Intrauterine formulation containing henna extract

Abstract

The present disclosure relates in certain aspects to specific organic compounds useful, including henna extract, for the treatment, amelioration and / or prevention of fungal infections in animals. This disclosure further relates in certain aspects to certain useful compositions centered on henna extract for the treatment of infection in female livestock. This invention is superior to existing standard treatments in terms of effectiveness and non-recurrence of infection, and it does not have serious side effects, microbial resistance and subsequent problems, including the presence of residues in meat and milk. The statistical results in figure1 show the effect of the formulation containing henna extract on the rate of infection compared to cefapim.

Description

[0001] Description

[0002] Title of Invention :

[0003] INTRAUTERINE FORMULATION CONTAINING HENNA EXTRACT

[0004] Technical Field

[0005] The present disclosure relates to livestock treatments. More particularly, it relates to a practical natural-based product product for treating and preventing diseases in female animals.

[0006] Background Art

[0007] For farmers raising livestock, animal health is a key concern. Lameness, mastitis and reproductive problems are the most common cow health problems and often result in heavy financial costs that significantly affect farm profits. Mastitis and uterine infections are mostly due to bacterial attack on these parts.

[0008] Because of the significant costs of identifying and treating such issues, preventive and treatment solutions that can be implemented en masse may be cost-effective. Antibiotics are widely used for this purpose. To prevent or treat hoof problems such as digital dermatitis or foot rot, antibiotics are sometimes used along with harsh chemical baths for hoofs. Antibiotics are used along with a nipple seal, usually with a syringe, to prevent the spread of infection. These syringes are usually single-dose, which creates a large amount of plastic waste at scale.

[0009] One of the major problems of the widespread use of antibiotics as disease prevention in livestock is the acceleration of antibiotic resistance in the target bacterial strains. This gradually renders common antibiotics ineffective, which ultimately leaves farmers struggling with poor livestock health and a lack of affordable and effective preventative medicine. This problem has now significantly affected the industry, making it increasingly desirable to find alternative solutions to prevent and / or treat common health problems. Alternative solutions should still be effective against bacteria, while being cost-effective and simple to manufacture and administer.

[0010] CN105816856 has applied traditional Chinese medicine compounds for preventing and treating livestock Endometritis. WO201 7103885 relates to dietary compositions to control infections & metabolic disorders in stock and method for the treatment to an animal.

[0011] Summary of Invention

[0012] Endometritis is an internal infection of the uterine structure that usually appears without systematic symptoms.This infectious disease causes significant economic changes in the livestock industry by reducing reproduction, reducing milk production, increasing maintenance costs and increasing the forced removal of dairy cows. For this reason, private production management programs are implemented in industrial cattle farms, and the most important goal of these programs is to create the biological ideal at the same time to control the economic time interval between the previous pregnancy and the new pregnancy. With the passage of time to the normal state after childbirth, the uterus will be removed from the germs and the result will be at the right time and will reduce the factors during my pregnancy.

[0013] The present invention exclusively describes a product containing mainly henna extract and other additives, having proper pharmaceutical properties and stability, after intrauterine injection, is able to eliminate the existing infection within a short period of time and lead to the removal of infectious secretions from the site. In terms of effectiveness and non-recurrence of infection, the product is superior to the existing standard treatment, which is cefaprim administration, while it does not have side effects and microbial resistance and subsequent problems such as the presence of residues in meat and milk.

[0014] Technical Problem

[0015] Endometritis is an internal infection of the uterine structure, which causes significant economic losses in the livestock industry by reducing reproductive efficiency, reducing milk production, increasing maintenance costs and increasing the forced removal of dairy cows.

[0016] Due to the side effects caused by the use of conventional therapeutic drugs in veterinary diseases, there is a real need to design new drugs with less side effects.

[0017] Solution to Problem

[0018] This invention describes a topical product for intrauterine treatment in livestock including dairy cattle and other animals including pets. In the present invention, henna plant extract is used as an antimicrobial agent, astringent, healing agent and expelling for infectious discharge in a topical form for vaginal intrauterine treatments.

[0019] Advantageous Effects of Invention

[0020] Medicinal plants are applied for treatment of many diseases due to their easy access and having compounds with various pharmacological effects;therefore, their use is considered as one of the alternative treatment methods. One of the most important advantages of applying natural products is not needing to use antibitics and chemical

[0021] Antimicrobial compounds and avoiding consequences such as residual compounds in meat and milk, creation and spread of microbial resistance.

[0022] - On the other side, the mentioned invention is based on herbal and natural ingredients which does not contain any chemical active ingredients and common antibiotics. Local and available items have been used in the formulation development without relying on foreign source materials. The product has proven its superiority over standard treatments in clinical studies specially its higher efficacy and long acting effect which doesn’t need to re-apply the treatment. Another important point is that after applying the product, there is no need to keep time in milking or slaughtering activities.

[0023] Brief Description of Drawings

[0024] Fig.1 - It demonstrates statistical results of the effect of Henna extract containing formulation on score of infection in comparison to cefaprim.

[0025] Fig.1

[0026] Description of Embodiments The present invention describes a topical formulation capable of intrauterine administration based on henna plant extract. In the preferred embodiment, the formulation is in the form of a gel based on biopolymers such as sodium alginate with the ability to be easily injected into the uterus. The mentioned gel contains ingredients, including co-solvents to disperse the gel-forming polymer and the extract, and the antimicrobial preservative agent to prevent the growth of resistant microorganisms during storage. The final product has a relatively acidic pH and is compatible with the uterine environment. The optimal formulation has sufficient consistency during the storage time and can be thinned when administered under pressure by syringe and can recover the original consistency after removing the force. Due to its muco-adhessiveness and gel structure, it is able to sustain release and have a long-term effect with a single use.

[0027] Examples

[0028] The invention is generally used for intrauterine treatments in livestock farms and pet clinics.

[0029] But herein, clinical results on dairy cows is presented as follow:

[0030] At the time of childbirth and after, due to the widening of the birth canal, many birth canals enter the reproductive system, especially the uterus. A wide range of the uterine area is separated after childbirth. Blood, cell corpses and carcinoid tissues provide a suitable environment for bacterial growth. The main mechanism in the removal is the phagocytic excess and precursor cytokines, persistent contractions during the postpartum days and physiological excretion. The investigation in these cases is the spread of metritis and endometritis. All of these factors prevent timely return and cause many problems in breeding programs in industrial cattle farms. There are features to retract the uterus and prepare the cow for pregnancy again. Preparing important uterine samples and checking the amount of consumption and the presence of pathogens, and then grading the amount of consumption, measuring the diameter of the uterus and cervix through ultrasound and its changes are among the indicators of uterine return.

[0031] In this research, 74 cows from industrial cattle farms around Shiraz entered the farm phase of the study. First, the involvement of the endometrium of each endometrial tissue is measured and graded based on the mucous fluids taken from the uterus. Then, the size of the diameter of the cervix and uterus of each vertex was determined with an ultrasound machine. According to the diagnosis of endometritis, fifty heads were treated with the common antibiotic Cefaprim and twenty-four heads were treated with drugs. After two weeks, all measurements were repeated.

[0032] Statistical data analysis was obtained using Prism V8.01 statistical software. The type of test was selected based on the input data and their generation type. In this study, the dependent variables are degree of uterine tissue involvement, size of cervix and uterus, and the independent variables are type of treatments and time after treatments. The data does not have a normal distribution and are paired meaning measured twice before and after (Pre / Post) treatments. Therefore, the appropriate test for statistical analyses was chosen as the signed rank test (Wilcoxon), which is more powerful to detect the difference between data by specifying the direction and amount of change. In this test, the input information is compared with the median of the data. In addition, the results of descriptive statistics were used to analyze the data and Pearson Correlation Test was used to determine the intensity and magnitude of the effects so that the results can be more accurate to generalize to population.

[0033] The uterus infection level was divided into four degrees based on the type of mucous membranes and clearity of secretions, zero (no observation / clear secretions) to three (complete infectious involvement). Analysis of the data obtained from examining the degree of involvement before and after treatment with cafaprim as standaed antibiotic treatment compared to the test treatment (the formulation based on the combination of sodium alginate and henna, performed by the Wilcoxon signed rank test, showed a highly significant difference. As it was shown, the statistically significant difference in the group treated with the test treatment of henna / alginate is far more than the group treated with cefaprim, which indicates its higher efficacy.

[0034] Industrial Applicability

[0035] Industrial production of antimicrobial formulations for the treatment of animal endometritis.

Claims

Claims

1. The present invention describes a product containing henna extract, which, while having proper pharmaceutical properties and stability, after intrauterine injection, is able to eliminate the existing infection within a short period of time and lead to the removal of infectious secretions from the site. In terms of effectiveness and non-recurrence of infection, the product is superior to the existing standard treatment, which is cefaprim administration, while it does not have side effects and microbial resistance and subsequent problems such as the presence of residues in meat and milk. The subject of the invention is a herbal formula containing henna leaf extract, which is used in the form of intrauterine gel, causes to the removal of uterine infections in cows and other livestock and animals.

2. According to claim No. 1 , henna leaf extract is used as an anti-microbial compound and inducer for expelling intrauterine discharges.

3. According to claim No. 2, aqueous-alcoholic extract of henna leaves is prepared by routine extraction techniques more preferably via percolation method.

4. The optimal formulation among others is a gel with suitable consistency and shear-thinning nature capable of intrauterine injection.

5. According to Claim 4, the aqueous alcoholic extract of henna leaves with different percentages with co-solvents including propylene glycol, glycerin, polyethylene glycol, etc. is dispersed in the gel system consisting of natural polymers such as sodium alginate, chitosan, xanthan gum, and or semi-synthetic and synthetic polymers such as sodium carboxymethyl cellulose, carbomer, etc.

6. According to claim 4, the optimal gel based on biopolymers such as sodium alginate alone is also capable of treating uterine infections efficiently.

7. ] According to the claim 1 , characterization experiments including the measurement of total phenolic content, pharmaceutical tests including the determination of density, pH, viscosity, microbiology tests,physicochemical stability, showed the atandard quality and stability of optimal formulation.

8. Clinical tests, including histopathology experiments and clinical efficacy tests in small laboratory animal and livestock, proved the significant safety and effectiveness of the product compared to standard treatment with Cefaprim antibiotic.

9. According to the claim 1 , the optimized formulation has a long-acting effect and doesn’t need to re-application.

10. After applying the product, there is no need to keep time in milking or slaughtering activities, in other words, It has no withdrawal period.

11. According to the claim 4, the active ingredients in the formulation are of natural origin which in addition to having more economical price, dosen't produce the microbial resistance related to routinely used antibiotic treatments.

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