts of alum, 15-25 parts of turmeric, 15-25 parts of snake slough, 15-25 parts of centella asiatica, 8-12 parts of georgia, 6-14 parts of liquorice, 2-4 parts of borneol, 85-95 parts of white vaseline, 8-12 parts of light liquid paraffin and 1-2 parts of azone.
Further, the pharmaceutical composition comprises 20 parts of snake reversing, 20 parts of rheum emodi, 20 parts of alum, 20 parts of turmeric, 20 parts of snake slough, 20 parts of centella asiatica, 10 parts of elephantopus scaber, 10 parts of liquorice, 3 parts of borneol, 90 parts of white vaseline, 10 parts of light liquid paraffin and 1 part of azone.
The preparation method of the pharmaceutical composition for treating herpes zoster provided by the invention comprises the following steps:
(1) Mixing and pulverizing snake back, rumex madaio, alumen, curcuma rhizome, periostracum Serpentis, herba Centellae, fel Ursi and Glycyrrhrizae radix, sieving, and mixing to obtain mixed fine powder;
(2) Heating white vaseline, light liquid paraffin and azone to melt;
(3) Adding the mixed fine powder obtained in the step (1) after melting, stirring uniformly, cooling to 45-55 ℃, adding borneol, grinding, stirring uniformly, preparing 1000g, cooling to 25-35 ℃ and packaging.
Further, the preparation method of the pharmaceutical composition for treating herpes zoster provided by the invention comprises the following steps:
(1) Mixing and pulverizing snake back, rumex madaio, alumen, curcuma rhizome, periostracum Serpentis, herba Centellae, fel Ursi and Glycyrrhrizae radix, sieving, and mixing to obtain mixed fine powder;
(2) Heating white vaseline, light liquid paraffin and azone to melt;
(3) Adding the mixed fine powder obtained in the step (1) after melting, stirring uniformly, cooling to 50 ℃, adding borneol, grinding, stirring uniformly, preparing 1000g, and cooling to 30 ℃ to obtain the product.
The mesh number of the sieve is as follows: 80-120 mesh.
Further, the mesh number of the sieving is as follows: 100 mesh.
The melting temperature of the invention is: 65-75 ℃.
Further, the melting temperature of the invention is: 70 ℃.
The invention relates to application of a pharmaceutical composition in preparing a medicament for treating herpes zoster.
The dosage of the medicine is as follows: the product is applied to affected part twice daily, and is avoided at the site of ulcer.
Compared with the prior art, the invention has the following beneficial effects:
1. the therapeutic effect is obviously improved, and the clinical curative effect test result shows that the total effective rate of the therapeutic effect of the conventional Western medicine therapeutic preparation is about 70%, and the total effective rate of the therapeutic effect of the preparation is about 90%, which is obviously higher than that of the conventional Western medicine therapeutic treatment, and the therapeutic effect of the herpes zoster can be improved by using the ointment.
2. The treatment time is shortened, and the clinical curative effect test result shows that the conventional Western medicine treatment requires patients to take medicines for 3 times every day, the treatment is carried out for 10 days, the time of stopping blisters, the time of relieving pain and the time of crusting are all longer, and the healing cannot be achieved, so that the treatment effect is general; the preparation of the invention can achieve basic cure after being applied once a day in the morning and evening at the pain part, and 5 days is a treatment course, namely, patients using the ointment of the invention have obvious differences in the time of stopping blisters, relieving pain and crusting, which are shorter than those of the conventional treatment of Western medicine.
3. The ointment has the advantages of reducing toxic and side effects, effectively avoiding sequelae, and ensuring that patients do not find any toxic and side effects in the process of using the ointment and do not find any sequelae in the follow-up investigation of patients.
4. The medicine composition has the advantages of less medicine taste, small prescription amount, low price, and low preparation process, thus having low cost and greatly reducing the economic burden of patients.
5. According to the invention, the results of research and investigation on medicinal material crushing are shown as follows:
1) Drying at 60 ℃ until the water content is below 5%, respectively crushing 7 medicinal materials such as snake retrograde, rhaponticum carthamoides, turmeric, snake slough, centella asiatica, elephantopus scaber, liquorice and the like in the formula, wherein the yield is lower after the snake retrograde, the snake slough and the centella asiatica are crushed singly, and the yield is lower than 90% after sieving through a No. seven sieve, because the 3 medicinal materials have more fibers, the medicinal materials are easy to waste after being crushed singly, and the full utilization of medicinal material resources is not facilitated;
2) Drying at 60 ℃ until the water content is below 5%, mixing and crushing 7 medicinal materials such as snake back, rhaponticum carthamoides, turmeric, snake slough, centella asiatica, elephantopus scaber, liquorice and the like in the formula, wherein the fine powder yield of the 7 medicinal materials through a No. seven sieve after mixing and crushing is obviously improved, and the yield is close to 94%, because fine powder generated in the crushing process of medicinal materials with stronger powdering such as turmeric, rhaponticum carthamoides and the like fully wraps fibers generated in the crushing process of snake back, snake slough and centella asiatica, and promotes the crushing of the fibers, so that the fine powder yield is greatly improved;
3) Drying at 60deg.C under mixing until water content is below 5%, mixing and pulverizing all the medicinal materials except Borneolum Syntheticum, mixing and pulverizing mineral Alumen and plant medicine, slightly improving the yield of fine powder passing through a No. seven sieve, and making the yield of fine powder passing through a No. six sieve be above 98% and the yield of fine powder passing through a No. seven sieve be above 94.6%; in consideration of the fact that the production process is simplified by mixing and crushing the plant medicine and the mineral medicine, the preparation is more convenient to operate and cost-saving, the preparation decides to adopt the mixing and crushing process of the plant medicine and the mineral medicine, and as the yield of fine powder passing through a No. six sieve after mixing and crushing the plant medicine and the mineral medicine is more than 98%, the No. six sieve can be preferably used as a medicinal material crushing process parameter.
6. According to the invention, through a matrix research test, the optimal matrix formula obtained by screening is white vaseline, light liquid paraffin, azone=90:10:1, namely 90 parts of white vaseline, 10 parts of light liquid paraffin and 1 part of azone, the spreadability of the preparation can be obviously improved, and the obtained preparation has good heat and cold resistance stability and high drug absorption rate.
7. According to the invention, by examining the temperature test of adding borneol, the result is that: the loss rate of added borneol is higher at the temperature of 60 ℃ and can reach 8.31%, the loss rate of added borneol is lower at the temperature of 50 ℃ and 40 ℃ and is respectively 2.12% and 0.89%, but the ointment is solidified at the temperature of 40 ℃ and is not easy to uniformly mix when added with borneol, so that the optimal temperature for adding the borneol at the temperature of 50 ℃ is achieved, the loss rate of the borneol is reduced, and the mixing uniformity of the borneol and the medicine is improved.
Detailed Description
The present invention will be further understood by those skilled in the art by reference to the following examples, which are included herein by way of illustration and not limitation, and various changes and modifications may be made by those skilled in the art without departing from the spirit of the invention.
Example 1
The formula comprises the following components: 20g of snake reversing, 20g of rheum officinale, 20g of alum, 20g of turmeric, 20g of snake slough, 20g of centella asiatica, 10g of elephantopus scaber, 10g of liquorice, 3g of borneol, 90g of white vaseline, 10g of light liquid paraffin and 1g of azone.
Example 2
The formula comprises the following components: 25g of snake reversing, 25g of rheum officinale, 25g of alum, 25g of turmeric, 25g of snake slough, 25g of centella asiatica, 12g of elephantopus scaber, 12g of liquorice, 4g of borneol, 90g of white vaseline, 10g of light liquid paraffin and 1g of azone.
Example 3
The formula comprises the following components: 15g of snake reversing, 15g of Rumex madaio, 15g of alum, 15g of turmeric, 15g of snake slough, 15g of centella asiatica, 8g of elephantopus scaber, 8g of liquorice, 2g of borneol, 90g of white vaseline, 10g of light liquid paraffin and 1g of azone.
Example 4
The formula comprises the following components: 10g of snake reversing, 10g of rheum officinale, 10g of alum, 10g of turmeric, 10g of snake slough, 10g of centella asiatica, 6g of elephantopus scaber, 2g of liquorice, 1g of borneol, 80g of white vaseline, 10g of light liquid paraffin and 1g of azone.
Example 5
The formula comprises the following components: 30g of snake reversing, 30g of rheum officinale, 30g of alum, 30g of turmeric, 30g of snake slough, 30g of centella asiatica, 14g of elephantopus scaber, 18g of liquorice, 5g of borneol, 90g of white vaseline, 10g of light liquid paraffin and 1g of azone.
Example 6
The formula comprises the following components: 28g of snake reversing, 28g of rheum officinale, 28g of alum, 28g of turmeric, 28g of snake slough, 28g of centella asiatica, 12g of elephantopus scaber, 16g of liquorice, 4g of borneol, 90g of white vaseline, 10g of light liquid paraffin and 1g of azone.
Example 7
The formula comprises the following components: 26g of snake reversing, 26g of rheum officinale, 26g of alum, 26g of turmeric, 26g of snake slough, 26g of centella asiatica, 10g of elephantopus scaber, 14g of liquorice, 3g of borneol, 90g of white vaseline, 10g of light liquid paraffin and 1g of azone.
Example 8
The formula comprises the following components: 24g of snake reversing, 24g of rheum officinale, 24g of alum, 24g of turmeric, 24g of snake slough, 24g of centella asiatica, 8g of elephantopus scaber, 12g of liquorice, 2g of borneol, 90g of white vaseline, 10g of light liquid paraffin and 1g of azone.
Example 9
The formula comprises the following components: 22g of snake reversing, 22g of rheum officinale, 22g of alum, 22g of turmeric, 22g of snake slough, 22g of centella asiatica, 6g of elephantopus scaber, 10g of liquorice, 1g of borneol, 90g of white vaseline, 10g of light liquid paraffin and 1g of azone.
Example 10
The formula comprises the following components: 20g of snake reversing, 20g of rheum officinale, 20g of alum, 20g of turmeric, 20g of snake slough, 20g of centella asiatica, 8g of elephantopus scaber, 8g of liquorice, 1g of borneol, 90g of white vaseline, 10g of light liquid paraffin and 1g of azone.
Example 11
The formula comprises the following components: 18g of snake reversing, 18g of rheum officinale, 18g of alum, 18g of turmeric, 18g of snake slough, 18g of centella asiatica, 10g of elephantopus scaber, 10g of liquorice, 2g of borneol, 90g of white vaseline, 10g of light liquid paraffin and 1g of azone.
Example 12
The formula comprises the following components: 16g of snake reversing, 16g of rheum officinale, 16g of alum, 16g of turmeric, 16g of snake slough, 16g of centella asiatica, 10g of elephantopus scaber, 10g of liquorice, 3g of borneol, 90g of white vaseline, 10g of light liquid paraffin and 1g of azone.
Example 13
The formula comprises the following components: 14g of snake reversing, 14g of rheum officinale, 14g of alum, 14g of turmeric, 14g of snake slough, 14g of centella asiatica, 10g of elephantopus scaber, 10g of liquorice, 3g of borneol, 90g of white vaseline, 10g of light liquid paraffin and 1g of azone.
Example 14
The formula comprises the following components: 12g of snake reversing, 12g of rheum emodi, 12g of alum, 12g of turmeric, 12g of snake slough, 12g of centella asiatica, 10g of elephantopus scaber, 10g of liquorice, 3g of borneol, 90g of white vaseline, 10g of light liquid paraffin and 1g of azone.
Example 15
The formula comprises the following components: 10g of snake reversing, 10g of rheum officinale, 10g of alum, 10g of turmeric, 10g of snake slough, 10g of centella asiatica, 8g of elephantopus scaber, 8g of liquorice, 2g of borneol, 90g of white vaseline, 10g of light liquid paraffin and 1g of azone.
Example 16
The formula comprises the following components: 20g of snake reversing, 20g of rheum emodi, 30g of alum, 20g of turmeric, 20g of snake slough, 20g of centella asiatica, 10g of elephantopus scaber, 6g of liquorice, 4g of borneol, 90g of white vaseline, 10g of light liquid paraffin and 1g of azone.
Example 17
The formula comprises the following components: 20g of snake reversing, 20g of rheum officinale, 10g of alum, 20g of turmeric, 20g of snake slough, 20g of centella asiatica, 10g of elephantopus scaber, 4g of liquorice, 2g of borneol, 90g of white vaseline, 10g of light liquid paraffin and 1g of azone.
Example 18
The formula comprises the following components: snake retrograde, rumex madaio, alum, turmeric, snake slough, centella asiatica, elephantopus scaber, licorice, borneol, white vaseline, light liquid paraffin and azone.
The formulations of examples 1-17 were each prepared according to any one of the following preparation methods.
Example 19
(1) Mixing and pulverizing herba Serpentis, radix Rumicis, alumen, curcuma rhizome, periostracum Serpentis, herba Centellae, fel Ursi and Glycyrrhrizae radix, sieving (100 mesh), and mixing to obtain mixed fine powder;
(2) Heating white vaseline, light liquid paraffin and azone to 70deg.C for melting;
(3) Adding the mixed fine powder obtained in the step (1) after melting, stirring uniformly, cooling to 50 ℃, adding borneol, grinding, stirring uniformly, preparing 1000g, and cooling to 30 ℃ to obtain the product.
Example 20
(1) Mixing and pulverizing herba Serpentis, radix Rumicis, alumen, curcuma rhizome, periostracum Serpentis, herba Centellae, fel Ursi and Glycyrrhrizae radix, sieving (120 mesh), and mixing to obtain mixed fine powder;
(2) Heating white vaseline, light liquid paraffin and azone to 75deg.C for melting;
(3) Adding the mixed fine powder obtained in the step (1) after melting, stirring uniformly, cooling to 55 ℃, adding borneol, grinding, stirring uniformly, preparing 1000g, and cooling to 35 ℃ to obtain the product.
Example 21
(1) Mixing and pulverizing herba Serpentis, radix Rumicis, alumen, curcuma rhizome, periostracum Serpentis, herba Centellae, fel Ursi and Glycyrrhrizae radix, sieving (120 mesh), and mixing to obtain mixed fine powder;
(2) Heating white vaseline, light liquid paraffin and azone to 65deg.C for melting;
(3) Adding the mixed fine powder obtained in the step (1) after melting, stirring uniformly, cooling to 45 ℃, adding the borneol fine powder obtained in the step (1), grinding, stirring uniformly, preparing 1000g, cooling to 25 ℃ and packaging.
Example 22
(1) Mixing and pulverizing herba Serpentis, radix Rumicis, alumen, curcuma rhizome, periostracum Serpentis, herba Centellae, fel Ursi and Glycyrrhrizae radix, sieving (120 mesh), and mixing to obtain mixed fine powder;
(2) Heating white vaseline, light liquid paraffin and azone to 70deg.C for melting;
(3) Adding the mixed fine powder obtained in the step (1) after melting, stirring uniformly, cooling to 50 ℃, adding borneol, grinding, stirring uniformly, preparing 1000g, and cooling to 30 ℃ to obtain the product.
In order to further verify the effectiveness of the present invention, the invention performed a series of verification tests, specifically as follows:
1. prescription composition and compatibility relationship
1. Prescription composition
The traditional Chinese medicine composition comprises the following components: snake retrograde, rumex madaio, alum, turmeric, snake slough, centella asiatica, elephantopus scaber, licorice root, borneol.
2. Compatibility of medicines
Snake reversing and Rumex madaio are monarch drugs, alum is used for clearing heat and detoxicating, cooling blood and removing stasis, and detumescence and pain relieving, and turmeric is pungent, bitter and warm in nature, enters liver and spleen channels, breaks blood and promotes qi circulation, relieves pain, clears menstruation and relieves swelling, and the medicines are ministerial medicines. The snake slough, the centella and the elephantopus are used for dispelling wind and removing dampness, clearing heat and detoxicating and relieving swelling, and especially for treating the refractory skin itch caused by herpes zoster, liquorice and borneol are used as guiding drugs for purging pathogenic fire and removing toxin, clearing heat and drying dampness, and the drugs are used together to play roles of clearing heat and removing toxin, and relieving swelling and pain.
2. Research and test of preparation process
1. Research on pulverizing process of medicinal materials
The invention is to crush the medicine composition to prepare ointment, and the ointment is classified according to Chinese pharmacopoeia ointment, and the ointment prepared by the invention contains medicine powder, belongs to suspension type ointment, and can not detect particles larger than 180 mu m according to the requirement of ointment 'inspection'. Therefore, the particle size of the crushed traditional Chinese medicinal materials is required to be smaller than 180 μm, according to the specification of Chinese pharmacopoeia, the fine powder is powder which passes through a No. five sieve (80 meshes and 180 μm) and contains not less than 95% of powder which can pass through a No. six sieve (100 meshes and 150 μm), and the powder is selected as crushing parameters by taking the fact that the powder possibly absorbs water in the matrix to expand after being mixed with the ointment matrix.
(1) Each medicinal material is singly crushed and inspected
Drying the above materials at 60deg.C until the water content is below 5%, pulverizing respectively, and examining the yield of medicinal powder to obtain the results shown in Table 1.
Table 1 investigation table of individual pulverizing yields of various medicinal materials
| Medicinal material name | Six-size screen | No. seven screen |
| Snake reversing device | 94.2 | 89.3 |
| Radix Rumicis | 98.6 | 95.2 |
| Alum | 100 | 100 |
| (Curcuma longa) | 99.4 | 96.5 |
| Snake slough | 88.5 | 85.2 |
| Centella asiatica | 90.2 | 85.3 |
| Herba Elephantopi scaberis | 98.1 | 92.2 |
| Licorice root | 97.7 | 90.5 |
From the test results in table 1, the yield of the snake is lower after the snake is reversed, the snake slough and the centella are crushed independently, because the 3 medicinal materials have more fibers, the medicinal materials are wasted easily after being crushed independently, and the full utilization of medicinal material resources is not facilitated.
(2) Mixing, crushing and examining plant medicinal materials
Drying the above materials at 60deg.C until water content is below 5%, mixing and pulverizing 7 materials including snake back, radix Rumicis, curcuma rhizome, periostracum Serpentis, herba Centellae, herba Elephantopi scaberis, and Glycyrrhrizae radix, and examining the yield of the medicinal powder, and the result is shown in Table 2.
Table 2 investigation table of yield of mixed crushing of plant materials
| Medicinal material name | Six-size screen | No. seven screen |
| 7 plant medicines in the formula | 96.7 | 93.6 |
From the test results in table 2, the yield of the fine powder passing through the seventh sieve after the 7 medicinal materials are mixed and crushed is obviously improved, because the fine powder generated in the crushing process of the medicinal materials with stronger powder properties such as turmeric, rheum officinale and the like fully wraps fibers generated in the crushing process of snake reversing, snake slough and centella asiatica, and promotes the crushing of the fibers, thereby greatly improving the yield of the fine powder.
(3) Mixing, crushing and examining plant medicine and mineral medicine
Drying the above materials at 60deg.C until water content is below 5%, mixing and pulverizing all materials except Borneolum Syntheticum, mixing and pulverizing Alumen and plant materials, and examining the yield of medicinal powder to obtain the results shown in Table 3.
TABLE 3 investigation of yield of Mixed crushing of vegetable drugs and mineral drugs
| Medicinal material name | Six-size screen | No. seven screen |
| Plant medicine and mineral medicine | 98.2 | 94.6 |
As can be seen from the test results in Table 3, the yield of fine powder obtained by pulverizing the mixture of a plant drug and a mineral drug was slightly improved as compared with the pulverization of the mixture of a plant drug. In consideration of the fact that the production process is simplified by mixing and crushing the plant medicine and the mineral medicine, the preparation is more convenient to operate and cost-saving, the preparation decides to adopt the mixing and crushing process of the plant medicine and the mineral medicine, and as the yield of fine powder passing through a No. six sieve after mixing and crushing the plant medicine and the mineral medicine is more than 98%, the No. six sieve can be selected as a medicinal material crushing process parameter.
2. Matrix selection study test
In order to avoid swelling of medicinal powder due to water absorption, the ointment is easy to delaminate after being prepared, and the stability of the preparation medicine is poor, so the ointment prepared by the product is preferably selected from oil-soluble matrixes with better stability. Common oily bases are vaseline, liquid paraffin, lanolin, silicone oil, etc. According to the pre-test result, white vaseline and light liquid paraffin are selected as matrix, and 1% azone is added in the matrix preparation process according to the conventional process of ointment preparation in order to strengthen the transdermal absorption effect of the ointment. The present test was conducted as follows with respect to the selection of the matrix formulation and the preparation method.
(1) Matrix quality evaluation index and evaluation method
(1) Spreadability of coating
And taking a proper amount of samples, carefully smearing the samples on the palm back, observing whether the samples are uniform and fine, and comparing the spreading difficulty of the samples.
(2) Stability against heat and cold
Placing a certain amount of ointment at 45 deg.C and-15 deg.C for 24 hr, and observing the change of ointment consistency, color and uniformity and layering.
(3) Centrifugal stability
And (3) putting a proper amount of ointment into a centrifuge tube, centrifuging for 20min (4000 r/min), and observing the color change and layering phenomenon of the centrifuged sample.
(4) Comprehensive scoring
The total weight is divided into 100 minutes, wherein the spreadability accounts for 30 minutes, the heat and cold resistance stability accounts for 30 minutes, and the centrifugal stability accounts for 40 minutes. The scoring items and criteria are shown in table 4.
TABLE 4 ointment scoring items and criteria
(2) Matrix proportioning screening
Taking white vaseline, light liquid paraffin and azone according to the matrix formula of Table 5, heating to 70deg.C for melting, adding the fine powder of the medicinal materials of snake back, rumex madaio, alumen, curcuma rhizome, periostracum Serpentis, herba Centellae, herba Ajugae, glycyrrhrizae radix in the different medicinal compositions of examples 1-3, stirring, cooling to 50deg.C, adding Borneolum Syntheticum, grinding, stirring, cooling, detecting each index of the ointment, and obtaining the results shown in Table 6-8.
Table 5 matrix formulation table
Table 6 1 results of the matrix formulation test
| Pharmaceutical combination | Spreadability of coating | Stability against heat and cold | Centrifugal stability | Total score |
| Example 1 | 17 | 29 | 35 | 81 |
| Example 2 | 15 | 28 | 38 | 81 |
| Example 3 | 12 | 27 | 36 | 75 |
Table 7 2 results of the matrix formulation test
| Pharmaceutical combination | Spreadability of coating | Stability against heat and cold | Centrifugal stability | Total score |
| Example 1 | 29 | 27 | 34 | 90 |
| Example 2 | 28 | 27 | 36 | 91 |
| Example 3 | 28 | 28 | 35 | 91 |
Table 8 3 results of the matrix formulation test
| Pharmaceutical combination | Spreadability of coating | Stability against heat and cold | Centrifugal stability | Total score |
| Example 1 | 30 | 22 | 25 | 77 |
| Example 2 | 29 | 20 | 27 | 76 |
| Example 3 | 28 | 18 | 13 | 59 |
From the test results in tables 6 to 8, when white vaseline and azone are used as matrixes, the coating property of the preparation is poor, the coating property is obviously improved after light liquid paraffin is added, but the heat-resistant and cold-resistant stability and the centrifugal stability of the preparation are obviously reduced after the addition of the preparation is excessive, the formula of the matrix No. 2 is best comprehensively considered, and the formula of the matrix is finally determined to be white vaseline, light liquid paraffin, azone=90:10:1, namely 90 parts of white vaseline, 10 parts of light liquid paraffin and 1 part of azone.
3. Borneol addition temperature optimization test
The borneol is easy to volatilize when being heated, and the higher the temperature is, the faster the volatilization is, so that investigation and research on the addition temperature of the borneol in the ointment preparation process are necessary, and the optimal addition temperature is preferred. The preparation method comprises mixing and pulverizing the eight materials of herba Serpentis, radix Rumicis, alumen, etc., sieving, and mixing. And respectively taking white vaseline, light liquid paraffin and azone according to a ratio of 90:10:1, heating to 70 ℃ to melt, adding the standby mixed fine powder, uniformly stirring, respectively adding borneol after the temperature is reduced to 60 ℃,50 ℃ and 40 ℃, grinding, uniformly stirring, preparing into ointment, and respectively measuring the loss rate of the added borneol at each temperature, wherein the result is shown in Table 9.
TABLE 9 Table of results of temperature investigation of borneol addition
| Temperature (temperature) | 60℃ | 50℃ | 40℃ |
| Loss rate | 8.31％ | 2.12％ | 0.89％ |
As can be seen from the test results in Table 9, the loss rate of added borneol at 60℃is high, and the loss rates of added borneol at 50℃and 40℃are low, but the ointment starts to solidify at 40℃and the added borneol is not easy to mix uniformly, so that 50℃is selected as the optimal addition temperature of the borneol in the preparation process.
4. Optimal preparation method of preparation
Through the experimental study, the optimal preparation process of the ointment of the invention is finally determined as follows:
mixing and pulverizing the rest eight medicinal materials except for deicer, sieving, and mixing to obtain mixed fine powder; and respectively taking white vaseline, light liquid paraffin and azone according to a ratio of 90:10:1, heating to 70 ℃ to melt, adding the standby mixed fine powder, uniformly stirring, cooling to 50 ℃, adding borneol, grinding, uniformly stirring, preparing 1000g, cooling to 30 ℃ and packaging.
2. Clinical efficacy evaluation test
1. Case sources
Referring to the diagnosis standard of herpes zoster in clinical diagnosis and treatment guide, dermatological disease and venereal disease division, the collection of 120 patients with herpes zoster (the ratio of men to women is 1:1) who visit hospitals in Guizhou, qian, and Guizhou from 8 months in 2018 to 2021.
2. Therapeutic method
The treatment groups were divided into 1 control group and 3 treatment groups according to the random number table method, 30 cases per group. The general data of each group of patients are compared, and the differences have no statistical significance (P is more than 0.05) and are comparable.
The first group is set as a control group, and is used for treating Western medicine with conventional treatment, wherein acyclovir tablets are orally taken for 0.2g each time and 5 times daily, mecobalamin capsules are orally taken for 0.5mg each time and 3 times daily for 10 days; the second group to the fourth group were used as test groups, the ointments prepared in examples 1 to 3 were applied once a day, each morning and evening, and the ointment was uniformly applied to the pain part, 5 days as a treatment course, and after 2 continuous treatment courses, the treatment effect was comprehensively compared, the experimental data were analyzed by using SPSS23.0 statistical software, and the data were measured to obtain the following resultsThe expression is t-test, the count data is expressed as example (%), and χ is used 2 And (5) checking. P < 0.05 is statistically significant for the differences.
The curative effect evaluation standard refers to the traditional Chinese medicine disease diagnosis curative effect standard. And (3) healing: the recovery area of the skin is more than 90%, and the pain is basically eliminated; the effect is shown: the recovery area of the skin is 70-90%, and the pain is obviously relieved in comparison with the prior art; improvement: the recovery area of the skin is 30-69%, and the pain is slightly relieved; invalidation: the recovery area of the skin is less than 30%, and pain relief is not significant or even exacerbated. The total effective rate is the sum of the cure rate, the obvious efficiency and the good turning rate.
3. Results
The specific results are shown in tables 10 to 11.
Table 10 results table of test results for evaluating efficacy of formulations
| Group of | Number of examples | Healing of the wound | Has obvious effect | Improvement of | Invalidation of | Total effective rate (%) |
| Control group | 30 | 10 | 9 | 3 | 8 | 73.3 |
| Example 1 | 30 | 14 | 9 | 4 | 3 | 90.0* |
| Example 2 | 30 | 16 | 9 | 3 | 2 | 93.3* |
| Example 3 | 30 | 13 | 10 | 3 | 4 | 86.7* |
Note that: p < 0.05 compared to the control group.
As can be seen from Table 10, the total effective rate of examples 1-3 is higher than that of the control group, and the difference is statistically significant (P < 0.05) compared with the control group, wherein the total effective rate of example 2 is as high as 93.3%. Thus, the ointments prepared in examples 1 to 3 of the present invention can enhance the therapeutic effect of herpes zoster.
Table 11 comparison of time to improvement of clinical symptoms
| Group of | Number of effective cases | Time to stop blisters | Pain relief time | Scab formation time |
| Control group | 22 | 3.17±1.01 | 6.26±1.32 | 9.94±2.77 |
| Example 1 | 27 | 1.83±0.52* | 3.34±1.04* | 6.72±1.18* |
| Example 2 | 28 | 1.49±0.72* | 3.02±0.98* | 5.89±1.87* |
| Example 3 | 26 | 2.33±0.46* | 4.20±0.96* | 6.98±2.65* |
Note that: p < 0.05 compared to the control group.
As can be seen from Table 11, the time to blister, pain relief, and crusting for the patients of examples 1-3 were shorter than the control group, and the differences were statistically significant (P < 0.05), with the shortest time for example 2. Therefore, the ointments prepared in the embodiments 1 to 3 of the invention can diminish inflammation and relieve pain quickly, shorten the course of disease, effectively improve the clinical symptoms of patients, relieve pain and improve the life quality of the patients.
In addition, the test is carried out on blood routine, urine routine, liver and kidney functions and electrocardiogram detection on all patients before and after treatment, and the result is free from abnormality.
In conclusion, the medicine composition has no obvious toxic or side effect on human bodies, does not have adverse reaction after being used by patients, has a treatment effect which is obviously superior to that of the traditional clinical conventional treatment method, is an external good medicine for treating herpes zoster, and has a wide application value.
While the invention has been described in detail in the foregoing general description, embodiments and experiments, it will be apparent to those skilled in the art that modifications and improvements can be made thereto. Accordingly, such modifications or improvements may be made without departing from the spirit of the invention and are intended to be within the scope of the invention as claimed.
Claims (10)
1. The external pharmaceutical composition for treating herpes zoster is characterized by comprising 10-30 parts of snake reversing, 10-30 parts of rheum officinale, 10-30 parts of alum, 10-30 parts of turmeric, 10-30 parts of snake slough, 10-30 parts of centella asiatica, 6-14 parts of elephantopus scaber, 2-18 parts of liquorice, 1-5 parts of borneol, 80-100 parts of white vaseline, 5-15 parts of light liquid paraffin and 1-3 parts of azone.
2. The pharmaceutical composition for external use for treating herpes zoster according to claim 1, being composed of 15-25 parts of snake retrograde, 15-25 parts of rheum emodi, 15-25 parts of alum, 15-25 parts of turmeric, 15-25 parts of snake slough, 15-25 parts of centella asiatica, 8-12 parts of elephantopus scaber, 6-14 parts of licorice, 2-4 parts of borneol, 85-95 parts of white vaseline, 8-12 parts of light liquid paraffin and 1-2 parts of azone.
3. The pharmaceutical composition for external use for treating herpes zoster according to claim 2, being composed of 20 parts of snake retrograde, 20 parts of rheum officinale, 20 parts of alum, 20 parts of turmeric, 20 parts of snake slough, 20 parts of centella asiatica, 10 parts of elephantopus scaber, 10 parts of liquorice, 3 parts of borneol, 90 parts of white vaseline, 10 parts of light liquid paraffin and 1 part of azone.
4. A method for preparing the pharmaceutical composition for external use according to any one of claims 1 to 3, characterized in that the preparation method is:
mixing and pulverizing snake back, rumex madaio, alumen, curcuma rhizome, periostracum Serpentis, herba Centellae, fel Ursi and Glycyrrhrizae radix, sieving, and mixing to obtain mixed fine powder;
heating white vaseline, light liquid paraffin and azone to melt;
adding the mixed fine powder obtained in the step (1) after melting, stirring uniformly, cooling to 45-55 ℃, adding borneol, grinding, stirring uniformly, preparing 1000g, cooling to 25-35 ℃ and packaging.
5. The method of preparing a pharmaceutical composition for external use according to claim 4, wherein the method of preparing comprises:
mixing and pulverizing snake back, rumex madaio, alumen, curcuma rhizome, periostracum Serpentis, herba Centellae, fel Ursi and Glycyrrhrizae radix, sieving, and mixing to obtain mixed fine powder;
heating white vaseline, light liquid paraffin and azone to melt;
adding the mixed fine powder obtained in the step (1) after melting, stirring uniformly, cooling to 50 ℃, adding borneol, grinding, stirring uniformly, preparing 1000g, cooling to 30 ℃ and packaging.
6. The method of preparing a pharmaceutical composition for external use according to claim 4, wherein the mesh number of the sieving is: 80-120 mesh.
7. The topical pharmaceutical composition of claim 5, wherein the screened mesh number is: 100 mesh.
8. The method of preparing a pharmaceutical composition for external use according to claim 4, wherein the melting temperature is: 65-75 ℃.
9. The method of preparing a pharmaceutical composition for external use according to claim 5, wherein the melting temperature is: 70 ℃.
10. Use of a pharmaceutical composition for external use according to any one of claims 1 to 3 for the preparation of a medicament for the treatment of shingles.
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